Insights Magazine Spring 2022 by BIOTECanada

Canada’s voice for biotechnology / Canada’s voice for biotechnology / Leporte-parole porte-parole canadien la biotechnologie Le canadien dede la biotechnologie

LA BIOTECH AU COEUR DE LA RECONSTRUCTION ÉCONOMIQUE ET DE LA PRÉPARATION FUTURE DU CANADA

BioVectra Inc. announces a $144.6 million A Progressive View on Developing Canada’s Federal perspective: Honourable Minister of Innovation, Talent: Women on Life Science Corporate Boards expansion project / BioVectra Inc. Leadership Expertise / Une vision moderne Science and Industry, François-Philippe Champagne Talent: Des femmes aux conseils d’administration annonce un projet d’expansion de de la mise en place d’une expertise en gestion le point de vue fédéral par l’honorable François-Philippe des entreprises des sciences de la vie 144,6 M$ » page 24 au Canada » page 72 Champagne, C.P., député Ministre de l’innovation, des Sciences et de l’Industrie

2019

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BIOTECH CENTRAL TO CANADA'S ECONOMIC REBUILD AND FUTURE PREPAREDNESS

Spring / Spring / Printemps Printemps biotech.ca biotech.ca

At Biogen, our mission is clear: we are pioneers in neuroscience. At Biogen, we care deeply and work fearlessly to make a meaningful difference and truly change the lives of people suffering from devastating neurological and neurodegenerative conditions. Not because we can, but because we must. biogen.ca

CASTL Online Academy Biopharma Manufacturing Training Your business is growing and demands for quality talent have never been greater. CASTL (Canadian Alliance for Skills and Training in Life Sciences), in partnership with NIBRT, has launched a catalogue of online biopharmaceutical manufacturing training, to help you and your employees develop the right skills for success.

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Start your training journey now! castlcanada.ca/coa • coa@castlcanada.ca biotech.ca

Success starts with making the right connections By making intelligent connections bet ween your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.

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CONTENTS / TABLE DES MATIÈRES

MESSAGE FROM THE PRESIDENT AND CEO by Andrew Casey, BIOTECanada

MESSAGE DU PRÉSIDENT ET CHEF DE LA DIRECTION par Andrew Casey, BIOTECanada

,800+

DEPARTMENTS / SECTIONS 12

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FEDERAL PERSPECTIVE/ LE POINT DE VUE FÉDÉRAL An ambitious plan for Canada’s Biotech Industry Un plan ambitieux pour l’industrie canadianne de la biotechnologie

dical doctors

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vice experts28

6,800+

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by the Honourable François-Philippe Champagne, P.C., M.P. Minister of Innovation, Science and Industry par l’honorable François-Philippe Champagne, C.P., député Ministre de l’innovation, des Sciences et de l’Industrie

42 VACCINE NEWS/ DU NOUVEAU CÔTÉ VACCINS Moderna: Bringing the Promise of mRNA to Canada Moderna : Les promesses pe L’ARNm en sol Canadien by/par Patricia Gauthier, President & General Manager/ Présidente et directrice générale Moderna Canada

46 ECOSYSTEM Glycomics is Writing the Next Chapter in Bioinnovation La glycomique ouvre le prochain chapitre de la bioinnovation by/par Warren Wakarchuk, Scientific Director/ directeur scientifique, GlycoNet

58 PARTNERSHIP/PARTENARIAT Discovery behind blockbuster Pfizer-Trillium deal started at UHN and SickKids

NEWS/ NOUVELLES

L’UHN et SickKids à l’origine du mariage de géants entre Pfizer et Trillium

Virica Biotech is Changing the Landscape of Viral Medicine Manufacturing

by/par Shawn Jeffords & Ania Jones, University Health Network Communications

Virica Biotech fait évoluer la delivery fabrication de médicaments viraux Q&A with Jean-Simon Diallo Jean-Simon Diallo a répondu aux questions de BIOTECanada

32 NEWS/ NOUVELLES Building a Ready-to-use Data System from the Ground Up Before Data Exists! Construire un système de données prêt à l’emploi, avant même que les données n’existent !

64 PARTNERSHIP/PARTENARIAT Proposing a solution for Canada’s drug supply shortage - The Canadian Critical Drug Initiative Une solution possible aux pénuries de médicaments au Canada : l’initiative canadienne de fabrication de médicaments essentiels by/par Andrew MacIsaac, CEO of Applied Pharmaceutical Innovation/ chef de la direction d’Applied Pharmaceutical Innovation et associé directeur principal de Lumira Ventures

by/par Michael Celarek1, Ramila Peiris1 and Olivier Moureau2

biotech.ca

DEPARTMENTS / SECTIONS

68 spring / printemps 2022

68 TALENT

Published for/Publié pour :

Building Canada’s Life Science Industry Requires a Strong Foundation of Canadian Talent

1, rue Nicholas St., Suite/bureau 600 Ottawa, ON K1N 7B7 Tel: 613-230-5585 Fax: 613-563-8850 www.biotech.ca

Le développement de l’industrie des sciences de la vie au canada nécessite une base solide de talents

EDITOR IN CHIEF/RÉDACTRICE EN CHEF : Nadine Lunt

by/par Gino Calabretta, adMare BioInnovations

TRANSLATION/TRADUCTION : Sophie Campbell

72 TALENT

Published by/Publié par :

CATTI: Closing Canada’s biomanufacturing skills gap

55 Murray Street / Suite 108 Ottawa, Ontario K1N 5M3 613-234-8468 www.gordongroup.com

CATTI : Combler le déficit de compétences en biofabrication au Canada

CREATIVE DIRECTOR/ DIRECTEUR DE CRÉATION : Louise Casavant

by Nadine Lunt, Editor in Chief, Insights par Nadine Lunt, Rédactrice en chef, Insights

PROJECT MANAGERS/ DIRECTRICES DE PROJET : Terry McMillan | Kim Latreille

106 LEGAL

DIRECTOR OF ADVERTISING SALES/ DIRECTEUR, VENTES PUBLICITAIRES : Stephan Pigeon

BIOTECanada Trends BIOTECanada : les tendances by/par Melanie Baird, Emma Costante, Joseph Garcia, Christopher Jones, Kyle Misewich, Mark Mohamed, Joanna Myszka, Andrew Skodyn, Blake, Cassels & Graydon LLP

© 2022 BIOTECanada insights. Any errors, omissions or opinions found in this magazine should not be attributed to the publisher. The authors, the publisher and the collaborating organizations will not assume any responsibility for commercial loss due to business decisions made based on the information contained in this magazine. No part of this publication may be reproduced, reprinted, stored in a retrieval system or transmitted in part or whole, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written consent of the publisher.

ON THE COVER / EN COUVERTURE

Canada’s voice for biotechnology / Le porte-parole canadien de la biotechnologie

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BIOTECH CENTRAL TO CANADA'S ECONOMIC REBUILD AND FUTURE PREPAREDNESS

Federal perspective: Honourable Minister of Innovation, Science and Industry, François-Philippe Champagne le point de vue fédéral par l’honorable François-Philippe Champagne, C.P., député Ministre de l’innovation, des Sciences et de l’Industrie

LA BIOTECH AU COEUR DE LA RECONSTRUCTION ÉCONOMIQUE ET DE LA PRÉPARATION FUTURE DU CANADA Talent: Women on Life Science Corporate Boards Talent: Des femmes aux conseils d’administration des entreprises des sciences de la vie

Spring / Printemps biotech.ca

BIOTECanada’s BIONATION initiative was launched in the Spring of 2020 and has continued through the pandemic with virtual programming designed to showcase the various components of the ecosystem and their connectivity. Over that period, the COVID-19 pandemic offered an up-close learning opportunity of the Canadian biotech industry which has led to an increased awareness publicly and amongst policymakers regarding the value of the biotechnology industry and the important social and economic benefit of a robust domestic biotech ecosystem. In this context, BIONATION presents an important and timely opportunity to recognize the sectors’ importance as Canada rebuilds economically following the pandemic and looks to prepare for future health-related challenges.

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L’initiative BIONATION de BIOTECanada a été lancée au printemps 2020 et s’est poursuivie tout au long de la pandémie avec une programmation virtuelle conçue pour présenter les diverses composantes de l’écosystème et leur connectivité. Au cours de cette période, la pandémie de COVID-19 a offert une occasion d’apprendre de près l’industrie canadienne de la biotechnologie, ce qui a conduit à une prise de conscience accrue du public et des décideurs concernant la valeur de l’industrie de la biotechnologie et l’important avantage social et économique d’une économie nationale robuste. écosystème biotechnologique. Dans ce contexte, BIONATION présente une occasion importante et opportune de reconnaître l’importance des secteurs alors que le Canada se reconstruit économiquement après la pandémie et cherche à se préparer aux futurs défis liés à la santé.

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© 2022 BIOTECanada insights. Aucune erreur ou omission décelée dans ce magazine ou aucune opinion qui y est exprimée ne doit être imputée à l’éditeur. Les auteurs, l’éditeur et les organismes qui ont collaboré à la publication rejettent toute responsabilité à l’égard des éventuelles pertes commerciales pouvant découler de décisions d’affaires prises à la lumière des renseignements contenus dans ce magazine. Il est interdit de reproduire, de réimprimer, d’emmagasiner dans un système de recherche documentaire ou de transmettre cette publication en tout ou en partie, sous quelque forme ou par quelque moyen que ce soit (électronique, mécanique, photocopie, enregistrement ou autre), sans avoir obtenu au préalable le consentement écrit de l’éditeur. Insights is grateful to the COVID-19 Emergency Support Fund for Cultural, Heritage and Sports administered through the Canada Periodical Fund, Special Measures for Journalism, Department of Canadian Heritage/Insights remercie le Fonds de soutien d’urgence COVID-19 pour la culture, le patrimoine et le sport, administré par le Fonds des périodiques canadiens, Mesures spéciales pour le journalisme, ministère du Patrimoine canadien. Publication Mail Agreement #/ Numéro de convention de Poste-publication : #43136012 Return undeliverable Canadian addresses to: Retourner les numéros non distribuables à une adresse canadienne à : 55 Murray Street / Suite 108 Ottawa, Ontario K1N 5M3 Printed in Canada/Imprimé au Canada. Please recycle where facilities exist/ Veuillez recycler là où ce service existe.

At Eisai, meeting patients means meeting their needs

TO MEET EXPECTATIONS, SUCCESSFUL COMPANIES MUST KNOW THEIR PRODUCTS AND SERVICES. To exceed expectations, they must also understand the families and individuals who rely on those products and services. Count Eisai Canada Limited, a growing research-based biopharmaceutical company headquartered in Mississauga, among those companies that exceed expectations. Eisai (pronounced A-zai) and its employees are firm in the belief that health care is about people first, a belief that is the driving force behind their mission to improve human health care, particularly in the areas of oncology and neurology, where tough challenges and treatment gaps persist. This people-first philosophy is part of the DNA at Eisai, says General Manager Pat Forsythe. “Our first thought is always with patients and their families,” he says. “Understanding their needs and concerns drives us to create the breakthrough solutions and medicines they require.” Those breakthroughs don’t happen just in the lab. Every Eisai employee is empowered – and encouraged – to challenge traditional thinking, to collaborate on innovation and to act with urgency to do what is required to make positive change happen. If Eisai’s talented team of innovators is constantly inspired to improve the lives of patients and families it is, in large part, because they get to know those patients and their families personally. Every year, each Eisai employee spends at least 1 per cent of their working time – two or three days a year – interacting with and getting to know patients, families and caregivers. Eisai team members use that time to learn more about patients and their concerns. The knowledge they acquire and the insight they gain guides the team’s – and Eisai’s – future activities. “After those meetings,” says Pat, “Our team gets together to share what they’ve learned and to 8

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discuss how we can use that knowledge to ensure we’re fully meeting our patient’s needs.” And it’s not always about the medicine. Two years ago, working with advocacy groups, Eisai created Ella the Jellyfish, a free, voice-enabled play and meditation Amazon Alexa skill designed for children with Lennox-Gastaut Syndrome (LGS) and their families. LGS is a rare and severe form of childhood epilepsy. The idea for Ella the Jellyfish – who can sing, play games, tell stories and offer guided meditations – began with Eisai employees who regularly spent time with LGS patients and their families. Those employees recognized the need to ease the burden on caregivers and for a different kind of entertainment and fun for the child. Eisai’s commitment to engage and learn from the people it serves reflects its belief that the company is part of a human health care ecosystem, a network comprised of those who develop and manufacture medicines, those who prescribe them and those who benefit from them, as well as other areas that can benefit patients, like technology. “It’s not just about selling medicines,” says Pat. “It’s about doing all we can to improve outcomes.” With a focus on oncology and neurology, Eisai is using the power of its research and development capabilities, and the support of partnerships, to discover and deliver life-changing medicines to people living with cancer, epilepsy, insomnia and Alzheimer’s Disease. “We believe in science, and we’re pushing its boundaries to discover, develop and deliver innovative medicines that will help patients live their lives as fully as possible,” says Pat. “We’re small but we’re nimble and we’re committed,” he continues. “And we’re delivering results.” In fact, Eisai currently has 18 compounds in clinical development (phase 2 or later). For many companies, that would be a remarkable achievement; for Eisai, it’s simply another example of how it exceeds expectations.

MESSAGE FROM THE PRESIDENT AND CEO by Andrew Casey, BIOTECanada

AT THE TIME OF WRITING THE WORLD HAS REACHED THE TWOYEAR MARK OF THE COVID19 PANDEMIC. While there are clearly differing opinions of how and when our societies and economies should transition out of life with restrictions, that the debate can even be had is in large part due to this industry’s timely delivery of highly effective vaccines. At a minimum, hundreds of thousands of lives have been saved and the overall impact of the pandemic on economies has been greatly reduced as a result of the solutions this industry discovered, developed, and delivered. While there is still some COVID-19 road ahead, many governments are wisely preparing for the possibility of another pandemic at some point. Having spent over two years solving for COVID-19 on the fly, it is clear there is now a strong desire to avoid repeating the experience and prepare now for COVID-30 or whatever other global health threat may emerge down the road. Global investors are also seeing the opportunity the sector represents. For the most part, the increased recognition of the sector’s value and importance is good news for Canada. Canada’s biotech ecosystem is built on a reputation of strong scientific research including a diverse mix of early-stage companies, universities, incubators/accelerators, research centres, investors, and multinational pharmaceutical/biotech companies.

From a biomanufacturing/vaccine perspective, Canada is also home to two established commercial vaccine facilities, BioVectra’s Atlantic Canada premises and the soon to be operational Medicago site in Quebec City. Combined, there is in place a valuable life sciences sector and biomanufacturing base in Canada which can form the foundation upon which to build. Investing more in enhancing this foundation will not only help meet the preparedness objective, but if done strategically, can be leveraged as the federal government moves forward with its life sciences strategy and corresponding biomanufacturing initiative. It is important to recognize that Canada is not alone in its quest to grow its life sciences sector and biomanufacturing capacity. Not surprisingly, the pandemic has focussed the attention of many governments globally on the importance of building strong domestic biotech sectors. As federal and provincial governments implement strategies to grow the sector, attract investment and talent, Canada will need to keep pace with other nations seeking to do likewise. It is a competitive space where the elbows will be sharp and high. As the COVID-19 fog begins to lift and we focus on moving forward, rebuilding and preparing for future challenges (including that of global climate change which has continued

unabated throughout the pandemic, as evidenced by the UN International Panel on Climate Change report), the importance of this sector and the solutions it provides will only increase. Accordingly, the federal government is making significant investments to enhance Canada’s life sciences and biomanufacturing sector. There remains much work to be done to attract investment, grow and diversify the pool of talent and ultimately create Canadian based anchor companies. It will not be easy, but the past year represents a solid start with enormous promise for the future. The months ahead represent an important opportunity for the entire BIOTECanada membership which is representative of the Canadian biotech ecosystem.

biotech.ca

Therapeutic Applications for Messenger RNA Lipid Nanoparticles by Dr. Ying Tam, MSc, PhD, Chief Scientific Officer, Acuitas Therapeutics

ALTHOUGH THE THERAPEUTIC POTENTIAL OF MESSENGER RNA (MRNA) WAS FIRST PROPOSED MANY YEARS AGO, technical advances to mRNA itself (improved translatability, stability and manufacturability and reduced immunogenicity) and the enabling lipid nanoparticle (LNP) delivery systems (improved potency and safety) has only recently allowed this potential to be realized. As a result of COVID-19, mRNA has been proven, and now has widespread acceptance as an infectious disease vaccine. This opens the opportunity for mRNA LNP-based drugs that are in development to treat a broad range of diseases and represents a technology that could revolutionize the drug development process. VACCINES: The successful development of mRNA LNP vaccines was vital in the battle against COVID-19. Large clinical trials and real-world vaccination experience have shown that COMIRNATY® (Pfizer/BioNTech) and SPIKEVAX™ (Moderna) are safe and they provide robust protection against infection and illness from the SARSCoV-2 virus. With this, it is expected that infectious disease vaccines will remain a major focus of mRNA therapies. In fact, significant efforts are underway in pursuing vaccines for many infectious diseases such as influenza, tuberculosis and hepatitis C, among others. Furthermore, mRNA’s success in battling COVID-19 has reinvigorated efforts in vaccine development against particularly challenging infectious diseases with a high global health impact, such as malaria and HIV. Further, the speed at which effective and safe vaccines can be developed and manufactured on a large scale, using a scalable process consistent across multiple vaccines, demonstrates that compared to conventional vaccine approaches, mRNA LNP vaccines are uniquely positioned to address the health and societal threat of epidemic outbreaks caused by new or re-emergent pathogens such as Zika, Ebola and pandemic influenza. The ability to not only induce antibodies, but also develop potent adaptive cellular immune responses has highlighted the potential value of mRNA LNP as vaccines to induce anti-cancer immune responses to treat malignant disease. GENE EDITING: Another exciting therapeutic application for mRNA is genome editing. The identification and development of genome editing systems such as CRISPR/Cas9, zinc-finger nucleases and TALENs engineered to 10

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precisely edit cellular DNA sequences to stably correct mutated genes, and deactivate disease-causing genes has led to a renaissance in gene therapy. However, safe and efficient delivery of the editing systems to target cells in the body represents a significant challenge. This can be addressed using non-viral LNP delivery of mRNA to encode the editing enzymes. LNP delivery is able to accommodate the larger payloads required for editing systems compared to alternative approaches. LNP delivery may also provide potential safety benefits, including avoiding direct risks associated with viral delivery systems and prolonged enzyme expression to minimize the likelihood of editing at non-target sites. IN VIVO PROTEIN PRODUCTION: Perhaps the most direct application of mRNA LNP as a therapeutic is for in vivo production of therapeutic proteins. In one aspect, mRNA LNP could be used to produce an intracellular or secreted protein to treat diseases where gene mutations have resulted in either loss of protein expression or production of a non-functional protein. This could be applied to a range of inherited monogenic diseases including hemophilia and lysosomal storage diseases, such as Fabry and Gaucher disease. In addition to protein replacement, mRNA LNP could be used to deliver therapeutic proteins such as growth factors to treat diseases. These range from erythropoietin for anemia, hepatocyte growth factors to treat chronic and acute liver diseases, and immunomodulatory chemokines and cytokines for immunotherapy of cancer. Finally, mRNA LNP have been applied as a form of passive immunization, mediating in vivo production of monoclonal antibodies to provide protection against infectious pathogens and anti-cancer therapies. mRNA therapeutics represent a rapidly expanding drug class. With the first mRNA-based drugs having been approved and a range of others in development, the breadth of applications and the number of diseases that mRNA drugs will ultimately be used to treat is difficult to estimate. With advances that have been made over the past decade, the validated safety and efficacy, and global acceptance, it is clear that mRNA therapeutics have the potential to treat a broad range of serious human diseases – helping to advance human health in multiple areas of focus that have been recently out of reach. Illustration: Synthetic mRNA (yellow) delivered into cell inside LNP, mRNA translated on ribosome (green) to new protein (red)

MESSAGE DU PRÉSIDENT ET CHEF DE LA DIRECTION par Andrew Casey, BIOTECanada

AU MOMENT OÙ J’ÉCRIS CES LIGNES, DEUX ANS SE SONT ÉCOULÉS DEPUIS LE DÉBUT DE LA PANDÉMIE DE COVID-19. De toute évidence, les opinions divergent quant à la façon dont les sociétés et les économies devraient assurer la transition vers une vie exempte de restrictions sanitaires et quant au moment de le faire, mais c’est grâce à la mise au point rapide de vaccins hautement efficaces par notre secteur que l’on peut aujourd’hui en débattre. Des centaines de milliers de vies, au moins, ont été épargnées, et les répercussions globales de la pandémie sur les économies ont été grandement réduites par suite des solutions que l’industrie a trouvées, mises au point et offertes au monde. Bien que la COVID-19 ne soit pas sur le point de disparaître, de nombreux gouvernements ont la sagesse de se préparer à la possibilité d’une nouvelle pandémie, qui surviendra à un moment ou à un autre. Après deux ans d’improvisation en vue de résoudre la crise pandémique, il y a actuellement une forte volonté d’éviter la répétition de cette expérience et de se préparer dès maintenant à la « COVID-30 » ou à la prochaine menace sanitaire mondiale qui se présentera, quelle qu’elle soit. Les investisseurs de partout sur la planète constatent d’ailleurs les occasions que représente le secteur. Dans l’ensemble, la reconnaissance accrue dont jouissent la valeur et l’importance de l’industrie est une bonne nouvelle pour le Canada. L’écosystème canadien des biotechs s’est construit sur une réputation de recherche scientifique de qualité et comprend un ensemble hétérogène de jeunes pousses, d’université, d’incubateurs et accélérateurs

d’entreprises, de centres de recherche, d’investisseurs, ainsi que de multinationales pharmaceutiques et de sociétés de biotechnologie. Du point de vue de la biofabrication et des vaccins, le Canada accueille aussi deux établissements de fabrication commerciale de vaccins bien établis, soit les installations de BioVectra, dans l’Atlantique, et le site de Medicago de Québec, qui sera bientôt opérationnel. Ils constituent ensemble une base de grande valeur sur laquelle peuvent s’appuyer la biofabrication et le secteur des sciences de la vie au Canada. Investir encore davantage dans ces fondements, d’une part, permettra au pays d’être prêt et, d’autre part – si l’on agit de façon stratégique –, pourra aider le gouvernement fédéral à faire progresser sa stratégie en sciences de la vie et le projet de biofabrication qui y est associé. Il convient de reconnaître que, comme le Canada, d’autres joueurs cherchent à faire croître leur secteur des sciences de la vie et leurs capacités en biofabrication. Fait peu surprenant, la pandémie a fait converger les regards de nombreux gouvernement du monde sur l’importance de mettre en place de solides secteurs nationaux des biotechs. Au moment où les gouvernements fédéral et provinciaux en sont à mettre en œuvre des stratégies de croissance, d’obtention d’investissements et de recherche de talents, le Canada devra maintenir le rythme par rapport aux autres pays qui tentent de faire de même. La concurrence risque de faire rage. À mesure que le brouillard de la COVID-19 se dissipera et que l’on se tournera vers l’avenir en vue de reconstruire et de se préparer aux défis

qui s’annoncent (notamment celui du changement climatique, que la pandémie a laissé inchangé, comme en témoigne le plus récent rapport du GIEC sur le sujet), l’importance de notre secteur et des solutions qu’il propose ne fera qu’augmenter. Conséquemment, le gouvernement fédéral a prévu des investissements considérables destinés à renforcer l’industrie canadienne de la biofabrication et des sciences de la vie. Beaucoup reste à faire pour susciter l’intérêt des investisseurs, élargir et diversifier le bassin de talents en biotechnologie et, en fin de compte, créer des entreprises phares au pays. Ce ne sera pas facile, mais la dernière année constitue un début solide, extrêmement prometteur. Au cours des mois qui s’annoncent, il y aura d’importantes occasions pour l’ensemble des membres de BIOTECanada, qui représentent bien l’ensemble de l’écosystème canadien des biotechs.

biotech.ca

federal perspective le point de vue fédéral

An ambitious plan for Canada’s biotech industry Un plan ambitieux pour l’industrie canadienne de la biotechnologie by the Honourable François-Philippe Champagne, P.C., M.P. Minister of Innovation, Science and Industry par l’honorable François-Philippe Champagne, C.P., député Ministre de l’innovation, des Sciences et de l’Industrie

MOST CANADIANS KNOW ABOUT THE IMPORTANT ROLE CANADA PLAYED IN THE DISCOVERY OF INSULIN, A LIFE-SAVING DISCOVERY that has improved the lives of countless diabetics around the world. But many are not aware that Canadian scientists have also been instrumental in discoveries related to the polio and Ebola vaccines, or that it was in a Canadian lab that a compound was developed to stunt HIV’s vicious rate of replication. These innovations have literally saved millions of lives globally and are examples of the life-saving work being done right here at home. When the COVID-19 pandemic began, our government knew the answer to solve this global challenge was through science. That’s why we acted quickly to make major investments to build up the sector and to help Canadians cope with the pandemic. Our government’s response was focused not only on the short-term strategic solutions but also on developing a long-term vision for Canada’s recovery. Thanks to these early investments to fight the pandemic, we are helping homegrown firms like AbCellera, BIOVECTRA and Medicago, and many others, across the country grow. Our goal it to reinforce the overall strength of our domestic sector. To date, we have supported 29 Canadian COVID‑19 biomanufacturing, vaccines and therapeutics projects through the Strategic Innovation Fund, Next Generation Manufacturing Canada, the National Research Council of Canada, and many other government agencies and partners.1 As the minister responsible for innovation, science, and industry, and as the former minister for foreign affairs, I am proud to see that by supporting the long-term resilience of our domestic biomanufacturing capacity, we have also attracted the attention of the world. We have seen global firms like Moderna, Sanofi and Merck initiate new operations here. https://www.ic.gc.ca/eic/site/151.nsf/eng/00006.html

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NOUS CONNAISSONS BIEN LE RÔLE IMPORTANT QUE LE CANADA A JOUÉ DANS LA DÉCOUVERTE DE L’INSULINE, qui améliore la vie d’innombrables diabétiques dans le monde. Cependant, peu savent que des scientifiques canadiens ont joué un rôle crucial dans des découvertes liées aux vaccins contre la poliomyélite et la maladie à virus Ebola, et que c’est dans un laboratoire canadien qu’a été mise au point une substance qui ralentit la réplication du VIH. Ces innovations ont sauvé des millions de vies et sont des exemples du travail salutaire qui s’effectue dans notre pays. Dès l’éclosion de la pandémie, le gouvernement a misé sur la science pour contrer ce fléau mondial. Nous avons dégagé des sommes importantes pour reconstruire le secteur de la biofabrication et des sciences de la vie et aider les Canadiens à traverser la crise. Nous avons mis l’accent sur des solutions stratégiques et immédiates conjuguées avec une vision à long terme pour assurer une reprise économique prospère et durable. Nos investissements pour lutter contre la pandémie ont aidé et aident encore des entreprises canadiennes comme AbCellera, BIOVECTRA et Medicago, et bien d’autres encore, à prendre de l’expansion. Notre objectif est de renforcer le secteur dans son ensemble. À ce jour, nous avons annoncé 30 projets dans l’écosystème de la biofabrication, des vaccins et des thérapies, renforçant les capacités nationales d’intervention en cas de pandémie et innovation en sciences de la vie par l’entremise du Fonds stratégique pour l’innovation, de Next Generation Manufacturing Canada, du Conseil national de recherches Canada et de nombreux autres partenaires des secteurs public et privé1 . À titre de ministre de l’Innovation, des Sciences et de l’Industrie et d’ancien ministre des Affaires étrangères, je suis fier de voir que les mesures pour assurer la résilience à long terme de la capacité nationale de biofabrication ont attiré l’attention du monde entier. Des multinationales comme Moderna, Sanofi et https://www.ic.gc.ca/eic/site/151.nsf/fra/00006.html

BIOTECanada

federal perspective le point de vue fédéral

When the COVID-19 pandemic began, our government knew the answer to solve this global challenge was through science. That’s why we acted quickly to make major investments to build up the sector and to help Canadians cope with the pandemic. Our government’s response was focused not only on the short-term strategic solutions but also on developing a long-term vision for Canada’s recovery. They have made these decisions because they understand the many advantages of partnering with Canada. Whether its our numerous trade deals, our preferential access to markets and global supply chains, or our highly educated and competitively skilled population, we have what’s needed to attract both talent and investments to Canada. We are a country that values stability, predictability and the rule of law. And in these unprecedented times, it is clear that these values will guide not only the immediate investments and innovations we’re seeing but also the long-term growth and resilience of our country’s future. As we look to a post-pandemic future for Canada, there is no doubt that we must supercharge the amazing potential we’ve seen in this key economic sector. To guide us in this endeavour, we look to our leading scientists, researchers, industry experts, and key stakeholders, in order to develop Canada’s Biomanufacturing and Life Sciences Strategy. This cross-government effort will help ensure that businesses, scientists, researchers and post-secondary institutions have the tools and resources they need to advance future discoveries of vaccines and therapeutics, and that we can grow the domestic talent needed to support our ambitious objectives. In support of the strategy, the 2021 federal budget devoted more than $2 billion to growing our biomanufacturing and life sciences sector. This funding included $500 million for the Canada Foundation for Innovation to support the bioscience capital and research

Merck ont entrepris de nouvelles activités dans notre pays parce qu’elles savent que le Canada a toutes les ressources pour être un partenaire de choix. De nombreux accords commerciaux, un accès privilégié aux marchés et aux chaînes d’approvisionnement mondiales, une population très instruite et compétente; nous possédons tous les atouts pour attirer les talents et les investissements. Notre pays valorise la stabilité, la prévisibilité et la primauté du droit. En ces temps sans précédent, il est clair que ces valeurs orientent les décisions d’ investissements et d’innovations, de même que celles relatives à la croissance à long terme et à la résilience de notre pays. L’avenir postpandémique se dessine. Nous avons une occasion de stimuler le potentiel phénoménal de ce secteur économique clé, et nous comptons sur nos plus éminents scientifiques, chercheurs, experts de l’industrie et intervenants clés pour mettre en œuvre la Stratégie en matière de biofabrication et de sciences de la vie. Ce travail pangouvernemental nous permettra de veiller à ce que les entreprises, les scientifiques, les chercheurs et les établissements postsecondaires disposent des outils et des ressources dont ils ont besoin pour faire avancer la recherche sur les vaccins et les thérapies. Il nous permettra également de former un bassin d’experts pour soutenir nos ambitieux objectifs. En appui à la Stratégie, le budget fédéral de 2021 prévoit plus de 2 milliards de dollars pour la croissance du secteur de la biofabrication et des sciences de la vie. Ce financement comprend 500 millions de dollars pour la Fondation canadienne pour l’innovation. La Fondation répondra ainsi aux besoins en capital et en infrastructure de recherche en sciences biologiques des établissements postsecondaires et

Dès l’éclosion de la pandémie, le gouvernement a misé sur la science pour contrer ce fléau mondial. Nous avons dégagé des sommes importantes pour reconstruire le secteur de la biofabrication et des sciences de la vie et aider les Canadiens à traverser la crise. Nous avons mis l’accent sur des solutions stratégiques et immédiates conjuguées avec une vision à long terme pour assurer une reprise économique prospère et durable. biotech.ca

federal perspective le point de vue fédéral

infrastructure needs of post-secondary institutions and research hospitals across the country. These major investments will also create a new tri-council biomedical research fund; support company creation, scale-up and training activities in the life sciences sector; increase clinical research capacity through a new Canadian Institutes of Health Research clinical trials fund; support stem cell and regenerative medicine research; and further invest in the Vaccine and Infectious Disease Organization to support the development of its vaccine candidates and expand its facility in Saskatoon. This is all critical groundwork for Canada. These investments will not only help see us through the COVID19 pandemic and address possible future health crises, but they’ll also help to consolidate our long-term approach to Canadian healthcare in areas such as cancer research and various other chronic diseases. That’s why we will continue to support the growth of our domestic life sciences firms. Because it means more life-saving breakthroughs. It means thousands of new well-paying and highly-skilled jobs. And it means a future where Canada is a world leader in preventing, treating and curing all kinds of illness and disease. As Canada continues to battle COVID-19, we should allow ourselves to be inspired by a few truths that have come to light during the course of this pandemic: first, Canadians are capable of great things when we work together; second, our world-class science and research enterprises deliver innovations that help the world weather tough times; and third, the biomanufacturing and life sciences sector can count on our government’s support in whatever comes next.

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BIOTECanada

des hôpitaux de recherche partout au pays. Cette enveloppe permettra également de créer un nouveau fonds de recherche biomédicale administré par les trois conseils subventionnaires; de soutenir la création d’entreprises et leur expansion; et d’effectuer de la formation dans le secteur des sciences de la vie. En outre, ces sommes serviront à accroître la capacité de recherche clinique grâce à un fonds pour les essais cliniques des Instituts de recherche en santé du Canada; à appuyer la recherche sur les cellules souches et sur la médecine régénératrice; et à investir davantage dans la Vaccine and Infectious Disease Organization pour soutenir la mise au point de ses vaccins candidats et agrandir ses installations à Saskatoon. Il s’agit d’un travail préparatoire essentiel pour le Canada. Ces investissements nous aideront, non seulement à traverser la pandémie de COVID-19 et à affronter de futures crises sanitaires, mais aussi à consolider notre approche à long terme à l’égard du système de santé dans le domaine de la recherche sur le cancer et sur diverses autres maladies chroniques. Nous continuerons de soutenir la croissance des entreprises canadiennes dans le domaine des sciences de la vie qui réalisent des percées susceptibles de sauver des vies et qui créent des milliers d’emplois hautement spécialisés et bien rémunérés. Nous positionnons le Canada comme chef de file mondial dans le domaine de la prévention, du traitement et de la guérison de toutes sortes de maladies. La lutte contre la COVID-19 n’est pas terminée. Nous pouvons toutefois en tirer quelques constats: les Canadiens sont capables de grandes choses lorsqu’ils travaillent ensemble; nos scientifiques et chercheurs de calibre mondial continueront d’innover pour aider le Canada et le monde à passer au travers de cette période difficile; et le secteur de la biofabrication et des sciences de la vie pourra continuer à compter sur le gouvernement fédéral pour le soutenir, peu importe ce que nous réserve l’avenir.

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Cell and Gene Therapy in Canada: Leading Companies and the Commercial Opportunity By Kyle O’Neil and Brendan Wang, Back Bay Life Science Advisors

AS INDUSTRY TRENDS CONTINUE TO POINT TOWARDS INCREASED CONSOLIDATOR INTEREST, THE CANADIAN cell and gene sector is advancing technology and moving towards commercialization. Back Bay Life Science Advisors shares which Canadian companies are progressing technology in the sector and offers a perspective of the inherent nuances of Canada’s unique market dynamics and public health insurance system. “Overview of selected Canadian cell and gene therapy biotech companies” – figure available upon request at www.bblsa.com THEME #1: CRISPR 2.0 Intellia’s in vivo proof-of-concept CRISPR data from NTLA-2001 in six patients with hereditary transthyretin amyloidosis (hATTR) has spurred extensive investor interest in improved editing technologies (1). Potential improvements to CRISPR/Cas9 aim to overcome limitations such as: 1. Restrictions to specific protospacer adjacent motifs (PAMs), a short DNA sequence (usually 2-6 base pairs) where CRISPR binds to perform its editing function 2. Delivery, which often limits the applicability of CRISPR platforms such as Intellia’s to the liver, where most molecules traffic Quebec-based Feldan Therapeutics raised ~$16M and published multiple papers on a system of amphiphilic peptides called the “Feldan Shuttle” for CRISPR delivery (2, 3), which potentially addresses one of the key challenges of delivery for DNA editing approaches. The “Shuttle” is a short peptide that circumvents delivery challenges by avoiding endosomal entrapment and can be applied to multiple therapeutic modalities. THEME #2: CELL THERAPY 2.0 With five launched autologous CAR-T therapies targeting CD19 and BCMA rapidly surpassing $1B in total sales, a variety of platform technologies have been advanced to address the limitations of autologous therapies including: 1. Long manufacturing time that limits their utility for rapidly progressing tumors 2. Safety concerns such as cytokine release syndrome (CRS)

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BIOTECanada

Canadian biotech companies such as Notch Therapeutics are advancing platforms ranging from induced pluripotent stem cell (iPSC) engineered CAR-Ts to innate immune cells and even in vivo engineered CAR-Ts. Given Notch has raised ~$90M to date, the company may look beyond immunooncology with its listed pipeline programs in Tregs, which have potential across a range of autoimmune and ocular indications and other immune cell types. THEME #3: INTEGRATED MANUFACTURING COMPANIES There is an increasing number of therapeutic companies in the cell and gene therapy space formed at inception with manufacturing capabilities. Recently launched companies developing the integrated product and platform business model include Forge Biologics, Resilience, and ElevateBio, who have collectively raised over $1.5B since mid-2019. Similarly, companies with manufacturing capabilities such as Codexis and Oxford BioMedica are leveraging their manufacturing capabilities to increasingly branch into more “high-risk, high-reward” therapeutics development. Since the cost of goods sold (COGS) for cell and gene therapies is higher than other therapeutic modalities (~40%) and manufacturing times for components such as viral vectors are long, there are significant manufacturing constraints (4). This trend is perhaps more important for early-stage companies, who should consider manufacturing in their exit planning and company growth model. In Canada, companies such as the Centre for Commercialization of Regenerative Medicine (CCRM) are ideal manufacturing partners throughout the product lifecycle. Companies may also opt to build their manufacturing system in-house; one such example is Avrobio, which was founded based on work from two Canadian scientists through CCRM’s incubator arm and has developed a proprietary plato® platform that includes manufacturing technology. Also notable is Canada’s recent $164M investment in Resilience to expand a biomanufacturing site in Ontario. THEME #4: LARGE MARKET C&GT Due to the limited whitespace and commercial challenges in rare indications on the backdrop of a cash-strapped market environment, gene therapy

companies are also exploring non-orphan opportunities. There are several different non-orphan indications under exploration including CNS diseases (e.g., Eli Lilly’s PD-GBA in Parkinson’s disease), autoimmune diseases (e.g., Orchard Therapeutics’ OTL-104 in Crohn’s disease) and cardiovascular diseases (e.g., Tenaya Therapeutics’ DWORF in dilated cardiomyopathy). Unlocking these larger indications will be critical for gene therapy companies to deliver value to investors, which is likely to require substantial differentiation from the standard of care, as existing therapies are available at prices much lower than traditional gene and cell therapies. Canadian company BlueRock Therapeutics, acquired by founding investor Bayer in 2019 and valued at up to $1B, has a proprietary induced pluripotent stem cell (iPSC) platform. BlueRock’s lead program in Parkinson’s disease is aimed at delivering the lost dopaminergic neurons in the substantia nigra and dosed its first patient in Canada in January 2022, with further applications of its platform expected to be used in cardiology, immunology and ophthalmology. COMMERCIALIZING CELL AND GENE THERAPIES IN CANADA Key to ensuring that innovative cell and gene therapies make it from the lab to patients is an understanding of the pathway to commercialization within the Canadian market, which has a vastly different healthcare ecosystem compared to the US. Canada’s universal public health insurance system ensures access to medically necessary physician visits, diagnostics and hospital stays (5). However, prescription drugs fall outside of this structure and are covered on a provincial and territorial level. While the federal government provides some funding to provinces, it is up to the individual provinces and territories to make reimbursement decisions. Patients may additionally opt into private insurance for supplemental prescription drug coverage, either individually or through an employer (6). There are several stakeholders relevant to commercializing a cell or gene therapy including at the provincial/territorial and national level. At the provincial and territorial level, provincial-level payers manage their own budgets and decide whether and for whom they will reimburse a new product. Additionally, multiple provinces can band together to negotiate prices with manufacturers through the Pan-Canadian Pharmaceutical Alliance

(pCPA). National-level stakeholders include the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Patented Medicine Prices Review Board (PMPRB). The CADTH serves as Canada’s HTA authority and evaluates new therapies, making a national, non-binding recommendation on how novel therapies should be utilized and whether they should be reimbursed. Nonetheless, each individual province/territory ultimately decides whether to reimburse a particular product. The PMPRB sets ceiling prices for drugs based on international reference pricing (IRP) and a variety of other factors. Recent reforms (7) have the potential to change several elements of the PMPRB’s price ceiling calculations by allowing them to drop higher cost markets (e.g., US) from the reference basket, thus lowering the price ceiling and enabling consideration of cost-effectiveness of new therapies and their potential impact to government budgets, further making early consideration of potential Canadian market access issues critical for early-stage companies. Article references available upon request: info@bblsa.com ABOUT BACK BAY LIFE SCIENCE ADVISORS Back Bay Life Science Advisors is top-ranked life sciences consultancy specializing in biopharma and medtech development. We provide life science companies across all stages and sectors with strategic development and investment banking expertise and execution across a wide range of therapeutic areas including cancer, inflammation, vaccines, rare disease, neurology and cell and gene therapy development. EXPERTS IN CELL & GENE THERAPY DEVELOPMENT Back Bay has a special and nuanced understanding of the scientific, clinical and commercial positioning of novel cell and gene therapy technologies across the product life cycle, including preclinical and clinical development, product launch and manufacturing. Our cell and gene therapy expertise spans established therapeutic areas, such as oncology and technologies, such as gene editing, and novel therapies. At Back Bay Life Science Advisors, we analyze technologies to inform development strategies and determine the best path forward for commercial success and the betterment of human health. Contact the Back Bay team in Boston, Toronto, or Europe to learn more about our cell and gene therapy projects. www.bblsa.com

biotech.ca

Fonds de solidarité FTQ — Let’s Support Creativity in Developing New Businesses encourageons la créativité dans la création d’entreprises by/par Geneviève Guertin, Vice-présidente Placements privés et investissement d’impact | Sciences de la vie/ Vice-President Private Equity and Impact Investing | Life Sciences

DEVELOPING NEW BUSINESSES IS A PRIMARY AREA OF INTEREST FOR INVESTORS LIKE THE FONDS, both as a source of companies to build our portfolio and from an economic standpoint, as they contribute to producing collective wealth. The life sciences are a vibrant sector that builds highpotential businesses, generates many high-quality jobs, and contributes to the province’s GDP, all while developing therapeutic applications that can improve patients’ health and quality of life.

LA CRÉATION D’ENTREPRISES EST UNE ACTIVITÉ PRIMORDIALE POUR LES INVESTISSEURS COMME LE FONDS, autant en étant une source d’entreprise pour bâtir notre portefeuille que du point de vue économique, participant à la création de richesse collective. Les sciences de la vie est un secteur hautement dynamique permettant de bâtir des entreprises à fort potentiel, générant de nombreux emplois de qualité et contribuant au PIB de la province, tout en développant des applications thérapeutiques capables d’améliorer la santé et la qualité de vie des patients.

A RAPIDLY GROWING, VIBRANT SECTOR UN SECTEUR DYNAMIQUE EN PLEIN ESSOR While the life sciences ecosystem has expended Bien que l’écosystème des sciences de la vie ait consacré significant resources in the search for a cure for COVID-19, des ressources considérables à trouver une solution à la it is gratifying to see that several companies with other COVID-19, il est réjouissant de constater que plusieurs areas of focus have emerged during this time. The following entreprises visant d’autres indications ont émergé pendant table lists 12 biotech companies focused on developing cette période. Le tableau ci-dessous présente une liste de therapeutics that deserve our utmost respect for raising douze entreprises de biotechnologie en développement de their first round with institutional investors since the thérapeutiques qui méritent pandemic began in Canada. tout notre respect pour avoir This list, which does not LOCATION PARTICIPANTS levé leur première ronde claim to be exhaustive, allows auprès d’investisseurs us to appreciate the sector’s FIND THERAPEUTICS MONTREAL ADMARE, CTI institutionnels depuis vitality. The Fonds is proud to NEURASIC MONTREAL ADMARE, AMORCHEM THERAPEUTICS l’avènement de la pandémie have invested directly in three PHENOMIC AI TORONTO AV8 VENTURES, CTI, au Canada. of these promising new LUMINOUS VENTURES, VIVA Cette liste, qui n’a pas la businesses, and indirectly BIOINNOVATOR. prétention d’être exhaustive, through intermediary funds in RADIANT TORONTO AMPLITUDE nous permet d’apprécier la eight of them. ABDERA VANCOUVER ADMARE, AMPLITUDE, THERAPEUTICS

OUR CONTRIBUTION TO THE WAR EFFORT The Fonds has always contributed to creating and fostering biotechnology companies. Our modus operandi typically is by participating in traditionally syndicated investment rounds, where several investors join forces to implement a business plan. Always striving to improve its impact, the Fonds launched 18

VERSANT

FORUS THERAPEUTICS

MONTREAL

ADMARE, BEIGENE

GIIANT

MONTREAL

AMORCHEM, AMPLITUDE, FONDS DE SOLIDARITÉ GENESYS,

PHARMA

THEODORUS CONGRUENCE THERAPEUTICS

MONTREAL

AMPLITUDE, FONDS DE SOLIDARITÉ

EPITOPEA

MONTREAL/ CAMBRIDGE (UK)

ADVENT LIFE SCIENCE, CAMBRIDGE INNOVATION CAPITAL, CTI FONDS DE SOLIDARITÉ

SPECIFIC BIOLOGICS

TORONTO

VALENCE DISCOVERY

MONTREAL

GANDEEVA

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BIOTECanada

ADMARE, LUMIRA AMPLITUDE, BRIGHTSPARK AMPLITUDE, LEAPS, LUX

vitalité du secteur. Le Fonds est fier d’avoir investi directement dans trois de ces nouvelles entreprises prometteuses, et indirectement par fonds interposé dans huit d’entre elles.

NOTRE CONTRIBUTION À L’EFFORT DE GUERRE Le Fonds contribue de tout temps à la création et à l’essor des entreprises de

Clarissa Desjardins

Claude Perreault

Let’s think outside the box and come up with creative ideas to encourage the development of new life sciences companies built around local science. You have an original project in mind? Let’s meet to discuss it! an initiative in 2019 to create entrepreneur-oriented businesses. A perfect example of “building the plane while flying it,” these investments are intended to provide entrepreneurs with a proven track record with the means to actualize their business concept so they can raise their first round of institutional financing faster and under better conditions. By choosing trusted, experienced entrepreneurs who share our values, we aim to speed up the process of launching a business. Guided by this vision, we partnered with Paul Truex in November 2019 to help launch LQT Therapeutics, a project serving to develop inhibitors to treat Long QT Syndrome and resistant cancers. As such, he was able to begin operations and hire his first employees. Our Amplitude Partner Fund jumped on board in January 2021, and our combined support helped provide favorable conditions to secure a US$19 million Series A round in July 2021 and recent additional financing to expedite new development programs. In September 2021, we happily repeated the experience with Clarissa Desjardins, who was then setting up her 4th company: Congruence Therapeutics, a computational platform targeting rare diseases associated with protein misfolding.

Paul Truex

biotechnologie. Notre modus operandi général est de participer à des rondes d’investissement syndiquées de manière traditionnelle, où plusieurs investisseurs joignent leurs forces pour concrétiser un plan d’affaires. Toujours en quête d’améliorer son impact, le Fonds a lancé en 2019 une initiative de création d’entreprises axées sur l’entrepreneur. Exemple parfait de l’expression « bâtir l’avion en plein vol », ces investissements visent à offrir à un entrepreneur de confiance les moyens de réaliser son concept d’affaires de manière à lui permettre de lever plus rapidement et dans de meilleures conditions une première ronde de financement institutionnel. En choisissant des entrepreneurs expérimentés en qui nous avons confiance et qui partagent nos valeurs, nous visons à accélérer le lancement d’entreprises. C’est sous cette vision que nous nous sommes joints à Paul Truex en novembre 2019 pour l’aider à lancer LQT Therapeutics, son projet de développement d’inhibiteurs pour le traitement du syndrome du QT long et des cancers résistants. Il a ainsi pu débuter les opérations et embaucher ses premiers employés. Notre fonds partenaire Amplitude s’est joint à l’aventure en janvier 2021 et notre appui conjoint a permis de réunir les conditions gagnantes pour conclure une ronde de série A de 19 M$ US en juillet 2021 et un financement supplémentaire récent pour accélérer de nouveaux programmes de développement. En septembre 2021, nous avons récidivé avec bonheur auprès de Clarissa Desjardins qui s’affairait alors à mettre sur pied sa 4e entreprise, Congruence Thérapeutique, une plateforme computationnelle ciblant les maladies rares associées au repliement défectueux de protéines Pour combler des besoins plus importants, nous avons travaillé dès le départ avec le fonds Amplitude pour aider à lancer rapidement la société avec une ronde de démarrage de 15 M$ US. L’entreprise a eu un prompt succès en

biotech.ca

As this company had greater needs, we worked with the Amplitude Fund from the outset to expedite its launch with a US$15 million start-up round. The company prospered quickly, and as announced in February 2022, it was able to secure a US$35 million extension backed by some prestigious investors. CONSIDERING NEW LEVERS TO START BUSINESSES Entrepreneurs, capital, and innovation are the hat trick of creating a business. The work being done by university researchers is an infinite source of innovation that can serve as a foundation for developing new companies. This retrospective is an opportunity to understand the relative scarcity of new businesses based on Canadian or Quebec university research. Looking at our own activities, we can see that out of nearly one hundred investments made over the years for the development of therapeutics, only ten successful projects’ origins can be traced to Quebec university research. Epitopea, the most recent, stems from the work of Dr. Claude Perrault and Dr. Pierre Thibault of the Institute for Research in Immunology and Cancer affiliated with the Université de Montréal, whose findings have caught the attention of British investors, who joined forces with CTI (a local fund) to launch Epitopea. An arsenal of complementary means must be deployed to improve this performance. Of particular interest is the Theodorus Fund’s recent initiative with the CQDM biopharmaceutical research consortium, which announced a call for projects to find promising start-ups and support them in launching their businesses. Also noteworthy is adMare’s business creation model (technological maturation in their labs before creating a start-up), which complements the approach of Amorchem, a group specializing in pre-startups in universities (an extreme sport if ever there was one). Let’s think outside the box and come up with creative ideas to encourage the development of new life sciences companies. You have an original project in mind? Let’s meet to discuss it! LET’S CONTINUE TO SUPPORT CREATIVITY IN LAUNCHING NEW BUSINESSES Canada has a vibrant life sciences ecosystem. We’ll be taking advantage of BIO in San Diego from June 13-16 to meet with our neighbours to the south and invite them to be a part of the vibrant ecosystem that exists north of the border. The Fonds is proud to help create innovative businesses, build a strong economy, and improve patient care. We welcome new ideas and original initiatives which will support entrepreneurs’ ingenuity, leadership and “chutzpah” as they develop their companies.

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BIOTECanada

réussissant à conclure une extension de 35 M$ US annoncée en février 2022 et à laquelle se sont greffés des investisseurs prestigieux.

IMAGINER DE NOUVEAUX LEVIERS POUR LANCER DES ENTREPRISES Entrepreneurs, capital et innovation représentent la Sainte Trinité de la création d’entreprise. Le travail des chercheurs universitaires est une source incommensurable d’innovations pouvant servir de fondation à l’émergence de nouvelles sociétés. La présente rétrospective est l’occasion de remarquer la relative rareté de création d’entreprises basées sur de la recherche universitaire canadienne ou québécoise. En examinant nos propres activités, nous constatons que sur près d’une centaine d’investissements effectués au cours des années aux fins de développement de thérapeutiques, seulement dix projets couronnés de succès provenaient de recherche universitaire québécoise. Epitopea, la plus récente, découle des travaux des Dr Claude Perrault et Pierre Thibault de l’Institut de recherche en immunologie et en cancérologie affilié à l’Université de Montréal, dont les découvertes ont capté l’intérêt d’investisseurs anglais, qui se sont unis au fonds local CTI pour lancer Epitopea. Un arsenal de moyens complémentaires doit être déployé pour améliorer cette performance. Notons l’initiative récente du fonds Theodorus et du consortium de recherche biopharmaceutique CQDM qui ont ouvert un appel à projets pour dénicher des start-ups prometteuses et les accompagner dans le démarrage de leur entreprise. Soulignons également le modèle de création d’entreprise d’adMare (maturation technologique dans leurs laboratoires avant la création d’une start-up), qui opère en complémentarité avec l’approche d’Amorchem, un groupe spécialisé dans le pré-démarrage en milieu universitaire (sport extrême s’il en est un). Sortons des sentiers battus et proposons des idées créatives pour favoriser l’émergence de nouvelles entreprises en sciences de la vie. Vous avez un projet original en tête ? Venez nous rencontrer pour en discuter !

CONTINUONS DE SUPPORTER LA CRÉATIVITÉ DANS LE DÉMARRAGE DE NOUVELLES ENTREPRISES Le Canada possède un écosystème dynamique en sciences de la vie. Nous profitons de BIO qui se tiendra à San Diego du 13 au 16 juin pour saluer nos voisins du sud et les inviter à venir participer à l’écosytème dynamique qui existe au nord de la frontière. Le Fonds est fier de contribuer à la création d’entreprises innovantes, participant à bâtir une économie forte et à améliorer les soins aux patients. Nous accueillons avec enthousiasme les nouvelles idées et les initiatives créatives visant à supporter l’ingéniosité, le leadership et le « chutzpah » des entrepreneurs dans le lancement de leur entreprise.

Celebrating science, innovation and solutions September 26 – October 2, 2022

globalbiotechweek.ca #GBW2022

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BRING BETTER ANTIBODIES TO PATIENTS, FASTER.

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We search, decode, and analyze natural immune systems to find antibodies that our partners can develop into drugs to treat and prevent disease.

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DRIVEN BY SCIENCE, FOCUSED ON PEOPLE.

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Bristol Myers Squibb’s Diverse Pipeline Drives Next Wave of Innovation La gamme de produits diversifiée de Bristol Myers Squibb, au cœur de la prochaine vague d’innovation

WITH A LEGACY BUILT ON SCIENTIFIC EXCELLENCE, AND A STRONG INNOVATION ENGINE IN PLACE, Bristol Myers Squibb (BMS) Canada has entrenched itself as one of Canada’s leading biopharmaceutical companies. “Working to address serious disease with breakthrough science, and then bringing these innovative advancements to Canadians, is at our core as our company,” says Troy André, the Montreal-based general manager of BMS Canada. This approach has lead to advancements in the development of cancer and immuno-oncology (I-O) treatments, an extensive hematology portfolio, deep expertise in cardiovascular and emerging growth in immunology.

FORTE D’UN HÉRITAGE FONDÉ SUR L’EXCELLENCE SCIENTIFIQUE ET D’UN PUISSANT MOTEUR D’INNOVATION, Bristol Myers Squibb (BMS) Canada s’est imposée comme l’une des principales sociétés biopharmaceutiques du Canada. « Notre société se concentre sur la lutte contre les maladies graves; elle fait des percées scientifiques, puis fait profiter les Canadiens et les Canadiennes de ces avancées », a déclaré Troy André, directeur général de BMS Canada, société basée à Montréal. Cette approche a mené à des progrès dans le développement de traitements contre le cancer et en immuno-oncologie, à un vaste portefeuille en hématologie, à une expertise approfondie dans le domaine cardiovasculaire et à l’émergence de nouveaux produits en immunologie.

L’INNOVATION EN IMMUNOONCOLOGIE AMÉLIORE LES TAUX DE SURVIE

IMMUNO-ONCOLOGY INNOVATION CHANGES SURVIVAL RATES Ten years ago, BMS Canada was the first company to bring an I-O medicine to Canadians. “Over the last decade, the median overall survival rates for those diagnosed with metastatic melanoma have increased from just over 6 months to now being over 6 years.1 This is a true testament to the impact the field of I-O has had on a serious disease, and it reinforces why innovation is so important to us,” stresses André.

Il y a dix ans, BMS Canada a été la première société à offrir un médicament immunooncologique (I-O) aux Canadiens et aux Canadiennes. « Au cours de la dernière décennie, le taux de survie globale médiane chez les personnes ayant reçu un diagnostic de mélanome métastatique est passé d’à peine six mois à plus de six ans2 . Voilà une preuve tangible de l’impact que le domaine de l’I-O a eu sur une maladie, qui nous rappelle pourquoi l’innovation est si importante pour nous », souligne Troy André.

INNOVATION IS THE CATALYST FOR EVOLUTIONS IN PATIENT CARE As treatment options become more widely available to patients, and new standards of care are established, it’s important that Troy André, General Manager/ directeur général, Bristol Myers Squibb Canada

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L’INNOVATION EST LE CATALYSEUR DE L’ÉVOLUTION DES SOINS AUX PATIENTS

these accomplishments are not accepted as the final frontier of patient care. “We continue to focus on developing first-in-class and best-in-class medicines to address significant unmet patient needs. One place we’ve done this is in the area of personalized medicines. With many of our investigational therapies and increased disease understanding, we are now able to take a targeted approach to research, subtyping patient populations to help better identify personalized treatment options.” The development of personalized medicines means that each patient may be able to have their own unique disease management plans, or treatment “road map” that can be followed and revised over time. RESEARCH PARTNERSHIPS ARE A WIN-WIN IN CANADA In Canada, BMS’ research approach is exemplified through our strong external research partnerships. “To stay at the center of innovation, we’ve made strategic decisions to strengthen our connections in academia and biotech,” explains André. For Canadian patients, this means they may have access to more treatment options at an earlier stage. For researchers, particularly in the early in the process, this provides primary experience with new treatment possibilities. The next five years will be important for BMS Canada. With an expanding treatment portfolio, and one of the most diverse pipelines in the industry, BMS has a major opportunity to help patients and communities manage challenging health conditions. “We know that we have an important role to bring the next wave of medicines,” says André. “We also believe that Canadian patients who can benefit from our medicines should have access to them. We will continue to work collaboratively with stakeholders, including payers, physicians, and patient advocates to enhance access.”

Même si les options de traitement deviennent de plus en plus accessibles aux patients et que de nouvelles normes de soins sont établies, il est important d’aller au-delà de ces réalisations pour améliorer les soins aux patients. « Nous continuons de mettre l’accent sur la mise au point de médicaments novateurs qui occupent le premier rang dans leur catégorie pour répondre à d’importants besoins non satisfaits des patients. Nous l’avons notamment fait dans le domaine des médicaments personnalisés. Grâce à bon nombre de nos traitements expérimentaux et à une meilleure compréhension de la maladie, nous sommes maintenant en mesure d’adopter une approche ciblée de la recherche, en classant les populations de patients par sous-type, ce qui nous permet de mieux définir les options de traitement personnalisées. » Grâce à la mise au point de médicaments personnalisés, chaque patient peut avoir son propre plan de prise en charge de la maladie, ou sa feuille de route pour le traitement, qui seront suivis et révisés au fil du temps.

LES PARTENARIATS DE RECHERCHE SONT AVANTAGEUX POUR TOUS Au Canada, l’approche de recherche de BMS s’exprime par de solides partenariats de recherche externes. « Pour rester au cœur de l’innovation, nous avons pris des décisions stratégiques afin de renforcer nos liens avec les milieux universitaire et biotechnologique », explique Troy André. Les patients canadiens ont ainsi accès à plus d’options de traitement, et ce, plus rapidement. De leur côté, les chercheurs, en particulier au début du processus, acquièrent une première expérience de ces nouvelles possibilités de traitement. Les cinq prochaines années seront importantes pour BMS Canada. Avec un portefeuille de traitements en expansion et l’une des gammes de produits les plus diversifiées de l’industrie, BMS a une occasion en or d’aider les patients et les collectivités à prendre en charge des problèmes de santé difficiles. « Nous savons que nous avons un rôle important à jouer pour offrir la prochaine génération de médicaments, déclare Troy André. Nous croyons également que les patients qui peuvent profiter des bienfaits de nos médicaments devraient pouvoir y avoir accès. Nous continuerons de collaborer avec les divers intervenants, y compris les assureurs, les médecins et les défenseurs des droits des patients, pour en améliorer l’accès.

Developed in collaboration with our partner Bristol Myers Squibb Canada. Développé en collaboration avec notre partenaire Bristol Myers Squibb Canada.

1. Korn et al (2008) J Clin Oncol. ; 2. Wolchok et al (2021) J Clin Oncol. 2. Korn et coll. (2008) J Clin Oncol. ; 2. Wolchok et coll. (2021) J Clin Oncol.

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Let’s invest in the Canadian biotechnology industry

THE CANADIAN BIOTECHNOLOGY INDUSTRY HAS A COMMERCIALIZATION PROBLEM, researchers across the country publish groundbreaking discoveries at rates similar to other nations but show relatively limited commercial successes. Luckily there is an easy fix – significantly increase investments in the early-stage companies that drive innovation. When nations make significant investments in their domestic biotech companies scientific discoveries translate into commercial successes. For example, a $25M DARPA grant from the United States government to Moderna to develop mRNA therapeutic technologies in 2013, followed by a $1.53B investment in the company from Operation Warp Speed, enabled the success of its COVID-19 mRNA vaccine. In contrast to the United States, Canada’s investments in its biotechnology companies have been slow and modest in size. In fact, Canada’s failure to invest in its domestic pharmaceutical industry left it ill-prepared to produce vaccines during the pandemic. Canada is home to several innovative biotech companies, such as Alberta-based Entos Pharmaceuticals Inc. (Entos), with its Fusogenix proteolipid vehicle (PLV) genetic medicines delivery technology. Entos is at the vanguard of advances in the new frontier of genetic medicine technologies transforming the pharmaceutical industry. “Canadian companies can contribute significantly to the biomanufacturing industry with breakthrough technologies,” says John Lewis, founder and chief executive officer of Entos. “We have world-class academic centres, highly trained and qualified personnel, and the expertise needed to be a global leader in the growing field of genetic medicines. In fact, the COVID-19 mRNA vaccines use Canadian-developed LNP technology for delivery.” Lewis 26

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adds, “but what we don’t have is similar funding support mechanisms compared to our international competitors.” “The pandemic showed us that having a domestic capacity for vaccine development and biomanufacturing is critical for national security. We can’t depend on other countries to innovate and manufacture medicines for us,” says Dr. Lewis. “Strategic investments from the Canadian government can pay huge dividends by providing Canada with the capacity to manufacture and produce genetic medicines domestically,” he adds. The biotechnology industry has taken notice of the limitless potential of Entos’ nucleic acid delivery PLV platform. Entos has several pharmaceutical partnerships, including BioMarin and Eli Lilly, that have invested in Entos and its Fusogenix PLV technology to develop cures for rare genetic diseases plus central and peripheral nervous system diseases. There is a major shift in the pharmaceutical industry towards genetic medicines. Most traditional pharmaceutical drugs are small molecules that target proteins and receptors known to cause disease symptoms. Genetic medicines comprise a viral or lipid nanoparticle platform that carries genetic cargo for delivery inside cells to target the root cause of the disease and uses the cells’ replication machinery to amplify treatment. “Because of the huge success of COVID-19 mRNA vaccines, we’re going to see a wave of new genetic medicines against every disease plaguing humanity,” says Dr. Lewis, who predicts that within 20 years, half of the medicines we take will be genetic medicines. However, challenges remain for the widespread adoption of genetic medicines as therapeutics. The first challenge is

having a flexible and safe delivery vehicle that can protect and effectively deliver the genetic cargo into the cell. “Traditional viral and lipid nanoparticle delivery platforms can only address about ten percent of the diseases due to limitations around redosing and poor tolerability. Viral-based platforms can’t be administered to a patient more than once due to immunogenicity concerns and lipid nanoparticles are poorly tolerated by the body, limiting dosing levels,” says Dr. Lewis. Fusogenix PLVs overcome these limitations by combining the best features of viral and lipid nanoparticle delivery platforms. PLVs are formulated with the smallest known viral fusion peptide and well-tolerated lipids to safely and efficiently deliver any cargo directly into the cell. With PLVs, “we can deliver genetic medicine to the right cell at the right time to provide a therapeutic effect, so we can re-dose with much lower toxicity than the current delivery platforms,” Dr. Lewis explains. During the pandemic, Entos used its Fusogenix PLV platform to develop a DNA-based COVID-19 vaccine called Covigenix. In under a year, Entos brought Covigenix to Phase I clinical trials. “We created a DNA based vaccine that appears effective at low doses, similar in range to the current mRNA COVID-19 vaccines. This low dose compares favourably to other DNA vaccines that use much higher doses of DNA,” says Dr. Lewis. He also notes that RNA vaccines need to be kept very cold to remain stable, making shipping and storage expensive and not universally available. Although the mRNA-based COVID-19 vaccines have proven safe and effective, the Fusogenix PLV DNA vaccine offers the important advantage of stability at refrigerator temperatures and appears effective as a single shot with

high durability over time. Entos’ vaccine is now in Phase II clinical trials in Africa to study its immunogenicity and safety. “Once we have this data, we plan to run Phase III clinical trials in North America to evaluate its effectiveness as a COVID-19 booster,” Lewis says. Another major challenge genetic medicine manufacturers must overcome is the ability to significantly increase the scale of production of these therapeutics. Again, the COVID-19 pandemic helped mitigate this challenge with the swift deployment of many new facilities worldwide to meet demand. However, demand still exceeds supply and production capabilities, and significant infrastructure investments are required to support this rapidly expanding industry. Federal investments in homegrown biotechnology companies with new programs like the Canada Growth Fund will allow Canada to re-establish itself as a leader in the pharmaceutical industry. If Canada invests quickly to take advantage of the genetic medicine momentum, the nation could meet the demand for genetic medicines within and outside its border. Entos is excited to be a part of this industry. Through its Fusogenix PLV technology, it is ready to play a leading role in Canada, contributing to the innovation and manufacturing of this new generation of genetic medicines. With increased federal support Entos and other genetic medicine companies in Canada will be able to translate their scientific breakthroughs into vaccines and therapeutics, helping to save lives and build our economy. Let’s invest in Canadian biotechnology companies to re-build the industry and lead the future of genetic medicines.

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Virica Biotech is Changing the Landscape of Viral Medicine Manufacturing Virica Biotech fait évoluer la fabrication de médicaments viraux Q&A with Jean-Simon Diallo Jean-Simon Diallo a répondu aux questions de BIOTECanada

DR. JEAN-SIMON DIALLO, PH.D., IS A SCIENTIST WITH BROAD EXPERTISE IN BIOCHEMISTRY, MOLECULAR BIOLOGY, CANCER THERAPEUTICS, AND VIRAL IMMUNOLOGY. Dr. Diallo is an internationally recognized expert in oncolytic virotherapy and was seminal in the discovery of Viral Sensitizers and its development for virus manufacturing and cancer therapy applications in combination with oncolytic viruses. What are viral medicines and why are they important? When we say viral medicines, we refer to a medicine which relies on use of a virus to deliver the medical effect, such as vaccines and gene therapies for cancer and other diseases. This class of medicines is arguably the most effective we have to treat or prevent disease. For example, viral vaccines have irradicated smallpox. The use of viral vectors to deliver genes into cells have led to breakthrough cancer treatments like CAR-T and potential treatment of genetic diseases such as hemophilia. Today, biotech companies are developing thousands of new treatments for a range of diseases including Alzheimer’s, heart disease, diabetes, Parkinson’s, and many more. While eager to speed development, companies are struggling to produce these medicines at scale. At the heart of these new treatments are viral vectors, disabled viruses used to slip good genes into cells that lack them. Without efficient commercial-scale manufacturing of viral vectors, there is no treatment. WHAT IS THE BIGGEST CHALLENGE FACING GENE THERAPIES AND VACCINES? The most serious challenge is the cost of manufacturing process itself. Manufacturing custommade viral vectors can cost biotech firms a third or more of their development budget. When production is so expensive, the

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JEAN-SIMON DIALLO, PH. D., POSSÈDE UNE VASTE EXPERTISE EN BIOCHIMIE, EN BIOLOGIE MOLÉCULAIRE, EN TRAITEMENT DU CANCER ET EN IMMUNOLOGIE VIRALE. En tant qu’expert de renommée internationale dans le domaine de la virothérapie oncolytique, il a joué un rôle déterminant dans la découverte des médicaments de type « sensibilisateurs viraux », dans leur utilisation pour la fabrication de virus et dans les traitements contre le cancer en combinaison avec des virus oncolytiques.

À QUELLES FINS UTILISE-T-ON LES MÉDICAMENTS VIRAUX ET POURQUOI SONT-ILS IMPORTANTS?

Les médicaments viraux reposent sur l’utilisation d’un virus pour transmettre l’effet médical escompté; il s’agit par exemple des vaccins et des thérapies géniques contre le cancer et d’autres maladies. Cette catégorie de médicaments est sans doute la plus efficace dont nous disposons pour traiter ou prévenir les maladies. Les vaccins viraux ont notamment permis d’éradiquer la variole. L’utilisation de vecteurs viraux pour introduire des gènes dans les cellules a permis de mettre au point des traitements révolutionnaires contre le cancer, comme le traitement par cellules CAR-T, et ouvre de nouvelles perspectives pour le traitement de maladies génétiques comme l’hémophilie. Aujourd’hui, les entreprises de biotechnologie mettent au point des milliers de nouveaux traitements pour toute une série de maladies, dont la maladie d’Alzheimer, les maladies cardiaques, le diabète, la maladie de Parkinson, et bien d’autres encore. Bien que désireuses d’accélérer la chaîne de commercialisation, les entreprises ont du mal à produire ces médicaments à grande échelle. Au cœur de ces nouveaux traitements interviennent les vecteurs viraux, des virus désactivés utilisés pour acheminer de bons gènes dans des cellules Jean-Simon Diallo, CEO and Founder of Virica Biotech qui en sont dépourvues. Sans une BIOTECanada

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chaîne de fabrication treatment itself must be efficace pour les vecteurs expensive, which limits the viraux sur le plan potential for these commercial, on ne peut important therapies to envisager d’arriver à créer reach a very broad des traitements. population in need. Quel est le plus grand The cost and complexity of obstacle pour les thérapies production is high because géniques et les vaccins? viral vectors used in gene Le plus grand problème therapies and vaccines are auquel nous sommes grown in cells (such as confrontés est le coût du HEK 293, Vero, MRC-5 processus de fabrication cells, and embryonic eggs). lui-même. La fabrication de But, like all cells, these How VSEs Work? (TITLE) VSEs are small molecules that suppress vecteurs viraux sur mesure manufacturing cells have anti-viral defences found in manufacturing cells. (subtitle) peut coûter aux entreprises innate anti-viral de biotechnologie un tiers ou responses that kick in to plus de leur budget de développement. Une production si eliminate the virus. This innate response significantly coûteuse signifie que le traitement lui-même le sera aussi, ce diminishes the production yield of viral vectors. In fact, the qui limite la portée de ces importants traitements auprès manufacturing cell’s immune response can have d’une vaste population qui en a besoin. unpredictable negative effects on viral vector production, Le coût et la complexité de la production sont élevés, car impacting both quantity and quality.

WHAT IS VIRICA DOING ABOUT THE HIGH COST OF MANUFACTURING VIRAL VECTORS? We believe in making viral medicines more accessible to treat not only the rare but common diseases too. We are the first company to develop a proprietary platform that uses small molecules, called viral sensitizers (VSEs™) as additives to optimize viral vector production. Our targeted VSE™ formulations attenuate the anti-viral response pathways of manufacturing cells, significantly increasing production yields, in some cases by five to 10 times. We also offer custom VSE™ formulation services designed to tailor a formulation to our clients’ specific manufacturing platforms. Our molecules are made according to the regulatory standards required for treating patients. Adding our custom VSE™ media additives lower production costs for our clients, shorten their time frames to meet production targets, and will ultimately increase access to life-saving vaccines and gene therapies. What companies are using Virica’s VSEs™ today? We have customers from around the world using our VSEs™ to develop vaccines, gene therapies and anti-cancer therapies. We are helping them move from small-scale clinical production into advanced commercial manufacturing levels. Most recently we have partnered with Oxford Biomedica to improve the yield and production efficiency of their next generation lentiviral vector gene therapies. WHAT’S NEXT FOR VIRICA BIOTECH? Our plan is to enhance viral vector manufacturing around the world. We intend to help clear the bottleneck for those who have been waiting in line, sometimes years, to scale

les vecteurs viraux utilisés dans les thérapies géniques et les vaccins sont cultivés dans des cellules (telles que les cellules HEK 293, Vero, MRC-5 et embryonnaires). Mais, comme toutes les cellules, ces cellules issues de la fabrication ont des réponses antivirales innées qui se déclenchent pour éliminer le virus. Ce type de réponse innée a pour conséquence de diminuer considérablement le rendement de production des vecteurs viraux. En fait, la réponse immunitaire des cellules fabriquées en laboratoire peut avoir des effets négatifs imprévisibles sur la production de vecteurs viraux, tant sur le plan de la quantité que de la qualité.

QUE FAIT VIRICA POUR FAIRE FACE AU COÛT ÉLEVÉ DE LA FABRICATION DES VECTEURS VIRAUX? Nous croyons que les médicaments viraux devraient être plus largement accessibles pour le traitement non seulement des maladies rares mais aussi des maladies courantes. Nous sommes la première entreprise à avoir créé une plateforme exclusive qui utilise de petites molécules, appelées sensibilisateurs viraux (VSE™), comme additifs pour optimiser la production de vecteurs viraux. Nos formulations VSE™ ciblées atténuent les voies de réponse antivirale des cellules fabriquées, ce qui augmente considérablement les rendements de production, dans certains cas de cinq à dix fois. Nous proposons également des services de formulation VSE™ personnalisés, conçus pour adapter une formulation directement aux plateformes de fabrication de nos clients. Nos molécules sont conçues selon les normes réglementaires requises pour le traitement des patients. L’ajout de nos additifs pour milieux de culture VSE™ personnalisés permet à nos clients de réduire leurs coûts de production, de raccourcir les délais et d’atteindre leurs objectifs de production et, en fin de

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compte, d’accroître l’accès aux vaccins et aux thérapies géniques qui sauvent des vies.

QUELLES SONT LES ENTREPRISES QUI UTILISENT LES VSE™ DE VIRICA AUJOURD’HUI? Nous avons des clients qui utilisent les VSE™ pour créer des vaccins, des thérapies géniques et des traitements contre le cancer partout au monde. Nous les aidons à passer d’une production clinique à petite échelle à des niveaux de fabrication commerciale avancés. Tout récemment, nous nous sommes associés à Oxford Biomedica pour améliorer le rendement et l’efficacité de la production de ses thérapies géniques à base de vecteurs lentiviraux de nouvelle génération.

À QUOI RESSEMBLERA L’AVENIR POUR VIRICA BIOTECH? Virica Researchers at their production innovation facility, part of the Ottawa Health Innovation Hub

up their vaccines and gene therapies for testing in clinical trials and for commercial manufacturing. Virica has the expertise to help innovators and manufacturers meet market demand and get more life-saving treatments to those who need it. HOW IT ALL BEGAN Virica Biotech was founded in 2018 based on a decade of research in the laboratory of Dr. Jean-Simon Diallo at the Ottawa Hospital Research Institute. While Dr. Diallo was investigating novel oncolytic viral therapies (OVTs) he recognized the need for VSEs™ to enhance the effectiveness of OVTs. After developing VSEs™ to address the innate anti-viral defenses of cells in the OVT space, Dr. Diallo realized how broadly applicable their attributes would be to gene therapy and vaccine production. Recent influenza outbreaks and the COVID-19 pandemic highlight the need for scalability in the production of vaccines. Virica has the products and experience to combat these challenges. Today, Virica is changing the landscape of viral medicine manufacturing. More and more developers are incorporating custom VSE™ formulations into their process, to increase production yields and reduce their cost of goods. To learn more visit viricabiotech.com.

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Notre but est de contribuer à l’amélioration de la fabrication de vecteurs viraux dans le monde entier. Nous avons l’intention d’aider les entreprises à passer un cap, notamment celles qui attendent, parfois depuis des années, pour finaliser leurs vaccins et leurs thérapies géniques en vue de les tester dans le cadre d’essais cliniques et de les commercialiser. Virica possède l’expertise nécessaire pour aider les entreprises novatrices et les fabricants à répondre à la demande du marché et à fournir davantage de traitements vitaux à ceux qui en ont besoin.

PETIT RETOUR EN ARRIÈRE Virica Biotech a été fondée en 2018 à la suite d’une décennie de recherche dans le laboratoire de Jean-Simon Diallo à l’Institut de recherche de l’Hôpital d’Ottawa. Alors que M. Diallo s’intéressait aux nouveaux traitements viraux oncolytiques (OVT), il a découvert qu’il était nécessaire de disposer de VSE™ pour améliorer l’efficacité des OVT. Après avoir créé des VSE™ pour atténuer les défenses antivirales innées des cellules dans la sphère des traitements viraux oncolytiques, Jean-Simon Diallo a réalisé à quel point leurs attributs seraient largement applicables à la thérapie génique et à la production de vaccins. Les récentes épidémies de grippe et la pandémie de COVID-19 ont mis en lumière la nécessité de faire évoluer la production de vaccins. Virica dispose des produits et de l’expérience nécessaires pour relever ces défis. Aujourd’hui, Virica joue un rôle de premier plan dans la fabrication de médicaments viraux. De plus en plus d’entreprises pharmaceutiques intègrent des formulations VSE™ personnalisées dans leur processus, afin d’augmenter les rendements de production et de réduire le coût des matériaux. Pour en apprendre davantage, veuillez consulter le site viricabiotech.com.

NEW T CELL TACTIC HELPS CANCER PATIENTS FIGHT BACK CANADIAN AND US SCIENTISTS ARE WORKING TOGETHER TO POTENTIALLY HELP MILLIONS OF CANCER PATIENTS by targeting tough-to-treat tumors through an innovative technology that unleashes the power of the body’s own immune system by activating T cells. The solid tumor T cell therapy space is a growing research field, and Triumvira, a clinical-stage immunooncology company, is taking a unique approach in developing targeted autologous and allogeneic T cell therapeutics to provide patients with state-of-the-art treatment options that do not have the challenging limitations of other standard of care therapies such as chemotherapy and radiation. “We are empowering the immune system of cancer patients to fight back,” says Paul Lammers, MD, President and CEO of Triumvira. “We believe that our unique technology platform has the potential to treat patients suffering from different unique cancer types and many other serious diseases.” Triumvira’s approach is different from other T cell therapies, like CAR-Ts that involve genetically engineered receptors that modify the TCR itself. “T cells are a type of white blood cell that play an important role in helping the body’s immune system fight cancer by directly killing tumor cells and activating other

immune cells to join the battle,” adds Dr. Lammers. “With our T cell Antigen Coupler – or TAC platform – we are developing T cell therapies to treat cancer patients featuring a genetically engineered TAC molecule that interacts with the natural T cell receptor (TCR) to help them recognize and eliminate cancer cells.” By co-opting the TCR, TAC-T cells enhance the natural anti-cancer abilities of T cells through a more passive, controlled mechanism with potential for a reduced risk of unwanted toxicities common to T cell therapies, such as cytokine release syndrome or, severe neurological toxicities. Triumvira’s TAC-T program pipeline consists of multiple product candidates targeting overexpressed genes across a wide variety of solid tumors, including breast, ovarian, gastric, liver, colon and non-small cell lung cancers. The lead clinical candidate, TAC01-HER2, designed to target HER2-positive solid tumors, is being evaluated in a Phase 1/2 clinical trial that is actively enrolling patients. Triumvira is working with Lonza, a global expert in T cell manufacturing, to develop its autologous TAC-T cell products using Lonza’s automated and self-contained Cocoon™ Manufacturing System. Use of the Cocoon significantly streamlines the cell engineering procedure, leading to high quantity and quality TAC T-cells. Triumvira is well-financed having recently completed an extension to its Series A financing in March 2022, bringing the total round to just over $100 million and featuring participation from prominent investors including Leaps by Bayer, Northpond Ventures, and B Capital Group. With its technology platform independently validated in preclinical models of cancer by a top-tier pharmaceutical company and an independent CRO, Triumvira is now progressing its robust pipeline with additional Investigational New Drug applications planned for 2023 through 2025. Triumvira is also discussing its TAC T-cell product development progress with several companies as product licensing will provide additional growth opportunities for its business. For more information, visit: www.triumvira.com

Dr. Paul Lammers, President and CEO

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Building a Ready-to-use Data System from the Ground Up Before Data Exists! – A Paradigm Shift for New Manufacturing Facilities Construire un système de données prêt à l’emploi, avant même que les données n’existent ! - Un changement de paradigme pour les nouvelles unités de production by/par Michael Celarek1 , Ramila Peiris1 and Olivier Moureau2

YOU WOULD BE SHOCKED TO REALIZE THAT YOUR BRAND-NEW HOME YOU JUST WALKED INTO HAS NO ACCESS TO POTABLE WATER. Your builder never installed pipes and faucets which deliver water to your kitchen, bathroom, or laundry. Ready-to-use potable water available in a new home is a basic need and an unconscious expectation of any home buyer in the developed world. Like potable water for a home, timely access to ready-to-use (RTU) data is fundamental and should be considered a basic need for digital transformation. Not long ago, The Economist declared that data has replaced oil as the world’s most valuable resource.1 Like crude oil, raw data is not valuable in itself, but only when it is contextualized and presented in an RTU format. However, the expectation of timely access to RTU data for new manufacturing facilities seems to have a lower bar. RTU data can be an extremely helpful enabler for teams supporting new facility projects to make data-driven decisions and maintain the scheduled cadence of project execution activities. This would allow them to avoid unplanned delays, move to consistency runs and GMP manufacturing operations on time. This need is not often considered during the planning and design stages of most new manufacturing buildings and is especially the case for new pharmaceutical/biologics manufacturing facilities. When it comes to designing and building new manufacturing sites, most of the resources are allocated and attention is given to equipment, buildings, and other infrastructure, such as automation, execution and control systems, and basic raw data storage systems. Building data pipelines that connect this valuable infrastructure to end-users and a data contextualization system, which cleans, aggregates, and organizes data into an RTU/

IMAGINEZ LA SURPRISE EN RÉALISANT QUE LA MAISON TOUTE NEUVE DANS LAQUELLE VOUS VENEZ D’ENTRER N’A PAS D’ACCÈS À L’EAU POTABLE. Votre constructeur n’a jamais installé les tuyaux et les robinets qui alimentent en eau votre cuisine, votre salle de bain ou votre buanderie. L’eau potable disponible dans une nouvelle maison est un besoin indispensable et un acquis de tout acheteur dans le monde dans lequel nous vivons. À l’instar de l’eau potable pour une maison, l’accès en temps voulu à des données prêtes à l’emploi (RTU - Ready To Use) est fondamental et devrait être considéré comme un besoin de base pour une transformation numérique. Il n’y a pas si longtemps, The Economist déclarait que les données avaient remplacé le pétrole en tant que ressource la plus précieuse au monde 1 . Comme le pétrole brut, les données brutes n’ont pas de valeur en soi, c’est seulement lorsqu’elles sont contextualisées et présentées dans un format RTU qu’elles en ont. Cependant, l’attente pour l’accès aux données RTU en temps voulu pour les nouvelles unités de production ne semble pas toujours être une priorité. Les données RTU peuvent être extrêmement utiles aux équipes en charge de projets de nouvelles installations pour prendre des décisions fondées sur les données et tenir ainsi les engagements des projets. En particulier, cela leur permet d’éviter les retards non planifiés, en réalisant notamment les lots de consistency et les opérations de fabrication BPF dans les temps. Ce besoin de données RTU n’est pas souvent pris en compte lors des étapes de planification et de conception de la plupart des nouveaux bâtiments de production, en particulier pour les nouvelles unités de production de produits pharmaceutiques/biologiques. Lorsqu’il s’agit de concevoir et de construire de nouveaux sites de fabrication, la plupart des ressources sont allouées essentiellement aux équipements, aux bâtiments et aux autres infrastructures. Les

Email address(es): michael.celarek@sanofi.com; ramila.peiris@sanofi.com; olivier.moureau@sanofi.com Author affiliations: 1.Sanofi, 1755 Steeles Avenue West, Toronto, ON M2R 3T4, Canada 2. Sanofi, 1541 Avenue Marcel Merieux 69280 Marcy-L’ Etoile France 1. The Economist, (2017, May 6), The world’s most valuable resource is no longer oil, but data, https://www.economist.com/leaders/2017/05/06/the-worlds-most-valuable-resource-is-no-longer-oil-but-data

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business-ready format, is often left outside the perimeter of planning, designing and execution of new building projects. Once a manufacturing building is in regular operation, the burden of building a data contextualization system typically falls on Data Science and other supporting business units. This would mean that RTU data is not available to monitor and troubleshoot manufacturing operations from day one, i.e., right at the start of test/ engineering runs of new pharmaceutical/ biologics manufacturing facilities. This would also mean that either additional resources must be brought in, or the existing resources will need to be stretched to support manual collection (a.k.a., data pulling), aggregation, cleaning, and organization of data to support process monitoring and decision making until an automated data pipeline and data contextualization system are built. It is time for the industry to realize that the current paradigm of delivering new facilities need a facelift when it comes to data readiness and digitalization. Just like a homeowner expects RTU water from day one of assuming ownership of a house, industries must shift the current mindset and enable access to RTU data from day one. After all, when access to RTU data can put you in an advantageous position in terms of financials, schedule, and compliance targets, why wouldn’t you change the current paradigm? In this article, we want to share what Sanofi’s Toronto site has done differently. We hope that the information provided here would be beneficial to the industry. PARADIGM SHIFT At Sanofi’s Toronto site, a new bulk vaccine facility with over CAD 500 million in investment is getting ready to start manufacturing operations. This new facility, named Building 100 (B100), has presented an opportunity for the organization to build a data system that would provide RTU data to the end-users from day one. In the past, such data

Michael Celarek

Olivier Moureau

systèmes d’automatisation, d’exécution et de contrôle, et les systèmes de base de stockage des données brutes sont les plus concernés. La construction de pipelines de données qui relient ces infrastructures aux utilisateurs finaux et au système de contextualisation des données, qui nettoie, regroupe et organise les données dans un format prêt à l’emploi (RTU), est fréquemment laissé en dehors du périmètre de planification, de conception et d’exécution des projets de nouveaux bâtiments. Une fois qu’un bâtiment de production est en fonctionnement de routine, la mise en place d’un système de contextualisation des données incombe généralement aux data scientists et aux autres équipes support. Les données RTU ne sont donc pas disponibles pour surveiller et dépanner les opérations de fabrication dès le premier jour, c’est-à-dire dès le début des essais/exploitations techniques des nouvelles unités de production. Cela signifie également que des ressources supplémentaires doivent être mises à disposition (dans un second temps) et que le personnel existant doive souvent gérer manuellement des activités de gestion de données. C’est-à-dire l’extraction des données, l’agrégation, le nettoyage et l’organisation des données afin de réaliser la surveillance des procédés et gérer la prise de décision jusqu’à ce qu’un pipeline de données automatisé et un système de contextualisation des données soient mis en place. Il est temps que l’industrie se rende compte que le paradigme actuel de livraison de nouvelles unités de production a besoin d’un lifting en ce qui concerne la préparation des données et la numérisation. De la même manière qu’un propriétaire s’attend à recevoir l’eau dès le premier jour de sa prise de possession d’une maison, les industries doivent changer l’état d’esprit actuel et permettre l’accès aux données prêtes à l’emploie (RTU) dès le premier jour. Puisque l’accès aux données RTU peut vous donner un avantage en termes de finances, de planning et d’objectifs de conformité, alors pourquoi ne pas changer le paradigme actuel ? Dans cet article, nous souhaitons partager ce que le

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Figure 1 An illustration of how data contextualization is performed to generate RTU data, taking the voice of customers into consideration

Figure 1 Illustration de la manière dont la contextualisation des données est effectuée pour générer des données RTU, en prenant en compte la voix des clients.

systems were developed months after a project reached the execution stage, as it allowed data management teams to know where to find data, build data management systems and test data connections using executed batch data. However, this meant that the business did not have access to RTU data for supporting and troubleshooting the initial execution phase of the operations, including engineering batches. Against this backdrop, the Data Science Team on site embarked on a journey to build a data contextualization pipeline even before the start of any operational activities in B100. That meant building a data system before data existed.

site de Sanofi à Toronto a fait de façon différente. Nous espérons que les informations fournies vous seront utiles.

NOVELTY OF WORK B100 with its state-of-the-art automation systems, manufacturing execution system (MES) and PI data historian systems, represented a challenging situation to access business-ready data. Raw data from MES and PI are messy and not easily readable. Data from MES, PI, laboratory information management system (LIMS) and the enterprise resource planning (ERP) system needed to be contextualized (i.e., cleaning, filtering, and adding business context) so that end-users can avoid non-value-added manual efforts. This required cross-functional partnerships between different stakeholders to understand how data is structured in different source systems, capture end-user requirements, and build novel data engineering solutions.

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CHANGEMENT DE PARADIGME Sur le site de Sanofi à Toronto, une nouvelle unité de production de vaccins, représentant un investissement de plus de 500 millions de dollars canadiens, s’apprête à lancer ses activités de fabrication. Cette nouvelle installation, baptisée Building 100 (B100), a offert à l’organisation l’occasion de mettre en place un système de données qui fournira des données RTU aux utilisateurs finaux dès le premier jour. Par le passé, de tels systèmes de données étaient développés des mois après qu’un projet ait atteint le stade de production. Ce délai permettait aux équipes de data science de savoir où trouver les données, de construire des systèmes de gestion des données et d’en tester les connexions à partir de données existantes sur les lots produits. Cependant, cela signifiait que l’entreprise n’avait pas accès aux données RTU pour supporter la production dès les premiers jours de manière rapide et automatique, y compris pour les lots d’ingénierie. Dans ce contexte, l’équipe de data scientists sur le site s’est lancée dans la construction d’un pipeline de contextualisation des données avant même le début de toute activité opérationnelle au B100. Cela signifiait construire un système de données avant que les données n’existent.

NOUVEAUTÉ DU TRAVAIL Le B100 et ses systèmes d’automatisation de pointe, son système d’exécution de la fabrication (Manufacturing Execution System - MES) et ses systèmes d’historisation des données (PI), ne permettent pas d’accéder à des données

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It is time for the industry to realize that the current paradigm of delivering new facilities need a facelift when it comes to data readiness and digitalization. Just like a homeowner expects RTU water from day one of assuming ownership of a house, industries must shift the current mindset and enable access to RTU data from day one. After all, when access to RTU data can put you in an advantageous position in terms of financials, schedule, and compliance targets, why wouldn’t you change the current paradigm? SERVING VOICE OF CUSTOMERS Imagine for a second that building your brand-new home is still in progress. You have been focusing on the bathroom and laundry room, the plumber now finishing up the final touches to the sink installation. Everything there is perfect, exactly as you had imagined. Suddenly you get a call from the contractor that the kitchen is entirely complete! But wait a minute, you never provided the builder with your plan or even discussed how you needed the kitchen built. The builder simply decided they knew best how to design. For some of us this might be a nightmare scenario, but this kind of situation can occur in industry when dealing with RTU data. The experts building out the infrastructure or contextualizing the data may assume they know what data is needed, how it should be structured and presented to the end-users. The Data Science team at Sanofi pivoted away from this mentality and made the “voice of customers” a key driver for building the RTU data pipeline. The voice of the customer (user requirements) is captured digitally in a user specification management interface (USMI) and used for data contextualization. This is crucial for delivering the RTU data solution right-first time. The USMI captures several mandatory pieces of product and process specific information: business parameter name, process area, data source, data type, associated equipment ID, etc. Additionally,

facilement exploitables. Les données brutes provenant du MES et du PI sont désordonnées et difficilement lisibles. Les données provenant des MES, PI, du système de gestion des informations de laboratoire (Laboratory Information Management Systems - LIMS) et du système de gestion intégré de l’entreprise (Enterprise Resource Planning - ERP) devaient nécessairement être contextualisées (c’est-à-dire nettoyées, filtrées et enrichies d’information métier) afin que les utilisateurs finaux puissent s’éviter de nombreuses tâches manuelles sans valeur ajoutée. Cela a nécessité un important travail d’équipes pluridisciplinaires pour comprendre comment les données sont structurées dans les différents systèmes sources, capturer les exigences des utilisateurs finaux et élaborer de nouvelles solutions de data engineering.

AU SERVICE DES CLIENTS Imaginez un instant que la construction de votre maison neuve est encore en cours. Vous vous êtes concentré sur la salle de bains et la buanderie, le plombier apportant maintenant la touche finale à l’installation de l’évier. Tout y est parfait, exactement comme vous l’aviez imaginé. Soudainement, l’entrepreneur vous appelle pour vous dire que la cuisine est entièrement terminée ! Mais attendez une minute, vous n’avez jamais fourni votre plan au constructeur ni même discuté de la manière dont vous vouliez que la cuisine soit construite. Le constructeur a simplement décidé qu’il savait mieux que vous comment concevoir. Pour certains d’entre nous, il s’agit d’un scénario cauchemardesque, mais ce genre de situation peut se produire dans l’industrie lorsqu’il est question de données RTU. Les experts qui construisent l’infrastructure ou contextualisent les données peuvent supposer qu’ils savent quelles données sont nécessaires, et comment elles doivent être structurées et présentées aux utilisateurs finaux. L’équipe data science de Sanofi s’est éloignée de cette mentalité et a fait de la «voix des clients» un élément clé de la construction du pipeline de données RTU. La voix du client (les exigences de l’utilisateur) est saisie numériquement dans une interface de gestion des spécifications utilisateur (USMI) et est utilisée pour la contextualisation des données. Cette étape est cruciale pour livrer la solution permettant l’accès aux données RTU correctement dès la première fois. L’USMI recense plusieurs éléments obligatoires liés à des informations spécifiques aux produits et aux procédés : nom du paramètre métier, domaine du procédés, source de données, type de données, ID (identification) de l’équipement associé, etc. En outre, l’emplacement exact de chaque paramètre métier dans les systèmes de données sources est également cartographié dans l’USMI, permettant une identification unique des différentes informations. Le moteur de contextualisation est connecté en direct à l’USMI. Le moteur de contextualisation extrait les données brutes des nombreux systèmes sources. Ces systèmes sources sont connectés au Sanofi Cloud Data Lake et le moteur de contextualisation des données est mis en œuvre biotech.ca

the exact location of each business parameter in source data systems is also mapped, in terms of unique combination of computer queryable field names, in the USMI. The contextualization engine has a live connection to the USMI. The contextualization engine extracts raw data from a variety of source systems. These source systems are connected to the Sanofi Cloud Data Lake and the data contextualization engine is implemented in this cloud environment, where different automated data transformation steps are carried out to match user specifications. All information captured in the USMI are available before the start-up of B100 operations, including pre-engineering and engineering runs. This makes it possible to build the RTU data pipeline before the start of B100 operations. Since the USMI captures all the product and process specific user requirements, the contextualization logic and its programming scripts do not need to be cluttered with any hard-coded information related to user specifications. This allows rapid changes/ updates to the user specifications to be made without changing the contextualization logic. As a result, changes to data contextualization can be made in a nimble way to reduce maintenance efforts and turnaround times to support end-user change requests. BUILDING FOUNDATIONS Let’s take a step back for a moment. Everybody knows a building will not last with an incomplete foundation. Cracks can form, moisture will get in, collapse might even happen! Some of us are afraid to go to the basement and check. During the infancy of our RTU data system project, the current state of the B100 data foundation was assessed and the gaps identified, provided opportunities to build foundational data system capabilities to help the organization and its digital transformation journey. One key missing element was Event Frames. Event Frames (EFs) act as the backbone for some of the data contextualization needs. In B100, the EFs are built on the PI data historian system. They organize the process stages along the time axis. Using trigger conditions, such as

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dans cet environnement, où différentes étapes de transformation automatisées des données sont effectuées pour correspondre aux besoins des utilisateurs. Toutes les informations capturées dans l’USMI sont disponibles avant le démarrage des opérations au B100, y compris pour les lots de pré-ingénierie et d’ingénierie. Il est donc possible de construire le pipeline de données RTU avant le début des opérations au B100. Étant donné que l’USMI recueille toutes les exigences des utilisateurs spécifiques aux produits et aux procédés, la logique de contextualisation et les scripts associés n’ont pas besoin d’être codés en dur mais sont seulement liés aux spécifications des utilisateurs via un paramétrage. Cela permet de réaliser rapidement des modifications/mises à jour via la modification des spécifications utilisateurs sans modifier la logique de contextualisation. Par conséquent, les modifications de contextualisation des données peuvent être effectuées de manière souple en réduisant les efforts de maintenance et les délais de mise en œuvre pour répondre aux demandes de modification des utilisateurs finaux.

CONSTRUIRE DES FONDATIONS Prenons un peu de recul. Tout le monde sait qu’un bâtiment ne durera pas avec des fondations incomplètes. Des fissures peuvent se former, l’humidité s’infiltrer et un effondrement peut même se produire ! Au début de notre projet de système de données RTU, l’état actuel des fondations des données du B100 a été évalué et des lacunes ont été identifiées. Ces lacunes sont autant d’opportunités de construire un système pertinent pour aider l’organisation à accomplir sa transformation numérique. Un élément clé manquant était la gestion des événements temporels jalonnant le déroulement d’un procédé (Events Frame EF). Ces EF sont l’épine dorsale de certains besoins de contextualisation des données. Au B100, les EF sont construits via le système d’historisation des données PI. Ils organisent les étapes des procédés dans le temps. En utilisant des conditions de déclenchement, telles que des recettes d’automatisation et des valeurs de sondes/capteurs, un EF peut commencer et se terminer pour encadrer une étape du

automation recipes and probes/sensor values an Event Frame can begin and end to bracket a process step of interest. For example, a specific phase in a manufacturing step such as the harvest stage during fermentation, or material charge for buffer preparation can be identified using EFs. With EFs, it is possible to capture and monitor time series or discrete data of interest based on specific process requirements. Hundreds of EFs that are required for data contextualization were identified and built in collaboration with process experts, automation, and engineering teams. These efforts have not only enabled RTU data flows, but they would also enable the organization to benefit from these foundational data capabilities when it adopts additional digital solutions in the future.

DÉVELOPPER LES COMPÉTENCES

BUILDING COMPETENCIES Building an RTU data system from the ground up before data exists is not a cakewalk. It requires strong technical competencies in data engineering and deep knowledge in how source data systems work. Sanofi’s Toronto Data Science team walked into this challenge as a young team with most of the key contributors being either new to the industry or not having background or experience with the new B100 data systems. Different stakeholder groups in the organization also did not have a proper grasp of what data contextualization was and what needed to be done to get an RTU system up and running. What made it possible though is the strong collaborations and partnerships that formed between different stakeholders, including the process subject matter experts, information technology (IT) specialists, source data system experts and the Data Science team. Known as “iContext” within the organization, this project is not only creating a paradigm shift in the way we deliver RTU data from a brand-new facility to the business, but it has also increased the foundational and technical capabilities within the organization and paves the way to build high-caliber Data Science talents for the future.

Construire un système de données RTU à partir de zéro, avant même que les données n’existent, n’est pas une sinécure. Elle exige de solides compétences techniques en ingénierie des données et une connaissance approfondie du fonctionnement des systèmes de données sources. Les équipes data science de Sanofi à Toronto ont relevé ce défi, bien que la plupart des contributeurs clés étant soit nouveaux dans l’entreprise, soit sans expérience des nouveaux systèmes de données du B100. Les différents groupes d’intervenants n’avaient pas non plus une bonne compréhension de ce qu’était la contextualisation des données et de ce qu’il fallait faire pour mettre en place et faire fonctionner un système RTU. Ce qui a rendu la chose possible, ce sont les collaborations solides qui se sont formées entre les différentes parties prenantes. Notamment les experts en matière de procédés, les spécialistes des technologies de l’information (IT), les experts des systèmes de données sources et l’équipe data science. Connu sous le nom de «iContext» en interne, ce projet ne crée pas seulement un changement de paradigme dans la façon dont nous fournissons les données RTU d’une nouvelle unité, mais il a également augmenté les compétences au sein de l’organisation et ouvre la voie à la formation de talents de haut niveau en science des données pour l’avenir.

procédé d’intérêt. Par exemple, une phase spécifique d’une étape de fabrication, telle que la phase de récolte pendant la fermentation ou la préparation d’un tampon, peut être identifiée à l’aide d’un EF. Grâce aux EF, il est possible de capturer et de surveiller des séries chronologiques ou des données discrètes d’intérêt en fonction des besoins spécifiques du procédé. Des centaines de EF nécessaires à la contextualisation des données ont été identifiés et intégrés en collaboration avec des experts procédés, des équipes d’automatisation et d’ingénierie. Ces efforts ont non seulement permis de mettre en place les flux de données RTU, mais ils permettront également de bénéficier de ces informations pour d’autres solutions numériques à l’avenir.

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Canada’s Fusion Pharmaceuticals at the Forefront in Resurgence of Radiopharmaceuticals in Development to Treat Cancer La Canadienne Fusion Pharmaceuticals à l’avant-garde du retour des produits radiopharmaceutiques dans la recherche en oncologie Q&A with John Valliant, Ph.D., Chief Executive Officer, Fusion Pharmaceuticals Entretien avec John Valliant, Ph. D., Chef de la direction, Fusion Pharmaceuticals

QUEL PROBLÈME TENTEZ-VOUS DE RÉSOUDRE? WHAT IS THE PROBLEM YOU ARE TRYING TO SOLVE? Le cancer. Nous avons de grandes ambitions quant à la Cancer. We have big ambitions to develop personalized mise en point de puissants traitements personnalisés dans and potent treatments in areas of high unmet medical need. des domaines où d’importants besoins demeurent à combler We feel we have a unique opportunity to achieve this sur le plan médical. lofty goal based upon our team’s expertise and Fusion’s Nous croyons disposer d’une occasion unique d’atteindre platform technology. ce vaste objectif grâce à l’expertise de l’équipe et aux People are generally familiar with external beam technologies de Fusion. radiation, which has been a mainstay of cancer therapy for En général, les gens connaissent la radiothérapie externe, decades. Here, a tumor is bathed in a beam of radiation qui est une constante dans les traitements du cancer depuis delivered from a machine. Despite the success of external des décennies : une machine projette sur la tumeur un beam radiation treatment, its use is limited to treating a faisceau de radiation. Bien que cette technique ait fait ses finite number of tumors and not all cancers respond. We preuves, on ne peut l’employer que pour traiter un certain asked the question, what if we could bring the radiation nombre de tumeurs, et certains cancers y sont insensibles. directly to cancer cells? Nous nous sommes donc posé la question : et si nous Radiopharmaceuticals, which are injected intravenously, pouvions irradier de plus près les cellules cancéreuses? take radiation therapy to the next level by delivering Cela nous a menés aux produits radiopharmaceutiques, radiation directly to cancer cells. Fusion focuses on qui sont injectés par intraveineuse et qui constituent en actinium-based alpha-emitting radiopharmaceuticals, radiothérapie un nouveau palier, où la radiation vise which are designed to cause substantial physical damage directement les cellules cancéreuses. Fusion axe ses efforts to cancer cells, including multiple double-stranded DNA sur les produits radiopharmaceutiques de type isotope breaks that are lethal to the tumor. When combined with a émetteur alpha à base d’actinium, qui sont conçus pour targeting molecule, such as an antibody or small molecule, causer des dommages considérables aux cellules alpha particles are “smart bombs” for cancer cells. cancéreuses, notamment des cassures des deux brins de Not only do radiopharmaceuticals offer a way to l’ADN, qui s’avèrent létales pour les tumeurs. Lorsqu’elles irradicate multiple cancers simultaneously, we can also see sont associées à une molécule ciblant les cellules where they go in patients. A benefit of cancéreuses, par exemple un anticorps ou une petite radiopharmaceuticals is that imaging can be used to molécule, les particules alpha se assess the uptake of the drug into tumors transforment en « bombes intelligentes ». and to determine radiation doses to key Ainsi, non seulement les produits organs, helping to identify patients most radiopharmaceutiques offrent-ils un moyen likely to respond to therapy. This d’irradier de multiples tumeurs à la fois, mais personalized approach to medicine is leur mécanisme fait que l’on sait où ils se designed to ensure the right drug is given trouvent dans l’organisme du patient. En to the right patient. effet, un des avantages des produits Our field of radiopharmaceuticals is radiopharmaceutiques est que l’imagerie experiencing a resurgence of interest right permet d’évaluer l’envahissement des now, driven by the opportunity to harness tumeurs par le médicament et de déterminer the power of radiation to kill cancer cells. les doses de radiation à envoyer aux organes In addition, technology advancements essentiels, puis de savoir quels patients allow this new generation to overcome répondent favorablement au traitement. Une prior challenges of radiopharmaceuticals, telle approche personnalisée de la médecine and recent positive clinical data is leading John Valiant, Chief Executive vise à faire en sorte que le bon médicament est to a surge in investments and product Officer/Chef de la direction administré au bon patient. 38

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launches. Having spent 25+ years in the field, it’s been rewarding for me to see these therapies becoming one of the primary pillars of modern cancer treatment. HOW HAS FUSION BENEFITTED FROM THE CANADIAN BIOTECH ENVIRONMENT? The Canadian biotech environment is rapidly growing and has significant untapped potential. We have benefitted from Canada’s investments in basic research, Ontario’s commitment to translational research and various funding agencies making major investments in research infrastructure. We have also benefitted from access to top-tier talent, particularly in science. Our Hamilton headquarters is adjacent to the campus of McMaster University. Since we spun out of the Centre for Probe Development and Commercialization (CPDC), which was founded at McMaster, where I’ve been a professor for over 20 years, we have had a close relationship with the University since our inception. With these origins in academia, we have benefitted from attracting employees who focus on innovation, transformational R&D and who are advancing innovations in cancer therapy. We are also re-investing in the Canadian biotech landscape. We recently entered a partnership with McMaster University, supported by MITACS. Through internships for graduate, undergraduate and post-doctoral fellows, our partnership with McMaster will explore projects related to radiopharmaceutical R&D. In addition to advancing our research, the partnership will foster a pipeline of scientists with the skills that Fusion will need to grow.

Fusion has shown itself to be an incredibly adaptable organisation with a strong and positive work culture. During the early days of the COVID-19 pandemic, we faced a particular challenge: how to continue our ambitious business growth plans, which included hiring a significant number of new employees, completing a major financing, and executing transformative business development transactions in a new virtual world. We succeeded in all cases.

Il y a une recrudescence d’intérêt pour le domaine des produits radiopharmaceutiques à l’heure actuelle, en raison de la possibilité d’exploiter la puissance de la radiation pour tuer les cellules cancéreuses. De plus, les progrès technologiques permettent aux produits radiopharmaceutiques de nouvelle génération de surmonter certains défis, et de récentes données cliniques favorables ont suscité une hausse des investissements et du nombre de lancements de nouveaux produits. Ayant travaillé plus de 25 ans dans le domaine, je trouve très gratifiant de voir ces traitements en passe de devenir l’un des grands piliers du traitement moderne du cancer.

EN QUOI FUSION A-T-ELLE TIRÉ PARTI DU MILIEU CANADIEN DES BIOTECHS? Le milieu canadien des biotechs connaît une croissance rapide et recèle toujours un important potentiel inexploité. Nous avons tiré avantage des investissements du Canada dans la recherche fondamentale, de l’engagement de l’Ontario envers la recherche translationnelle et d’investissements majeurs effectués par divers organismes de financement dans les infrastructures de recherche. Nous avons aussi eu accès à des talents de premier plan, particulièrement en sciences. Notre siège social de Hamilton est voisin du complexe de l’Université McMaster. Depuis que Fusion a essaimé du Centre for Probe Development and Commercialization (CPDC), qui avait été fondé à McMaster, où j’ai enseigné pendant plus de 20 ans, nous avons maintenu une relation étroite avec l’université. Étant nous-mêmes issus du milieu universitaire, nous avons pu attirer des employés ayant à cœur l’innovation et la R.-D. transformationnelle et capables d’œuvrer à faire progresser les découvertes en oncologie. En outre, nous réinvestissons dans le milieu canadien des biotechs. Nous avons récemment conclu un accord de partenariat avec l’Université McMaster, avec le soutien de MITACS. Ce partenariat, qui nous permettra d’offrir des stages aux diplômés et des bourses de recherche aux étudiants des cycles supérieurs et aux postdoctorants, sera axé sur des projets de R.-D. radiopharmaceutique. En plus de faire progresser nos travaux de recherche, le partenariat créera un bassin de chercheurs possédant les compétences dont Fusion a besoin pour croître. Si l’on regarde en arrière, on constate que le Canada a joué un rôle de leader dans le domaine radiopharmaceutique. À partir de travaux qui remontent aux années 1950, j’ai fondé le CPDC en 2008 dans le giron du programme fédéral de Centres d’excellence en commercialisation et en recherche (CECR). Grâce à l’appui du programme des CECR, de l’Institut ontarien de recherche sur le cancer (IORC), de McMaster et de multiples partenaires commerciaux, le CPDC a mis au point des technologies de recherche, de mise au point et de fabrication de produits radiopharmaceutiques, qui profiteront aux patients de partout dans le monde. Fusion a essaimé du CPDC pour faire progresser certaines des technologies, mais

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Looking back in history, Canada has had a leadership role in radiopharmaceuticals. Leveraging that work which goes back to the 1950s, in 2008, I founded the CPDC, a Centre of Excellence for Commercialization Research under the Canadian federal government’s Centres of Excellence for Commercialization and Research (CECR) program. With support of the CECR program, the Ontario Institute for Cancer Research (OICR), McMaster and multiple commercial partners, CPDC established technology to discover, develop and manufacture radiopharmaceuticals to the benefit of patients the world-over. Fusion spun out of the CPDC to advance certain technologies developed there, and we continue to partner with them in manufacturing our radiopharmaceuticals. We also partner with Vancouver-based TRIUMF to develop, produce and procure the supply of actinium-225, used in the creation of our radiopharmaceutical therapies. These resources, along with great Canadian venture capital firms like Genesys Capital, are examples of how the Canadian biotech environment has supported Fusion’s launch and growth, particularly in our niche area of radiopharmaceuticals. With the well-known challenges facing the industry (including access to capital and talent), what unique abilities have you discovered about yourselves? Fusion has shown itself to be an incredibly adaptable organisation with a strong and positive work culture. During the early days of the COVID-19 pandemic, we faced a particular challenge: how to continue our ambitious business growth plans, which included hiring a significant number of new employees, completing a major financing, and executing transformative business development transactions in a new virtual world. We succeeded in all cases. In the past two years, we grew by approximately 60

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la collaboration entre Fusion et le CPDC se poursuit en ce qui a trait à la fabrication. Nous avons aussi conclu un partenariat avec la vancouvéroise TRIUMF, qui assure la mise au point, la production et l’approvisionnement de stocks d’actinium-225, sur lequel s’appuie la création de nos traitements radiopharmaceutiques. Ces ressources, auxquelles s’ajoutent les grandes entreprises canadiennes de capital de risque telles que Genesys Capital, sont des exemples de la façon dont le milieu canadien des biotechs a appuyé les premiers pas et la croissance de Fusion, en particulier dans la niche commerciale des produits radiopharmaceutiques. Par rapport aux défis permanents que doit relever l’industrie (dont l’accès au capital et aux talents), de quelles capacités uniques dispose l’équipe de Fusion? Fusion a fait la preuve d’une incroyable capacité d’adaptation, ainsi que d’une culture professionnelle forte et optimiste. Au début de la pandémie de COVID-19, nous avons rencontré une difficulté particulière : il nous fallait continuer de mettre en œuvre un ambitieux plan d’affaires, qui supposait l’embauche d’un grand nombre d’employés, la réalisation d’un important cycle de financement et la conclusion de transactions transformationnelles sur le plan de l’expansion de l’entreprise, tout cela dans le contexte virtuel auquel nous étions tous astreints. Nous avons connu la réussite sur tous les plans. Au cours des deux dernières années, nous nous sommes adjoint les services d’environ 60 nouveaux employés. Nous avons aussi conclu des accords d’envergure avec des multinationales pharmaceutiques telles qu’AstraZeneca et Ipsen. Enfin, notre premier appel public à l’épargne, en juin 2020, a été succès. Nous avons levé 212 millions $ US au plus fort de la pandémie, lorsque l’on cherchait encore comment fonctionner dans la « nouvelle normalité ».

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employees. We also completed major deals with large pharmaceutical companies such as AstraZeneca and Ipsen. Finally, we executed a successful initial public offering in June 2020, raising $212 million (USD) through the height of the pandemic when we were all still trying to figure out how to operate in the “new normal.” I attribute this success to a couple of factors: 1) the innovative nature of the business we are in that supports creative thinking in the face of challenges; and 2) the phenotype of employees that are drawn to Fusion. I’ve been incredibly proud of how the employees at Fusion came together to work through the challenges presented by COVID and how they have embraced the challenges and opportunities of working on innovative cancer medicines. We have built a close-knit culture of collaboration and science driven innovation. In a time when many people have felt isolated, we leaned on social connections at Fusion and our common mission as the foundation for a positive work environment. WHAT DRIVES THE FUSION TEAM EVERY DAY? Innovation, data and scientific curiosity drive our work to develop novel treatments to benefit cancer patients. This is not just a corporate perspective but one that is inspired by the individual motivations of Fusion employees. As a science-driven organization, we believe that data and knowledge are powerful tools that can be used to improve healthcare and our communities. At the end of the day, for me it boils down to the fact that collectively we have an opportunity to bring forward truly innovative science to tackle a problem that touches almost every human being globally. What could be more motivating than the potential to have such an important impact on people?

J’attribue cette réussite à deux facteurs : 1) le caractère innovant du secteur dans lequel nous évoluons, qui appuie la pensée créatrice en cas de défis; 2) le « phénotype » des employés qui se sentent appelés par une carrière chez Fusion. Je suis extrêmement fier du fait que les employés de Fusion ont su travailler ensemble et surmonter les difficultés liées à la COVID, ainsi que du fait qu’ils ont pu relever les défis et saisir les occasions d’œuvrer à des médicaments oncologiques novateurs. Nous avons mis en place une culture d’étroite collaboration et d’innovation scientifique. En cette période où nombre de gens se sentaient isolés, chez Fusion, nous nous sommes appuyés sur les liens sociaux et sur notre mission commune, qui ont constitué les bases d’un milieu de travail favorable.

QU’EST-CE QUI MOTIVE L’ÉQUIPE DE FUSION AU QUOTIDIEN? L’innovation, les données et la curiosité scientifique sont les moteurs de travaux qui visent la mise au point de traitements novateurs à l’intention des patients qui ont un cancer. Or, la source de cette vision n’est pas uniquement le haut de l’entreprise. Elle correspond aux motivations individuelles des employés de Fusion. En tant qu’organisation scientifique, nous croyons que les données et les connaissances sont de puissantes ressources qui peuvent servir à améliorer les soins de santé et la vie dans nos collectivités. En fin de compte, tout cela se résume pour moi au fait que nous disposons collectivement d’une occasion de donner naissance à des découvertes scientifiques réellement novatrices, qui permettront de lutter contre un problème qui touche pratiquement tous les humains de la planète. Que pourrait-il y avoir de plus motivant que le potentiel d’avoir une telle incidence sur la vie des gens?

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Moderna: Bringing the Promise of mRNA to Canada Moderna : Les promesses pe L’ARNm en sol Canadien by Patricia Gauthier, President & General Manager, Moderna Canada par Patricia Gauthier, Présidente et directrice générale, Moderna Canada

IN AUGUST 2021, MODERNA AND THE GOVERNMENT OF CANADA SIGNED AN AGREEMENT THAT AIMS TO SEE Moderna build and launch a state-of-the-art messenger RNA (mRNA) vaccine manufacturing facility in Canada. But this is more than a manufacturing facility; it’s also part of Canada’s public health and pandemic preparedness solution, that will allow Canadian researchers to benefit from Moderna’s expertise and collaborations to address the ‘next’ global public health threat. This will help sustain the same level of ambition in tackling global health threats that we have seen for COVID-19.

EN AOÛT 2021, MODERNA ET LE GOUVERNEMENT DU CANADA ONT SIGNÉ UN ACCORD DE PRINCIPE SELON lequel Moderna devrait construire et exploiter des installations de pointe destinées à la fabrication de vaccins à ARN messager (ARNm) au Canada. Toutefois, ce projet dépasse la création d’une simple usine de production. Il fait partie d’une solution qu’a élaborée le Canada en matière de santé publique, plus précisément pour être prêt en cas de pandémie, qui permettra aux chercheurs canadiens de bénéficier de l’expertise et des contacts de Moderna pour intervenir face à la « prochaine » menace sanitaire mondiale. Il s’agira de maintenir la même réactivité vis-à-vis de la lutte contre les menaces sanitaires mondiales que celle que nous avons pu voir à l’œuvre par rapport à la COVID-19.

A COMPLETE PUBLIC HEALTH AND PANDEMIC PREPAREDNESS “SOLUTION” Once operational, the facility will give Canadians local access to a portfolio of vaccines against common respiratory viruses, including Respiratory Syncytial Virus (RSV), SARS-CoV-2 (COVID-19), human influenza viruses, various combination vaccines, and, potentially, other needed vaccines pending licensure. The flexibility and scalability of our manufacturing process will also allow us to pivot manufacturing priorities during a potential future pandemic to give Canadians front-of-the-line access to life-saving vaccines. Moderna was able to identify, develop and manufacture a safe and effective vaccine for COVID-19 at scale in only 11 months. This proved the value of our mRNA platform. Combined with the clear sense of urgency shown by governments and regulators that opened everyone’s Patricia Gauthier, President & General Manager, Moderna Canada/Présidente et minds to working together differently. directrice générale, Moderna Canada

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UNE « SOLUTION » COMPLÈTE EN MATIÈRE DE SANTÉ PUBLIQUE EN VUE D’ANTICIPER LES PANDÉMIES Une fois opérationnelle, l’usine offrira aux Canadiens l’accès direct à des vaccins contre les virus respiratoires courants – notamment le virus respiratoire syncytial (VRS), le SRASCoV-2 (COVID-19) et les virus de la grippe humaine –, à divers vaccins combinés et, éventuellement, à d’autres vaccins nécessaires en attente d’homologation. La souplesse et l’évolutivité de notre processus de fabrication nous permettront également de modifier les priorités de fabrication au cours d’une éventuelle pandémie future afin de donner aux Canadiens l’accès à des vaccins indispensables. Moderna a pu découvrir et fabriquer à grande échelle un vaccin sûr et efficace contre la COVID-19 en seulement 11 mois.

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Cela a permis à notre plateforme ARNm de faire ses preuves. Ce facteur et la réactivité dont ont fait montre les gouvernements et les autorités de réglementation, qui a incité chacun à collaborer différemment, nous ont permis d’accélérer les processus d’approbation habituels sans abaisser les normes de sécurité rigoureuses auxquelles s’attendent les Canadiens. Par conséquent, les Canadiens ont été parmi les premières personnes au monde à recevoir le vaccin de Moderna, et le Canada est finalement devenu l’un des pays où la vaccination s’est déployée le plus rapidement.

This allowed us to accelerate normal approval processes without compromising the rigorous safety standards Canadians expect. As a result, Canadians were among the first people in the world to receive Moderna’s vaccine, with Canada ultimately becoming one of the most rapidly vaccinated jurisdictions anywhere. AN INNOVATIVE APPROACH TO R&D While the details of the project continue to be discussed, Moderna’s investment in domestic manufacturing and its expanding network of public and private partnerships will deliver tangible benefits to the research community, such as Moderna’s 2021 decision to enroll Canadian volunteers in clinical trials across several vaccines programs. These and other R&D partnerships will bring advantages to Canadian researchers in advancing their work on new vaccines and therapies, as well as in other areas like the use of AI. One recent Moderna initiative is our mRNA Access program, which provides partner organizations with an on-ramp to our technology platform to tackle pressing, emerging and neglected public health threats. In March 2022, McGill University became our first mRNA Access partner in Canada. Through the program, McGill researchers will accelerate their work in key areas of public health and infectious disease, including those connected to Moderna’s R&D priorities. Outside the mRNA Access program, we also entered into a research agreement with University of Toronto to advance research in key strategic areas of science, innovation, and technology. Moderna recently announced it would expand its global public health portfolio to include a list of the 15 priority pathogens identified by the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI) as being persistent global health threats. These pathogens include COVID-19, HIV, Nipah, Zika, tuberculosis (TB), malaria, and a framework for addressing a future “Disease X.” Rather than addressing only few pathogens at a time, Moderna’s ambitious clinical research programs will

UNE APPROCHE INNOVANTE DE LA R.-D. Bien que les détails du projet continuent d’être discutés, l’investissement de Moderna dans la fabrication sur le plan national et l’expansion de son réseau de partenariats publics et privés apporteront des avantages tangibles à la communauté des chercheurs, à l’instar de la décision prise par Moderna en 2021 de recruter des volontaires canadiens pour des essais cliniques associés à plusieurs programmes vaccinaux. Ces partenariats de R.-D., ainsi que d’autres, permettront aux chercheurs canadiens de faire progresser leurs travaux sur de nouveaux vaccins et traitements, ainsi que dans d’autres domaines tels que l’utilisation de l’IA. La plus récente initiative de Moderna est un programme intitulé « mRNA Access », qui offre à des organisations partenaires la possibilité d’accéder à sa plateforme technologique pour s’attaquer à des menaces sanitaires urgentes, émergentes ou négligées. En mars 2022, l’Université McGill est devenue le premier partenaire du programme « mRNA Access » au Canada. Grâce à ce programme, les chercheurs de McGill pourront voir leurs travaux prendre une nouvelle dimension sur des sujets clés liés à la santé publique et aux maladies infectieuses, notamment ceux liés aux priorités de Moderna en matière de R.-D. En dehors du programme « mRNA Access », nous avons également conclu un accord avec l’Université de Toronto pour faire progresser la recherche sur des sujets stratégiques clés liés à la science, à l’innovation et aux technologies. Moderna a récemment annoncé qu’elle élargirait son portefeuille mondial lié à la santé publique pour y inclure une liste des 15 agents pathogènes prioritaires recensés par l’Organisation mondiale de la Santé (OMS) et la Coalition pour les innovations en matière de préparation aux épidémies (CEPI) comme étant des menaces récurrentes pour la santé à l’échelle de la planète. Parmi ceux-ci, on compte le SRASCoV-2, le VIH, le virus Nipah, le virus Zika, le bacille de la tuberculose (TB) et le parasite à l’origine du paludisme; le portefeuille de Moderna comprendra aussi un cadre permettant de faire face à une future « maladie inconnue ».

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Moderna was able to identify, develop and manufacture a safe and effective vaccine for COVID-19 at scale in only 11 months. This proved the value of our mRNA platform. Combined with the clear sense of urgency shown by governments and regulators that opened everyone’s minds to working together advance research on all fifteen identified potential public health threats by 2025 using our prototype vaccine approach and leading to the creation of “vaccine libraries.” This is the same approach that allowed us to be successful in responding quickly to SARS-CoV-2 (COVID-19), using our earlier research on the SARS-CoV-1 and MERS viruses. BUILDING IN CANADA FOR THE LONG-TERM This experience – and the benefits Moderna has brought to Canadians over the past year and a half – is foundational to Moderna’s interest in building a future in Canada. The facility represents an advancement on the traditional approach to global manufacturing by building local and regional vaccine production capacity that reduce supply chain delays. This model is already being emulated in other countries including Australia and in Kenya, with the potential to have a global impact on the way vaccines and other pharmaceuticals can be made. WE LOOK FORWARD TO A LONG AND PRODUCTIVE FUTURE The global COVID-19 pandemic gave us the opportunity see what can be accomplished when we collaborate toward shared goals and values. Developing mRNA research expertise and manufacturing capacity at home is one area in which Canada can become more nimble and self-reliant in the face of a changing world. With our industry-leading mRNA technology platform and rapid drug development capabilities, we look forward to being an active and ambitious contributor to the Canadian life sciences ecosystem. We can prepare for future health crises today. We have the capabilities to develop real, scalable science-based solutions for the world and we have a duty to put this potential to work now – rather than wait for the next crisis. That’s what Moderna sees with this collaboration. If we can develop a culture of urgency around getting ahead of tomorrow’s problems, Canada will have a big role to play in a better future for everyone. 44

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Plutôt que de ne s’attaquer qu’à quelques agents pathogènes à la fois, les ambitieux programmes de recherche clinique de Moderna feront progresser la recherche sur les quinze menaces pour la santé publique d’ici 2025 au moyen de l’approche de vaccin prototype de l’entreprise, qui mènera à la création de « bibliothèques de vaccins ». C’est cette même approche qui nous a permis de réagir rapidement au SRAS-CoV-2 (COVID-19), grâce à nos recherches antérieures sur le SRAS-CoV-1 et le virus responsable du SRMO.

SE DÉVELOPPER AU CANADA À LONG TERME Cette dynamique, qui a permis à Moderna d’apporter son soutien aux Canadiens au cours de la dernière année et demie, prépare l’entreprise à s’engager plus avant en vue d’assurer un meilleur avenir en matière de soins de santé au Canada. Les nouvelles installations permettront une grande souplesse quant aux vaccins fabriqués; ainsi, on pourra produire une gamme classique de vaccins contre les virus respiratoires la plupart du temps et changer rapidement de production en cas de nouvelle pandémie. On constate que ce modèle inspire déjà d’autres pays, dont l’Australie et le Kenya, et il pourrait avoir une incidence à l’échelle mondiale sur la façon dont on peut fabriquer les vaccins et d’autres produits pharmaceutiques.

NOUS POUVONS ENVISAGER DES PERSPECTIVES FRUCTUEUSES DE DÉVELOPPEMENT À LONG TERME La pandémie mondiale de COVID-19 nous a donné l’occasion de voir ce qui peut être accompli lorsque nous collaborons et œuvrons à partir d’objectifs et de valeurs communs. La promotion de l’expertise en matière de recherche sur les ARNm et le déploiement de la capacité de fabrication au pays sont des domaines dans lesquels le Canada peut devenir plus agile et autonome compte tenu de notre monde en mutation. Disposant d’une plateforme de pointe axée sur les technologies à base d’ARNm et de capacités de développement rapide de médicaments, il nous tarde de devenir ce contributeur actif et ambitieux de l’écosystème canadien en sciences de la vie. Nous pouvons nous préparer dès aujourd’hui à faire face aux futures crises sanitaires. Nous avons désormais non seulement les moyens d’élaborer des solutions scientifiques concrètes et évolutives pour le monde, mais aussi le devoir de mettre ce potentiel à profit dès maintenant, et non pas d’attendre la prochaine crise. C’est ce que Moderna attend de cette collaboration. Si nous pouvons mettre en place une dynamique permettant de faire face à l’urgence, nous serons en mesure alors d’anticiper les problèmes de demain, et le Canada aura un rôle important à jouer en vue d’assurer un avenir meilleur pour tous.

HOPE IS HARD WORK For somebody living with melanoma, like Beth, it wasn’t always easy to stay hopeful. But thanks to innovative treatments that resulted from thousands of compounds screened and years of clinical trials, Beth now lives tumor free. Find out how we’re making Canadian lives better at

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Glycomics is Writing the Next Chapter in Bioinnovation La glycomique ouvre le prochain chapitre de la bioinnovation by Warren Wakarchuk, Scientific Director, GlycoNet par Warren Wakarchuk, directeur scientifique, GlycoNet

BEYOND THE COVID-19 PANDEMIC, NATIONS AU-DELÀ DE LA PANDÉMIE DE COVID-19, LES NATIONS CONTINUENT DE SE DÉBATTRE AVEC LES CRISES CONTINUE TO GRAPPLE WITH GLOBAL CRISES IN MONDIALES DE LA RÉSISTANCE AUX ANTIMICROBIENS, DE ANTIMICROBIAL RESISTANCE, FOOD SECURITY, AND LA SÉCURITÉ ALIMENTAIRE ET DU CHANGEMENT CLIMATE CHANGE. As we look to science for innovative CLIMATIQUE. Alors que nous nous tournons vers la science solutions, one area quickly gaining momentum is pour trouver des solutions innovantes, un domaine qui prend glycomics—the study of the roles of carbohydrates (or rapidement de l’ampleur est la glycomique, c’est-à-dire glycans) in humans, animals, plants, bacteria, and l’étude du rôle des glucides (ou glycanes) chez les humains, viruses. For example, the COVID-19 virus uses glycans on les animaux, les plantes, les bactéries et les virus. Par its spike protein to elude the immune system, while the exemple, le virus COVID-19 utilise les glycanes de sa protéine spike protein binds to glycans on our cells. How we fight spike pour échapper au système immunitaire, tandis que la infection, how our bodies heal, and how crops resist protéine spike se lie aux glycanes de nos cellules. La façon drought and pests are just a few examples of the critical dont nous combattons les infections, dont notre corps guérit roles of glycans in biology. et dont les cultures résistent à la sécheresse et aux parasites ne The applications of glycomics extend to many of sont que quelques exemples du rôle essentiel des glycanes en Canada’s strategic industrial sectors, including human biologie. and animal health, agriculture, and resource Les applications de la glycomique s’étendent à de management. However, until recently, the limited nombreux secteurs industriels stratégiques du Canada, availability of analytical platforms to elucidate the notamment la santé humaine et sophisticated structures of animale, l’agriculture et la gestion glycans impeded glycomics des ressources naturelles. research and hampered Cependant, jusqu’à récemment, la technology adoption in these disponibilité limitée des industries. Thanks to plateformes analytiques permettant technological advances, d’élucider les structures glycomics has taken significant sophistiquées des glycanes a leaps forward and is expected to entravé la recherche en glycomique generate explosive growth, like et a freiné l’adoption de cette that of genomics, over the next technologie dans ces industries. decade in the biotechnology and Grâce aux progrès technologiques, pharma sectors. la glycomique a fait d’importants Glycan structures and bonds en avant et devrait connaître functions vary enormously; this une croissance explosive, comme is why they hold so much celle de la génomique, au cours de potential. For example, a subtle la prochaine décennie, notamment change in glycans influences dans les secteurs de la blood type and organ donor biotechnologie et de l’industrie compatibility—small differences pharmaceutique. that greatly impact the ability to Les structures et les fonctions save lives. Understanding des glycanes varient énormément; glycan changes and interactions c’est pourquoi elles recèlent un tel gives us new tools to broaden Warren Wakarchuk, Scientific Director, GlycoNet directeur scientifique, GlycoNet

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our knowledge of biology and accelerate development of innovative solutions to pressing health and environmental challenges. GLYCOMICS TO IMPROVE HEALTH Glycomics is spurring the development of new drug alternatives and delivery strategies to address global issues in health. Five of the top ten global protein therapeutics are glycan-linked proteins with total sales of US $58 billion in 2020.1 Understanding the biological roles of glycans has yielded key drug components for use in a variety of health applications, such as anti-cancer antibodies, therapeutics for conditions such as arthritis and Crohn’s disease, and vaccines against illnesses such as meningitis and pneumonia. Where current drug discovery approaches have failed to find long-term solutions to diseases such as Alzheimer’s and Parkinson’s, glycomics offers new knowledge and methods to develop state-of-the-art glycan-based diagnostics and therapeutic strategies. GLYCOMICS TO DRIVE SUSTAINABLE FOOD AND ENERGY Beyond health, glycomics is poised to develop solutions to global challenges in food security and climate change. Plants are an abundant source of many different types of glycans that can be used for food and the production of sustainable biomaterials and renewable fuels. For example, plant glycans are used to make food ingredients such as the low-calorie sweetener xylitol (derived from xylose). Biofuel companies are transforming plant glycans (cellulose) into feedstocks for high-value sustainable biofuels.

1. Sagonowsky, E. The top 20 drugs by worldwide sales in 2020. https://www.fiercepharma.com/special-report/top-20-drugs-by-2020-sales (accessed Dec 15, 2021).

potentiel. Par exemple, une modification subtile des glycanes influence le groupe sanguin et la compatibilité avec les donneurs d’organes — de petites différences qui ont un impact considérable sur la capacité à sauver des vies. Comprendre les changements et les interactions des glycanes nous donne de nouveaux outils pour élargir notre connaissance de la biologie et accélérer le développement de solutions innovantes aux défis urgents en matière de santé et d’environnement.

LA GLYCOMIQUE AU SERVICE DE LA SANTÉ La glycomique stimule le développement de nouvelles alternatives médicamenteuses et de nouvelles stratégies d’administration pour répondre aux problèmes de santé mondiaux. Cinq des dix principales protéines thérapeutiques mondiales sont des protéines liées aux glycanes, avec des ventes totales de 58 milliards de dollars américains en 2020.1 La compréhension du rôle biologique des glycanes a permis de mettre au point des composants médicamenteux clés pour diverses applications dans le domaine de la santé, comme les anticorps anticancéreux, les traitements pour des maladies telles que l’arthrite et la maladie de Crohn, et les vaccins contre des maladies telles que la méningite et la pneumonie. Là où les approches actuelles de découverte de médicaments ont échoué à trouver des solutions à long terme pour des maladies telles que les maladies d’Alzheimer et de Parkinson, la glycomique offre de nouvelles connaissances et méthodes pour développer des diagnostics et des stratégies thérapeutiques de pointe basés sur les glycanes.

LA GLYCOMIQUE AU SERVICE DE L’ALIMENTATION ET DE L’ÉNERGIE DURABLES Au-delà de la santé, la glycomique est en bonne voie pour développer des solutions aux défis mondiaux de la sécurité alimentaire et du changement climatique. Les plantes sont une source abondante de nombreux types de glycanes différents qui peuvent être utilisés pour l’alimentation et la production de biomatériaux durables et de carburants renouvelables. Par exemple, les glycanes végétaux sont utilisés pour fabriquer des ingrédients alimentaires tels que l’édulcorant hypocalorique xylitol (dérivé du xylose). Les entreprises de biocarburants transforment les glycanes végétaux (cellulose) en matières premières pour la production de biocarburants durables de grande valeur. L’utilisation de la glycomique pour créer de la valeur à partir des glycanes trouvés dans les algues (abondamment disponibles au Canada) est un autre exemple d’une incroyable opportunité économique pour la glycomique canadienne. Les algues ont une teneur élevée en glycanes, sont riches en micronutriments, poussent rapidement et ne consomment pas de ressources rares comme l’eau et les terres arables. Comprendre comment les glycanes dérivés des algues peuvent être décomposés par les microbes et 1. Sagonowsky, E. The top 20 drugs by worldwide sales in 2020. https://www.fiercepharma.com/special-report/top-20-drugs-by-2020-sales (consulté le 15 décembre 2021)

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Using glycomics to create value from the glycans found in seaweed (abundantly available in Canada) is another example of an incredible economic opportunity for Canadian glycomics. Seaweed has a high glycan content, is rich in micronutrients, grows rapidly, and doesn’t take up scarce resources such as water and arable land. Understanding how seaweed-derived glycans can be broken down by microbes and absorbed as food could make seaweed a sustainable food source for livestock and reduce methane emissions from animals. CANADIAN GLYCOMICS EXPERTISE Since 2015, GlycoNet, a federally funded Network of Centres of Excellence led out of Alberta, has mobilized glycomics scientists across the country, positioning Canada at the global forefront of glycomics research. GlycoNet researchers continue to advance glycomics to deliver new made-in-Canada disease therapies, diagnostics, vaccines, biomaterials and methods for biomanufacturing. Critical to GlycoNet’s operations is GlycoNet Integrated Services—a nationally distributed glycomics service organization that leverages $35 million in federal and provincial infrastructure investments in seven institutions across Canada. By providing Canadian researchers and companies with one-stop access to glycomics tools, specialized expertise, and unique infrastructure, GlycoNet Integrated Services supports both fundamental research and translation of research discoveries into applied and commercial outcomes.

absorbés comme nourriture pourrait faire des algues une source alimentaire durable pour le bétail et réduire les émissions de méthane des animaux.

EXPERTISE CANADIENNE EN MATIÈRE DE GLYCOMIQUE Depuis 2015, GlycoNet, un réseau de centres d’excellence financé par le gouvernement fédéral et dirigé par l’Alberta, a mobilisé des scientifiques en glycomique dans tout le pays, plaçant le Canada à l’avant-garde mondiale de la recherche en glycomique. Les chercheurs de GlycoNet continuent de faire progresser la glycomique pour offrir de nouvelles thérapies contre les maladies, de nouveaux diagnostics, de nouveaux vaccins, de nouveaux biomatériaux et de nouvelles méthodes de biofabrication, tous et toutes conçus au Canada. Les Services intégrés de GlycoNet sont essentiels aux opérations de GlycoNet. Il s’agit d’une organisation de services de glycomique distribués à l’échelle nationale qui mobilise des investissements fédéraux et provinciaux de 35 millions de dollars dans sept institutions au Canada. En fournissant aux chercheurs et aux entreprises du Canada un accès unique aux outils de la glycomique, une expertise spécialisée et une infrastructure unique, les services intégrés de GlycoNet soutiennent à la fois la recherche fondamentale et la transformation des découvertes de la recherche en résultats appliqués et commerciaux.

LES SERVICES INTÉGRÉS DE GLYCONET COMPRENNENT : •

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GLYCONET INTEGRATED SERVICES INCLUDE: • Detailed screening of glycan interactions, using a variety of glycan-binding proteins to identify natural glycans with biological relevance. • Identification of glycans carried by proteins and lipids in cells and tissues and as isolated molecules.

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Criblage détaillé des interactions entre les glycanes, à l’aide d’une variété de protéines de liaison aux glycanes, afin d’identifier les glycanes naturels présentant un intérêt biologique. Identification des glycanes portés par les protéines et les lipides dans les cellules et les tissus et sous forme de molécules isolées. Synthèse de glycanes par synthèse conventionnelle ou assistée par enzyme, plus assemblage automatisé de glycanes avec le système Glyconeer (1 des 5 au monde). Découverte de ligands à l’aide de bibliothèques d’affichage de phages, donnant accès à une technologie

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Synthesis of glycans by conventional or enzymeassisted synthesis, plus automated glycan assembly with the Glyconeer system (1 of 5 in the world). • Ligand discovery using phage display libraries, giving access to a genetically encoded glycan ligand discovery technology—liquid glycan array (LiGA). • Screening of large ligand libraries or high throughput screening to identify compounds that block or enhance functions of proteins and enzymes of interest: microbial cell targets, screening of human and animal cell cultures, and screening of model organisms and organoids (miniature organs grown in vitro). • Biophysical characterization of glycan–protein interactions for binding affinity, stoichiometry, and other physicochemical parameters. • Molecular glycobiology using cell engineering to identify glycan ligands and their binding partners, for developing new assays to determine biological outcomes of glycan binding. • Microbial glycan analysis of extracellular glycans on human, animal, and plant pathogens. • Recombinant glycoengineering of biologicals, including in vitro remodelling of glycans from a library of recombinant enzymes to prepare glycoconjugates for biological testing. GlycoNet and its Integrated Services provide glycomics expertise, specialized services, consulting, and opportunities for research collaborations to academia and industry, both nationally and internationally. The mission of GlycoNet and its Integrated Services is to empower Canadian glycomics research as the engine to accelerate discovery, development, and commercialization of tomorrow’s glycomics-based solutions, leading to a healthier, more sustainable future. We welcome any service and research collaboration requests, and are happy to discuss how glycomics can advance your research and development agenda. Contact us at info@glyconet.ca for more information about GlycoNet Integrated Services and opportunities to partner. To learn more about how glycomics research is improving the lives of Canadians, visit glyconet.ca

de découverte de ligands de glycanes codés génétiquement — le réseau de glycanes liquides (LiGA). • Criblage de vastes bibliothèques de ligands ou criblage à haut débit pour identifier les composés qui bloquent ou améliorent les fonctions des protéines et des enzymes d’intérêt : cibles cellulaires microbiennes, criblage de cultures cellulaires humaines et animales, et criblage d’organismes modèles et d’organoïdes (organes miniatures cultivés in vitro). • Caractérisation biophysique des interactions glycanesprotéines en fonction de l’affinité de liaison, de la stœchiométrie et d’autres paramètres physicochimiques. • Glycobiologie moléculaire utilisant l’ingénierie cellulaire pour identifier les ligands des glycanes et leurs partenaires de liaison, afin de développer de nouveaux tests pour déterminer les résultats biologiques de la liaison des glycanes. • Analyse microbienne des glycanes extracellulaires sur les agents pathogènes humains, animaux et végétaux. • Glyco-ingénierie recombinante de produits biologiques, y compris le remodelage in vitro de glycanes à partir d’une bibliothèque d’enzymes recombinantes afin de préparer des glycoconjugués pour des tests biologiques. GlycoNet et ses services intégrés fournissent aux milieux universitaires et industriels une expertise en matière de glycomique, des services spécialisés, des consultations et des opportunités de collaboration en matière de recherche, tant au niveau national qu’international. La mission de GlycoNet et de ses services intégrés est d’habiliter la recherche canadienne en glycomique en tant que force motrice pour accélérer la découverte, le développement et la commercialisation des solutions glycomiques de demain, menant à un avenir plus sain et plus durable. Nous accueillons toutes les demandes de services et de collaboration en matière de recherche, et nous sommes heureux de discuter de la manière dont la glycomique peut faire progresser votre programme de recherche et de développement. Communiquez avec nous à l’adresse info@ glyconet.ca pour obtenir de plus amples renseignements sur les services intégrés de GlycoNet et les possibilités de partenariat. Pour en savoir plus sur la façon dont la recherche glycomique améliore la vie des Canadiens, visitez glyconet.ca biotech.ca

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The power of bold leadership at Biogen Canada Le pouvoir du leadership audacieux à Biogen Canada Q&A Feature with Eric Tse, General Manager, Biogen Canada

PLEASE TELL US ABOUT YOUR BACKGROUND, AND HOW IT LED YOU TO BIOGEN CANADA. ’I’ve had a long-standing fondness for science and business, and early in my quest to establish a career path, the pharmaceutical and biotech industry became an obvious destination to marry these two passions. I began my career in sales 25 years ago, and this first experience with the industry ignited a passion that drove me to broaden my horizons across multiple therapeutic areas and at a number of leading organizations. From sales, I moved into product management, sales operations, sales management, then business unit management, and eventually general management. When I joined Biogen Canada in October 2021, it was the fulfilment of a long-term aspiration. The company had been on my radar for many years because its mission and values resonated so strongly with me. I’ve always had a deep respect for Biogen’s patient-centred focus, its impressive legacy of innovation in neuroscience, and its drive to defeat the most complex and devastating diseases. It has already been a rewarding experience and I am humbled to be part of a team that truly lives by the values of caring deeply and working fearlessly to change lives. WHAT DO YOU THINK SETS BIOGEN APART FROM OTHER BIOTECH COMPANIES? Biogen is one of the world’s first biotechnology companies with a deep history of innovation in neuroscience, a disease area with great unmet need for breakthrough treatment advances and discoveries. Neurological disorders affect an estimated 3.6 million Canadians,1 and are the leading cause of disability and second most prevalent cause of deaths worldwide.2 Biogen’s commitment in this area is truly inspirational and we continue to push the boundaries of medical research and beyond to transform patient care and improve patient outcomes. We have always championed underserved patient communities, as

PARLEZ-NOUS DE VOS ANTÉCÉDENTS ET DE CE QUI VOUS A MENÉ À BIOGEN CANADA. J’aime depuis longtemps les sciences et les affaires, et dès le début de mon parcours professionnel, il était évident pour moi que l’industrie pharmaceutique et biotechnologique était la destination idéale pour marier ces deux passions. J’ai commencé ma carrière dans la vente il y a 25 ans. Cette première expérience avec l’industrie a réveillé une passion en moi qui m’a poussé à élargir mes horizons dans de nombreux domaines thérapeutiques et dans un certain nombre d’organisations de premier plan. De la vente, je suis passé à la gestion de produits, aux opérations de vente, à la gestion des ventes, puis à la gestion d’unité opérationnelle, et plus tard à la gestion générale. En joignant Biogen Canada en octobre 2021, j’ai atteint un objectif à long terme. L’entreprise avait attiré mon attention depuis de nombreuses années, car sa mission et ses valeurs correspondaient fortement aux miennes. J’ai toujours eu un profond respect pour l’orientation centrée sur le patient de Biogen, son impressionnant héritage d’innovation en neurosciences et sa détermination de vaincre les maladies les plus complexes et dévastatrices. Ce fut déjà une expérience enrichissante, et je suis honoré de faire partie d’une équipe qui met en pratique les valeurs de compassion profonde et de travail courageux pour changer des vies.

Eric Tse, General Manager, Biogen Canada

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SELON VOUS, QU’EST-CE QUI DISTINGUE BIOGEN DES AUTRES ENTREPRISES DE BIOTECHNOLOGIE? Biogen est l’une des premières sociétés de biotechnologie au monde avec une riche histoire d’innovation en neuroscience, un domaine pathologique pour lequel le besoin d’avancées et de découvertes majeures est immense en matière de traitements. Les troubles neurologiques touchent environ 3,6 millions de Canadiens1 et sont la principale cause d’invalidité et la deuxième cause de décès dans le monde. 2 L’engagement de Biogen dans ce domaine est vraiment inspirant, et nous continuons de repousser les limites de la recherche médicale pour

ecosystem écosystème

demonstrated with the advent of game-changing treatments for Multiple Sclerosis and Spinal Muscular Atrophy. This tradition is alive and well today as we continue to stand up for patients with unmet healthcare needs, like those with Alzheimer’s Disease, for whom no new treatment option has been offered for decades. We are committed to providing patients and their families with hope – that’s our north star. Our strong ethical foundation and patient-centric focus will continue to support sound decision-making, which is essential when taking on the high risks inherent in the discovery of new medicines. I believe that our willingness to boldly explore new treatment avenues takes tremendous compassion and heart, and this sets us apart.

Biogen is one of the world’s first biotechnology companies with a deep history of innovation in neuroscience, a disease area with great unmet need for breakthrough treatment advances and discoveries. Neurological disorders affect an estimated 3.6 million Canadians, and are the leading cause of disability and second most prevalent cause of deaths worldwide. HOW DO YOU BELIEVE LEADERSHIP STYLE INFLUENCES AN ORGANIZATION’S PERFORMANCE? I believe transparency and accessibility to leadership at all levels is key. It sets the tone that we are all equal, and signals to everyone that all ideas and perspectives are respected and welcome. I’m so heartened to have observed that Biogen’s culture is founded upon principles of diversity, equity and inclusion, with real meaning throughout the organization – it helps create an environment in which employees feel safe to share ideas, communicate openly and feel heard. I also believe that a major part of my role as General Manager is to encourage our employees to think big and to cultivate a solutions-oriented mindset. Biogen is always tackling novel challenges, often treading in uncharted territory, and it’s inevitable we will experience ups and downs along this pathway – it’s part of the journey of a pioneer and true leader. But it’s how we tackle these

aller plus loin afin de transformer les soins aux patients et d’améliorer les résultats pour les patients. Nous avons toujours défendu les communautés de patients défavorisées, comme en témoigne l’avènement de traitements révolutionnaires pour la sclérose en plaques et l’amyotrophie spinale. Cette tradition est bien vivante aujourd’hui, alors que nous continuons de défendre les patients qui ont des besoins non comblés en matière de soins de santé, comme ceux atteints de la maladie d’Alzheimer, pour lesquels aucune nouvelle option de traitement n’a été offerte depuis des décennies. Nous sommes déterminés à donner de l’espoir aux patients et à leur famille; cet objectif est notre étoile polaire. Nos solides assises en matière d’éthique et notre orientation centrée sur le patient continueront d’appuyer la prise de décisions éclairées, ce qui est essentiel lorsque nous prenons en charge les risques élevés inhérents à la découverte de nouveaux médicaments. Je crois que notre volonté d’explorer résolument de nouvelles possibilités de traitement exige énormément de compassion et de cœur, et cela nous distingue.

Biogen est l’une des premières sociétés de biotechnologie au monde avec une riche histoire d’innovation en neuroscience, un domaine pathologique pour lequel le besoin d’avancées et de découvertes majeures est immense en matière de traitements. Les troubles neurologiques touchent environ 3,6 millions de Canadiens et sont la principale cause d’invalidité et la deuxième cause de décès dans le monde. SELON VOUS, COMMENT LE STYLE DE LEADERSHIP INFLUENCE-T-IL LE RENDEMENT D’UNE ORGANISATION? Je crois que la transparence et l’accessibilité au leadership à tous les niveaux sont des éléments essentiels. Ils transmettent le message que nous sommes tous égaux et que toutes les idées et tous les points de vue sont respectés et bien accueillis. Ça me fait chaud au cœur d’observer la culture de Biogen qui est fondée sur les principes de la diversité, de l’équité et de l’inclusion. Ces principes sont sincèrement valorisés dans toute l’organisation, ce qui aide à créer un environnement dans lequel les employés se sentent en sécurité pour échanger des idées, communiquer ouvertement et se sentir écoutés. Je crois aussi qu’une grande partie de mon rôle de directeur général est d’encourager nos employés à voir grand et à cultiver une mentalité axée sur les solutions. Souvent en biotech.ca

challenges that is key – instilling a shared sense of purpose in our employees and a “can-do” attitude in our culture will help us be resilient in the face of adversity and ultimately set us up for long-term success. PLEASE TELL US ABOUT THE PEOPLE AT BIOGEN CANADA. I’m privileged to have inherited an incredibly passionate and engaged workforce, and I intend to preserve and build upon the collaborative environment that’s well-established at Biogen Canada. Our team cares deeply for the patient communities we serve, and I continue to be impressed with the commitment, drive, and incredible grit everyone has shown as we’ve passed through the pandemic together. Following two years of working apart and under pandemic restrictions, I am excited to welcome our teams back together at our new Canadian Head Office in Toronto. The new office is designed to support a variety of different work styles, but above all, provides a space for us to gather again and relate to one another as people. I firmly believe face-to-face interactions build both trust and respect, which are essential ingredients for strengthening cohesiveness and taking teamwork to the next level. That said, we also embrace flexibility and understand the challenges and importance of balancing our personal and professional lives, something the whole world has learned throughout the pandemic. I am proud that as an employer, we are also leading the way by implementing a hybrid work approach that empowers our team to optimize work-life integration and do their best work.

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terrain inconnu, Biogen affronte toujours de nouveaux défis, et il est inévitable qu’en cours de route nous éprouvions des hauts et des bas; cela fait partie du parcours d’un pionnier et d’un vrai leader. Mais ce qui est le plus important, c’est la façon dont nous faisons face à ces défis. En inculquant un but commun à nos employés et en cultivant une attitude positive au sein de notre culture, nous sommes plus résilients face à l’adversité et équipés pour atteindre la réussite à long terme.

PARLEZ-NOUS DU PERSONNEL DE BIOGEN CANADA. J’ai le privilège d’avoir hérité d’un effectif incroyablement passionné et motivé, et j’ai l’intention de préserver et de renforcer l’environnement de collaboration bien établi à Biogen Canada. Notre équipe se soucie profondément des communautés de patients que nous servons, et je continue d’être impressionné par le dévouement, la motivation et le courage incroyable dont tout le monde a fait preuve pendant que nous traversions la pandémie ensemble. Après deux ans de travail séparés les uns des autres, et sous le coup des restrictions liées à la pandémie, je suis heureux d’accueillir de nouveau nos équipes au nouveau siège social canadien à Toronto. Le nouveau bureau est conçu pour soutenir une variété de styles de travail, mais surtout, il nous fournit un espace où nous pouvons nous réunir de nouveau et établir des liens en personne. Je crois fermement que les interactions en personne renforcent à la fois la confiance et le respect, qui sont des ingrédients essentiels pour renforcer la cohésion et faire passer le travail d’équipe à un niveau supérieur. Cela dit, nous sommes aussi flexibles, et nous comprenons les difficultés et l’importance de trouver un équilibre personnel et professionnel, quelque chose que tout le monde a appris pendant la pandémie. Je suis fier de montrer la voie en tant qu’employeur en mettant en œuvre une approche de travail hybride qui permet à notre équipe d’optimiser l’intégration travail-vie personnelle et de faire le meilleur travail possible.

Regenerative Medicine Powering life-saving

therapies and technologies for the benefit of all CANADA HAS BEEN A WORLD LEADER IN THE STEM FUELLING BIOTECHNOLOGY PARTNERSHIPS OF TODAY CELL AND REGENERATIVE MEDICINE (RM) SECTOR AND TOMORROW since two Canadian researchers Drs. James Till and Ernest For 20 years, Canada’s Stem Cell Network (SCN) has McCulloch proved the existence of stem cells in 1961. Now, been leading the way in building national capacity in stem over 60 years later, the RM research and biotech sector in cell and RM research. For example, its Fuelling Canada is generating innovative advancements that offer Biotechnology Partnerships Program supports the immeasurable opportunities to address chronic illness and commercialization of RM research and early-stage disease that have the potential to reduce the burden on biotechnology companies committed to bringing RM health care systems and increase economic growth and research to market. The program has funded projects prosperity, which is of particular importance as our nation focused on vision loss, acute liver failure, type 1 diabetes, takes steps to recover from the COVID-19 pandemic. and gene therapies for underdeveloped lungs. Awards are As a key contributor to the RM sector, Canada has a lot valued at up to $400,000 for 24 months, and awardees of to be excited about. According to a 2021 report published SCN’s most recent funding competition are expected to be by the Institute of Health announced in May 2022, with a Economics (IHE), Canada is new funding competition to well-positioned to realize — or begin in September 2022. For even surpass — a target of $5 early stage biotechs focused on billion in RM-generated regenerative medicine and economic growth and create working with an academic 6,000 highly skilled jobs. partner this funding program Canada is home to several worth investigating. innovative companies in the RM By the end of fiscal year field such as, Morphocell 2023, it is projected that SCN Technologies, BlueRock will have provided over $160 Therapeutics, STEMCELL million for innovative research Technologies, Satellos Bioscience and training and leveraged Source IHE Report, Stem Cell/ Regenerative Medicine in Canada: Current State and Future Prospects, 2021 and Mesentech, with several additional partner contributions at emerging companies joining the approximately a 1:1 rate, enabling ranks in recent years such as Notch Therapeutics, Aspect 270 projects and 231 world-class research teams, and Biosystems, and AmacaThera Inc. training more than 5,000 highly qualified personnel across However, continuing this momentum and ultimately Canada. SCN will also have catalyzed over 30 clinical trials realizing the projected growth of the sector will take and catalyzed or enhanced 29 biotech start-up companies. national leadership, strong partnerships and resources. It’s an exciting time for SCN come join us! stemcellnetwork.ca

A snapshot of some of the biotech start-up companies catalyzed or enhanced through SCN

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Our apologies to the Maple Leaf. With all due respect to our national foliage, there’s another plant that’s also worthy of your heartfelt salute. That’s something we can all be proud of.

Can you imagine a world where vaccines are manufactured using plants?

Becoming a global player

That’s what Medicago, a Canadian biopharmaceutical company, is working to do.

The continued dedication and passion of our more than 500 employees has driven our progress over the past 20 years. Medicago is thankful for the ongoing support of the Government of Canada and the Government of Quebec as well as the broader Canadian scientiﬁc ecosystem which has helped us continue to innovate.

Our ambition to bring vaccines to market is transforming Medicago from an R&D company to a manufacturing and commercial one. The goal to help protect human life fuels our relentless and distinctive approach to vaccine discovery and development.

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Medicago has strong roots in Canada, and global aspirations. We have ambitions for the years to come to provide Canada with the domestic capabilities needed for future pandemics, and to become a global player with the ability to supply doses of vaccines to many other countries.

Nous présentons demandons Nous pardon à la à nos excuses feuille d’érable la feuille d’érable.

Malgré tout le respect que nous devons à notre feuillage national, il y a une autre plante qui vaut le détour.

Avec tout le respect que nous devons à notre Bien qu’elle ne soit pas rouge, elle a rendu possible feuillage national,du il existe autre plante le développement premierune vaccin produit sur plantes qui mérite votre attention. C’est quelque chose à usage humain. dont nous pouvons tous être ﬁers. Et ça, c’est quelque chose dont nous pouvons être ﬁers.

Pouvez-vous imaginer un monde où les vaccins seraient fabriqués à partir de plantes? C’est ce que Medicago, une société biopharmaceutique canadienne, s’efforce de faire. Notre ambition de mettre des vaccins sur le marché a transformé Medicago d’entreprise de R&D en entreprise de production et de commercialisation. L’objectif d’aider à protéger la vie humaine alimente notre approche continuelle et distinctive de la découverte et du développement de vaccins.

Devenir un acteur mondial Medicago a des racines solides au Canada et des aspirations mondiales. Pour les années à venir,

nous avons l’ambition de fournir au Canada les capacités nationales nécessaires pour faire face aux pandémies. Et, ainsi, devenir un acteur mondial ayant la capacité de fournir des doses de vaccins à de nombreux autres pays. Le dévouement et la passion de nos plus de 500 employé.e.s ont été les moteurs de nos progrès des 20 dernières années. Medicago est reconnaissante du soutien continu du gouvernement du Canada et du gouvernement du Québec, ainsi que de celui de l’écosystème scientiﬁque canadien dans son ensemble, qui nous ont permis de continuer à innover.

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BIOQuébec, Quebec’s Biotechnology Association BIOQuébec, l’association québécoise des biotechnologies BIOQUÉBEC IS THE QUEBEC BIOTECHNOLOGY AND LIFE SCIENCES’ ASSOCIATION. IT REPRESENTS MORE than 160 Quebec-based businesses working in health research and supports them by fostering the growth of the province’s biotechnology and health sciences’ industry and positioning Quebec as one of the most significant and valuable stakeholders on the international stage. BUILDING A STRONG INDUSTRY BIOQuébec members are part of the entire innovation chain, from basic research to integrating therapeutic innovations into the healthcare system. BIOQuébec views the various links in this chain as interrelated and considers their interactions to be crucial in expediting the development of innovative therapies. The association offers networking and connection opportunities to help its members find the right people and foster partnerships. Having a strong network will take us further! BIOQUÉBEC, QUEBEC BUSINESSES’ VOICE IN GOVERNMENT INTERACTIONS One of the association’s strengths is its ability to listen to its members’ concerns so it can adequately represent their interests in discussions with government representatives. These important issues for biotechs and the entire industry have been the focus of attention this past year: • Advocate for a coherent and structured Canadian innovation strategy that would include a discussion on drug pricing review • Facilitate access to patients’ medical data for life science companies to expedite the development of new treatments • Foster the integration of innovations in the healthcare system so that discoveries made by Quebec-based researchers and entrepreneurs can benefit patients IN 2021, BIOQUÉBEC CELEBRATED ITS 30TH ANNIVERSARY! Thirty years of serving the interests of Quebec’s life sciences companies. To mark the occasion, we met with former executives who described the association’s history and long-time partners who shared the impact the association has had on the industry. Watch the videos and rediscover our history at bioquebec.com/30ans.

Spring | Printemps 2022

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BIOQUÉBEC EST L’ASSOCIATION QUÉBÉCOISE DES BIOTECHNOLOGIES ET DES SCIENCES DE LA VIE. Elle représente plus de 160 entreprises établies au Québec qui œuvrent dans le domaine de la recherche en santé. Elle les supporte pour favoriser la croissance de l’industrie québécoise de la biotechnologie et des sciences de la vie et pour faire du Québec un des acteurs clés et incontournables de cette industrie à l’échelle internationale.

BÂTIR UNE INDUSTRIE FORTE Les membres de BIOQuébec font partie de toute la chaîne de l’innovation, de la recherche fondamentale jusqu’à l’intégration des innovations thérapeutiques dans le système de santé. BIOQuébec considère que les différents maillons de la chaîne sont tous interreliés et leurs interactions sont cruciales pour accélérer le développement de thérapies novatrices. L’association offre des occasions de réseautage et des mises en relation pour aider ses membres à trouver les bonnes personnes et pour favoriser les collaborations. C’est avec un réseau fort que nous irons plus loin !

BIOQUÉBEC, LE PORTE-VOIX DES ENTREPRISES QUÉBÉCOISES AUPRÈS DU GOUVERNEMENT L’une des forces de l’association est d’être à l’écoute des préoccupations de ses entreprises membres afin de représenter leurs intérêts auprès des instances gouvernementales. Des enjeux importants pour les biotech et l’industrie ont été mis de l’avant dans la dernière année : • Plaider pour une stratégie canadienne de l’innovation cohérente et structurée, incluant une discussion sur la révision des prix des médicaments. • Faciliter l’accès aux données médicales des patients aux entreprises en sciences de la vie pour accélérer le développement de nouveaux traitements. • Favoriser l’intégration des innovations dans le système de santé pour que les découvertes des chercheurs et entrepreneurs d’ici puissent profiter aux patients.

EN 2021, BIOQUÉBEC CÉLÉBRAIT SES 30 ANS ! 30 ans à servir les intérêts des entreprises en sciences de la vie du Québec. Pour l’occasion, nous avons rencontré des dirigeants des dernières années qui ont relaté l’histoire de l’association et des partenaires de longue date qui ont témoigné de l’impact de l’organisation sur l’industrie. Revoyez nos capsules vidéo et redécouvrez notre histoire sur bioquebec.com/30ans.

Harnessing the ‘most powerful immune system of any land animal’ Seneca partners with ostrich farm for cosmetics, antibody applied research FORGET CELEBRITIES AND THEIR HIGH-PRICED MOISTURIZERS. A TEAM OF SENECA COSMETIC science students has developed an all-natural face cream that may just hold the secret to softer and smoother skin. And they have Yelena Anikeyeva and her ostriches to thank. “If you touch my skin, you’ll see how crazy soft it is,” said Ms. Anikeyeva, founder and CEO of Ostrich Land and owner of its online store, Power of Ostrich, which is partnering with Seneca on a suite of applied research projects looking at the benefits of ostrich oil and ostrich egg white, yolk and shells. Ms. Anikeyeva, her husband, Vladimir, and their son, Alexsey, are ostrich farmers in the Niagara Region. They initially teamed up with Seneca on a cosmetic science capstone project, for which the Seneca team developed a moisturizing face cream using ostrich oil and egg yolk. “Ostriches have the most powerful immune system of any land animal,” Ms. Anikeyeva said. “For some people, ostrich oil works like a miracle. Look at me, I work outside every day, but my skin looks like I work in an office.” Ms. Anikeyeva is now working with the Seneca Centre for Innovation in Life Sciences on two new projects. The first is to design and formulate an eczema cream infused with ostrich oil and yolk. It will be co-led by Sonal Kamath and Sharon Robertson, both professors in the School of Biological Sciences & Applied Chemistry. They will supervise a Cosmetic Science

student, who will be a full-time research assistant on this project. The resulting prototype cream will add to Power of Ostrich’s product line. “With an ostrich egg, you get more fatty acids because it’s bigger than a chicken egg,” Ms. Robertson said. “You are putting all this concentrated stuff into a very thick yolk, which has a lot of antioxidants to help the skin to rejuvenate itself. It’s like you are double dipping and getting twice the amount of the good things.” The second project with Power of Ostrich will investigate antibodies found in ostrich eggs and extracting them to potentially fight eczema, acne and other skin disorders. This project will be co-led by Dr. Frank Merante and Bryan Chalk and supported by two part-time student research assistants. Dr. Merante, who previously worked on developing chicken antibodies as part of his PhD, says they will get about four to five grams of antibodies from each ostrich egg. “This is desirable as an ostrich can lay up to 100 eggs a year in Africa and 50 in Canada, and they can live for 60 years in captivity,” he said. “The avian species are clever. They load up their yolk with antibodies, which then get transferred into the embryo. Everything the mother bird is immune to gets passed on the chicks.” With the same theory in mind, the team has been monitoring an ostrich farm in British Columbia working on developing antibodies against COVID-19. “If an ostrich is vaccinated against COVID-19 using a vaccine or similar protein, then the yolk from her eggs could theoretically contain antibodies against the virus or another pathogen of interest,” said Dr. Merante. The goal for Seneca’s ostrich egg-related applied research is to develop a procedure that can be implemented for large-scale productions of antibodies for cosmetic and immunodiagnostic applications. “Utilizing ostrich eggs as a resource could be really impactful across several disciplines, including cosmetics, diagnostics and therapeutics,” Dr. Merante said. “It’s fascinating.”

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partnerships partenariats

Discovery behind blockbuster Pfizer-Trillium deal started at UHN and SickKids L’UHN et SickKids à l’origine du mariage de géants entre Pfizer et Trillium by/par Shawn Jeffords & Ania Jones, University Health Network Communications

“DON’T EAT ME” It’s a simple biological message whispered by crafty cancer cells to the immune system as they attempt to spread, grow and avoid destruction. But the complex work to understand and control that signal which gives those dangerous cells the power to hide has taken decades of research to understand. Last year, the story took a new twist when it spurred pharmaceutical giant Pfizer Inc.’s acquisition of Trillium Therapeutics in a US$2.22 billion deal. The groundbreaking research that led to the deal started at UHN’s Princess Margaret Cancer Centre and The Hospital for Sick Children (SickKids). A key collaboration between scientists at both hospitals focused on the cell signal receptor CD47 and its “Don’t Eat Me” axis – research that resulted in the creation of a molecule to shut down the protective mechanism used by cancer cells to evade destruction. Drs. John Dick, Senior Scientist, and Jean Wang, clinician-scientist, both at the Princess Margaret, and Dr. Jayne Danska, Senior Scientist at SickKids, did biological and pre-clinical research that led to the development of TTI-621, a SIRPα fusion protein that targets the signal receptor CD47, thus bolstering the immune system’s ability to destroy cancer stem cells. TTI-621 became a key technology at the Trillium Therapeutics start-up, licensed with support from Commercialization at UHN and Industry Partnerships &

Spring | Printemps 2022

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« NE ME MANGEZ PAS ». Il s’agit d’un simple message biologique « chuchoté » au système immunitaire par des cellules cancéreuses rusées alors qu’elles tentent de se propager, de croître et d’éviter d’être détruites. Néanmoins, il a fallu des décennies de recherche pour comprendre et maîtriser ce signal, qui donne à de dangereuses cellules le pouvoir de se cacher. L’histoire de cette découverte a pris une nouvelle tournure l’an dernier, lorsque Pfizer a fait l’acquisition de Trillium Therapeutics dans le cadre d’une transaction d’un montant de 2,22 milliards de dollars américains. Les recherches de pointe à l’origine de cette acquisition ont débuté au Princess Margaret Cancer Centre et au Hospital for Sick Children (SickKids) de l’University Health Network. Une collaboration clé entre les scientifiques des deux hôpitaux a porté sur le récepteur de signaux cellulaires CD47 et son mode « Ne me mangez pas ». Le fruit de ce travail a abouti à la création d’une molécule permettant de désactiver le mécanisme de protection utilisé par les cellules cancéreuses pour éviter d’être repérées et détruites. M. John Dick, Ph. D., chercheur principal, et la Dre Jean Wang, chercheuse clinicienne, tous deux du Princess Margaret Cancer Centre de l’University Health Network, ainsi que Mme Jayne Danska, Ph. D., chercheuse principale à SickKids*, ont effectué des recherches biologiques et précliniques qui ont conduit au développement du TTI-621, une protéine hybride SIRPα qui cible le récepteur de signaux CD47, renforçant ainsi la capacité du système immunitaire à détruire les cellules souches cancéreuses. Le TTI-621 est devenu une technologie clé pour la jeune pousse Trillium Therapeutics, qui s’est vu octroyer une licence, avec le soutien de Commercialization at UHN et de Partenariats et commercialisation avec l’industrie (IP&C) à SickKids, en vue de l’éventuelle mise en marché de la protéine SIRPα, avec pour mission de veiller à que celle-ci puisse être transformée en traitements destinés aux patients atteints de cancer. Les travaux en ce sens ont attiré l’attention du géant pharmaceutique Pfizer l’année dernière, qui a alors décidé d’aller de l’avant et d’acquérir Trillium, avec l’objectif de

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DR. JAMES TILL & DR. ERNEST MCCULLOCH REFINED THE DEFINITION OF STEM CELLS AND ESTABLISHED AN ENTIRELY NEW FIELD OF MEDICINE. TODAY, MANY RESEARCHERS ARE BUILDING ON THE FOUNDATION LAID BY THESE TWO REMARKABLE MEN. LEARN MORE: HTTP://OW.LY/SB5U50BQJ6N Biophysicist Dr. James Till and hematologist Dr. Ernest McCulloch began their professional partnership at the Ontario Cancer Institute, now Princess Margaret Cancer Centre, in Toronto. In the late 1950s, they transformed the world’s understanding of tissue renewal by confirming the existence of stem cells – the master cells of a tissue or organ – and laid the foundations for regenerative medicine that has the potential to treat serious conditions such as blindness, paralysis and cancer.

M. JAMES TILL, PH. D., ET LE DR ERNEST MCCULLOCH ONT PRÉCISÉ CE QU’ÉTAIENT LES CELLULES SOUCHES ET FONDÉ UN DOMAINE MÉDICAL ENTIÈREMENT NOUVEAU. AUJOURD’HUI, QUANTITÉ DE CHERCHEURS S’APPUIENT SUR LES BASES JETÉES PAR CES DEUX HOMMES REMARQUABLES. DÉCOUVREZ LEUR HISTOIRE ICI : HTTP://OW.LY/SB5U50BQJ6N Le partenariat du biophysicien James Till et de l’hématologue Ernest McCulloch a débuté à Toronto, à l’Institut ontarien du cancer, qui s’appelle désormais le Princess Margaret Cancer Centre. Ensemble, à la fin des années 1950, ils ont confirmé l’existence des cellules souches – les cellules maîtresses des tissus et des organes –, transformant ainsi la compréhension que nous avons des tissus de l’organisme et établissant les fondements de la médecine régénérative, qui pourrait permettre le traitement de troubles aussi graves que la cécité, la paralysie et le cancer.

The groundbreaking research of (L to R) Drs. John Dick, Jayne Danska and Jean Wang ultimately led to pharmaceutical giant Pfizer Inc. acquiring Trillium Therapeutics for US$2.22 billion. (Photo: UHN)

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Commercialization (IP&C) at SickKids to commercialize the SIRPα discovery and ensure it could be developed for treatments to help cancer patients. That work drew the attention of Pfizer last year and its desire to ink the deal to buy Trillium with a special interest in the TTI-621 drug development project. In its announcement that the acquisition had closed late last year, Pfizer touted TTI-621 as “a key immune checkpoint inhibitor currently in Phase 1b/2 development across several indications, with a focus on hematological malignancies.” The company says the molecule is also being tested to evaluate clinical potential in solid tumours. “Pfizer’s decision to buy Trillium Therapeutics is the latest testament to UHN’s commercialization expertise guiding early-stage science to maximum societal impact, and is proof of the world-class science that powers our ecosystem here in Toronto,” says Mark Taylor, Director of Commercialization at UHN. ‘THIS IS A STORY OF REAL DISCOVERY’ ”Over a decade ago, our scientists recognized the potential that targeting this pathway could have in cancer and licensed this compound to UHN spinoff Trillium Therapeutics to best steward its development,” says Dr. Brad Wouters, UHN’s Executive Vice President of Science and Research. But going back to the earliest experiments, success was hardly assured according to Dr. Dick, who is also Senior Scientist at UHN’s McEwen Stem Cell Institute and Professor of Molecular Genetics at University of Toronto (U of T). “This is a story of real discovery,” Dr. Dick says. “We ended up in a place that was completely unexpected.” The three scientists collaborated on a painstaking process that took a decade to create the ideal pre-clinical models for their experiments. It eventually yielded the finding that blocking SIRPα signaling in pre-clinical models of leukemia enabled elimination of human leukemia stem cells, a sub-population of tumour cells that are resistant to standard chemotherapy. Dr. Stephen Scherer, Chief of Research at SickKids, says the strong collaboration between the three investigators as well as between the two institutions’ commercialization offices was fundamental to accelerating the research. “SickKids and UHN are globally renowned for pushing the boundaries of scientific discovery,” he says. “Open collaboration throughout the initial innovation process enabled a faster understanding of the underlying science and the visioning of potential clinical applications.” The implication of the work was that if the signaling could be blocked by a therapeutic agent, it would unleash the patient’s immune system to destroy the cancer cells.

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concrétiser le projet de développement du médicament TTI-621. Dans son annonce lors de l’officialisation de l’acquisition à la fin de l’année dernière, Pfizer a présenté le TTI-621 comme « un important inhibiteur de points de contrôle immunitaire actuellement aux essais de phase 1b/2 relativement à plusieurs indications, notamment les hémopathies malignes ». La société indique que la molécule est également soumise à des essais évaluant son potentiel clinique contre les tumeurs solides. « La décision de Pfizer d’acheter Trillium Therapeutics est la plus récente preuve de l’expertise de l’UHN en matière de commercialisation, plus précisément pour ce qui est de mener les découvertes scientifiques de la phase initiale au point où elles ont une incidence majeure dans la société. Elle témoigne aussi du fait que de la science qui alimente notre écosystème ici à Toronto est de classe mondiale », explique Mark Taylor, directeur de la commercialisation à l’UHN. « Il y a plus de dix ans, nos scientifiques ont reconnu le potentiel qu’avait ce mécanisme par rapport au cancer. Ils ont ainsi accordé une licence pour ce composé à Trillium Therapeutics, une entreprise ayant essaimé de l’UHN, afin de veiller au mieux à son développement. Aujourd’hui, elle poursuit activement ses recherches sur cette nouvelle approche de l’immuno-oncologie dans des essais cliniques, car il y a un réel potentiel de création de nouveaux traitements contre le cancer », affirme Brad Wouters, viceprésident directeur, science et recherche à l’UHN. Cependant, selon John Dick, si l’on remonte aux résultats des premières expériences, le succès n’était guère assuré. « On parle ici de l’histoire d’une véritable découverte », dit-il. « Nous nous sommes retrouvés dans une sphère complètement nouvelle et inattendue. » Les trois scientifiques se sont engagés dans un long processus, très exigeant. Il leur a fallu pas moins d’une décennie pour créer les modèles précliniques qui convenaient à leurs expériences. Ce processus leur a finalement permis de découvrir que le fait de bloquer les signaux SIRP dans des modèles précliniques de leucémie permettait d’éliminer les cellules souches leucémiques humaines, une sous-population de cellules tumorales qui résistent aux traitements de chimiothérapie courants. Stephen Scherer, le directeur de la recherche à SickKids, affirme que l’étroite collaboration qui a uni les trois chercheurs et les bureaux de la commercialisation des deux établissements a été un facteur déterminant en ce qui a trait à l’accélération de la recherche. « SickKids et l’UHN sont réputés dans le monde entier pour repousser les limites de la découverte scientifique. Une collaboration ouverte tout au long du processus d’innovation initial a permis une compréhension plus rapide des données scientifiques sous-jacentes et des perspectives d’applications cliniques potentielles », affirme-t-il.

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The findings had wide-ranging implications beyond just leukemia treatment. Further research in the labs of Drs. Dick, Wang and Danska led to the development of a molecule that defeats the inhibitory “Don’t Eat Me” signal, unleashing macrophages – a type of white blood cell powering the immune system’s disease fighting response – on the cancer cells. “Our molecule unblinds the immune system so it can attack the aberrant cancer cells and destroy them,” says Dr. Wang, who is also a staff hematologist at the Princess Margaret and Associate Professor in the Department of Medicine at U of T. “Normal cells are much less reliant on this signaling axis because they don’t have the abnormal characteristics of cancer cells.

“So when you interrupt that “Don’t Eat Me” signal, the immune system tends to see the cancer cells first.” “It’s not every investigator that gets a chance to take something from bench to bedside,” Dr. Wang adds. “It’s very promising.” COLLABORATION DRIVEN BY A SHARED CURIOSITY The research teams say Pfizer’s acquisition of Trillium Therapeutics could help ensure that their work is further developed, advancing to one day realize its full potential as a novel immunotherapy in the treatment of many different cancers. Dr. Danska says the scientific collaboration between the three investigators was driven by a shared curiosity to find the biology behind a puzzling observation. “We discussed this curious finding multiple times and decided to use a combination of scientific approaches and novel models we had each developed to find the source,” says Dr. Danska, Senior Scientist in the Genetics & Genome Biology Program and Associate Chief, Faculty Development and Diversity at SickKids Research Institute, and Professor in the Departments of Immunology and Medical Biophysics at U of T. “There were no preconceptions – we followed the results and made the discovery. “I’m hoping that a well-resourced company like Pfizer will be able to take this into all the potential avenues where it might make an impact,” Dr. Dick says. “We’re talking about products that are useful for patients. “That’s the ultimate goal here.”

L’objectif était d’arriver à ce que les signaux puissent être bloqués par un agent thérapeutique, afin que le système immunitaire du patient se mette à détruire les cellules cancéreuses. Les conclusions de cette étude ont eu des répercussions importantes, au-delà du seul traitement de la leucémie. D’autres recherches au sein des laboratoires de nos trois chercheurs ont permis la mise au point d’une molécule qui déjoue le signal inhibiteur de la phagocytose, envoyant ainsi les macrophages – un type de globules blancs qui agit dans la réponse du système immunitaire à la maladie – attaquer les cellules cancéreuses. « Cette molécule permet au système immunitaire de “voir” les cellules cancéreuses anormales et de les détruire », explique Jean Wang, clinicienne-chercheuse au Princess Margaret Cancer Centre. « Les cellules normales dépendent beaucoup moins de cette “voie de signalisation”, car elles ne présentent pas les caractéristiques anormales des cellules cancéreuses. Autrement dit, lorsque l’on interrompt le signal “don’t eat me”, le système immunitaire a tendance à repérer d’abord les cellules cancéreuses. Ce n’est pas tous les chercheurs qui ont la chance de faire passer leur découverte du laboratoire au chevet du patient », déclare la Dre Wang. « C’est vraiment très prometteur. » Selon les équipes de recherche, l’acquisition de Trillium Therapeutics par Pfizer pourrait favoriser la poursuite de leurs travaux, afin que leur découverte puisse un jour atteindre son plein potentiel en tant que nouvelle immunothérapie pour le traitement de toutes sortes de cancers. Selon Jayne Danska, la collaboration scientifique entre les trois chercheurs a été motivée par la curiosité. Chacun d’eux souhaitait découvrir ce que pouvait bien cacher le phénomène déroutant qu’il avait observé. « Nous avons discuté de cette curieuse découverte à plusieurs reprises et avons décidé d’utiliser une combinaison d’approches scientifiques et de nouveaux modèles que nous avions chacun développés pour arriver à nos fins. Nous n’avions pas d’idées préconçues. Ce sont les résultats qui nous ont menés à faire cette découverte », explique-t-elle. « Notre approche témoigne de ce qui se passe véritablement lorsque l’on tente de répondre à des questions de biologie fondamentale en laboratoire. Le riche écosystème de recherche de SickKids et de l’UHN nous a permis de résoudre l’énigme, de démontrer le potentiel thérapeutique de notre découverte et de nous associer à l’industrie pour en faire une application clinique », conclut-elle. « J’espère qu’une entreprise disposant de bonnes ressources comme Pfizer sera en mesure d’exploiter toutes les voies potentielles où notre découverte pourrait jouer un rôle important », précise John Dick. « Il s’agira de créer des produits qui sont utiles aux patients. C’est là l’objectif ultime ».

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Proposing a solution for Canada’s drug supply shortage - The Canadian Critical Drug Initiative Une solution possible aux pénuries de médicaments au Canada : l’initiative canadienne de fabrication de médicaments essentiels by Andrew MacIsaac, CEO of Applied Pharmaceutical Innovation par Andrew MacIsaac, chef de la direction d’Applied Pharmaceutical Innovation IN THE WAKE OF THE COVID-19 PANDEMIC, EVERY COUNTRY HAS FELT THE NEED TO REASSESS ITS PHARMACEUTICAL SUPPLY CHAIN, infrastructure, and address challenges within its life sciences ecosystem. The Government of Canada has also recognized shortcomings in Canada’s vaccine manufacturing capacity, our overreliance on import of essential drugs and lack of necessary resources such as infrastructure, investments, and talent for domestic manufacturing. With the federal government’s Biomanufacturing and Life Sciences Strategy in place, Canada has taken the first step in acknowledging this gap and made some significant investments. These investments include boosting vaccine manufacturing capabilities for future pandemic preparedness, supporting talent development to address the industry skill gap, and simplifying regulatory processes to support commercialization of innovation. However, this recipe is missing a key ingredient – small molecule drug manufacturing.

DANS LE SILLAGE DE LA PANDÉMIE DE COVID-19, TOUS LES PAYS ONT RESSENTI LE BESOIN DE RENFORCER LEUR CHAÎNE D’APPROVISIONNEMENT EN PRODUITS PHARMACEUTIQUES et leur infrastructure, ainsi que de remédier à certaines insuffisances au sein de leur secteur des sciences de la vie. Le gouvernement du Canada a aussi pris la mesure des faiblesses canadiennes sur le plan des capacités de fabrication de vaccins, notamment une trop grande dépendance vis-à-vis des importations de médicaments essentiels et des lacunes en matière d’infrastructures, d’investissements et de ressources humaines. Par la mise en place de la Stratégie en matière de biofabrication et de sciences de la vie du gouvernement fédéral, le Canada a indiqué qu’il avait bien pris la mesure des lacunes et a fait des investissements considérables. Ceux-ci ont notamment consisté à augmenter les capacités de fabrication de vaccins de telle sorte que le pays soit prêt à faire face à la prochaine pandémie, à appuyer la formation des talents de manière à remédier au manque de maind’œuvre compétente et à simplifier les processus réglementaires en vue de soutenir la commercialisation des innovations. Il manque toutefois un ingrédient à la réussite du plat : la fabrication de médicaments à petites molécules.

THE SMALL MOLECULE DRUG DEVELOPMENT GAP Small molecule drugs play a very significant role in our healthcare system for use in hospitals for treating patients and as over-the-counter drugs. You may know them as antivirals to treat Covid-19, pain relievers like ibuprofen and propofol as an anaesthetic before surgeries, etc., and most of which are currently imported through India and China. While both India and China are doing a good job at maintaining a global supply of manufactured pharmaceutical drugs, almost any crisis in these source countries or globally can disrupt the supply of essential drugs for countries like ours. The shortage of urgent hospital drugs, empty drug store shelves and higher Andrew MacIsaac, CEO of Applied Pharmaceutical Innovation | chef de la pricing for drugs at the start of the direction d’Applied Pharmaceutical pandemic is one of the biggest examples Innovation 64

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DES CAPACITÉS INSUFFISANTES SUR LE PLAN DE LA MISE AU POINT DE MÉDICAMENTS À PETITES MOLÉCULES Les médicaments à petites molécules, qui servent au traitement des patients hospitalisés et dont certains sont offerts en vente libre, jouent un rôle considérable dans le système de santé. Vous les connaissez : il s’agit des antiviraux contre la COVID-19, des analgésiques tels que l’ibuprofène ou encore des anesthésiants tels que le propofol, administré en cas de chirurgie, la plupart desquels sont importés d’Inde ou de Chine. Même si l’Inde et la Chine arrivent bien à maintenir l’approvisionnement mondial en produits pharmaceutiques, une crise dans

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of what can happen when the global supply chain gets disrupted. Even today, we continue to face this shortage in some critical drugs across Canada. The real remedy to this concentrated overreliance on the import of these essential drugs is to increase domestic manufacturing capacity along with equal investment in increasing manufacturing of pharmaceutical ingredients to produce essential drugs on a large scale. WHAT CANADA HAS VERSUS WHAT IT’S LACKING “There is an astonishing amount of innovative research happening within Canada’s academic institutions and life sciences organizations. Unfortunately, a lot of these discoveries are not being commercialized in Canada,” said Dr. Michael Houghton. Dr. Houghton’s discovery of the hepatitis C (HCV) virus led to him being awarded the 2020 Nobel Prize in Physiology or Medicine. Today, Dr. Houghton and the Li Ka Shing Applied Virology Institute based at the University of Alberta are working with Applied Pharmaceutical Innovation (API) to develop a vaccine for HCV, a pandemic resulting in around 300,000 deaths around the world every year. Another hurdle that scientists and drug development organizations face is the lack of access to industry experts and highly qualified personnel (HQPs) to conduct the later stages of research and clinical trials. This is where API comes in. API has developed a collaborative framework bridging the gap between academia and industry by creating the translational capacity needed to help a researcher access expertise, services, and the infrastructure of a pharmaceutical organization that they need to scale and commercialize their intellectual property (IP). API also uses an industrybased model to hire and train postdoctoral fellows and researchers on industry projects to help them become HQPs. This means that both the innovator and their IP stay within Canada, commercialize their products and start production of their pharmaceutical, natural health product or medical device domestically. To further expand Canada’s capabilities in manufacturing essential drugs, to secure the supply chain resiliency, and to ensure that we retain our talent and life science IP within the country, we need the public and private sectors, and academic institutions working together to find a holistic solution. THE CANADIAN CRITICAL DRUG INITIATIVE (CCDI) As part of a unique-in-Canada partnership, API, the University of Alberta and the Li Ka Shing Applied Virology Institute (LKSAVI) are developing an integrated research, commercialization and manufacturing life science cluster in Western Canada with partnerships spanning the country. This will include a 40,000-sq-ft. facility that will address Canada’s critical drug needs, support the

l’un de ces pays sources ou à l’échelle mondiale risquerait quasi invariablement de perturber l’approvisionnement en médicaments essentiels dans des pays comme le nôtre. D’ailleurs, la pénurie de médicaments dont les hôpitaux avaient un urgent besoin, les tablettes de pharmacie dégarnies et le prix élevé des médicaments au début de la pandémie constituent un exemple patent de ce qui peut se produire en cas de rupture de la chaîne logistique mondiale. À l’heure actuelle, il y a toujours pénurie de certains médicaments essentiels au Canada par suite de la crise pandémique. Pour remédier efficacement à la dépendance excessive envers l’importation des médicaments essentiels, il faudrait augmenter les capacités nationales de fabrication et, proportionnellement, les investissements dans la fabrication des ingrédients pharmaceutiques nécessaires à la production à grande échelle des médicaments essentiels.

ATOUTS ET DÉSAVANTAGES DU CANADA « L’ampleur de la recherche et de l’innovation au sein des établissements universitaires et des organisations de sciences de la vie au Canada est extraordinaire. Malheureusement, quantité des découvertes effectuées ne sont pas commercialisées au pays », explique M. Michael Houghton, Ph. D. En 2020, M. Houghton s’est vu décerner le prix Nobel de physiologie ou médecine pour la découverte du virus de l’hépatite C (VHC). Aujourd’hui, M. Houghton et l’Institut de virologie appliquée Li Ka Shing, dont le siège se trouve à l’Université de l’Alberta, travaillent en collaboration avec Applied Pharmaceutical Innovation (API) en vue de mettre au point un vaccin contre le VHC, que l’on peut considérer comme pandémique au vu des 300 000 décès qu’il cause chaque année dans le monde. Un des obstacles auxquels se butent les scientifiques et les organisations de recherche-développement de médicaments est le manque, au sein du secteur, d’experts et de professionnels hautement qualifiés (PHQ), alors que leur présence est essentielle aux dernières étapes de la recherche et des essais cliniques. La contribution d’API s’avère ici essentielle. En effet, API a conçu un cadre collaboratif qui permet de combler le fossé entre le milieu universitaire et celui de l’entreprise. Ce cadre offre les capacités translationnelles dont les chercheurs ont besoin pour accéder à de l’expertise, à des services et à l’infrastructure organisationnelle nécessaires à la mise à l’échelle et à la commercialisation de leur propriété intellectuelle (PI). API s’appuie de plus sur un modèle de collaboration avec l’industrie, qui permet l’embauche et la formation de boursiers postdoctoraux et de chercheurs au sein de projets concrets, faisant ainsi d’eux des PHQ. Cela signifie que les auteurs des innovations et leur PI demeurent au Canada, puis que les produits pharmaceutiques, les produits de santé naturels et les instruments médicaux peuvent être produits et commercialisés au pays. Pour élargir encore les capacités du Canada sur le plan de la fabrication de médicaments essentiels, assurer la résilience biotech.ca

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While both India and China are doing a good job at maintaining a global supply of manufactured pharmaceutical drugs, almost any crisis in these source countries or globally can disrupt the supply of essential drugs for countries like ours. The shortage of urgent hospital drugs, empty drug store shelves and higher pricing for drugs at the start of the pandemic is one of the biggest examples of what can happen when the global supply chain gets disrupted. innovative research of Nobel laureate Dr. Michael Houghton and Dr. Lorne Tyrrell, develop a talent pipeline of life science professionals, and provide commercialization opportunities for local innovators. The CCDI will increase Canada’s capacity to manufacture critical drugs to supply nationally as well as be part of the global supply chain. This not only gives us a competitive advantage as a country but also gives security in crisis situations like a pandemic. This cluster will also be used as a research and development centre to empower companies and innovators to conduct their drug discoveries, de-risk their innovation, conduct clinical trials and commercialize their IP to scale right here in Canada. The CCDI will position Canada as a leader in the global active pharmaceutical production market. We will be able to domestically manufacture and supply critical drugs and fill-finish for vaccines on a large scale as well as create a specialized talent pipeline through training partnerships with the University of Ottawa and the Universite de Montreal. The core work of API and the added capacity of the CCDI will create an additional 500 – 1,000 high-paying jobs for Canadians in the life sciences industry and ensure that we are not only attracting investment in this sector but commercializing Canadian IP and manufacturing locally, while supporting our life science graduates in the path from academia to industry. The growth of the life science sector will be a critical economic driver as we address pandemic needs, create meaningful jobs and strengthen our economy by ensuring that our talent and IP stay here. 66

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de la chaîne d’approvisionnement et retenir les talents et la PI en sciences de la vie au pays, il faut que les secteurs public et privé, ainsi que les établissements universitaires œuvrent ensemble à une solution globale.

L’INITIATIVE CANADIENNE DE FABRICATION DE MÉDICAMENTS ESSENTIELS (ICFME) Dans le cadre d’un partenariat unique au Canada, API, l’Université de l’Alberta et l’Institut de virologie Li Ka Shing (LKSAVI) travaillent à mettre en place dans l’ouest du Canada un pôle en sciences de la vie intégrant la recherche, la commercialisation et la fabrication, qui serait fort de différentes collaborations dans l’ensemble du pays. Le pôle comprendra des installations de 40 000 pieds carrés appelées à répondre aux besoins du Canada en médicaments essentiels, à appuyer la recherche innovante du lauréat du Nobel, M. Michael Houghton, et du Dr Lorne Tyrrell, à permettre la constitution d’un bassin de professionnels de talent en sciences de la vie et à offrir des possibilités de commercialisation aux innovateurs locaux. L’ICFME augmentera la capacité du Canada sur le plan de la fabrication de médicaments essentiels destinés à approvisionner le pays et la chaîne logistique mondiale. Cette initiative nous procure non seulement un avantage concurrentiel à titre de pays, mais aussi une sécurité en vue des situations de crise telles que les pandémies. Le pôle servira aussi de centre de recherchedéveloppement et habilitera les entreprises et les innovateurs à mener des recherches dans le domaine pharmaceutique, à réduire le risque associé à l’innovation, à mener des essais cliniques et à commercialiser la PI à grande échelle, ici même, au Canada. L’ICFME fera du Canada un leader du marché mondial de la production de principes actifs. Nous pourrons, au pays, assurer à grande échelle la fabrication et l’approvisionnement de médicaments essentiels, ainsi que le remplissage et la finition de vaccins et mettre en place un bassin de talents spécialisés grâce à des partenariats avec l’Université d’Ottawa et l’Université de Montréal. Les efforts ciblés d’API et les capacités supplémentaires apportées par l’ICFME créeront 500 à 1 000 emplois bien rémunérés pour les Canadiens du secteur des sciences de la vie et nous permettront de ne pas nous limiter à attirer des investissements dans le secteur, mais plutôt, en plus, de commercialiser la PI canadienne et d’assurer la fabrication à l’échelle locale, tout en soutenant les diplômés en sciences de la vie sur le chemin qui mène des études à la vie professionnelle. La croissance du secteur des sciences de la vie, qui permettra de répondre aux besoins en cas de pandémie, constituera aussi un moteur économique essentiel, créera des emplois de qualité et, en retenant les talents et la PI au pays, en renforcera l’économie.

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Better Health, Brighter Future Since our founding in 1781 in Osaka, Japan, our values endure by putting patient needs first, building trust with society, strengthening our reputation and developing the business – in that order. Takeda will always be unwavering in our commitment to bring better health and a brighter future to Canadians through leading innovations in gastroenterology, oncology, neuroscience and rare diseases. To ﬁnd out more about Takeda and our commitment to Canadians, visit www.takeda.com/en-ca.

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Building Canada’s Life Science Industry Requires a Strong Foundation of Canadian Talent Le développement de l’industrie des sciences de la vie au canada nécessite une base solide de talents by/par Gino Calabretta, adMare BioInnovations

LABOUR SHORTAGES ARE HITTING VIRTUALLY EVERY CANADIAN SECTOR, FROM COFFEE SHOPS TO CAR MANUFACTURING – AND LIFE SCIENCES IS NO EXCEPTION. But what is exceptional about our industry is its vital importance to Canada’s health security and economic future, and its urgent demand for high-skilled talent to drive its growth. With the COVID pandemic came tectonic shifts across the life sciences landscape – from unparalleled public and political focus to the rapid development of (and further need for) new health innovation, to record-level investment globally – and in Canada, a reckoning around the value of domestic innovation capacity. This confluence of forces has created not only an unprecedented opportunity, but a critical need to build the Canadian life sciences industry. With the wealth of worldclass research at Canada’s academic institutions, its foundation is well-primed, but requires some emergency underpinning with strong talent ready to support its growth. BioTalent Canada predicts Canada will be short 65,000 life sciences workers by 2029; and further warns, “Some of the most severe shortages are expected in bio-manufacturing

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LES PÉNURIES DE MAIN-D’ŒUVRE FRAPPENT PRATIQUEMENT TOUS LES SECTEURS CANADIENS, DES CAFÉS AU SECTEUR DE LA CONSTRUCTION AUTOMOBILE, ET LES SCIENCES DE LA VIE NE FONT PAS EXCEPTION. Mais ce qui est exceptionnel dans notre industrie, c’est l’importance vitale de talents hautement qualifiés pour assurer la sécurité sanitaire, l’avenir économique et la croissance du Canada. La pandémie de COVID a entraîné des changements de fond dans le paysage des sciences de la vie :D de l’attention publique et politique sans précédentes accordées au développement rapide et au besoin accru d’innovations en matière de santé, aux investissements records à l’échelle mondiale. Au Canada, nous avons aussi connu une prise de conscience de la valeur nationale de la capacité d’innovation. Cette confluence de forces a créé non seulement une opportunité sans précédent, mais aussi un besoin crucial de développer l’industrie canadienne des sciences de la vie. Grâce à la richesse de notre recherche de calibre mondial menée par nos institutions universitaires canadiennes, les fondations sont bien amorcées. Elles ont cependant besoin d’un soutien urgent de talents solides prêts à soutenir leur croissance.

Photo taken onsite at NIBRT

Photo prise sur place au NIBRT

and processing. Forecasts suggest employers will be able to fill only 25% of job openings in these areas between now and 2029. The shortage is expected to intensify as Canada seeks to expand its manufacturing sector due to the glaring lack of capacity highlighted by COVID-19.” The talent challenge is exacerbated by a significant equity gap in the life science workforce. Women make up only 34 per cent of workers in the bioeconomy, while other equity-seeking groups have even less representation. Visible minorities represent only one-fifth of the workforce, internationally educated professionals 17 per cent, recent immigrants nine per cent, while Indigenous workers and workers with disabilities combined make up one per cent of the bioeconomy workforce. To combat this looming and double-barrelled challenge, adMare BioInnovations and the Canadian Alliance for Skills and Training in Life Sciences (CASTL) have come together to build the talent desperately needed in Canada’s biopharmaceutical manufacturing sector. adMare is a national life sciences leader that uses its scientific and commercial expertise, specialized R&D infrastructure, and investment capital to build new

BioTalent Canada prévoit un déficit de 65 000 travailleurs dans le domaine des sciences de la vie au Canada d’ici 2029 et prévient que « certaines des pénuries les plus graves sont attendues dans la biofabrication et la biotransformation. Les prévisions indiquent que les employeurs ne pourront combler que 25 % des postes vacants dans ces domaines d’ici 2029. La pénurie devrait s’intensifier à mesure que le Canada cherche à développer son secteur manufacturier en réponse au manque flagrant de capacité mise en évidence par la pandémie de COVID-19. » Le défi posé par la recherche de talents est exacerbé par un important déficit d’équité dans la main-d’œuvre en sciences de la vie. Les femmes ne représentent que 34% des travailleurs de la bioéconomie, tandis que d’autres groupes en quête d’équité sont encore moins représentés. Les minorités visibles ne représentent qu’un cinquième de la main-d’œuvre, les professionnels formés à l’étranger 17%, les immigrants récents 9%, tandis que les travailleurs autochtones et les travailleurs handicapés représentent ensemble 1% de la main-d’œuvre de la bioéconomie. Pour lutter contre ce défi imminent et à double tranchant, adMare BioInnovations et l’Alliance canadienne pour

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Canadian life sciences companies, robust ecosystems, and industry-ready talent through the extremely successful adMare Academy. The Academy provides unique and substantive programs to train the highly-qualified personnel, from undergrads to industry executives, who will drive the growth of the industry – and more than 500 Academy alumni are now doing just that. CASTL is the exclusive provider in Canada of training curriculum licensed by the National Institute for Bioprocessing Research and Training (NIBRT), a worldclass program for the biopharmaceutical manufacturing industry. As a partner in NIBRT’s global partner’s program, CASTL has access to NIBRT’s globally-recognized biopharma manufacturing curriculum, will collaborate on

l’acquisition de compétences et la formation en sciences de la vie (CASTL) ont uni leurs efforts pour former les talents dont a désespérément besoin le secteur canadien de la fabrication biopharmaceutique. adMare est un chef de file national dans le domaine des sciences de la vie qui utilise son expertise scientifique et commerciale, son infrastructure de R&D spécialisée et son capital d’investissement pour développer de nouvelles entreprises canadiennes dans le domaine des sciences de la vie, des écosystèmes robustes et des talents prêts pour l’industrie grâce à son Académie adMare, qui connaît un grand succès. L’Académie offre des programmes uniques et substantiels pour former le personnel hautement qualifié, des étudiants de premier cycle aux cadres de l’industrie, qui

new and customized curriculum design, and apply best practices in the development of new skills and training centres in Canada. Through their partnership, the adMare Academy becomes the Lead National Partner for CASTL; and the two organizations are working together to facilitate the development, delivery, and growth of CASTL’s gold standard training programs across the country.

seront le moteur de la croissance de l’industrie. Et c’est exactement ce que font aujourd’hui plus de 500 anciens étudiants de l’Académie adMare. CASTL est l’unique fournisseur au Canada des programmes de formation du National Institute for Bioprocessing Research and Training (NIBRT), un programme de calibre mondial pour l’industrie de la fabrication biopharmaceutique. En tant que partenaire NIBRT mondial, CASTL a accès à son programme

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“Together, adMare and CASTL are building the domestic talent to support the growth of Canada’s biomanufacturing and broader life sciences sectors,” said Gordon C. McCauley, President and CEO of adMare. “And we know that diverse and inclusive workforces are far stronger, which is why priority focus for all our Academy programs is given to addressing the gender gap within life sciences and to building opportunities for under-represented groups.” “CASTL is prepared to deliver on the economic demand for individuals who are work-ready to enter, thrive and meet the needs of Canada’s biopharma manufacturing sector,” said Penny Walsh-McGuire, CASTL’s Executive Director. “We are pleased to be bringing world-class bioprocessing training curriculum to Canada to help meet the growing needs of industry.” In partnership with academia, industry, and governments, CASTL offers multiple applied learning streams and pathways for individuals to acquire hands-on technical training, theoretical knowledge and professional skills. Through universities, colleges, and CEGEPs, CASTL will provide specialized courses and customized training programs to meet the needs of students who wish to develop their careers in the biopharma manufacturing industry. For current industry employees, CASTL offers more than 20 core curriculum training modules to support upskilling, cross-skilling, and onboarding. The CASTL Online Academy powered by NIBRT, offers learners a catalogue of more than 60 immersive and interactive biopharmaceutical manufacturing training courses. With new courses continuously being added, the CASTL Online Academy is a cost-effective and efficient way to help employees develop their knowledge on a variety of relevant industry topics. For additional information on CASTL, see: castlcanada.ca To learn more about the programs offered by the adMare Academy, visit admarebio.com/admare-academy

d’études sur la fabrication de produits biopharmaceutiques. Grâce à ce programme reconnu dans le monde entier, CASTL travaillera à la conception de nouveaux programmes d’études et appliquera les meilleures pratiques dans le développement de nouvelles compétences et de nouveaux centres de formation biopharmaceutiques au Canada. Dans le cadre de ce partenariat, l’Académie adMare devient le principal partenaire national de CASTL, et les deux organisations collaborent pour faciliter l’élaboration, la prestation et la croissance des programmes de formation de CASTL dans tout le pays. « Ensemble, adMare et CASTL développent les talents nationaux qui soutiendront la croissance du secteur de la biofabrication et des sciences de la vie au Canada », a déclaré Gordon C. McCauley, président et chef de la direction d’adMare. « Nous savons que des effectifs diversifiés et inclusifs sont beaucoup plus forts, c’est pourquoi la priorité de tous nos programmes de l’Académie est donnée à la lutte contre l’écart entre les sexes dans les sciences de la vie et à la création d’opportunités pour les groupes sous-représentés. » « CASTL veut répondre aux demandes de personnes prêtes à travailler pour entrer dans le secteur canadien de la fabrication de produits biopharmaceutiques, y prospérer et répondre à ses besoins », a déclaré Penny Walsh-McGuire, directrice générale de CASTL. « Nous sommes ravis d’apporter au Canada un programme de formation en bioprocédés de calibre mondial pour aider à répondre aux besoins croissants de l’industrie. » En partenariat avec le milieu universitaire, l’industrie, et les gouvernements, CASTL offre de multiples filières et voies d’apprentissage appliqué permettant aux individus d’acquérir une formation technique pratique, des connaissances théoriques et des aptitudes professionnelles. Par l’intermédiaire des universités, des collèges et des cégeps, CASTL offrira des cours spécialisés et des programmes de formation personnalisés pour répondre aux besoins des étudiants qui souhaitent développer leur carrière dans l’industrie de la biofabrication. Pour les employés actuels de l’industrie, CASTL offre plus de 20 modules de formation de base pour favoriser le perfectionnement, la formation polyvalente et l’intégration. L’Académie en ligne de CASTL, alimentée par le NIBRT, offre aux étudiants un catalogue de plus de 60 formations en ligne immersives et interactives sur la biofabrication. De nouveaux cours sont constamment ajoutés, ainsi l’Académie en ligne de CASTL est un moyen rentable et efficace d’aider les employés à développer leurs connaissances sur une gamme de sujets pertinents pour l’industrie. Pour de plus amples renseignements sur CASTL, visitez le site : castlcanada.ca Pour en savoir plus sur les programmes proposés par l’Académie adMare, visitez la page admarebio.com/ lacademie-admare

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CATTI: Closing Canada’s biomanufacturing skills gap CATTI : Combler le déficit de compétences en biofabrication au Canada by Nadine Lunt, Editor in Chief, Insights par Nadine Lunt, Rédactrice en chef, Insights

“DESIGNING COURSES FOR THE NEXT GENERATION OF CANADIAN BIOMANUFACTURING TALENT IS NO SMALL TASK,” explains Vanessa Laflamme, Chief Executive Officer of the Canadian Advanced Therapies Training Institute (CATTI). “That’s why we’re working collaboratively with businesses to coproduce and constantly evolve our courses to ensure they’re equipping the advanced therapies workforce with all of the skills and knowledge they need to hit the ground running when they transition into the workforce.” When CATTI burst onto the scene in 2021, it entered a rapidly expanding cell and gene therapy (CGT) industry struggling to keep up with talent requirements. Rising to the challenge, CellCAN, a knowledge mobilization network in CGTs, and CCRM, a leader in developing and commercializing regenerative medicine-based technologies and CGTs, launched CATTI last July. Today, CATTI offers more than 50 online courses in English and French that are fully stackable and user centric. “Our curriculum is governed and qualified by CATTI’s Education Committee, composed of 16 key opinion leaders from across Canada and internationally who provide

Spring | Printemps 2022

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« CONCEVOIR DES COURS POUR LA PROCHAINE GÉNÉRATION DE TALENTS CANADIENS EN BIOFABRICATION N’EST PAS UNE MINCE TÂCHE », explique Vanessa Laflamme, directrice générale de l’Institut canadien de formation en thérapies avancées (CATTI). C’est pourquoi nous travaillons en collaboration avec les entreprises pour coproduire et faire évoluer constamment nos cours, afin de nous assurer qu’ils dotent la main-d’œuvre en thérapies avancées de toutes les compétences et connaissances dont elle a besoin pour être opérationnelle dès son entrée sur le marché du travail. » Lorsque CATTI a fait son entrée sur la scène en 2021, il est arrivé dans un secteur des thérapies cellulaires et géniques (TCG) en pleine expansion, qui avait du mal à répondre aux besoins en talents. Relevant le défi, CellCAN, un réseau de mobilisation des connaissances dans les TCG, et CCRM, un leader dans le développement et la commercialisation de technologies basées sur la médecine régénératrice et les TCG, ont lancé CATTI en juillet dernier. Aujourd’hui, CATTI offre plus de 50 cours en ligne en anglais et en français qui sont entièrement cumulables et centrés sur l’utilisateur. « Notre programme de formations est encadré et qualifié par un comité d’éducation, composé de 16 leaders d’opinion de premier plan provenant de partout au Canada et de l’étranger, qui fournissent des commentaires sur les écarts en matière de formation, ainsi que sur les lacunes et les programmes essentiels qui font actuellement défaut dans le secteur », explique Craig Hasilo, directeur scientifique de CATTI. « Ces leaders représentent les principaux fabricants de produits de thérapies avancées. Ils sont responsables de la formation du personnel hautement qualifié et de la conformité aux bonnes pratiques de fabrication actuelles (BPF) au sein de leurs organisations respectives. »

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organizational know-how leaves, taking their accumulated l’industrie biopharmaceutique de suivre ces cours. Ils facilitent certainement la recherche d’un emploi». knowledge with them.” Les entreprises voient également la valeur de la formation Khadija Cherif, a Biomanufacturing Specialist who en ligne flexible de CATTI. Jack Harvey, vice-président recently completed CATTI’s Advanced Therapies GMP directeur du développement et de la fabrication des Onboarding, explains how it helped her to transition into a processus chez Aspect biosystems, a récemment demandé à GMP role. “I’ve always worked in non-GMP environments. une équipe de huit personnes de suivre le parcours de This training enriched my knowledge of all things GMP, formation Programme d’intégration aux BPF en thérapies from clean rooms, where the majority of activities in my avancées de CATTI - un programme qui peut être suivi en current role take place, to quality management systems, moins de 20 heures. good documentation practices, process validation, process « Avec la pénurie nationale de compétences dans le qualification and risk management. I would recommend secteur de la biofabrication, nous nous retrouvons souvent à that anyone wanting to pursue careers in the recruter dans un réservoir limité de talents. Une formation pharmaceutical industry consider taking these courses. comme celle de CATTI signifie que nous pouvons prendre They certainly make it easier to find jobs.” quelqu’un qui vient d’un milieu professionnel différent, qu’il Companies also see the value in CATTI’s flexible online s’agisse de la transformation des aliments, des tests de training. Jack Harvey, Senior Vice President, Process sécurité alimentaire ou de la gestion des eaux usées, et nous Development and Manufacturing at Aspect Biosystems, pouvons lui donner une formation qui comble le fossé et recently sent a team of eight through CATTI’s Advanced adapte ses compétences au fonctionnement dans un Therapies GMP Onboarding Learning Path — a curriculum environnement BPF. » that can be completed in under 20 hours. « Le Programme d’intégration aux BPF en thérapies “With the national skills shortage in biomanufacturing, avancées nous donne la certitude que nous pouvons faire we often find ourselves recruiting from a limited pool of appel à des personnes qui sont un peu en marge du centre talent. Training like CATTI’s means that we can take pour nous, nous débarrasser de toute idée préconçue de ce someone from a different professional background, que sont les BPF et définir la formation des personnes pour anything from food processing or food safety testing to garantir un niveau de conformité avec lequel nous sommes wastewater management, and we can give them training à l’aise. » that bridges the gap and translates their skills into ones fit « Nous donnons aux employés un mois pour terminer le for operating in a GMP environment. cours. Cela offre la souplesse nécessaire pour que la “The Advanced Therapies GMP Onboarding program gives formation n’interrompe pas le déroulement de leur journée de us the confidence that we can bring in people who are a little travail prévue ou ne perturbe pas leur équilibre entre vie outside of centre for us, get rid of any preconceived notions of professionnelle et vie privée », explique M. Harvey. what GMP may be, and level-set people’s training to ensure a Le catalogue de cours de CATTI évolue pour inclure des level of compliance that we’re comfortable with. sujets qui vont au-delà des principes essentiels des BPF. Un “We give employees a month to complete the course. This cours à venir, Planifier des offers the flexibility to ensure that demandes d’essais cliniques (DEC) the training doesn’t interrupt the en thérapie cellulaire, permettra flow of their planned workday or aux participants de discuter en disrupt their work-life balance,” toute confiance et de contribuer says Harvey. aux conversations mondiales sur CATTI’s course catalogue is les plans réglementaires des essais evolving to include topics that go cliniques, d’identifier les beyond GMP essentials. One différences juridictionnelles de upcoming course, “Planning for base entre les systèmes Cell Therapy Clinical Trial réglementaires mondiaux, et Applications (CTAs),” will equip finalement de gagner en confiance graduates to confidently discuss pour aborder les interactions and contribute to global réglementaires pour leurs propres conversations around clinical trial DEC. regulatory plans, identify basic Les prochaines étapes de CATTI jurisdictional differences between consistent à lancer deux sites de different global regulatory formation physique en Ontario et systems, and ultimately gain au Québec, afin d’offrir un confidence for approaching Khadija Cherif, Biomanufacturing Specialist/ regulatory interactions for their Khadija Cherif, Spécialiste en biofabrication own CTAs. 74

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7 out of the 8 Aspect biosystems trainees that did the CATTI training/ 7 des 8 apprenants de Aspect biosystems qui ont suivi la formation de CATTI

CATTI’s next steps are to launch two physical training sites in Ontario and Quebec to deliver a hands-on training curriculum for both new graduates and the current workforce. The focus of these sites is to deliver practical skills for upstream and downstream production steps. These include aseptic techniques, clean room gowning, and workflow and manipulation of cell and gene therapy products. Appetite for such training will no doubt keep pace with the rapidly expanding industry. On March 31, CCRM announced that it had received funding from the Government of Ontario to launch OmniaBio Inc., Canada’s first commercial-scale manufacturing facility for cell and gene therapies that is projected to employ up to 2000 people by 2026. As a founding partner of CATTI, CCRM and its new subsidiary, OmniaBio, will benefit from CATTI training while also helping to develop it. CATTI is offering a 20 per cent discount for all courses to BIOTECanada members. Use the code BIOTECanada2022 by July 31, 2022, to qualify. Sign up for the CATTI newsletter on their website.

programme de formation pratique aux nouveaux diplômés et à la main-d’œuvre actuelle. L’objectif de ces sites est d’offrir des compétences pratiques pour les étapes de production en amont (upstream) et en aval (downstream). Il s’agit notamment des techniques aseptiques, de l’habillage en salles blanches, du flux de travail et de la manipulation des produits de thérapie cellulaire et génique. L’appétit pour une telle formation suivra sans doute le rythme de l’expansion rapide de l’industrie. Le 31 mars, CCRM a annoncé qu’il avait reçu un financement du gouvernement de l’Ontario pour lancer OmniaBio Inc, la première installation de biofabrication à l’échelle commerciale au Canada pour les thérapies cellulaires et géniques, qui devrait employer jusqu’à 2000 personnes d’ici 2026. En tant que partenaire fondateur de CATTI, CCRM et sa nouvelle filiale, OmniaBio, bénéficieront de la formation de CATTI tout en contribuant à son développement. CATTI offre un rabais de 20% sur tous les cours aux membres de BIOTECanada. Utilisez le code BIOTECanada2022 avant le 31 juillet

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Excellence In Canadian Board Governance: Breaking down the barriers for women on Life Science Corporate Boards L’excellence dans la gouvernance des conseils d’administration canadiens : faire tomber les barrières pour l’accès des femmes aux conseils d’administration des entreprises des sciences de la vie by/par Deborah Blake

WE ALL KNOW HIGHLY QUALIFIED, INSPIRATIONAL WOMEN FULLY CAPABLE OF SITTING ON A CORPORATE BOARD. And yet, there is a general perception that the existing pool of experienced senior women on which to draw is simply too small, and that gender parity on corporate boards is, in fact, a “pipeline” problem. With the number of Canadian women executive officers having remained stagnant for the last seven years at 15 to 18%1, more work is required to increase opportunities for women to achieve senior leadership roles. This extends to governance roles such as board placement, for which access is similarly a major obstacle. Filling new board positions can be a challenging, time consuming process, thus it is unsurprising that corporate board members select from their own networks, thereby often recruiting in their own image. Connecting “face-to-face” with the people filling these important positions is therefore critical for anyone aspiring to achieve a corporate board appointment, as is clearly articulating one’s goals to ensure consideration 2. An intangible but unavoidable hurdle for many women aiming to join boards is an unwelcoming corporate culture. This seemingly insurmountable barrier can range from a boardroom culture wherein replacement positions are chosen from a narrow, homogenous pool, to outright discrimination. Trends are improving, with 71.7% of companies of the S&P/TSX 60 having now adopted targets for women directors. However, the results of these targets continue to be disappointing with women in this same pool of companies holding only 33.2% of all board seats, a modest increase of “1.9%” compared to 2020. (Osler: Andrew Deborah Blake

Spring | Printemps 2022

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NOUS CONNAISSONS TOUS DES FEMMES HAUTEMENT QUALIFIÉES ET INSPIRÉES, TOUT À FAIT CAPABLES DE SIÉGER AU CONSEIL D’ADMINISTRATION D’UNE ENTREPRISE. Et pourtant, la perception générale est que le vivier existant de femmes expérimentées dans lequel puiser est tout simplement trop petit et que la parité hommesfemmes au sein des conseils d’administration des entreprises est, en fait, un problème de «pipeline». Le nombre de femmes cadres supérieurs au Canada ayant stagné au cours des sept dernières années entre 15 et 18 %1, il faut redoubler d’efforts pour accroître les possibilités pour les femmes d’accéder à des postes de direction. Cela s’étend aux rôles de gouvernance tels que le fait de siéger dans les conseils d’administration, pour lesquels l’accès est également un obstacle majeur. Il n’est donc pas surprenant que les membres des conseils d’administration des entreprises sélectionnent dans leurs propres réseaux, recrutant ainsi souvent à leur propre image. Il est donc essentiel pour toute personne aspirant à une nomination au conseil d’administration d’une entreprise d’entrer en contact «face à face» avec les personnes qui occupent ces postes importants, ainsi que de formuler clairement ses objectifs pour s’assurer qu’ils seront pris en considération2 . La culture d’entreprise peu accueillante constitue un obstacle insidieux mais inévitable pour de nombreuses femmes souhaitant intégrer un conseil d’administration. Cet obstacle apparemment insurmontable peut aller d’une culture de salle de conseil dans laquelle remplaçants aux sièges vacants sont choisis dans un vivier étroit et homogène, à une discrimination pure et simple. Les tendances s’améliorent, puisque 71,7 % des entreprises

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MacDougall et al, 2021)1. To achieve their goals of better representation, companies must go beyond vocalizing a need for diversity and actually seek it out. This can mean formalizing the expansion of who is sought to fill vacant seats, having a board Chair who makes an effort to ensure diversity of thought is being heard and valued on the board, and creating skill matrices and board performance evaluation structures. Effective boards are built on a culture of directors who challenge and ask questions. Ineffective boards tend to stick to the status quo and are thus less responsive to new opportunities and the demands of changing business needs. Diversity of thought and lived experience helps counteract stagnation; board representatives should be as diverse as the people they serve. The perpetual dilemma of needing previous board experience to qualify for a board position makes it difficult to break in, especially for those without the “right” network. Succession planning can be a huge drain on their resources. Understandably, there is a bias towards recruiting directors with experience, since they must

du S&P/TSX 60 ont maintenant adopté des objectifs pour les administratrices. Toutefois, les résultats de ces objectifs continuent d’être décevants, les femmes de ce même groupe d’entreprises n’occupant que 33,2 % de l’ensemble des sièges des conseils d’administration, soit une modeste augmentation de 1,9 % par rapport à 2020. (Osler : Andrew MacDougall et al, 2021) 1 . Pour atteindre leurs objectifs de meilleure représentation, les entreprises doivent aller au-delà de la simple expression d’un besoin de diversité et la rechercher réellement. Cela peut signifier formaliser l’extension du champ des personnes recherchées pour occuper les sièges vacants, avoir un président de conseil qui s’efforce de s’assurer que la diversité de pensée est entendue et valorisée au sein du conseil, et créer des matrices de compétences et des structures d’évaluation des performances dudit conseil. Les conseils efficaces reposent sur une culture d’administrateurs qui remettent en question et posent des questions. Les conseils inefficaces ont tendance à s’en tenir au statu quo et sont donc moins réactifs aux nouvelles opportunités et aux exigences de l’évolution des besoins des entreprises. La diversité des idées et des expériences vécues permet de lutter contre la stagnation ; les représentants des conseils d’administration devraient être aussi divers que les personnes qu’ils servent. Le dilemme perpétuel de la nécessité d’avoir une expérience préalable au sein d’un conseil d’administration pour se qualifier pour un poste de ce type rend difficile l’entrée, en particulier pour ceux qui n’ont pas le «bon» réseau. La planification de la relève peut représenter une charge énorme pour leurs ressources. Il est compréhensible que l’on ait tendance à recruter des administrateurs expérimentés, car ils doivent absorber un grand nombre d’informations spécifiques à l’entreprise et devenir opérationnels en très peu de temps - un défi même pour des dirigeants chevronnés. Certains conseils reconnaissent ce problème et mettent en place des processus formels pour mettre rapidement les nouveaux membres à niveau. Toutefois, cette formation est moins complète que les programmes d’accueil classiques, car le conseil s’attend à ce qu’un nouvel administrateur comprenne déjà son rôle et ses attentes, notamment en ce qui concerne les règles de gouvernance. Cela peut être décourageant pour les nouveaux membres qui

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absorb a large volume of company-specific information and become useful in a very short period of time – a challenge even for seasoned veterans. Some boards recognize this problem and implement formal processes to bring new members up to speed quickly. However, this training is less comprehensive than conventional onboarding programs, as the board would expect a new director to already understand their role and expectations, especially as they relate to governance regulations. This can be daunting for new members with no previous board experience . Moreover, for many it requires a massive ideological shift to understand the distinction between management and oversight. This all boils down to many qualified candidates lacking the confidence to raise their hand and take an open board position. Many dynamic professionals feel they lack the skill set to be impactful on a board, or when asked to apply, feel it is a token request to fill a quota. First time directors can mitigate the problems related to onboarding by acquiring skills-based governance training prior to taking a board appointment. With these programs, they will learn the roles and responsibility of a board, governance regulations, current issues that generally affect boards, and most importantly, the language and confidence they need to effectively leverage their skills and make an impact. Another way to navigate this process is through mentorship. Boards that already have onboarding programs often also encourage mentorship by pairing a senior board member with a new recruit. This formal process assists with the socialization that is required for a collaborative group to function effectively. Mentorship in general is a powerful tool that helps candidates searching for that first board seat to make critical decisions. In response to these concerns, the Greater Montreal Chapter of Women in Bio (WIB-Greater Montreal), in collaboration with the McGill University Executive Institute, has created a professional development program as part of the solution to accelerate the process for Life Sciences Boards across Canada. The Excellence in Canadian Board Governance (ECBG) program aims to address these issues by providing opportunities for exclusive networking, peer mentorship, and a board competency-building curriculum, enabling participants to gain confidence as an effective director. This board governance training program will be delivered as 10 half-day live virtual modules from September to December 2022. Graduates will receive a certificate from the McGill Executive Institute upon successful completion. Interested candidates are invited to apply here: https://www.womeninbio.org/page/ECBGApp.

n’ont aucune expérience des conseils d’administration. En outre, pour beaucoup, il faut un changement idéologique radical pour comprendre la distinction entre gestion et supervision. Tout cela se traduit par le fait que de nombreux candidats qualifiés n’ont pas la confiance nécessaire pour lever la main et accepter un poste ouvert au sein d’un conseil d’administration. De nombreux professionnels dynamiques estiment qu’ils n’ont pas les compétences nécessaires pour avoir un impact sur ce conseil ou, lorsqu’on leur demande de postuler, pensent qu’il s’agit d’une demande symbolique pour remplir un quota. Les nouveaux administrateurs peuvent atténuer les problèmes liés à l’intégration en suivant une formation à la gouvernance axée sur les compétences avant d’être nommés au conseil. Grâce à ces programmes, ils apprendront les rôles et les responsabilités d’un conseil d’administration, les règlements en matière de gouvernance, les questions d’actualité qui concernent généralement ces conseils et, surtout, le langage et la confiance nécessaires pour exploiter efficacement leurs compétences et avoir un impact. Le mentorat est une autre manière de naviguer dans ce processus. Les conseils d’administration qui disposent déjà de programmes d’accueil encouragent souvent le mentorat en jumelant un membre chevronné du conseil avec une nouvelle recrue. Ce processus formel contribue à la socialisation nécessaire au bon fonctionnement d’un groupe collaboratif. Le mentorat en général est un outil puissant qui aide les candidats à la recherche de leur premier siège au conseil à prendre des décisions critiques. En réponse à ces préoccupations, le chapitre du Grand Montréal de Women in Bio (WIB-Greater Montreal), en collaboration avec l’Institut des cadres exécutifs de l’Université McGill, a créé un programme de développement professionnel visant à accélérer le processus pour les conseils des entreprises des sciences de la vie implantées au Canada. Le programme « Excellence dans la gouvernance des conseils d’administration canadiens » (Excellence in Canadian Board Governance, ECBG) vise à résoudre ces problèmes en offrant des possibilités de réseautage exclusif, de mentorat par les pairs et un programme de renforcement des compétences des conseils d’administration, permettant aux participantes de gagner en confiance en tant qu’administratrice efficace. Ce programme de formation à la gouvernance des conseils d’administration sera dispensé sous la forme de 10 modules virtuels en direct d’une demi-journée, de septembre à décembre 2022. Les diplômées recevront un certificat de l’Institut exécutif de McGill après l’avoir suivi avec succès. Les candidates intéressées sont invitées à postuler ici : https://www.womeninbio.org/page/ECBGApp.

References 1. 2021 Diversity Disclosure Practices – Diversity and leadership at Canadian public companies. Andrew MacDougall et al, Osler Report 2021

Références 1. 2021 Diversity Disclosure Practices – Diversity and leadership at Canadian public companies. Andrew MacDougall et al, Osler Report 2021

2. How Networking Can Help Women Secure Board Seats. Lisa D Ellis, Harvard T.H.Chan School of Public Health, Executives and Continuing Professional Education. https://www.hsph.harvard.edu/ecpe/networking-help-women-board-seats/

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talent

“The pilot will also facilitate direct input from industry. We have set our targets on connecting students within the pilot program to industry-based internships that will enable feedback generation from companies to identify any knowledge gaps that we can fill,” feedback on the training gaps, pain points and impactful programing that are currently lacking in the sector,” explains Craig Hasilo, Chief Scientific Officer of CATTI. “These individuals represent leading biomanufacturers of advanced therapy products. They are responsible for training highly qualified personnel and current Good Manufacturing Practices (cGMP) compliance within their respective organizations.” It’s not just businesses that inform CATTI’s offering. The new training institute has also been busy building partnerships with universities across Canada, identifying where value can be added for students and their future employers alike. “We’re developing a pilot project with 10 universities across eight Canadian cities and four provinces. The pilot will serve as a test bed for CATTI’s curriculum, as well as allowing us to adapt or develop course materials for the universities. CATTI will deliver courses that are catered to the appropriate level, from undergraduates to PhDs and postdocs, with the real-world knowledge required to take their skills into a biopharmaceutical setting,” explains Laflamme. “The pilot will also facilitate direct input from industry. We have set our targets on connecting students within the pilot program to industry-based internships that will enable feedback generation from companies to identify any knowledge gaps that we can fill,” says Laflamme. Fierce competition in the sector is affecting productivity. Addressing the elephant in the room, Laflamme explains: “I’d be remiss not to mention that the talent displacement partially caused by poaching is hitting companies that delay investing in training particularly hard. Some businesses are still doing things a little back-to-front, inefficiently waiting too long to train staff because they are relying on senior team members to pass the knowledge on to new hires. Given the pace of the industry, I can see how this is tempting, but it’s an extremely risky strategy. Our sector is booming, and the talent displaced isn’t being replenished through training until it’s too late and somebody anchoring a lot of

Les entreprises ne sont pas les seules à contribuer à l’offre de CATTI. Le nouvel institut de formation s’est également assurer d’établir des partenariats avec des universités à travers le Canada, en identifiant les domaines où une valeur ajoutée peut être apportée aux étudiants et à leurs futurs employeurs. « Nous développons actuellement un projet pilote avec 10 universités dans 8 villes canadiennes et 4 provinces. Ce projet pilote servira de banc d’essai pour le programme de formations de CATTI et nous permettra d’adapter ou de développer du matériel pédagogique pour les universités. CATTI offrira des cours adaptés selon les niveaux, en partant du premier cycle jusqu’au doctorat, voire même au niveau post-doc, avec les connaissances appliquées requises pour mettre en pratique leurs compétences dans un environnement biopharmaceutique », explique Mme Laflamme. « Le programme pilote facilitera également l’apport direct de l’industrie. Nous nous sommes fixés pour objectif de mettre les étudiants du programme pilote en contact avec des stages dans l’industrie, ce qui permettra de générer un retour d’information de la part des entreprises afin d’identifier les lacunes en matière de connaissances que nous pouvons combler », explique Mme Laflamme. La concurrence féroce dans le secteur affecte la productivité. S’attaquant à l’éléphant dans la pièce, Mme Laflamme explique : « Je m’en voudrais de ne pas mentionner que le déplacement des talents causé entre autres par le maraudage frappe particulièrement fort les entreprises qui tardent à investir dans la formation. Certaines entreprises font encore les choses un peu à l’envers, attendant inefficacement trop longtemps pour former le personnel parce qu’elles comptent sur les membres de l’équipe senior pour transmettre les connaissances aux nouvelles recrues. Étant donné le rythme du secteur, je peux comprendre que ce soit tentant, mais c’est une stratégie extrêmement risquée. Notre secteur est en plein essor, et les talents déplacés ne sont pas remplacés par la formation jusqu’à ce qu’il soit trop tard et que quelqu’un qui a ancré un grand savoir-faire organisationnel parte, emportant avec lui les connaissances accumulées. » Khadija Cherif, spécialiste en biofabrication, qui a récemment suivi le parcours de formation Programme d’intégration aux BPF en thérapies avancées de CATTI, explique comment ce programme l’a aidée à passer à un rôle BPF. « J’ai toujours travaillé dans des environnements non BPF. Cette formation a enrichi mes connaissances de tout ce qui concerne les BPF, des salles blanches, où se déroulent la majorité des activités dans mon rôle actuel, aux systèmes de gestion de la qualité, aux bonnes pratiques de documentation, à la validation des processus, à la qualification des processus et à la gestion des risques. Je recommande à toute personne souhaitant faire carrière dans

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National Experimental Biology Laboratory Opening Level 3 Bio-Safety Laboratory

THE NATIONAL EXPERIMENTAL BIOLOGY LABORATORY (NEBL) A KEY RESEARCH FACILITY OF THE NATIONAL INSTITUTE OF SCIENTIFIC RESEARCH (INRS), is opening a new bio-safety laboratory, Level 3 (BSL-3), in the summer of 2022. The NEBL is one of the few venues in Canada that contains a level 3 containment vivarium infrastructure available to external clients who wish to conduct contractual preclinical studies. This laboratory, which will require high level security, and full safety gear, including a bio-hazard suit, will be equipped to handle research on infectious diseases. “With the opening of BSL-3 in vitro at INRS, and BSL-3 in vivo at NEBL, the Laval campus will be a rare place where you can conduct in vitro and in vivo studies at a level 3” says Julie Arcand, director of the NEBL in Laval. The NEBL, built in 1996, is a state-of-the-art facility accredited for biomedical and preclinical research. It is located on the campus of the INRS’s Armand-Frappier Santé Biotechnologie Research Centre, part of the ‘Biotech City’ science park, a hub of biotechnology and life sciences companies in Laval, part of suburban Montreal. The NEBL’s university INRS facilities have attained the Good Animal Practice accreditation from the Canadian Council on Animal Care (CCPA), and are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), the only such laboratory located at a Canadian university to be accredited as such. The highest international standards are applied to its research. The NEBL offers 25,000 square feet of housing space, which clients can rent to conduct in vivo research in controlled and safe environments at biosecurity levels 1, 2 and 3. This is one of the largest such facilities in Quebec. Alternatively, clients can elect to have the NEBL conduct the research studies for them and supply the resulting data for the client to interpret. “We offer good flexibility. Sometimes small businesses are looking for a place to rent because they don’t want to have their own animal housing space. So they can use the services we offer,” explains Julie Arcand, director of the NEBL in Laval.

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The NEBL provides animal care and housing services to both universities and businesses. It offers highly trained and qualified professionals, including preclinical scientists, veterinarians, and veterinary technicians, with expertise in preclinical research. Efforts are being directed to develop new vaccines and drugs which can be used against emerging or re-emerging diseases. For example, researchers at INRS are partnering with NEBL in developing vaccines and combination therapies to prevent or mitigate the effects of COVID-19. They are also developing glycoconjugate vaccines to prevent melioidosis, or Whitmore’s Disease. NEBL and the research company Nexelis have established a strategic partnership through which they carry out preclinical testing and immunological analysis. This strategic partnership provides both parties with expanded and integrated global contract research services in a variety of study fields, including toxicology, pharmacokinetics, and biomarker identification. This partnership also provides proof-of-concept studies with multiple models, as well as basic and complex immunoassay services that can be tailored to clients’ needs for the development of candidate compounds. The space available at the NEBL, as well as its ability to develop animal models, make it a partner of choice for private contract research organizations (CRO) such as Nexelis.

“We offer good flexibility. Sometimes small businesses are looking for a place to rent because they don’t want to have their own animal housing space. So they can use the services we offer,” For more information, please consult the website at https://inrs.ca/en/research/research-facilities/find-aresearch-facilitie/national-experimental-biology-laboratory/. For more information, contact the NEBL at (514) 291-9252.

PanTHERA CryoSolutions Advancing Cryopreservation Technology A CANADIAN COMPANY IS LEADING THE PATH FORWARD IN SCIENTIFIC AND COMMERCIAL APPLICATIONS for the cryopreservation and long-term storage of biological material at low temperatures. Cryopreservation often leads to progressive damage from ice crystals which adversely affects the function of the cells after thawing. PanTHERA CryoSolutions’ patented ice recrystallization inhibitor (IRI) technology has been proven to increase post-thaw cell recovery and function, and preserve and stabilize essential cell function. The IRI technology has evolved over time. “Within the last decade or so,we have shifted our focus from the academic laboratory to bringing this technology out to the world,” says Dr. Robert Ben, PanTHERA’s Ottawa-based co-founder and chief scientific officer. Incorporated in 2018, PanTHERA manufactures a small molecule that is added to commercial cryopreservation solutions. “We’ve examined about 1,500 different small molecules. Out of those 1,500, only a handful are potent at inhibiting ice recrystallization. It is also necessary to ensure that the small molecules are tolerated by various biological systems – cells, tissues, whatever it is you’re cryopreserving. So that’s part of this multi-step extensive screening process where we look for the ability of a small molecule to inhibit ice-crystal growth,” explains Dr. Ben. Compared to conventional technologies, the number of additional cells that PanTHERA is able to obtain following the cryopreservation process, while also protecting the functional capacity of the cells, is significant – sometimes up to five fold, says Dr. Ben. “Another value of this technology is that it protects against transient warming effects, or dramatic swings in temperature that can occur when cells and tissues are stored for long term applications at low temperatures.” Dr. Ben explains. There are several applications for PanTHERA’s technology including in organ, tissue and blood banking, in the biomanufacturing industry (such as viral vector, oncolytic vectors recombinant proteins and vaccines), in assisted reproductive technology, in animal and aquaculture-specific breeding and in the cell and gene therapy (CGT) markets. One example is where PanTHERA’s IRI technology can improve the post-cryopreservation quality of hematopoietic stem cells donated from cord blood

or apheresis collections that are used to treat many blood cancers. Other CGT applications include the cryopreservation of mesenchymal cells that have a very important role in protecting patients from immunological issues that may arise from a variety of conditions, such as graft-versus-host disease, organ transplantation, or lung injury, says Dr. Jason Acker, the Edmonton-based co-founder, president and CEO of PanTHERA. The benefits are significant, with cost advantages to the companies commercializing these therapies. PanTHERA’s technology improves the efficiency and cost-efficiency of their manufacturing processes and reduces operational expenses for logistics and shipping. These benefits translate into healthcare cost savings and in improved health outcomes, especially to patients who have an opportunity to receive a cell-based therapeutic product that is more efficacious. “We’re working with a number of cell therapy companies to evaluate our products in their manufacturing process. These companies represent manufacturers of chimeric antigen receptor (CAR)-T cells, hematopoietic stem cells, induced pluripotent stem (iPS) cells, and mesenchymal cells. We have selected partners who are bringing innovative cell therapy products to market and who would benefit from the enhanced cryoprotection afforded by PanTHERA’s technology,” says Dr. Acker. Major financial investors in PanTHERA include BioLife Solutions, Inc. and Casdin Capital, LLC. The company’s research has been funded by various sources, including the Natural Sciences and Engineering Research Council of Canada, Canadian Institutes of Health Research, Canadian Blood Services, Canadian Glycomics Network (GlycoNet), Alberta Innovates, Western Economic Diversification Canada, and the National Research Council’s Industrial Research Assistance Program. “We’ve benefitted from both research funding as well as provincial and federal government programs to support the company and the launch of the technology. We have many funding partners to thank for helping us bring this exciting new approach to preserving the quality and efficacy of cell-based therapies to market,” Dr. Acker says. With the support of its investors and partners, PanTHERA is delivering an innovative solution to the current challenges facing the cryopreservation and longterm storage of current and future cell-based therapies.

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Eating for a Sustainable Future Harnessing Science to Drive Canada’s Cellular Agriculture Opportunity by/par Laura Riley, Manager, Ontario Genomics, Elaine Corbett, Director, Ontario Genomics

GLOBAL POPULATION GROWTH AND FOOD INSECURITY, EVOLVING CONSUMER PREFERENCES, AND CONSEQUENCES OF CLIMATE CHANGE are increasing the need for new and sustainable food production methods to augment conventional agriculture and food industries. As a multi-sectoral discipline, cellular agriculture provides solutions using cell cultures, tissue engineering or precision fermentation to biomanufacture food and other products. Dairy, egg proteins, honey, and ingredients, such as flavours, pigments or fats to enhance plant-based products, are examples of the equivalent foods being made through precision fermentation, while cultivated products include various meats and seafood. These innovations are underpinned by genomics and engineering biology - a cross-sectoral platform technology built on the convergence of biological, computational, and engineering disciplines, enabling directed programming of biological systems to create miniature “biological factories”. Building on a 2020 whitepaper, the 2021 Ontario Genomics’ report1, Cellular Agriculture: Canada’s $12.5 Billion Opportunity in Food Innovation, articulates three interconnected, actionable opportunities for Canada to realize the enormous economic potential of this expanding global market: 1. Develop a national vision and strategy for a Canadian cellular agriculture industry in the near term; 2. Establish a clear and transparent regulatory framework for cellular agriculture products in Canada; 3. Provide supporting mechanisms for research and commercial development. With these opportunities in mind, Ontario Genomics partnered with the Canadian Food Innovation Network to create the AcCELLerate-ON - Food Innovation with Cellular Agriculture competition. By attracting highly competitive applications from across Ontario, encompassing innovations in precision fermentation and cultivation to create a variety of food products while addressing In partnership with the Food & Agriculture Institute at the University of the Fraser Valley, in collaboration with Dr. Mike von Massow, University of Guelph, and funded by Ontario Genomics and Agriculture & Agri-Food Canada.

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Ardra’s heme fermenter

challenges in the fundamental underlying science, this funding opportunity provides a snapshot of the budding industry in Ontario and Canada. One such budding Toronto-based start-up, Ardra, uses precision fermentation to produce animal-free heme, which

can be incorporated into plant-based products to create a naturally meaty flavour. In 2021, plant-based meat alternatives made up approximately $10B of the $800B+ meat industry. To capitalize on this growing consumer demand, Ardra was funded through AcCELLerate-ON to reach pilot-scale production and establish a clear path to market for their natural flavour ingredients. In another corner of the market, Ontario-based CELL AG TECH is seeking to become a global leader in the production of sustainable cell-cultured seafood. As a step towards prototype development, commercial manufacturing and ultimately commercialization, funding from AcCELLerate-ON will help transition CELL AG TECH’s snapper manufacturing process from a 2D to a 3D culture system. Insights from analyses of fish cells will enable regulation, optimization of the culture environment, and improved production yields.

CELL AG TECH’s Sushi

Kitchener-based Evolved (formerly CaroMeats) differentiates itself from competitors by using proprietary cell sheet engineering techniques to make whole cuts of meat applicable to any species. Evolved is creating scaffoldfree muscle tissue, which then goes through the muscle-tomeat transition to produce structured cultivated meat that is biochemically identical to conventional meat. Finding a niche in pork, this AcCELLerate-ON project will compare Evolved’s cultivated porcine meat samples with conventional cuts and will perform protein studies on known biomarkers of meat quality to evaluate their impact on the taste and mouthfeel of cultivated meat.

Evolved’s Engineering Process

In a collaboration between academia and industry, University of Toronto’s Professor Michael Garton is working to establish the foundational tools for synthetic biologydirected pork production. While the technology to grow pork in bioreactors exists, the biological and chemical agents required for pig muscle development and maturation are prohibitively expensive. To circumvent this requirement, this AcCELLerate-ON project will engineer gene circuits that can be integrated with stem cells and used to direct muscle transformation and maturation processes. This pilot study, in partnership with Torontobased start-up Myo Palate, will demonstrate proof-ofconcept for a comprehensive process to direct pig muscle development in bioreactors. These projects demonstrate the importance of targeted funding opportunities, such as AcCELLerate-ON, for innovators and entrepreneurs in the private and public sectors and a way for Canada to capitalize on the existing strong foundation in the domestic cellular agriculture industry. With changing consumer preferences, growing interest and global need for sustainable alternatives, alongside rapid advancement in underlying technologies, existing food systems are ripe for disruption. Worldwide, the cellular agriculture industry is accelerating, with over US$9.7B invested globally, new and innovative companies being created at a rapid pace, and more products entering the market all the time. By acting on the priority opportunities outlined in Ontario Genomics’ report and recognizing the potential of this industry, Canada can continue to grow and diversify its food and agriculture sector, become a leader in new and sustainable methods of food production and reap the benefits on offer.

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Unparalleled growth for Mississauga’s life sciences hub YEARS BEFORE MISSISSAUGA WAS INCORPORATED IN Not only is Mississauga attracting new companies, 1974, THE ABUNDANCE OF DEVELOPABLE LAND IN THE existing firms in the sector are also growing and area had already attracted the interest of pharmaceutical expanding. Last year, Resilience Biotechnologies Inc., the firms. In the mid-1960s, the first of these companies – now Mississauga-based subsidiary of National Resilience Inc., known as AstraZeneca – opened a manufacturing facility in announced plans to modernize and expand its the area. Other pharmaceutical firms soon followed, commercial scale manufacturing capacity. The eventually in such large numbers that $401 million project will increase the area was nicknamed ‘Pill Hill’. the company’s biomanufacturing Mississauga’s life sciences hub has capacity for vaccines and since diversified far beyond its therapeutics, including novel pharmaceutical roots. And while the technologies, such as mRNA, that name Pill Hill is still used on occasion, are used to fight COVID-19. the area is now described in more Roche, one of the world’s largest glowing terms. Like ‘one of the leading biotech companies, is also life sciences hubs in North America’. expanding its Mississauga And ‘a magnet for the brightest minds presence, investing $500 million, and leading-edge companies’ in and adding an additional 500 jobs, Canada. to establish a global pharma technical Those sentiments speak to the operation. “Our search included a incredible success and rapid growth of competitive review of life sciences Damian Siggins, Roche, Global Head of Mississauga’s life sciences sector. In centres of excellence all around the Pharma Technical Transformation less than six decades, Mississauga’s globe,” says Damian Siggins, Global life sciences hub has grown to more Head of Pharma Technical (PT) than 470 companies. Combined, those Transformation. “Mississauga was our companies employ more than 25,000 final choice for this investment, workers, nearly a third of all life sciences workers in because it is home to a thriving and growing life sciences Ontario. sector, is a collaborative municipal partner and is home to And it’s still growing. Growing rapidly, in fact. Over the some of the best talent we need today and for the future of past five years, the expansion of Mississauga’s life sciences our industry.” hub has exceeded the average of every other Canadian Homegrown companies are also spreading their wings. industry. In the past two years alone, this hub attracted Among them, the biotechnology company Microbix more than $1 billion in investment. Clearly, Mississauga’s Biosystems. Established in 1988 in Mississauga, Microbix Life Sciences Strategy, the first of its kind for a Canadian supplies key biological ingredients (antigens) for infectious municipality, is working.

“We chose Mississauga because it is home . . . to some of the best talent we need today and for the future of our industry.”

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disease tests to more than 100 diagnostics companies globally. After significantly extending its operations in the past two years, Microbix is now establishing a third site in Mississauga. Life sciences companies, whether international firms, scale-ups or start-ups, flock to Mississauga because they recognize its positioning at the very core of Canada’s innovation and technology activity. They come because Mississauga offers the support, resources and community life they need to cultivate growth, success and global impacts. They appreciate the virtually unlimited supply of exceptional talent (thanks to more than 30 universities and colleges, all within commuting distance). Then there’s the city’s strategic position in Southern Ontario’s Life Sciences Corridor, with the McMaster Innovation Park situated to

UTM New Science Building. Rendering by KieranTimberlake

the west and the MaRS Discovery District in downtown Toronto to the east. The result is quick and easy access to various partners from the regional life sciences ecosystem. While proud of the success of its life sciences sector, Mississauga remains focused on how best to support the cluster’s continued growth and development. The city is doubling down on its support for scaling, high-growth companies, especially in key sectors like life sciences. Acting on recommendations from a 2019 study on Mississauga’s Innovation Ecosystem and the City’s Economic Development Strategy, the city identified priority actions to enhance services in the entrepreneurship and innovation ecosystem.

Earlier this year, Mississauga launched IDEA (the Innovation District of Mississauga) to elevate the city’s entrepreneurship and innovation ecosystem by working with its partners collaboratively to help businesses launch and grow. Later this year, Mississauga will open IDEA Square One, a 4,300-square-foot innovation hub, in Square One Shopping Centre. IDEA Square One will be a collaborative venue for entrepreneurs and innovators to connect, learn and grow their ventures in the heart of Mississauga. “IDEA Mississauga brings together a rich network of mentorship, partners, talent and connections to test, scale and commercialize solutions to global challenges,” says Bonnie Brown, Mississauga’s Director of Economic Development. “Our new scale-up programming and mentorship will help startups develop into high-growth companies like Microbix.” Some of the sector’s most promising start-ups begin as scientific breakthroughs within the University of Toronto Mississauga’s (UTM) Centre for Medicinal Chemistry (CMC). Founded in 2017, CMC has developed innovations that have attracted significant investment and created several spinout companies (including Dalriada, Dunad, Janpix and HDAX) and numerous jobs. To scale up its success, a new state-of-the-art 90,000-square-foot facility including lab and incubation space, and support for affiliated new company start-ups is being built as part of the New Science Building at UTM. Construction is expected to be completed in the spring of 2023. “The UTM Centre is an important success story for Ontario’s life sciences sector,” says the centre’s Chief Scientific Director, Professor Patrick Gunning. “Strategically located in Mississauga, the CMC’s proximity to global pharmaceutical leaders brings together cuttingedge academic science with industry expertise.” Mississauga’s commitment to its life sciences hub, and those firms that populate it, is unrivalled. The City is committed to supporting life sciences companies at any phase of growth and has the necessary resources and connections to set them up for success. To learn more about Mississauga’s unlimited opportunities in life sciences and connect with a team of experts, visit: www.thefutureisunlimited.ca/lifesciences.

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“We chose Mississauga because it is home . . . to some of the best talent we need today and for the future of our industry.”

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UTM New Science Building. Rendering by KieranTimberlake

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Drug Manufacturer, Medicure, Launches E-Commerce Pharmacy to Provide Affordable Medications to U.S. Customers Motivated to get its cholesterol lowering medication Zypitamag® (pitavastatin) -- to patients who would most benefit from its use, Medicure decided to bypass the insurance pricing game and sell directly to U.S. consumers. It did so by purchasing the online pharmacy, Marley Drug®. Now the company has gone one step further, launching an E-commerce platform to provide patients with branded medications and hundreds of generic medications at low cost. In December 2020, Medicure purchased Marley Drug, an independent mail-order pharmacy licensed to dispense medications in all 50 states, the District of Columbia and most territories. Through Marley Drug, Medicure was able to provide its branded medication Zypitamag directly to consumers. The result was an immediate and dramatic increase in Zypitamag utilization – nearly 10-fold in the first year alone. Those numbers reinforced Medicure’s belief that patients and healthcare providers were better served when relieved of the burden caused by insurance, Pharmacy Benefit Managers (PBMs) and other intermediaries. One of the many patients who benefitted from the Marley Drug experience was Diana: “Initially, my doctor wanted me to use pitavastatin,” she says, “but insurance said I had to fail on five statins before they would even approve it. Now I buy Zypitamag from Marley Drug and I don’t even use my insurance!” Equally impressed was Dr. Kimberly Rieniets, an osteopathic physician with ABIM board certification in Endocrinology and Internal Medicine. “Utilizing Marley Drug to prescribe Zypitamag has greatly improved access to pitavastatin for several of my patients,” she says. “It’s great to have the resource and nice to be able to skip the ‘pain’ of step therapy and prior authorization hassles for patients.” For Medicure, the Marley Drug purchase was just the beginning. It continues to invest in infrastructure positioning. As a result, Marley Drug now also boasts a state-of-the-art ScriptPro® pharmacy management platform and robotic dispensing system. But Medicure’s crowning achievement came in January 2022 with the launch of the Marley Drug E-Commerce platform (www.marleydrug.com). “Building a Marley Drug E-Commerce platform was really the next logical step,” says Dr. Albert Friesen, CEO of 86

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Medicure. “Through marketing Zypitamag, we learned so much about the problems consumers face with accessing medications. PBMs have placed themselves firmly in the middle of the pharmaceutical industry. They control it all. But now we have a way around them, not only for Zypitamag but for all medications.” Dr. Friesen says he is convinced that consumer frustration with inconvenient monthly refills, astronomical drug prices set forth by PBMs, and unethical pricing schemes, will make Marley Drug’s home delivery and cash-based pricing model a dominant player in pharmacy sales in the U.S. “Certainly, Marley Drug’s 18 years of mail-order experience and its existing 137,000-customer base gives us a head start in the race to become the number one online pharmacy in the U.S.” The world is becoming more comfortable with buying things online, he points out. It’s only natural that those who now buy online would be comfortable with shopping for prescription medications in the same way. Certainly,

the success of Marley Drug – its E-Commerce platform now offers hundreds of medications at an attractive cash price, including more than 120 chronic care medications for just $70 per year – supports that view. One person not surprised by the positive response to Marley Drug’s E-commerce platform is Dr. Brian Forrest, CEO and founder of Access Healthcare. “I believe that what they are doing is truly saving lives. Since I began working with Marley Drug, I have seen compliance with medications improve significantly. As a result, patients’ outcomes are better and they are staying healthier.” And they’re doing that while saving time and money

FINE SURGICAL INSTRUMENTS FOR RESEARCH

ENDLESS DISCOVERIES

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How do you reach challenging therapeutic targets? Switch up your drug development paradigm

CANADIAN DRUG DEVELOPMENT COMPANY AMACATHERA TOOK ROOT IN THE DESIRE TO COMMERCIALIZE new technology and advance the underlying science from the bench to the clinic. Founded in 2016 and grounded in breakthrough research from the University of Toronto (U of T), the company sits at the intersection of biomaterials, regenerative medicine, and pharmaceuticals. One of the company’s founders is Dr. Molly Shoichet, a world-renowed biomaterials science and University Professor at U of T. With a focus on tissue regeneration and applying polymers for drug delivery, Shoichet has also launched companies before. In the earliest days of AmacaThera, she was interested in researching how biomaterials combined with stem cells could create new therapeutics to help stroke patients make cognitive and physical recoveries. “It was exciting research, but originally not commercially driven,” says Dr. Mike J. Cooke, Shoichet’s co-founder and CEO of AmacaThera. Originally a post-doctoral fellow in the Shoichet lab, Cooke worked with Shoichet to interview surgeons and

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anesthesiologists to identify a market need that would fit their technology. Cooke and the commercial team built a strong foundation for success through participation in Toronto accelerators like Creative Destruction and UTEST, with support from the Ontario Bioscience Innovation Organization and Toronto Innovation Acceleration Partners. Meanwhile, he and Shoichet continued to refine their proposal and iterate on the technology. AmacaThera’s novel hydrogel platform is designed to deliver long-lasting treatments with a variety of therapeutic applications, including post-surgical pain management, cancer, and other hard-to-reach areas, such as the brain. The first of its products to reach clinical trials, AMT-143, is an injectable anesthetic for postoperative pain relief that can be applied at the time of surgery. Patients eventually receiving its slow-release formulation would ideally experience pain relief for up to 72 hours, giving clinicians an alternative to dependency-forming opioids. AMT-143 is currently undergoing a Phase I clinical trial.

“AMT-143 has both a clear, large market need and a clear regulatory pathway,” says Cooke. “Creating a therapeutic solution that would allow surgeons to avoid patients’ current post-surgical needs for pain medication, such opioids in the first few days after surgery, is a widely understood concern. The polymer is an exciting biomaterial with granted patents, and our initial pitch was strong enough to raise a seed round.” Six years, three start-up accelerators and $10-million later, AmacaThera is a clinical-stage biotechnology company whose hydrogel drug technology promises to help address a variety of clinical conditions. “Our long-term goal is to revolutionize the range of treatment options available to patients in multiple areas,” says Dr. Mike J. Cooke, AmacaThera’s co-founder and CEO. “That aspect of AmacaThera’s story really resonates with people.” Several Canadian venture capitalists have shown their support for the new company, including Lumira Ventures, the Business Development Bank of Canada (BDC), StandUp Ventures, North Spring Capital Partners, MaRS Investment Accelerator Fund (IAF), and Waterloo Student Venture Fund (SVF).

AmacaThera’s novel hydrogel platform is designed to deliver longlasting treatments with a variety of therapeutic applications, including post-surgical pain management, cancer, and other hard-to-reach areas, such as the brain.

More broadly, the Covid-19 pandemic has reminded Canadians of the importance of investing in homegrown biotechnology and manufacturing capabilities in cities like Montreal and Toronto. Both cities have innovation hubs and a long history of pharmaceutical development and innovation. AmacaThera aims to channel this renewed interest into its developments, including other key support for entrepreneurial companies, such as the National Research Council of Canada’s Industrial Research Assistance Program (IRAP).

Cooke says it’s an exciting time to be in drug development. “The unique combination of these two excipients that compose AMT-143–the drug and the hydrogel–have never been done for slow-release injectability before. We’re excited to advance AMT-143 through clinical trials while applying our lessons learned to other assets from the lab.”

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Andrea Marazzi, General Manager, Novartis Pharmaceuticals Canada Inc. discusses the opportunities to improve the performance and resilience of the healthcare system in Canada through meaningful collaboration and partnership WHAT IMPACT HAS THE COVID-19 PANDEMIC HAD ON OUR HEALTHCARE SYSTEM AND ARE THERE LEARNINGS FROM THE LAST TWO YEARS THAT WE CAN APPLY TO THE FUTURE? The pandemic was extremely challenging across the board, causing procedural backlogs and delays in diagnosis and treatment for urgent diseases, such as cardiovascular disease (CVD), now resulting in a confluence of epidemics– or syndemics. A recent World Health Organization study found that in many countries the pandemic led to severe disruptions in healthcare for non-communicable diseases,1,2 including CVD. However, the encouraging news is that we have seen glimpses of what the future of healthcare could hold. The pandemic shone a light on what collaboration between the life sciences, government and healthcare systems can do to bring innovation to patients – whether it be a vaccine or other, to support patient care and patient outcomes.

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A specific accomplishment is the strong and seamless data management that we saw in our Canadian provinces from the vaccine passport to contact tracing and beyond. There is no question in my mind that this shows the value of health data management and I think it’s an area we can, and must, build on coming out of the pandemic. In addition to that, I would encourage more collaboration with the pharmaceutical industry and key stakeholders, especially now as governments begin to develop their life science strategies. There is already an element of trust and collaboration in place allowing us to work more quickly, breaking down barriers to provide faster and more equal access to treatment and care for patients across the country. HOW ARE THESE KEY LEARNINGS APPLICABLE IN THE AREAS OF CARDIOVASCULAR DISEASE? Cardiovascular disease is the second leading cause of death in Canada,3 with over 50,000 deaths taking place each year. Atherosclerotic cardiovascular disease (ASCVD) is the leading driver of CVD4 – yet premature heart disease and stroke are largely preventable.5 The ripple effect triggered by those suffering from these conditions has caused a significant strain on our healthcare system. In Canada, it is estimated that cardiovascular disease (CVD)

shift from a reactive to a proactive position. Early diagnosis and management, as well as the capacity to scale with consistency, are all advantages of having good data sets. This means better treatment options for patients, and ultimately a stronger life sciences sector in Canada with better research opportunities. I firmly believe that data infrastructure is the key to a sustainable, solid healthcare system.

costs approximately $22 billion a year.6 If we don’t come together to manage CVD, then any other crisis will be more difficult to manage as it will put an enormous burden on the healthcare system. To support action against this crisis, Novartis is partnering with healthcare system (HCS) decision-makers around the world to reduce and stop premature death from ASCVD by establishing Public-Private Partnerships (PPPs) that supports the shift to more prevention-oriented, efficient, and equitable CV care delivery models. For example, Novartis has launched a first-of-its-kind PPP with the NHS in England to take on the UK’s goal of reducing up to 150,000 deaths from CVD in the country over the next 10 years. It has also concluded Memorandums of Understanding (MoUs) with public entities around the world, with more planned in the future. These MoUs aim to improve CVD prevention, efficiency of interventions, performance, and digitalization of HCSs as well as clinical research investments. Further, we need to focus on primary and secondary disease prevention. With CVD, the risk of a second incident is high7– early detection and diagnosis are critical in terms of keeping people out of the hospital and reducing the need for surgery. We must leverage data and data collection to

BASED ON THESE LEARNINGS, WHAT IS NEEDED TO SUPPORT A STRONGER, MORE EFFICIENT HEALTHCARE SYSTEM IN CANADA? The pandemic enlightened our perspective and approach to healthcare and its delivery – we saw the immense benefits that can be harnessed when public and private organizations collaborate to drive solutions to critical healthcare problems. At Novartis, we are committed to leveraging this collaborative model to address the challenges facing our healthcare system by CVD. However, it is not the only issue our healthcare system is facing. We must now apply the lessons learned from the success of this collaborative approach across our full healthcare system to tackle the most complex problem areas within the system and build a new and more sustainable value- and access-oriented healthcare system for the future. Such a system can help us streamline and increase access to innovative medicines for patients, something in which Canada is too far behind and which has negative impacts on patient care, patient outcomes and the system overall. Novartis is optimistic that these new models for CVD management can be implemented by our health care systems across the country, and ultimately improve health outcomes for Canadians. 1. World Health Organization. COVID-19 significantly impacts health services for noncommunicable diseases. Taken from: https://www.who.int/news/item/01-062020-covid-19-significantly-impacts-health-services-for-noncommunicable-diseases. Accessed on April 12, 2022. 2. Canadian Medical Association. A struggling system: Understanding the health impacts of the pandemic. Taken from: https://www.cma.ca/sites/default/files/pdf/ health-advocacy/Deloitte-report-nov2021-EN.pdf. Accessed on April 19, 2022. 3. Government of Canada. Report from the Canadian Chronic Disease Surveillance System: Heart Disease in Canada, 2018.Taken from: https://www.canada.ca/en/ public-health/services/publications/diseases-conditions/report-heart-diseaseCanada-2018.html#s2-3. Accessed on April 13, 2022. 4. Herrington, W. Epidemiology of Atherosclerosis and the Potential to Reduce the Global Burden of Atherothrombotic Disease. Taken from: https://pubmed.ncbi.nlm. nih.gov/26892956/. Accessed on April 13, 2022. 5. Heart & Stroke. Risk & prevention. Taken from: https://www.heartandstroke.ca/ heart-disease/risk-and-prevention#:~:text=Prevention%20is%20key&text=Almost%20 80%25%20of%20premature%20heart,big%20impact%20on%20your%20health. Accessed on April 13, 2022. 6. Dat T. Tran. The Healthcare Cost Burden in Adults with High Risk for Cardiovascular Disease. Taken from: https://link.springer.com/article/10.1007/s41669021-00257-8#:~:text=In%20Canada%2C%20it%20is%20estimated,national%20 healthcare%20costs%20%5B3%5D. Accessed on April 13, 2022. 7. Hennekens, Charles et al. Prevention of cardiovascular disease events in those with established disease (secondary prevention) or at very high risk. Taken from: https:// www.uptodate.com/contents/prevention-of-cardiovascular-disease-events-in-thosewith-established-disease-secondary-prevention-or-at-very-high-risk Accessed on April 19, 2022.

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Innovation in Canadian ecosystem key to growth of life sciences investment Why do global companies continue to put their faith in Canada’s life sciences sector? Here are top reasons why:

L’innovation dans l’écosystème canadien est la clé de la croissance de l’investissement dans les sciences de la vie Pourquoi les entreprises mondiales continuent-elles de miser sur le secteur des sciences de la vie au Canada? Voici les principales raisons :

1. PHARMA MARKET SIZE AND STRENGTH: Canada is the world’s 9th largest market for pharmaceutical sales. 2. CLINICAL TRIALS OPPORTUNITIES: Canada ranks 9th globally, capturing 5% of the world’s clinical trials. The country’s multicultural population, world-renowned research clinicians, leading education system and publicly funded health-care system make it an ideal testing ground for life sciences. 3. EDUCATED TALENT: Canada ranks as the most highly educated country in the world: 59.4% of Canadians aged 25–64 have graduated from tertiary education institutions. 4. SPECIALIZED TALENT: Over 4.8 million of Canada’s graduates hold a degree from a STEM or health-care program, making Canada a prime destination for life sciences companies. 5. GLOBAL TALENT: In addition to ranking 4th globally for the availability of scientists and engineers, Canada has the Global Skills Strategy, which allows employers to bring in highly skilled workers from abroad in as little as two weeks.

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1. TAILLE ET FORCE DU MARCHÉ PHARMACEUTIQUE : Le Canada est le 9e plus grand marché mondial de vente de produits pharmaceutiques. 2. POSSIBILITÉS D’ESSAIS CLINIQUES : Avec 5 % des essais cliniques mondiaux, le Canada se classe au 9e rang mondial. La population multiculturelle du pays, les cliniciens de recherche de renommée mondiale, le système d’éducation de premier plan et le système de soins de santé financé par l’État en font un terrain d’essai idéal pour les sciences de la vie. 3. TALENTS INSTRUITS : Avec 59,4 % des Canadiens âgés de 25 à 64 ans qui ont obtenu un diplôme d’un établissement d’enseignement supérieur, le Canada est le pays le plus instruit au monde. 4. TALENTS SPÉCIALISÉS : Plus de 4,8 millions de diplômés canadiens détiennent un diplôme STGM ou en soins de santé, ce qui fait du Canada une destination privilégiée pour les entreprises du secteur des sciences de la vie. 5. TALENTS MONDIAUX : En plus de se classer au 4e rang mondial pour l’accessibilité à des scientifiques et des ingénieurs, le Canada dispose de la Stratégie en matière de compétences mondiales, qui permet aux employeurs d’embaucher des travailleurs hautement qualifiés de l’étranger en seulement deux semaines.

6. INNOVATION – MEDTECH LEADERSHIP: Innovation requires leadership. Canada’s global leadership in medtech includes medical and diagnostic imaging, cardiovascular devices, and assistive and rehabilitative devices. Strengths in emerging medical devices include technologies such as robotic surgery, surgical simulation, mobile health and wearables. 7. INNOVATION – RESEARCH INTENSITY: Canada’s proven research strengths include genomics, bioinformatics, immunotherapy, regenerative medicine and neuroscience. And the pharmaceutical industry ranks 1st – ahead of all other sectors in Canada – in R&D intensity. 8. INNOVATION – EXCEPTIONAL INSTITUTIONS: With locations ranging from the Medical Image Analysis Lab (MIAL) at Simon Fraser University to the Montreal Diabetes Research Center and the Brain Repair Centre in Halifax, institutions driving innovation in life sciences are found coast to coast. It’s clear why so many global companies in the life sciences sector choose Canada for their next expansion. They find exactly what they need here.

6. INNOVATION – LEADERSHIP EN TECHNOLOGIE MÉDICALE : L’innovation nécessite un leadership. Le leadership mondial du Canada dans le domaine de la technologie médicale comprend l’imagerie médicale et diagnostique, les appareils cardiovasculaires et les appareils d’assistance et de réadaptation. Les forces des nouveaux dispositifs médicaux comprennent des technologies telles que la chirurgie robotique, la simulation chirurgicale, la santé mobile et les technologies portables. 7. INNOVATION – INTENSITÉ DE LA RECHERCHE : Les forces de recherche éprouvées du Canada comprennent la génomique, la bio-informatique, l’immunothérapie, la médecine régénérative et les neurosciences. L’industrie pharmaceutique se classe au 1er rang, devant tous les autres secteurs au Canada, en matière d’intensité de la R-D. 8. INNOVATION – INSTITUTIONS EXCEPTIONNELLES : Avec le laboratoire d’analyse d’images médicales de l’Université Simon Fraser, le Centre de recherche sur le diabète de Montréal et le Centre de traitement des lésions cérébrales de Halifax, il y a d’un océan à l’autre des institutions qui stimulent l’innovation en sciences de la vie. La raison pour laquelle tant d’entreprises mondiales du secteur des sciences de la vie choisissent le Canada pour leur prochaine expansion est claire : elles trouvent exactement ce dont elles ont besoin ici.

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Mannin’s Contribution to Canada’s Biomanufacturing Strategy: Establishing commercial manufacturing facilities in Canada to secure drugs for Canadians in a connected world MANNIN’S MISSION IS TO INNOVATE IN THE LIFE SCIENCES SECTOR TO MAKE A DIFFERENCE IN HEALTH CARE GLOBALLY. Our goal over the next 24months is to manufacture the highest quality supply of therapeutics, beginning with our respiratory distress therapeutic. Establishing our manufacturing centre in Canada will contribute to the security and strategic importance of having drugs made in Canada, for Canadians, as part of a made-in-Canada supply chain. As such we are also proud to contribute to the federal government’s strategy to increase Canada’s biomanufacturing capacity. Mannin’s recombinant protein therapeutic has moved quickly along the developmental pathway. This drug, having demonstrate effectiveness in limiting vascular leakage, and with other clinical trial demonstrating efficacy as a treatment for Acute Respiratory Disease Syndrome (ARDS) in COVID-19 patients, is showing a significant promise Mannin’s therapeutic is not a cure for respiratory distress in COVID patients, instead it strengthens a patient’s blood vessels and protects them against organ damage, breathing problems, reducing the days on a ventilator thus ultimately reducing the days a patient is in hospital. Furthermore, because the therapeutic is enhancing the defenses of the host, rather than targeting a specific infectious agent, its efficacy is not affected by the various strains or variants of the coronavirus. Collaboration and working together in R&D helps meet the need for made-in-Canada solutions for new therapeutics to treat patients with COVID-19. This results in making Canada self-dependent on substantial aspects of the supply chain segments by utilizing Canadianowned and controlled firms. As demonstrated by our announced collaboration with DNAstack, a Canadian company and a global leader in genomic analysis, analytics and scalable health IT, we were invited to contribute to the COVID Cloud project through the Digital Technology Supercluster in Vancouver. By sharing genomic and other biomedical data from COVID patients and the virus itself, we are learning new ways to attack and treat the virus.

Together with another Canadian biotechnology company, Biosymmetrics, we are developing a biomarker to identify patients with ARDS. The combination of our novel therapeutic for ARDS and the companion diagnostic for ARDS, with enhance our ability to identify ARDS, treat them effectively, improving the health of Canadians. This is all accomplished with technologies developed within Canada. Mannin’s ARDS therapeutic is slated to begin clinical trials by the end of 2022. But that is just the beginning of a continued journey for further successes to come. In parallel is the need to build-out the capacity to manufacture the drug in Canada. This will enable Mannin to scale-up and meet the needs of Canadians, while also addressing global markets via a Canadian-based supply chain. This secures our commercial goals, while providing Canada with additional biomanufacturing assets that will be needed to address not only this evolving pandemic, but also future pandemics. We want to foster the ecosystem that helped bring our drug to this stage and grow that ecosystem to support it moving through the next stages. This will pay dividends in the future by rebuilding Canada’s biotechnology sector as a truly collaborative space where competitors work together and share in each other’s successes. We are onto our next steps in building a Canadian biotechnology company, securing our Canadian supply chain, and working on making a stronger Canadian biotechnology ecosystem. The path we are now on will ensure that Canada has the arsenal of tools and networks to address this pandemic and be ready for the next one. Finally, team Mannin is once again proud to be a part of the Canadian delegation attending BIO2022 in San Diego. It is an important milestone for all of us that we are able to attend the conference in person. Good luck to all our colleagues in the Canadian delegation this year, and looking forward to seeing you all again. George Nikopoulos is the President and Chief Executive Officer of Mannin Research Inc, a Canadian biotechnology firm focused on the development of novel therapeutics in vascular diseases. biotech.ca

Next-Generation Commercialization in Canada A Conversation with Charlie Pirraglia, General Manager, EVERSANA™

A NEW PHARMACEUTICAL STRATEGY IN CANADA Next generation commercialization is here. Driven by market dynamics such as the increasing complexity of therapies and faster, more global launches, this new approach is very much needed. With its extensive experience navigating the complexity of product launch, market access and patient advocacy, EVERSANA™ understands the complexities of launching in the Canadian marketplace, one of the world’s top 10 pharmaceutical markets. “The pharmaceutical and medical device market is rapidly changing and so is the commercialization business. With the collective power of EVERSANA, our clients – both emerging pharmaceutical companies and established companies – have immediate access to a more comprehensive end-to-end commercialization solution to meet any challenge,” says Charlie Pirraglia, General Manager of EVERSANA’s Toronto based Canadian advisory services team. SOLVING COMMERCIAL CHALLENGES EVERSANA offers services that are uniquely integrated to solve specific commercialization challenges faced by the pharmaceutical industry. With solutions that are measurable and accountable, EVERSANA is the industry’s first truly integrated platform helping pharma and biotech companies bring critical therapies to new markets with a single, connected vendor approach. “We offer a full array of services. For example, forecasting, pricing, regulatory support, market access and stakeholder engagement are issues that EVERSANA experts are well versed in,” says Pirraglia. EVERSANA’s wide ranging expertise continues after a successful launch, providing the tools clients need to sustain product success, including supply chain management, medical services, advocacy, stakeholder management, and public relations, including advertising. ADOPTING A NEW STRATEGY Understanding the complexities of entering the Canadian market is a daunting task. This is where EVERSANA has identified an opportunity to ensure all necessary services are working together with the product and patients in mind at every phase of the product’s life cycle.

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“Any kind of commercialization requirements that clients have – they can get at EVERSANA,” says Pirraglia. Pirraglia cites the following example: “A pharmaceutical company may develop a therapeutic with great promise but may not have the experience or infrastructure to successfully commercialize this asset. EVERSANA acts as a single point of contact that allows companies to enter into an agreement to support commercialization with a proven launch platform,” he explains. “EVERSANA will launch more than a dozen brands globally over the course of the next year, providing an unparalleled core capability for our clients,” he adds.

“We do all of the work to successfully launch their asset, gain regulatory approval with Health Canada, navigate the market access environment and deploy a highly experienced and effective commercial team. Following approval and reimbursement EVERSANA is in a unique position, providing a full suite of commercialization services.” Another advantage of EVERSANA’s innovative commercialization model, which provides an alternative to out-licensing, is that clients can maintain the marketing rights and value of their assets. This ultimately allows for more flexibility while accessing the broad services that EVERSANA provides. In June 2021, EVERSANA announced a commercialization partnership with Calgary-based Resverlogix to support the planned commercialization of apabetalone in the U.S., Canada and additional markets. “For launch of this novel COVID-19 treatment, authorization had already been granted for trials in Canada. Our team continues to work with Resverlogix to bring this important therapy to patients in Canada.” says Pirraglia. As EVERSANA continues to expand in Canada and globally, there are already many more new services and EVERSANA™ COMPLETE Commercialization projects in the works. “We are delighted to bring next generation commercial options to companies entering and established in Canada,” Pirraglia says.

NEXT GENERATION COMMERCIALIZATION The life sciences sector is changing by the minute. That’s why we’ve built the integrated commercial services platform to solve any drug pricing, reimbursement, regulatory, stakeholder engagement, or product delivery challenge. Powered by data & analytics. Ready-to-deploy infrastructure. Proven expertise. We’ll manage the complete launch and commercialization of products or address specific program or patient needs. We are EVERSANA.

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Ingenuity. Invention. Innovation:

The Bioscience Future is Bright in Manitoba

THE BIOSCIENCE INDUSTRY IN MANITOBA IS ONE THAT HAS SHOWN GREAT RESILIENCY AND THE ABILITY TO PIVOT in response to the challenges of COVID-19. Sectors of the bio-economy relating to health and manufacturing such as medical and diagnostic laboratories and pharmaceutical manufacturing demonstrated agility to leverage pandemic related opportunities for growth. The importance of agri-biotech to ensure food security became more relevant as shortages have occurred. Manitoba has a strong and vibrant bioscience economy with more than 700 companies and organizations generating $10.4 billion in total sales annually to Manitoba’s GDP. Between 2017 & 2020, total revenues grew by 12%, from $9.4 billion to $10.4 billion, employed persons in the industry grew by 14% from 14,300 to 16,330. The bioscience industry ranks 4th in the province among all major industries with respect to Direct GDP Contribution at $5.6 billion in 2019. It is a high valueadded industry with direct GDP per worker of $344,560. In 2021 medicaments, which includes pharmaceuticals, vaccines, antibiotics for human and animal use, as well as vitamins and their derivatives, were the number one export from Manitoba worth $2.2 billion. This category has been the number one export from the province since 2018. Manitoba is second only after Ontario for pharmaceutical and medicine manufacturing at $2.3 billion. The Bioscience Association Manitoba (BAM) is a passionate advocate for the bioscience community, supporting members from cleantech, agricultural and health biotechnology. Since its inception 30 years ago, BAM has helped drive Manitoba’s bioscience industry to become diverse, highly educated, and expansive, because of this, many long-standing companies have reached or are near the product expansion stage. This puts Manitoba in the right place, at the right time, to support the needs of our global community.

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Manitoba - Innovation Hub for Bioscience Industry BAUSCH HEALTH Bausch Health is Canada’s largest publicly-traded pharmaceutical company. With it’s largest North American manufacturing site located in Steinbach, Manitoba, and employing 500, the company owns and operates a sprawling state-of-the-art facility which handle all of Bausch Health’s manufacturing of controlled-release products. Each year, the facility produces and packages approximately 1.2 billion tablets or capsules of 12 different kinds of medications which are sold worldwide to treat pain, high blood pressure and depression. IVC VITA HEALTH Employing over 600, IVC Vita Health is Canada’s largest private label manufacturer of a broad line of high-quality OTC drug products. The company has extensively invested in their regulatory and quality infrastructure to meet evolving regulatory expectations. The company has over 260,00 square feet of GMP licensed manufacturing, packaging and distribution facilities for Over-the-Counter Drug, Controlled Drug Product and Natural Health Products. IVC Vita Health was acquired by the International Vitamin Corporation who are committed to investing in, and aggressively growing both the domestic and international sales portfolio. MEDICURE INC. A public company since 1999, Medicure develops and commercializes pharmaceuticals and healthcare products for patients and prescribers with a U.S. focus. As a Specialty Pharma company with established sales of cardiovascular drugs, Aggrastat and ZYPITAMAG, Medicure carefully monitors opportunities within its own pipeline of products and possible strategic acquisitions in order to realize long-term value. It houses a commerce pharmacy platform through its subsidiary, Marley Drug™, where FDA approved medications can be purchased at discount prices for home delivery in all 50 States.

ROQUETTE Roquette is a global leader in plant-based ingredients, a pioneer of plant proteins and a leading provider of pharmaceutical excipients. In late 2021, Roquette opened the largest pea protein processing facility in the world alongside some of the best experts in developing new plant-based foods – all based in Manitoba. The 200,000-square-foot-plant has the capacity to process 125,000 tons of yellow peas per year to meet an increase in annual global demand estimated at between 15 and 24 percent per year over the next decade.

Manitoba - Innovation Hub for Bioscience Research The pandemic highlighted the importance of science, research and innovation. At the heart of Manitoba’s bioscience industry are supporting research organizations developing cutting edge technologies and discoveries that have helped advance the global science and healthcare communities. RESEARCH MANITOBA Research Manitoba provides funding support for Manitoba based companies and are the lead for Research Improvements Through Harmonization in Manitoba (RITHIM), the only such program of its kind in Canada. RITHIM harmonizes the ethics, privacy and impact applications and processes throughout Manitoba into one streamlined system supported by a single electronic platform, making it easier and faster for researchers to undertake clinical studies. ST. BONIFACE HOSPITAL ALBRECHTSEN RESEARCH CENTRE (SBRC) SBRC is home to the: • Institute of Cardiovascular Sciences which is widely regarded as one of the preeminent basic cardiovascular research programs in the world; • Division of Neurodegenerative Disorders that is investigating mechanisms underlying, and identifying potential treatments for, diseases including Alzheimer’s Disease, ischemic stroke, traumatic brain injury and aging-related CNS degeneration; • Canadian Centre for Agri-Food Research in Health and Medicine that assesses health-related benefits found in nutraceuticals, functional foods, and natural health products (health food).

THE MANITOBA CENTRE FOR HEALTH POLICY (MCHP) MCHP is a centre of research excellence that conducts world class population-based research on health, and the social determinants of health. MCHP develops and maintains the largest population-based data repository in Canada for use by the local, national and international research community, the Manitoba Population Research Data Repository. This comprehensive database was developed to describe and explain patterns of health care and profiles of health and illness, facilitating interdisciplinary research in areas such as health care, education, social services and justice. CANADIAN SCIENCE CENTRE FOR HUMAN AND ANIMAL HEALTH (CSCHAH) CSCHAH is Canada’s only Containment Level 4 (CL4) laboratory facility. The Centre co-houses the Public Health Agency of Canada’s National Microbiology Laboratory and the Canadian Food Inspection Agency’s National Centre for Foreign Animal Disease. In concert, these laboratories have highly specialized construction and engineering controls and are equipped to safely diagnose, research, and develop treatments and vaccines for high-risk pathogens, such as Ebola and Nipah virus.

Why Manitoba? Traditionally known as the gateway to the West, Manitoba is quickly becoming the Gateway to the World. Winnipeg was named the World’s Most Intelligent Community in 2021, World greatest places of 2021 by TIME and one of the Top 20 Best locations to Invest by Site Selection magazine. Manitoba’s bioscience industry, while gaining strength and momentum, will continue to drive the bioeconomy to the next level through collaborations and partnerships across the country and around the world.

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Ingenuity. Invention. Innovation:

The Bioscience Future is Bright in Manitoba

Spring | Printemps 2022

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Where does Canada rank on its attractiveness for new medicine launch? New study pinpoints where Canada leads and where to focus improvements

THE BIOPHARMACEUTICAL LANDSCAPE HAS EVOLVED QUICKLY IN RECENT YEARS, BOTH DOMESTICALLY AND INTERNATIONALLY. The speed at which scientific discoveries occur and are developed into medicines that can cure or change the natural history of disease is unprecedented, making it a hopeful time for patients. Despite the promise of new medicines, recent analyses by PDCI and other researchers indicate a delay in regulatory submissions in Canada compared to the US and Europe, suggesting some manufacturers may have demoted Canada in launch sequence relative to other markets. Further evidence of this worrying trend appeared in the Patented Medicine Prices Review Board’s (PMPRB) 2020 Annual Report which showed an almost 30% decrease in the number of new patented medicines reported to PMPRB since 2018. Amid recent policy changes in Canada and around the globe, Canada’s ability to compete as an attractive early launch destination is being questioned. How will global biopharmaceutical decision-makers view the appeal of Canada? Will Canadian patients get timely access to future novel and life-changing medicines? Answering these questions requires we understand what indicators drive biopharmaceutical manufacturers’ perceptions of launch attractiveness and where Canada ranks on these indicators relative to its global peers. Over 2021-22, PDCI Market Access developed its Biopharmaceutical Ecosystem Index to answer these questions. Its goal is to understand why a submission lag is observed in Canada, and in doing so, inform where policymakers can focus to ensure Canada stays a competitive destination for new medicine investment. Supported by the expertise of its editorial advisory board, PDCI identified and weighted indicators, then researched, measured, and ranked Canada’s attractiveness for new medicine launch relative to other countries: Australia,

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Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, UK, and US. Eight indicators were selected, being considered generally applicable and important in launch sequencing decisions. These indictors were grouped under three technical areas: Development & Commercialization Infrastructure, Regulatory Landscape, and Access Environment. Authors conducted an extensive literature review to evaluate each country according to the indicators and measurements, assigned a score, and ranked the 14 countries in order of best performance. The index finds that overall, Canada ranks within the middle of the pack; performing well in some areas while falling behind in others, signalling where policymakers may prioritize efforts to best improve Canada’s attractiveness. • Top-notch regulatory approval: Canada’s regulatory approval processes for new medicines are highly competitive among the countries. When considering review times and prioritized review pathways, Canada scored second only to the US and tied with Japan. • Clinical trial registrations improving: Late-stage clinical trials attract research dollars in the short term and improve access to new drugs in the longer term. The index compared the number of phase 3 clinical trials in each country in 2020 registered with the World Health Organization’s International Clinical Trials Registry Platform. Canada performs strongly in this measurement, ranking 6th among the 14 comparator countries. • Market potential performing well: Canada ranked in the middle of the pack when evaluating market potential measurements including the share of the global pharmaceutical market the country represents, the country’s wealth (GDP/capita) and the share of pharmaceutical spending that occurs out-of-pocket (OOP), with more points allocated to countries with less OOP spending.

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Health Technology Assessment (HTA) and reimbursement falling behind: Canada ranks in the bottom third when it comes to the HTA and Reimbursement indicator. Despite strong performances on other indicators, this poorer performance is particularly challenging because this indicator carries almost one third of the index’s weight. Making up this indicator are measurements of the time from regulatory approval to public funding, the existence of a sizeable private market, and the complexity of the process towards achieving reimbursement. While Canada earns points for having a substantial private reimbursement opportunity, it falls behind on the time it takes to achieve public reimbursement and the fragmented pathway to achieve it. In contrast, most other countries evaluated have more integrated or coordinated processes from HTA, through price negotiation and eventually formulary listing and funding. It is hypothesized that Canada’s fragmented steppingstones between regulatory approval and reimbursement may give rise to the challenges observed between HTA, the pan-Canada Pharmaceutical Alliance (pCPA) and eventual public reimbursement. Correspondingly, we see relatively long time clocked between regulatory approval and achievement of public reimbursement, which causes Canada’s lower score. Overall, Canada performs well on several indicators considered important for new medicine launches. Yet, when it comes to demonstrating an attractive environment to achieve reimbursement, Canada has ground to make up. This area is where policymakers can focus their efforts to effectively influence Canada’s attractiveness for new medicine launch in the years to come. In the meantime, global biopharmaceutical decisionmakers can rest assured that Canada remains home to significant opportunities for biopharmaceutical

manufacturers to launch new medicines. To increase the likelihood of success, companies seeking to launch in the Canadian market should plan early and conduct a market assessment to understand the opportunities and challenges. Securing the right strategic guidance and partnerships with Canadian experts in market access are essential for successfully navigating Canada’s biopharmaceutical ecosystem. Through its Biopharmaceutical Ecosystem Index, PDCI has discovered that Canada ranks reasonably well overall and where challenges exist (specifically in HTA & public reimbursement), they can be planned for, and expertly navigated to avoid the pitfalls that may have undermined Canada’s reputation as an attractive country for launch in recent years. There are encouraging signs of a renewed partnership between policymakers and the biopharmaceutical sector in Canada. A recent federal decision (April 14, 2022) to retain most of Canada’s price regulatory system, and jettison many proposed changes, is a positive move recognizing the extensive value a robust biopharmaceutical industry brings to Canada. Policy makers must continually take stock of Canada’s relative positioning internationally and be sensitive to the delicate and interconnected ecosystem that influences decision-makers’ perception of attractiveness when they consider policy changes affecting any of the indicators and measurements examined in PDCI’s Biopharmaceutical Ecosystem Index. More results from PDCI’s Biopharmaceutical Ecosystem Index will be published in late Spring 2022.

For more information please contact info@pdci.ca.

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Northeastern’s Master of Science in Biotechnology Set to Launch at Toronto Campus

THE FUTURE OF BIOTECHNOLOGY HOLDS THE KEYS TO SOLVING SOME OF TODAY’S BIGGEST PROBLEMS, such as developing life-saving vaccines and curing diseases. This fall, the Master of Science in Biotechnology (MS BIOT) will launch its first cohort at Northeastern University’s Toronto campus. To gain some insight into the program and learn how students are being prepared to tackle these problems, we spoke to the College of Science Dean, Hazel Sive (HS), and Associate Dean of Professional Programs and Graduate Affairs, Jared Auclair (JRA). WHAT MAKES TORONTO A GREAT PLACE FOR THE INTERNATIONAL EXPANSION OF THE MS BIOT PROGRAM? JRA: A number of industry colleagues have been telling me how companies have been opening offices just in or outside of Toronto — so there’s a real opportunity for biotechnology in Toronto as an industry. I also think that, from a global perspective, it’s a great opportunity to think about how mobility might factor in or what international co-ops might look like over time — for students both in Boston and in Toronto. HOW ARE STUDENTS IN THE MS BIOT PROGRAM BEING POSITIONED TO COMPETE AND SUCCEED? JRA: Graduates are very competitive in the workforce for a number of reasons. One relates to how the program is designed. Our program is developed in collaboration with industry, faculty, and government. It is meant to address the needs that exist in the industry. In addition, we take a very holistic view. Our courses cover technical skills, how to deal with data, and regulatory science. We also provide a perspective on the business of biotechnology and the process of getting a drug from research and development to commercialization. Lastly, our experiential learning gives students an advantage. Our students do a mandatory co-op, which

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makes them very marketable when they are ready to seek full-time employment. HOW CAN GRADUATES OF THE MS BIOT PROGRAM HELP EMPLOYERS AND THE BIOTECH INDUSTRY? HS: The number of people who are helped by products that come out of this industry is in the billions. It takes a huge workforce to meet the needs of the biotech industry in order to address human health in the most powerful and useful ways. The program is like very few others in that it involves work experience for all of our students. About 93-95 per cent of graduating students walk right into a job in biopharma. JRA: We train students to be leaders and thinkers, and add value with new ideas and directions. Our students bring a huge energy to the industry because they’re new and excited, but they also bring their training, leveraging all the advantages Northeastern has to offer to really bolster the ecosystem of biotech. We expect the students to do the same in in Toronto. WHAT WOULD YOU SAY TO SOMEONE INTERESTED IN APPLYING TO THE PROGRAM? HS: It’s interesting to think about the breadth of opportunities across the world. We think about the breadth in North America, but there are continents where biotech is in short supply. It’s an opportunity for students to come and study with us, partly remotely, partly in person, and it’s an opportunity for Northeastern to really consider its partnerships in other parts of the world to promote this very important set of industries. Learn more about the Master of Science in Biotechnology, visit our website neuto.cc/biotech. If you are a biotech or biopharma company interested in hiring co-op students or working with us, please email hiretoronto@northeastern.edu.

Advance your career opportunities in the biotechnology industry. Life sciences and biotechnology are some of the fastest growing sectors in Ontario. Over the next seven years, the sector will add nearly 25,000 jobs to the bioeconomy. The cutting-edge Master of Science in Biotechnology program offers:

MASTER OF SCIENCE IN BIOTECHNOLOGY

• Flexible learning options so you can work and study • Specialization in concentrations that align with industry trends • Prestige and recognition from a global research university

Earn a graduate degree and gain real-world industry experience. toronto.northeastern.edu/biotech

Targeting access and affordability of advanced biological therapies by/par: Kelley Parato (Program Director, NRC-Cell and Gene Therapy Challenge Program), Lakshmi Krishnan (Vice-President, Life Sciences, NRC). BIOLOGICAL MEDICINES LIKE CELL AND GENE THERAPIES ARE LIFE CHANGING FOR PEOPLE BATTLING CANCER OR DEBILITATING RARE DISEASES. Cell and gene therapies have vast therapeutic potential, but are complex to design, optimize and manufacture, which limits the pace of their development and clinical experience. The few approved therapies have an astronomically high cost that is unsustainable for most people. Clearly, it’s no small task, but the challenge of bringing this type of therapy to Canadians also presents great opportunities for innovation. Unlike traditional small molecule or chemical drugs, biological therapies such as chimeric antigen receptor (CAR) T cells rely heavily on specialized biomanufacturing capabilities for two critical components: the lentivirus vectors used to engineer new targeting specificity for the therapeutic cell, and for the final therapeutic cell itself. To move early-stage therapeutic discoveries into clinical evaluation, researchers and small and medium enterprises need access to facilities capable of making both components using good manufacturing practices (GMP). However, until recently, there was limited domestic infrastructure or capability for GMP production of early-stage made-inCanada CAR T cells, which was disheartening for clinicians with patients who could benefit from these innovations. “Canadian cancer patients should be at the front of the line for these potentially life-saving CAR-T therapeutics,” says Natasha Kekre, Hematologist, Transplant and Cellular Therapy Program at the Ottawa Hospital Research Institute. “The only way to ensure access is to enable domestic manufacturing of CAR-T therapies, so we can build the next generation of CAR-T innovations, encourage excellent Canadian inventions in this space, and ultimately cure our patients.” This is where National Research Council of Canada’s (NRC) Cell and Gene Therapy Challenge program comes in to play. DISRUPTIVE SOLUTIONS FOR CELL AND GENE THERAPIES In 2019, the NRC launched the mission-oriented Cell and Gene Therapy (CGT) Challenge program to deliver made-in-Canada solutions for making cell and gene therapies more accessible and affordable. The 104

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program allows the NRC to engage in multi-sectoral collaborations and engage the research talent and expertise needed to develop and advance high-risk, high-reward innovations. The CGT program focuses on engineered cells and viral vector gene therapy platforms, with the aim of expanding the domestic value chain, and accelerating growth of future cell and gene therapies. To accomplish these goals, the program is: • Making targeted investments to fill critical expertise and infrastructure gaps; and • Developing, validating and delivering technology, tools, platforms and processes to accelerate the research cycle and facilitate cost-effective translation of early-stage biological medicines. “To accelerate disruptive technologies and made-inCanada cell and gene therapies, we are focused on strengthening our infrastructure, biomanufacturing processes and expertise,” says Dr. Lakshmi Krishnan, Vice-President of Life Sciences at the NRC. “The NRC’s CGT program is building the critical multi-sectoral collaborations to make this happen, but also making the strategic investments required to support these collaborations.” For example, the CGT program is supporting several cell product GMP infrastructure expansion projects to improve the development and clinical evaluation of an early-stage made-inCanada cancer therapy using engineered CAR T cells. MOBILIZING MADE-IN-CANADA CARS Scientists and clinical researchers in Canada have made great progress in discovering novel cell therapy treatments for cancer, including CAR T therapies. A large gap remains however, in effectively biomanufacturing both the lentiviral cell engineering vectors and the therapeutic CAR T cells themselves, which would enable Canadian discoveries in this area to be clinically evaluated. The academic community came together with an early approach to fill this gap in expertise. In 2017, the BioCanRx NCE network made early research investments that established a proof-of-concept model for enabling

point-of-care CAR T cell therapy production at British Columbia Cancer Agency. The funding supported a phase I/II clinical trial in Canada with a biosimilar CD19 CAR T product, and in parallel enabled GMP production of CARencoding lentivirus vectors on-site at the Ottawa Hospital Research Institute. Most Canadian hospitals still did not have GMPcompliant biomanufacturing facilities on site, which are necessary to produce the required vectors and cells for this type of therapy. Building on the initial investment, the NRC is now supporting infrastructure expansion at several other sites across Canada. This new infrastructure will create a network of centres with the capacity for on-site CAR T cell production. This new capacity will facilitate flexible manufacturing, enable multi-centre trials, and accelerate the development of early product designs. The NRC is also working with academic and clinical collaborators to design a made-in-Canada CAR T product that will leverage this newly expanded GMP network. This multi-sectoral approach combines complementary strengths and points-of-view to accelerate new therapeutic design, by specifically: • Engaging clinical champions to drive target selection and identify the optimal therapeutic population and clinical strategy; • Connecting with academic colleagues to enrich preclinical product validation and translational R&D capacity; and • Focusing public investment, through the NRC, in strategic infrastructure and capacity building, in parallel with the development of synthetic biology tools to advance novel drug components and optimize biomanufacturing. Together, these infrastructure, expertise and technology investments are bringing forward the first made-in-Canada CAR T therapy to be manufactured and clinically evaluated in Canadian centres. Phase I clinical trials are planned for late 2022 or early 2023.

Canada’s expanded biomanufacturing capability and these new research tools provide opportunities to advance novel engineered cell therapies, biomanufacturing processes, and complementary processes and methods. In addition to expanding access to CAR T therapies, the NRC’s Cell and Gene Therapy Challenge Program is advancing a parallel pathway to make AAV-based gene therapy vectors for rare diseases more accessible. This involves matching targeted investments in AAV GMP manufacturing with bioprocess development and therapeutic product innovation. The NRC is also collaborating with academic partners and small and medium sized enterprises to support domestic discovery and innovation of cell and gene therapies. By developing novel and disruptive tools and platforms to accelerate the arrival of targeted cell and gene therapies, these collaborations aim to bring more therapeutic benefits to Canadian patients. The CGT program is focusing on providing more, and less expensive, access to: • Microfluidic based technologies for inline biomanufacturing analytics; • High-throughput mammalian gene editing for iPSC and biomanufacturing cell line optimization; and • Tissue-specific targeting of nanoparticles delivering various cargoes. The NRC’s involvement in the cell and gene therapy challenge area uniquely brings public investment into collaborations that accelerate solutions for the public good”, says Dr. Kelley Parato, Director of the NRC Cell and Gene Therapy Challenge program.

“By helping our collaborators across multiple sectors leverage novel technologies and expertise, we can target key bottlenecks, technology gaps, and cost drivers in cell and gene therapy development, as we

OPPORTUNITIES FOR FUTURE INNOVATION To accelerate and optimize CAR T therapeutics, the CGT program has leveraged several tools that are now available to broader medical community. These include: • Single-domain antibody binders for tumour targeting; • High-throughput CAR screening platform; and • Suspension biomanufacturing cell lines for scalable lentivirus production.

work together to advance new therapeutic solutions for Canada.” The NRC’s Cell and Gene Therapy Challenge program is intended to leave a long-lasting legacy of facilities, expertise and technology that will accelerate more cost-effective and accessible made-in-Canada cell and gene therapies of the future. biotech.ca

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CANADA’S STRENGTH IN THE BIOTECH AND LIFE SCIENCES SECTOR can be seen in the role that companies in different Canadian regions play in the growing global life sciences industry. With a national perspective, we explore current Canadian trends and changes taking place in the sector, focusing on the areas of public and private mergers and acquisitions, corporate finance, venture capital and intellectual property. PUBLIC MARKET VALUATIONS ARE BEING TESTED Downward pressure on public market valuations in 2021, and continuing into 2022, has resulted in an opportunistic, if not challenging, transactional environment for biotech companies. A year that began with optimism on the heels of Abcellera’s US$555 million US IPO in December of 2020, saw little in the way of Canadian biotech IPOs in 2021, with Eupraxia’s C$41 million IPO on the TSX in March of 2021 standing as the exception. Despite such challenges, follow-on public financings were available to companies that were able to meet important milestones and we’re seeing that trend continue into 2022. In one such instance, Xenon Pharmaceuticals raised US$345 million in October of 2021 following the release of positive Phase 2 results for its epilepsy drug candidate XEN1101. Companies that were able to take advantage of material financing opportunities in 2020 and 2021 are generally in a much better position to weather the market volatility that we expect will continue in 2022. M&A valuations were also under pressure in 2021, with the XBI (S&P Biotech Select Industry Index) down 21% overall last year and over 20% thus far in 2022. Yet there was some blockbuster M&A activity in 2021 as evidenced by Pfizer’s US$2.22billion acquisition of Trillium Therapeutics, which closed in November of 2021. Compressed valuations and volatility are impacting the consideration analysis of large pharma and targets and we expect some time will be required for expectations to reset and M&A activity levels to accelerate.

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ON CONSTATE LES ATOUTS DU CANADA DANS LE SECTEUR DES BIOTECHS ET DES SCIENCES DE LA VIE lorsque l’on observe le rôle que jouent les entreprises de différentes parties du pays au sein du secteur mondial des sciences de la vie. Afin de proposer un panorama national, nous explorons dans le présent article les tendances et les changements qui animent le secteur, avec une attention particulière pour les fusions et acquisitions de sociétés ouvertes et fermées, les finances des entreprises, le capital de risque et la propriété intellectuelle.

LA VALORISATION SUR LES MARCHÉS PUBLICS MISE À L’ÉPREUVE Des pressions baissières sur les valeurs au sein des marchés publics en 2021, puis au début de 2022 ont donné lieu à un contexte transactionnel fait d’occasions et de défis pour les sociétés de biotechnologie. L’année avait débuté dans l’optimisme de l’introduction en bourse d’Abcellera pour une valeur de 555 millions $ US en décembre 2020, mais l’année 2021 fut pourtant peu fertile en premiers appels publics à l’épargne, Eupraxia ayant fait figure d’exception par son introduction à la bourse TSX en mars 2021, pour une valeur de 41 millions $ CA. En dépit du contexte difficile, il y a eu de nouveaux cycles de financement pour les entreprises qui avaient su franchir d’importantes étapes, et cette tendance demeure en 2022. Xenon Pharmaceuticals a par exemple obtenu 345 millions $ US en octobre 2021, à la suite de la publication de résultats favorables à des essais de phase 2 associés au candidat-médicament contre l’épilepsie XEN1101. Les entreprises qui ont pu tirer parti d’occasions concrètes de financement en 2020 et en 2021 sont dans l’ensemble en bien meilleure posture pour affronter la volatilité des marchés, qui devrait se maintenir en 2022. La valorisation des fusions-acquisitions a aussi été soumise à pression en 2021, le XBI (l’indice S&P propre aux biotechs) ayant connu une baisse globale de 21 % au cours de l’année dernière et de plus de 20 % depuis le début de 2022. Il y a toutefois eu de l’activité chez les géants du secteur du côté des fusions-acquisitions en 2021, comme en témoigne l’acquisition de Trillium Therapeutics par Pfizer au coût de

HEALTH CLINIC CONSOLIDATION Despite the challenges faced in public M&A, increased levels of private M&A activity during the pandemic have been widely reported. The Canadian biotech, life sciences and health care industries have been very attractive to investors during this period. Health care clinic ownership in Canada, which has remained largely fragmented, is currently undergoing consolidation of the nature observed in the United States and other jurisdictions. In what is known as a “roll-up”, an investor purchases several small independent healthcare practices to form a larger consolidated entity, with the individual practitioners often receiving consideration in the form of shares of the consolidated entity. The consolidated entity is able to provide economies of scale relating to pricing, marketing, and access to the latest technologies, while also managing the back-office administrative functions (payroll, IT, and billing), allowing the individual healthcare practitioners to focus on their core specialty of patient care. These type of roll-up transactions are particularly attractive to private equity investors and cover a range of clinics including dental, orthodontic, physiotherapy and fertility clinics, among others. SUPPLY CHAIN ISSUES PRESENT CHALLENGES The COVID-19 pandemic has created supply chain challenges for companies in the biotech sector. Companies have struggled to ensure guaranteed supply of critical inputs, and have been forced to re-allocate resources between products in the face of inconsistent supply. In addition to commercial constraints on the supply chain, companies also face import and export restrictions as governments look to ensure an adequate domestic supply of products and materials. Supply chain issues, import and export restrictions, and the dependence on foreign production of COVID-19 vaccines and other therapeutics have caused an increased focus on domestic production, both through commercial arrangements with foreign partners and through investment in local manufacturing infrastructure and domestic therapeutic, vaccine and drug development.

2,22 milliards $ US, qui s’est conclue en novembre 2021. La compression de la valorisation et la volatilité ont une incidence sur les analyses préalables des multinationales pharmaceutiques et des entreprises cibles; nous nous attendons à ce qu’il faille un certain temps pour l’établissement de nouvelles prévisions et un regain de la vigueur sur le plan des fusions-acquisitions.

REGROUPEMENT DES CLINIQUES MÉDICALES Malgré les difficultés sur le front des fusions-acquisitions de sociétés ouvertes, on a rapporté une intensification des mêmes activités pour ce qui est des sociétés fermées au cours de la période pandémique. En effet, les secteurs des biotechs, des sciences de la vie et des soins de santé ont suscité un important intérêt de la part des investisseurs. La propriété des cliniques médicales au Canada, jusqu’ici très fragmentée, connaît actuellement des regroupements qui évoquent ceux qui ont cours aux États-Unis et dans d’autres pays. On emploie le terme anglais « roll-up » pour désigner ce mécanisme, au cours duquel un investisseur achète plusieurs cabinets médicaux indépendants pour en faire une vaste entité consolidée, les praticiens recevant généralement en contrepartie des parts de l’entité. Celle-ci peut ensuite mettre en place des économies d’échelle liées aux prix, au marketing et à l’accès aux technologies de pointe, ainsi que centraliser les fonctions administratives (paye, TI et facturation), permettant ainsi aux professionnels de la santé de consacrer leur énergie à soigner les patients. Ces fusions de multiples petites entités sont tout particulièrement attrayantes pour les investisseurs de capital; elles ont entre autres lieu dans le domaine des soins dentaires, de l’orthodontie, de la physiothérapie et des cliniques de fertilité.

LES DÉFIS QUE REPRÉSENTENT LES RUPTURES DE LA CHAÎNE D’APPROVISIONNEMENT La pandémie de COVID-19 a entraîné des difficultés d’approvisionnement pour les entreprises du secteur des biotechs. Les sociétés ont en effet eu du mal à obtenir des garanties quant à l’approvisionnement de certains intrants essentiels et ont donc dû réattribuer des ressources. En plus des pressions commerciales sur la chaîne logistique, les entreprises doivent aussi composer avec des restrictions à biotech.ca

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The COVID-19 pandemic has created supply chain challenges for companies in the biotech sector. Companies have struggled to ensure guaranteed supply of critical inputs, and have been forced to re-allocate resources between products in the face of inconsistent supply. In addition to commercial constraints on the supply chain, companies also face import and export restrictions as governments look to ensure an adequate domestic supply of products and materials. The pandemic has also caused disruptions to pre-pandemic modelling of product supply and distribution of companies in the biotech sector. Companies that developed estimates of demand for non-COVID related therapeutics based on pre-pandemic metrics have encountered lower than expected demand due to pandemic-related restrictions and have, in some cases, had difficulty selling inventory of those products. VENTURE CAPITAL CONCENTRATES INVESTMENTS Venture funding to Canada’s biotech and life sciences sectors continued to grow in early and mid-2021, improving on the trend we have seen in recent years. While venture capital investments have seen strong growth across a number of industries, the recent broad engagement of the public with public health issues as a result of COVID-19 has raised the profile of the life sciences industry in particular. According to the Canadian Venture Capital Association’s (CVCA) reporting, as of the end of Q3 2021, the life sciences sector had received 13% of the venture capital investment in Canada, with $1.5 billion having been invested over 77 deals. This nine-month aggregate dollar value exceeded the total dollars invested in all of 2020 by 30%. In the last quarter of 2021 and early in 2022, general market volatility has put a damper on the exponential growth we have experienced over the past few years, but the long-term impacts of this volatility remain to be seen. In 2021, large-sized early financing rounds have been the trend, with Series A financings regularly falling in the $10 million to $20 million range, and some outliers, such as Notch Therapeutics’ $85 million Series A raise in February 2021, vastly exceeding those amounts. We have also seen an increasing number of non-Canadian venture investors 108

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l’importation et à l’exportation, en cette période où les gouvernements cherchent à s’assurer un approvisionnement national suffisant en produits et en matières premières. Les problèmes d’approvisionnement, les restrictions à l’importation et à l’exportation, ainsi que la dépendance envers la production étrangère de vaccins et de traitements contre la COVID-19 ont fait converger les regards vers la production nationale, qui s’organise grâce à des accords commerciaux avec des partenaires étrangers et à des investissements dans les infrastructures nationales de fabrication et la mise au point au Canada de traitements, de vaccins et de médicaments. La pandémie est aussi venue perturber les habitudes des entreprises du secteur des biotechs relativement aux quantités en stock et à la distribution. Les sociétés qui avaient établi des estimations quant à la demande en traitements non liés à la COVID selon des paramètres prépandémiques ont fait face à une demande inférieure à leurs prévisions en raison des restrictions associées à la pandémie et ont, dans certains cas, eu du mal à écouler leurs stocks de produits.

LES ACTEURS DU CAPITAL DE RISQUE CONCENTRENT LEURS INVESTISSEMENTS Le capital de risque investi dans les secteurs canadiens des biotechs et des sciences de la vie a continué de croître au début et au milieu de 2021, la tendance s’étant même révélée meilleure qu’au cours des dernières années. Le capital de risque investi a connu une forte croissance dans nombre de secteurs, mais le vaste engagement de la population par rapport aux questions sanitaires par suite de la pandémie a amélioré l’image de marque du secteur des sciences de la vie en particulier. Selon l’Association canadienne du capital de risque et d’investissement (ACCR) à la fin du 3e trimestre de 2021, le secteur des sciences de la vie avait reçu 13 % des investissements en capital de risque au Canada, 1,5 milliard de dollars ayant été investis dans 77 ententes de financement. Cette valeur en dollars agrégée sur neuf mois dépasse de 30 % la somme totale des dollars investis en 2020. Au dernier trimestre de 2021 et au début de 2022, la volatilité générale des marchés a freiné la croissance exponentielle que l’on vivait depuis quelques années, mais ses effets à long terme restent à découvrir. En 2021, la tendance a été aux vastes cycles de financement de début de croissance, les premiers cycles de financement ayant dans bien des cas atteint la tranche des 10 millions à 20 millions de dollars et, dans certains cas, une somme largement supérieure, par exemple de 85 millions de dollars pour Notch Therapeutics en février 2021. Les capital-risqueurs non canadiens ont aussi été plus nombreux à chercher à investir dans des entreprises canadiennes, et l’on a également assisté à plus de souplesse de la part des investisseurs sur le plan de la structure; ces deux éléments conjugués ont créé pour les sociétés canadiennes, quel que soit leur stade d’évolution, un éventail de possibilités plus large en matière d’obtention de capitaux.

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looking to invest in Canadian companies, as well as more flexibility from investors on structuring, both of which serve to create a broader scope of opportunities for Canadian companies to obtain capital at all stages. NEW PM(NOC) REGULATIONS FINALLY HAVING AN IMPACT The “new” Patented Medicines (Notice of Compliance) Regulations are now five years old and are finally beginning to have an impact. The Regulations changed in the fall of 2017, but the next few years were relatively quiet and saw many settlements. In contrast, in the last couple of years, the trend is towards cases proceeding through trial and the innovator and biotech sides of the industry are seeing some success. PM(NOC) cases continue to dominate the pharmaceutical and biotech patent litigation landscape, as intellectual property protection for new molecules and new biologic products is key to recouping the significant investments made in bringing those products to market. This is particularly the case for biologic products, which are generally more expensive to manufacture and often require the creation or development of patient support programs due to the nature of the diseases being treated or the routes of administration. As we go further into 2022 and 2023, we expect the trend of active litigation in this space to continue and will be watching closely to see if the move to accelerated trials as opposed to applications continues to bear fruit. PMPRB CHANGES AT THE CENTRE OF ATTENTION In August 2019, the Federal government announced significant amendments to the regulations and guidelines governing the Patented Medicine Prices Review Board (PMRPB). While the coming into force of those changes has been deferred multiple times (the current date is July 1, 2022), they have also been the subject of litigation in both Quebec and the Federal Court. On February 18, 2022, the Quebec Court of Appeal rendered its decision on the constitutionality of the changes and struck down the majority of them, leaving only the changes to the list of comparator countries. A week and a half later, on February 28, 2022, the Federal Court of Appeal heard an appeal of a second challenge to the amendments, which was reserved and is expected to be released later in the year. The Federal Court of Appeal also took the PMPRB to task in a July 2021 decision (Alexion Pharmaceuticals Inc. v Canada (Attorney General), 2021 FCA 157), which decision is currently under consideration for leave to appeal to the Supreme Court. All in all, the approach of the PMPRB and the scope of its power over the pricing of pharmaceuticals in Canada is and will be very much at play in 2022 and beyond, as these cases are decided, perhaps by the highest court in the land. The outcome will have significant impacts on pricing and price controls for pharmaceutical products in Canada.

LE NOUVEAU RÈGLEMENT SUR LES MÉDICAMENTS BREVETÉS (AVIS DE CONFORMITÉ) PRODUIT ENFIN SES EFFETS Le « nouveau » Règlement sur les médicaments brevetés (avis de conformité) [MB(AC)] a désormais cinq ans et commence enfin à produire ses effets. Le Règlement a été modifié à l’automne 2017, mais les quelques années qui ont suivi ont été assez calmes, alors que l’on assistait à la conclusion de nombreuses ententes négociées hors cour. Au contraire, depuis deux ans, les cas ont plutôt tendance à se rendre au tribunal, et le secteur de l’innovation et des biotechs a remporté certaines affaires. Les cas liés au Règlement sur les MB(AC) dominent toujours le paysage des litiges en matière de brevets dans le secteur pharmaceutique et des biotechs, car la protection de la propriété intellectuelle associée aux nouvelles molécules et aux nouveaux produits biologiques est essentielle à la récupération de fonds considérables investis dans la commercialisation des produits. C’est la situation que connaissent en particulier les produits biologiques, qui ont généralement un coût de fabrication élevé et exigent souvent la création ou le renforcement de programmes de soutien des patients, en raison de la nature des maladies visées et des voies d’administration des traitements. Nous nous attendons, pour la suite de l’exercice 2022-2023, à ce que la tendance sur le plan des litiges en cours se maintienne. Nous suivrons de près cette situation, afin de savoir si le fait de multiplier les procès plutôt que de formuler de nouvelles demandes continuera de porter des fruits.

POINT DE MIRE : DES CHANGEMENTS AU CEPMB En août 2019, le gouvernement fédéral annonçait des modifications considérables au règlement et aux directives régissant le Conseil d’examen du prix des médicaments brevetés (CEPMB). L’entrée en vigueur des changements a été reportée à plusieurs reprises (la date actuellement prévue étant le 1er juillet 2022), et ceux-ci ont été contestés tant au Québec que devant les tribunaux fédéraux. Le 18 février 2022, la Cour d’appel du Québec a rendu sa décision sur la constitutionnalité des changements et en a annulé la majorité, autorisant uniquement les changements apportés à la liste des pays de comparaison. Une semaine et demie plus tard, le 28 février 2022, la Cour d’appel fédérale a entendu l’appel relatif à une deuxième contestation des modifications; le jugement est pour le moment en délibéré et devrait être rendu public au cours de l’année. La Cour d’appel fédérale a aussi pris le CEPMB à partie dans une décision rendue en juillet 2021 (Alexion Pharmaceuticals, Inc. c. Procureur général du Canada, 2021 CAF 157). L’autorisation d’appel de cette dernière à la Cour suprême fait actuellement l’objet d’une évaluation. Somme toute, la démarche du CEPMB et la portée de ses pouvoirs en matière d’établissement du prix des médicaments au Canada sont en jeu et le demeureront en 2022 et au-delà, c’est-à-dire jusqu’à ce que les affaires soient tranchées, peut-être par le plus haut tribunal du pays. Cela aura une incidence majeure sur l’établissement et la régulation des prix des produits pharmaceutiques au Canada. biotech.ca

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ADVERTISERS DIRECTORY / RÉPERTOIRE DES ANNONCEURS

ABCELLERA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

INVEST IN CANADA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

ACUITAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

INNOVATIVE MEDICINE CANADA . . . . . . . . . . . . . . . . . . 45

AG WEST BIO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

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MANNIN RESEARCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

BIOGEN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

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BIOSCIENCE MANITOBA. . . . . . . . . . . . . . . . . . . . . . . . . . . 98

NORTHEASTERN UNIVERSITY . . . . . . . . . . . . . . . . . . . . . 102

BIO-QUÉBEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

NATIONAL RESEARCH CENTRE CANADA . . . . . . . . . . 104

BIOTALENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

NOVARTIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

BRISTOL MYERS SQUIBB . . . . . . . . . . . . . . . . . . . . . . . . . . 24

ONTARIO GENOMICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

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PANTHERA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

CITY OF MISSISSAUGA . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

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CPDN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

REPARE THERAPEUTICS . . . . . . . . . . . . . . . . . . . . . . . . . . 112

EISAI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

SENECA COLLEGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

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STEMCELL NETWORKS . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

EVERSANA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

TAKEDA CANADA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

FINE SCIENCE TOOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

TRIUMVIRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

FONDS DE SOLIDARITÉ DU QUÉBEC . . . . . . . . . . . . . . . . 18

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Spring | Printemps 2022

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Insights Magazine Spring 2022

Articles inside

LEGAL

TALENT

PARTNERSHIP/PARTENARIAT Discovery behind blockbuster Pfizer-Trillium deal started at UHN and SickKids

PARTNERSHIP/PARTENARIAT Proposing a solution for Canada’s drug supply shortage - The Canadian Critical Drug Initiative

NEWS NOUVELLES Building a Ready-to-use Data System from the Ground Up Before Data Exists!

NEWS NOUVELLES

VACCINE NEWS DU NOUVEAU CÔTÉ VACCINS Moderna: Bringing the Promise of mRNA to Canada

FEDERAL PERSPECTIVE LE POINT DE VUE FÉDÉRAL An ambitious plan for Canada’s Biotech Industry

MESSAGE FROM THE PRESIDENT AND CEO

MESSAGE DU PRÉSIDENT ET CHEF DE LA DIRECTION