Insights Magazine Fall 2021 by BIOTECanada

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

CANADIAN BIOTECHNOLOGY Solving today. Building tomorrow.

BIOTECHNOLOGIE DU CANADA Sanofi Delivers a Shot in the Arm for Canadian Biomanufacturing Sanofi fournit une contribution BioVectra Inc. announces a $144.6 million essentielle à project la biofabrication expansion / BioVectra Inc. canadienne » projet page 24 annonce un d’expansion de 144,6 M$ » page 24

Okanagan Specialty Fruits Celebrates a Quarter Century of Dedication to Innovation A Progressive View on Developing Canada’s Okanagan Specialty Fruits célèbre un Leadership Expertise / Une vision moderne quart deen siècle dévouement de la mise placede d’une expertise enàgestion l’innovation » page au Canada » page 72 90

2019

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S’occuper du présent. Bâtir l’avenir.

Fall / Automne Spring / biotech.ca Printemps 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

Life Science Companies Continue to Invest in Mississauga:

Canada's Leading Life Sciences Cluster People

Operations

Capacity

Equity & Diversity Collaborative Mississauga-based companies are among the 17 Life Sciences leaders committed to investing in more inclusive workplaces.

Roche Canada A $500M investment to establish a Global Pharma Technical Operation at its pharma HQ in Mississauga, creating 500 new jobs.

Resilience Biotechnologies Inc. A $200M investment for its Mississauga manufacturing facility expansion to increase production capacity for mRNA vaccines.

thefutureisunlimited.ca/lifesciences

biotech.ca

GETTING VACCINATED CAN BRING US ALL BACK TOGETHER. FASTER.

CONTENTS / TABLE DES MATIÈRES 24

MESSAGE FROM THE PRESIDENT AND CEO by Andrew Casey, BIOTECanada

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

DEPARTMENTS / SECTIONS 24 VACCINE NEWS/ DU NOUVEAU CÔTÉ VACCINS Sanofi Delivers a Shot in the Arm for Canadian Biomanufacuring Sanofi fournit une contribution essentielle à la biofabrication canadienne 32 NEWS/ NOUVELLES Building Resilient Healthcare Systems For A Post-Crisis Era La mise en place de systèmes de santé qui, au delà de la crise, sauront être résilients 38 ECOSYSTEM/ECOSYSTÈME Growing the Canadian biotech ecosystem together Développer ensenble l’écosystème canadien des biotechs

by Jennifer Hamilton, PhD, Early Innovation Partnering, Johnson & Johnson Innovation par Jennifer Hamilton, Ph. D., directrice des partenariats, innovations récentes, Johnson & Johnson Innovation

54 INDUSTRIAL BIOTECH/ BIOTECHNOLOGIE INDUSTRIELLE Uniting for growth with Canada’s Food & Agri-Tech Engine Faire avancer la croissance grâce au Moteur des technologies agroalimentaires du Canada by Lilian Schaer for Bioenterprise, Canada’s Food & Agri-Tech Engine par Lilian Schaer pour le Moteur des technologies agroalimentaires du Canada de Bioenterprise

60 INVESTMENT/INESTISSEMENT A thriving life sciences sector in Canada needs to be nurtured and supported if we are to leverage and build on its recent successes Le secteur florissant des sciences de la vie au Canada doit être nourri et soutenu si nous voulons tirer parti de ses récents succès. by Peter van der Velden, co-founder and the Managing General Partner, Lumira Ventures par Peter van der Velden, cofondateur et associé directeur principal de Lumira Ventures

48 TALENT How Incubators Are Powering Canada’s Life Sciences Sector Les incubateurs : des moteurs pour le secteur canadien des sciences de la vie

biotech.ca

DEPARTMENTS / SECTIONS

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72 KNOWLEDGE/CONNAISSANCE

Published for/Publié pour :

Canadian Commercialization Trends for Emerging Biopharma Tendances canadiennes de la mise en marché pour les sociétés biopharmaceutiques émergentes

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

By Matthew Norton, General Manager, Commercial, Technology and Government Solutions, IQVIA Canada

EDITOR IN CHIEF/RÉDACTRICE EN CHEF : Nadine Lunt TRANSLATION/TRADUCTION : Sophie Campbell Martine Leroux

par Matthew Norton, directeur général, Solutions commerciales, technologiques et gouvernementales, IQVIA Canada

80 LEGAL MATTERS/QUESTIONS DE DROIT

Published by/Publié par :

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

Biologics: overview of recent judicial proceedings and decisions

CREATIVE DIRECTOR/ DIRECTEUR DE CRÉATION : Louise Casavant

Produits biologiques : aperçu des récentes procédures et décisions judiciaires

PROJECT MANAGER/DIRECTRICE DE PROJET : Terry McMillan DIRECTOR OF ADVERTISING SALES/ DIRECTEUR, VENTES PUBLICITAIRES : Stephan Pigeon

by Urszula Wojtyra, Partner, Barrister & Solicitor, Smart & Biggar par Urszula Wojtyra, Associée, Avocate, Smart & Biggar

86 AGRICULTURE Okanagan Specialty Fruits Celebrates a Quarter Century of Dedication to Innovation Okanagan Specialty Fruits célèbre un quart de siècle de dévouement à l’innovation

by Denise Briggs – Communications Manager, Okanagan Specialty Fruits Inc. (OSF) par Denise Briggs – Gestionnaire des ommunications, Okanagan Specialty Fruits Inc. (OSF)

ON THE COVER / EN COUVERTURE Canada’s voice for biotechnology / Le porte-parole canadien de la biotechnologie Canada’s voice for biotechnology / Le porte-parole canadien de la biotechnologie

chnologie du Canada. S’occuu présent. Bâtir l’avenir.

CANADIAN BIOTECHNOLOGY Solving today. Building tomorrow.

BIOTECHNOLOGIE DU CANADA

144,6 M$ » page 24

Okanagan Specialty Fruits Celebrates a Quarter Century of Dedication to Innovation A Progressive View on Developing Canada’s OkanaganExpertise Specialty Fruits célèbre un Leadership / Une vision moderne quart deen siècle dévouement de la mise placede d’une expertise enàgestion l’innovation » page au Canada » page 72 90

2019

PM 43136012

S’occuper du présent. Bâtir l’avenir.

Sanofi Delivers a Shot in the Arm for Canadian Biomanufacturing Sanofi fournit une contribution BioVectra Inc. announces a $144.6 million essentielle à project la biofabrication expansion / BioVectra Inc. canadienne » projet page 26 annonce un d’expansion de

Fall / Automne

Spring / biotech.ca Printemps biotech.ca

From the onset of the pandemic, it was the science and innovation of the biotech sector which has demonstrated the enormous importance of biotech solutions. Similarly, climate change and population growth are other important areas needing biotech solutions. The biotech sector has shown its resiliency throughout the pandemic and is now poised for another leap forward. Investing more in enhancing this foundation will not only help meet the preparedness objective, but if done strategically, it can also generate and support early-stage companies in Canada. We invite you to MEET BIONATION. Dès le début de la pandémie, ce sont la science et l’innovation du secteur des biotechnologies qui ont démontré l’énorme importance des solutions biotechnologiques. De même, le

fall | autumn 2021

changement climatique et la croissance démographique sont d’autres domaines importants nécessitant des solutions biotechnologiques. Alors que certains secteurs seront naturellement lents à se redresser, le secteur des biotechnologies suit le rythme de la reprise. En effet, c’est l’un des rares secteurs à avoir fait preuve de résilience tout au long de la pandémie et est maintenant prêt pour un autre bond en avant. Investir davantage dans l’amélioration de cette fondation aidera non seulement à atteindre l’objectif de préparation, mais s’il est fait de manière stratégique, il peut également générer et soutenir des entreprises en démarrage au Canada. La biotechnologie a joué un rôle déterminant tout au long de la pandémie et une pierre angulaire importante pour la reprise économique à venir. Nous vous invitons à RENCONTRER BIONATION

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© 2021 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. © 2021 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.

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MESSAGE FROM THE PRESIDENT AND CEO by Andrew Casey, BIOTECanada

Biotech’s Moment A CENTRAL PILLAR OF BIOTECANADA’S NARRATIVE FOR THE INDUSTRY is the reality of a global population moving quickly to nine or ten billion people and the enormous pressure feeding, housing, healing, and fueling this population growth places on the environment and planet. Globally we must fundamentally alter how we grow, manufacture, cure and energize our economies and societies. Biotechnology can be central in meeting this challenge and for those countries home to vibrant biotech sectors there is enormous economic benefit to be had from developing these solutions. Amidst growing concerns about COVID-19 variants and the challenge of vaccinating the global population, the United Nations’ International Panel on Climate Change (IPCC) issued its climate change report (https://bit.ly/3yo92Ll ) which warned us in no uncertain terms that at current warming levels the world is like a large ocean-going cargo ship: it will take enormous effort to materially alter its course over the coming years. Quite clearly, we are currently on an unsustainable trajectory. The dinosaurs are a good reminder of the reality that ultimately the planet is not at risk, it is we as a species that is at risk if we do not urgently take meaningful steps to reduce our environmental footprint. Again, biotechnology is central to our ability for solving this challenge. The pandemic’s economic, social and health impact certainly has effectively focussed the attention of policymakers and the public on the strategic importance of having a

strong domestic life sciences industry and biomanufacturing capacity. Will lessons learned from the pandemic experience change how we respond to the IPCC report? The pandemic should not have been the surprise it was. Long before its arrival, experts cautioned governments regarding the real possibility of a pandemic (indeed, our very own Vaccine Industry Committee repeatedly urged government to takes steps to prepare for a pandemic). Most warnings went unheeded or were met with a minimal response. Accordingly, when it hit, governments found themselves in the uncomfortable position of building the plane while in flight. Several months later, it is clear they have little interest in reliving this experience and are now taking significant steps to prepare for future pandemics. In the 2021 budget, the federal government earmarked over $2 billion in the federal budget to grow the life sciences sector in Canada and develop domestic biomanufacturing capacity. Not only does this make good public policy sense, but it also presents an important and timely opportunity to accelerate the growth of Canada’s biotech sector beyond just a biomanufacturing response in a crisis. If we are to avoid the IPCC’s predicted pandemic-like crisis in the environment, then it would make good sense for all countries to urgently recognize and invest in the solutions coming out of the biotech sector. Launched in the spring of 2020, (read paper here) has been an important vehicle to communicate to policymakers on the value of the entire biotech ecosystem to Canada.

The ecosystem is a foundational piece upon which to build as it is national in scope and includes a diverse mix of early-stage companies, universities, incubators/accelerators research centres, investors, and multinational pharmaceutical/biotech companies. Federal and provincial governments have recognized the sector’s importance as they prepare for future covid-like challenges, improve environmental performance and begin the economic rebuild needed over the period ahead. Governments are correspondingly developing strategies and investing to advance the sector and Canada’s competitive position more broadly. While the investments and initiatives are welcome, they are for the most part strategically disconnected. In this context, Canada’s competitive position to attract global investment and grow Canada’s biotechnology sector would be significantly enhanced by federal and provincial governments strategically partnering with industry to coordinate and leverage their investments and policies. In addition, the sector’s overall competitiveness would be greatly enhanced by governments taking steps to modernize and coordinate regulatory oversight of the sector. Accordingly, this is a critical time for industry and government to partner constructively to deliver on diverse but connected objectives relating to the entire life sciences sector. With more than two hundred and forty members representing the full biotechnology ecosystem and all life sciences sectors including healthcare, agriculture, manufacturing, and investment, BIOTECanada will continue to support all undertakings designed to develop a cohesive national strategy to augment the vast potential of the entire biotechnology sector in Canada. Note: At the time of writing the federal election had just been called.

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Canada’s Pharma Supply Gap Needs Urgent Solutions DANGEROUSLY LOW STOCKS OF ESSENTIAL MEDICINES IN SOME INTENSIVE CARE UNITS EARLY IN THE COVID-19 PANDEMIC drove home how perilously dependent the Canadian medical system has become on other countries for raw pharmaceutical materials and finished drug products. Montreal-based Pharmascience Inc., one of the largest manufacturers of generic drugs in Canada, and the largest in Quebec, is calling on the federal and provincial governments to step up to the plate and assist the pharmaceutical industry with incentives to improve supply chain sustainability and discourage offshoring to lower wage, lower cost of production countries. Companies have offshored manufacturing away from Canada to countries like India and China, and to a lesser extent certain nations in the European Union, explains Alain Boisvert, head of government and public affairs at Pharmascience. “The issue here is not access to capital. Drug companies usually have good access to commercial bankloans or other types of capital sources. But in order to reverse the negative economics that we’ve had over the past 20 years, we would need some direct assistance from governments,” he adds. Business subsidies or fiscal credits are two strategies that could encourage Canadian pharmaceuticals to stay in Canada and enhance the country’s pharmaceutical manufacturing capacity. There are potential advantages to each. Business subsidies provide an opportunity to receive direct aid, while tax credits tied to achieving specific objectives would not have to be repaid. Both proposed options - subsidies or credits - could augment production capacity and, in turn, support greater supply chain reliability. The increased output would be measurable and the information derived from that could serve as key performance indicators, says Boisvert.

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Pharmascience says that a key strategy to incentivize domestic pharmaceutical production would be for the federal and provincial/territorial governments to collaborate and establish minimal Canadian manufactured contents in the public procurement of medicines. “If there was a minimum Canadian content in tenders, allowing manufacturers to either bid at a slightly higher price, or at least have a minimum quantity of allocated purchase…that would be good for hospital products,” Boisvert elaborates. “But we would need another form of local purchasing incentive for ambulatory drugs dispensed through retail pharmacies. For that, we think it would be possible for provincial or territorial governments to allocate local manufacturing credits at a level that would bridge the difference in costs of manufacturing with other countries,” he adds. This strategy would create an indirect procurement incentive system designed to reward Canadian manufacturing for pharmaceuticals, based on the extent and volume of local sales of Canadian manufactured products. To mitigate dependence on the global active pharmaceutical ingredients (API) supply chain, Pharmascience calls for the creation of permanent safety reserves of API or finished products for essential medicines, which would be available for purchase in quantities exceeding normal demand in emergency situations like COVID-19. “The longer-term solution is that we will have to very seriously consider rebuilding an API production capacity in Canada. The technology needs to be scaled up, and we need to create companies that would be suppliers to Canadian local manufacturers, to complete the production process, and be secure from API to finished product,” says Boisvert. “This is more than just a plain supply issue. This is more than a health care issue. It’s also a national security issue, as our recent COVID experience has demonstrated,” he stresses.

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

UN MOMENT HISTORIQUE POUR LA BIOTECHNOLOGIE L’un des piliers centraux du message que diffuse biotecanada pour le secteur est le fait que la population mondiale est sur le point de compter neuf ou dix milliards de personnes, ce qui crée d’énormes pressions sur l’environnement et la planète pour que tout ce monde ait accès à de la nourriture, un logement, des soins et du combustible. Les économies et sociétés de partout doivent revoir leurs méthodes de culture, de fabrication, de soins et de production de combustible. La biotechnologie peut jouer un rôle névralgique en ce sens. Les pays dotés d’un secteur dynamique de la biotechnologie capable de trouver des solutions à ces enjeux bénéficieront d’énormes avantages économiques. Alors que s’intensifient les inquiétudes concernant le variant delta et la difficulté de vacciner une population mondiale pour prévenir l’émergence de nouveaux variants, le Groupe d’experts intergouvernemental sur l’évolution du climat (GIEC) des Nations unies a publié un rapport [en anglais] sur le changement climatique (https://bit.ly/3yo92Ll) qui prévient sans équivoque que le taux de réchauffement actuel transforme le monde en une sorte de grand cargo océanique, c’est-à-dire qu’il faudra déployer d’énormes efforts pour modifier matériellement le cours des choses. De toute évidence, nous sommes engagés dans une voie insoutenable. Il est bon de se rappeler l’ère des dinosaures : à terme, ce n’est pas la planète qui est en danger, mais plutôt notre espèce si nous ne prenons pas urgemment les grands moyens pour réduire notre empreinte écologique. La biotechnologie pourrait se trouver au cœur de la solution à ce problème. L’incidence économique, sociale et sanitaire de la pandémie a certainement

fait voir aux décideurs et au public l’importance stratégique d’un secteur national des sciences de la vie et d’une capacité de biofabrication au pays qui sont solides. Les leçons tirées de la pandémie changeront-elles notre façon de réagir au rapport du GIEC? La pandémie n’aurait pas dû nous prendre autant au dépourvu. Bien avant son arrivée, les experts avertissaient les gouvernements de la probabilité concrète d’une pandémie (de fait, notre propre comité de l’industrie des vaccins a pressé le gouvernement à plusieurs reprises de prendre des mesures pour s’y préparer). La plupart des mises en garde sont restées sans écho ou ont à peine fait réagir. En conséquence, quand la pandémie a frappé, les autorités gouvernementales ont été prises de court et ont dû construire l’avion en plein vol. Quelques mois plus tard, il est clair qu’elles n’ont guère envie de revivre la même expérience et qu’elles prennent maintenant d’importantes mesures pour se préparer à de futures pandémies. Le budget fédéral de 2021 a affecté plus de 2 milliards de dollars à la croissance du secteur des sciences de la vie au Canada et au renforcement de la capacité nationale de biofabrication. En plus d’être logique sur le plan des politiques publiques, cette importante décision arrive à point nommé pour propulser la croissance du secteur de la biotechnologie au Canada au-delà de la simple biofabrication en période de crise. Pour éviter la crise environnementale d’envergure pandémique que prévoit le GIEC, il serait logique que tous les pays reconnaissent d’urgence les solutions issues de la biotechnologie et qu’ils y investissent. Lancée au printemps de 2020, l’initiative (lisez le document ici [en anglais]) a été un moteur important pour faire connaître aux stratèges politiques la valeur de tout

l’écosystème de la biotechnologie pour le Canada. Cet écosystème est une pierre angulaire. Il est d’envergure nationale et comprend toute une série d’entreprises en phase de démarrage, d’universités, d’incubateurs ou d’accélérateurs, de centres de recherche, d’investisseurs et de multinationales du secteur pharmaceutique et de la biotechnologie. Les gouvernements fédéral et provinciaux ont compris l’importance du secteur pour lutter contre les futurs défis de l’ampleur de ceux de la COVID, pour améliorer le bilan environnemental et pour amorcer la reconstruction économique nécessaire pour l’avenir. En conséquence, ils élaborent des stratégies et investissent pour faire progresser le secteur, mais aussi la position concurrentielle du Canada. Bien que les investissements et les initiatives soient de bon augure, ils ne sont généralement pas liés par une même stratégie. Ainsi, la position concurrentielle du Canada pour attirer des investisseurs étrangers et faire croître le secteur de la biotechnologie du pays s’améliorerait grandement si les gouvernements fédéral et provinciaux formaient un partenariat stratégique avec le secteur pour concerter leurs investissements et leurs politiques. Par ailleurs, la concurrentialité du secteur dans le monde s’améliorerait largement si les gouvernements prenaient des mesures pour moderniser et coordonner la surveillance réglementaire du secteur. En conséquence, le secteur et les pouvoirs publics doivent s’allier dès maintenant dans un esprit constructif en vue d’atteindre des objectifs variés mais connexes qui touchent à l’ensemble du secteur des sciences de la vie. Avec plus de 240 membres représentant tout l’écosystème de la biotechnologie et tous les secteurs des sciences de la vie, y compris les soins de santé, l’agriculture, la fabrication et l’investissement, BIOTECanada continuera de soutenir toutes les initiatives visant à élaborer une stratégie nationale cohérente pour accroître le vaste potentiel de l’ensemble du secteur de la biotechnologie au Canada. Note : Le présent texte a été rédigé au déclenchement de la campagne électorale.

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As its COVID-19 Vaccine Enters Phase 2 Clinical Trials, Entos Pharmaceuticals Sets Its Sights on Cancer, Aging and Rare Diseases ENTOS PHARMACEUTICALS INC.’S (ENTOS) Entos is hoping to have both vaccines completed in PROPRIETARY FUSOGENIX DRUG DELIVERY SYSTEM trials by the end of this year, and then ready for approval has proven to be a very effective COVID-19 vaccine platform in early 2022. in clinical trials. The Edmonton biotechnology company Entos has also been working closely with its partners believes that its DNA delivery platform can be leveraged to such as the Alberta Cell Therapy Manufacturing Centre at make potent COVID-19 vaccines that will make a big the University of Alberta in Edmonton to expand the difference in the Third World where dangerously low clinical-grade manufacturing of its Fusogenix platform. In vaccination rates against the global pandemic still prevail. addition to the fight against COVID-19, Entos has a robust Entos has two COVID-19 DNA vaccine candidates. The therapeutic development pipeline that leverages its next first candidate, encoding the SARS-Cov-2 spike protein, generation genetic medicine delivery system for many other has been successfully steered through a Phase I clinical indications such as oncology, age related diseases, and trial and is now headed on to Phase II. other infectious diseases. “It’s very similar in concept to the approved Moderna and Entos recently launched joint venture OncoSenX, which Pfizer coronavirus spike vaccines, except it’s made in DNA. is advancing a solid tumour gene therapy that Dr. Lewis That allows us to store it in the believes will be the first viable regular refrigerator, and our data gene therapy for cancer. suggests that it will be effective “It is a gene therapy that after a single dose,” says John detects cancer signalling and Lewis, Entos’ co-founder and chief basically instructs those cells executive officer. to commit suicide,” he explains. “Fortunately Canadians have “It looks for cells that have been vaccinated broadly already, defective P53 signalling, which so the Phase II trial will be are present in most cancers, conducted abroad, and will look at and activates a suicide program an expanded cohort of 500 to kill those cells.” patients to check if we see the Entos plans to initiate that same immunogencity after a trial in early 2022 at the Cross single dose or two doses,” he adds. Cancer Institute in Edmonton, Dr. Lewis notes that a fridge and examine how that stable, ideally single dose treatment will work for a First Participant Dosed in Entos’ COVID-19 Vaccine vaccine, will be much easier and variety of solid tumours, Clinical Trial compatible with the cold chain including prostate, lung, available in low and middle colorectal, and pancreatic. income countries around the globe where there is still an Entos is working with Oisin Biotechnologies of Seattle to enormous need for primary immunization. employ a very similar technology used to kill cancer cells to Entos’ second candidate is a pan-coronavirus vaccine. also kill senesence cells, which have been widely implicated “This is a next generation vaccine that should provide in various age-related diseases. protection against all of the emerging variants, plus “Based on our success with the COVID-19 vaccine, we’re potentially other coronaviruses. And so we’re looking at also looking at developing other vaccines and therapeutics this one as potentially a single shot booster for any of the for infectious disease. I think our next big target will be a other approved vaccines that should confer long term pan-flu vaccine,” says Dr. Lewis. pan-coronavirus protection,” explains Dr. Lewis. Over the longer-term, Entos is “looking at applying our “We’ve selected epitopes in that vaccine that are extremely technology to new advanced approaches like gene editing to similar among the different coronaviruses that in our precure childhood genetic diseases and other rare diseases,” clinical studies have elicited a strong T-cell response, which we Dr. Lewis adds. think is associated with long-term durability,” he adds. 12

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A united approach to the equity, diversity and inclusion challenge THE CITY OF MISSISSAUGA’S COMMITMENT TO ADVANCING GENDER EQUITY AND DIVERSITY extends far beyond its own workplace. It has committed to supporting an inclusive work environment through a new initiative with the Healthcare Businesswomen’s Association (HBA Canada) focused on the life sciences sector. “Mississauga is home to Canada’s second-largest life sciences sector, employing 25,000 people. And it’s growing rapidly – we expect the sector to add another 3,000 jobs in just the next four years,” says Jackie O’Connor, Life Sciences Business Consultant at the City of Mississauga Economic Development Office. “We have one of the most diverse populations in the world, with more than half of the city’s residents born outside of Canada. We must focus on inclusive growth and support our companies in building workforces representative of our diverse community.” HBA Canada is the Canadian Region of an international non-profit dedicated to elevating women into leadership positions in healthcare organizations. They, like the City of Mississauga, are wholly committed to advancing equity and diversity in the workplace. Acting on their common commitment, the two organizations established the Equity and Diversity Collaborative (EDC), a ground-breaking consortium of 17 healthcare and life sciences companies dedicated to promoting gender equity and diversity initiatives in the 14

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workplace. The Collaborative supports companies and Canadian boards striving to achieve gender parity and significant representation of other under-represented groups, including racialized persons, people living with disabilities and members of the LGBTQ2+ community across their organizations. It does this by facilitating opportunities for its members to connect, share best practices and learn from one another. This concept of industry-wide collaboration, cooperation and consensus has proven to be successful elsewhere. The Gender Parity Collaborative, a group similar to the EDC and based in the US, has demonstrated improved gender representation among its member companies. “We believe that we have an opportunity and obligation to improve our inclusion and diversity; for our employees, in the way we do business, and in the communities where we operate,” says Nicole Stuart, Country Head HR for GSK. “By volunteering to be a part of this important initiative, I am gaining external insights, best practices, and partnerships to further foster and support GSK’s I&D focus.” EDC adopted a Plan-Do-Study-Act (PDSA) approach. At the beginning of the year, Executive Sponsors select the priority area to focus on and, through a series of workshops designed as sprints, their ambassadors plan

specific tactics to implement and begin doing this work. Midway through the year, the Collaborative studies the impact of these tactics, adjusts course, and immediately acts upon those adjustments. For its initial year, the EDC chose to focus on recruitment, hiring and transition/ promotion practices. Adopting the PDSA approach allowed the collaborative to hit the ground running. So did the organizers’ decision to take immediate-action rather than go through a lengthy planning stage. This was critical as “the pace of change is frustrating, especially for those that have been waiting for equity and inclusion for so long,” says Nita Arora, Agility Coach at Roche Canada and Roche EDC Ambassador. “As individuals and organizational leaders, we need to shorten this time by applying our learnings as quickly as possible versus waiting for system and policy to catch up. Small quick shifts can have an enormous impact - learn and apply.” Their approach is already bearing fruit. One collaborative member is revamping its job descriptions after a workshop revealed significant differences in how they were perceived by various people in the organization. Also, organizations of all sizes are now readily sharing best practices, ideas and experiences. And some smaller companies, unable to access the resources required to best work with underrepresented groups, are using what they’ve learned from other EDC ambassadors.

Andrew Plank, President and General Manager at Roche (Diagnostics), one of the companies participating in the EDC, emphasized a vital but often overlooked quality of equity and diversity – that it is good for both humanity and business. “This intersection is sometimes missed by leaders . . . but it is this balance that brings people to a shared purpose and understanding to propel both individuals and organizations forward. Leaders play an important role in facilitating this work. The key is creating the conditions and environment for people to evolve and move the organization forward in an inclusive way” “Change begins when we seek to understand,” says Danielle Portnik, Canadian Regional Chair and co-founder of HBA in Canada. “Impact happens when we come together to do something about it.” The EDC will be measuring the outputs of these combined efforts at the end of the year as the first step in identifying the group’s priority for 2022.

Open to working with others to promote diversity and gender equity in your workplace? Visit https://www.thefutureisunlimited. ca/industries/life-sciences/equity-anddiversity/

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Insights-AWB-1Page-Fall2021.pdf 1 2021-09-01 11:12:58 AM

CMY

Victoria Biotech Attempting to Save Eyesight Of Patients With Rare Disease A VICTORIA-BASED BIOTECHNOLOGY COMPANY IS TRYING TO HALT THE PROGRESSION OF BLINDNESS for people born with a rare eye disease. Oak Bay Biosciences Inc., a 2020 startup, has developed a potential therapy using a patented molecule designed to halt the progression of Stargardt disease. “The technology is an aptamer that inhibits the catallytic function of Complement Factor D, a critical regulatory enzyme in the alternative complement pathway known to be inappropriately activated in the retinas of Stargardt patients,” explains Oak Bay chief executive officer David Kroeger. Stargardt is an autosomal recessive, inherited disease leading to progressive blindness that results from mutations in a gene called ABCA4. An individual needs to inherit two copies of the mutated gene to suffer from Stargardt disease, which causes a big blind spot in the middle of the vision, along with some blurriness and peripheral vision. “The reason for that is the mutation results in the accumulation of some toxic byproducts that are part of the normal visual cycle. Normally your eyes would deal with that, but they can’t because of the mutation in that gene, ABCA4. So what happens is the places where the most light hits is where you become the most blind,” Dr. Kroeger explains. Stargardt disease can begin anywhere between childhood and young adulthood. About half of cases involve rapid progression where there will be some level of visual impairment within five years of diagnosis. There are many known mutations of ABCA4 that affect this progression rate differently. But within about 20 years of onset, most of the rapid progressors will have reached legal blindness, says Dr. Kroeger. Oak Bay’s technology is still in the pre-clinical stage, with human trials expected to begin in mid-2023. Oak Bay hopes to receive conditional approval for the use of its molecule in human eye treatments by the U.S. Food and Drug Administration in 2027, perhaps earlier depending on clinical results and the regulatory environment.

This molecule would be administered by an ophthalmologist via an intravitreal injection. “One of the major benefits is that we are looking at a dosing interval of once every four months, rather than once a month,” says Dr. Kroeger, who explains that many intravitreal eye injections today need to occur monthly. “Based on the mouse models, we expect this would be more than 90 per cent effective in preventing retinal cell death, so that could extend the time to blindness to 70 years. That would, in some cases, be a definitive treatment if people are living 70 years, plus, without becoming blind,” Dr. Kroeger explains. Oak Bay’s board of directors and management team is steeped in knowledge and experience. Dr. Kroeger is an expert in immunology, having trained with some some of Canada’s top immunologists, including Dr. Brad Nelson at the BC Cancer Agency. Matthew Levy, Oak Bay’s chief scientific advisor, trained with a pioneer of aptamer technology, and is now himself one of the world’s most foremost aptamer experts. Levy initally developed Oak Bay’s aptamer as a faculty member at the Albert Einstein College of Medicine and followed it to a start-up company, Vitrisa Therapeutics in RaleighDurham, N.C. Oak Bay subsequently acquired that technology. Director Chris Astle has strength in Finance and Corporate Governance. Board Chairman Erich Mohr heads up translational development. He is also currently the chairman and CEO of Victoria-based MedGenesis Therapeutix Inc., a biopharmaceutical holding company. Director Paul Erickson is co-founder of Victoria-based Axys Group. Oak Bay Biosciences is currently fundraising via an equity crowdfunding platform, evaluating partnering opportunities, and is seeking potential clinical investigators and patients who may have an interest in collaborating on the Stargardt program. For more information see the website: www.oakbaybio.com. biotech.ca

New Immunomodulatory Cannabinoid Drug Shows Promise in Fight Against COVID-19

CANADIAN BIOPHARMACEUTICAL COMPANY TETRA decades of pre-clinical data supporting the potential of the BIO-PHARMA INC., A GLOBAL LEADER in cannabinoidactive pharmaceutical ingredient used in ARDS003 to derived drug discovery and development, will soon be dampen systemic hyperinflammation. “We had this taking its novel injectable cannabinoid drug product, incredibly robust pre-clinical data in our sepsis models ARDS003, into human clinical trials. and, given that with COVID-19 we’re essentially talking “Everything is poised to go,” says Tetra Bio-Pharma’s about a viral sepsis, we thought that our drug would have Chief Scientific Officer, Melanie Kelly. signficant efficacy for treating the hyperinflammation that “The non-clinical program, including all of the studies drives acute respiratory distress syndrome [ARDS] in required for an investigational new drug product by the U.S severe COVID-19,” Dr. Kelly explains. FDA and Health Canada, have been completed and Tetra ARDS003 acts by activating a novel drug target, the Bio-Pharma has also finished type 2 cannabinoid (CB2) receptor, manufacturing of the clinical drug to dampen the body’s inflammatory product in order to move forward response. In part, this works by with its clinical program,” she says. reducing the excessive release of Prior to the global pandemic, the pro-inflammatory mediators that Ottawa-headquartered Tetra can give rise to a ‘cytokine storm’ Bio-Pharma, which is publicly which drives the inflammatory listed, was initially targeting the stages of sepsis. development of an ophthalmic “There are many advantages of prescription drug to treat an ocular targeting the CB2 receptor. It’s inflammatory condition called localized very highly to immune uveitis via local delivery to the eye. cells with relatively low expression However, when the COVID-19 in the brain compared to the type 1 pandemic began in 2020, the cannabinoid (CB1) receptor, which company repositioned its drug is expressed throughout the brain candidate to aggressively develop it and the nervous system. That as ARDS003, an intravenous means drugs that activate the CB2 medication for systemic treatment receptor don’t have the same kinds of severe COVID-19 patients in a of behavioural [psychoactive] hospital setting. side-effects that you see with In moving forward with non-selective cannabinoid drugs ARDS003, the company’s Dr. Melanie Kelly, Tetra Bio-Pharma’s Chief Scientific Officer leadership took into consideration 18

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that act at the CB1 receptor,” says Dr. Kelly. Furthermore, because it acts differently than treatments like steroids, there is the potential for synergistic actions when combined with other antiinflammatory drugs, she explains. Using a drug that not only selectively modulates key immune cells involved in the host response to pathogens, but acts at a target whose expression is also inducible in inflammatory conditions provides excellent potential for treating hyperinflammation. “In that respect I think ARDS003 is a very promising drug candidate,” Dr. Kelly notes. The active ingredient in ARDS003 is considered a new molecular entity because it has not previously been used in humans. However, published preclinical studies in animals have characterized the effects of this active ingredient in hyperinflammatory disease models with pathological features comparable to those seen in COVID-19 patients. In these studies, treatment resulted in decreased levels of inflammatory mediators (which are responsible for much of the short- and long-term damage seen in inflammatory diseases), reduced tissue damage, and increased likelihood of survival. Studies conducted by Tetra Bio-Pharma further support pursuing ARDS003 for the treatment of severe inflammation in COVID-19 patients. Findings from these

studies include reduced inflammation and pulmonary fibrosis in a mouse model of hyperinflammatory lung injury, and improved daily health scores in an ongoing study evaluating the effects of ARDS003 in mice infected with the virus causing COVID-19. The clinical program involves an adaptative Phase 1 study. “As soon as the trial data from the first cohort of healthy subjects in the Phase Ia has been reviewed and the data safety monitoring board has given approval to proceed, we can move simultaneously with our COVID-19 patient group,” explains Dr. Kelly. Tetra Bio-Pharma’s multicenter Phase 1b trial could enroll COVID-19 patients in four countries, with clinical testing sites planned for Canada, the United States, Brazil, and India. The company may add additional clinical testing sites, depending on the COVID19 situation around the globe when the trial initiates. “I think there are some real opportunities here that could be taken advantage of with this particular drug,” Dr. Kelly stresses.

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We strive to improve human health and contribute to a society enriched by smiles Nous nous efforçons d’améliorer la santé humaine et de contribuer à une société enrichie de sourires

https://www.taihopharma.ca/en/

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Partner with Seneca’s Centre for Innovation in Life Sciences

Seneca’s Centre for Innovation in Life Sciences (SCILS) supports applied research opportunities in the life sciences and cosmetic science sectors with access to expertise from students, faculty and infrastructure. Our state-of-the-art technologies and instrumentation support cutting-edge research and innovative applications to solve business challenges faced by industry and community partners. Key areas of expertise in applied life sciences and cosmetic science • assay development and validation • product formulation • method development and process optimization • product stability enhancement and testing • quality control and regulatory affairs Work with us To find out how we can help with your business challenge, contact: Namrata.Barai@senecacollege.ca Director of Applied Research, Seneca Innovation

senecacollege.ca/SCILS We acknowledge the support of the Natural Sciences and Engineering Research Council of Canada (NSERC).

Natural Sciences and Engineering Research Council of Canada

Conseil de recherches en sciences naturelles et en génie du Canada

Seneca Centre for Innovation in Life Sciences:

Enabling Ontario’s life science industry to advance technologies and products THE SENECA CENTRE FOR INNOVATION IN LIFE SCIENCES (SCILS), LAUNCHED IN NOVEMBER 2020, plays a key role in supporting innovation within the local life science ecosystem. SCILS is a collaboration between Seneca’s School of Biological Sciences & Applied Chemistry and Seneca Innovation. Seneca Innovation supports all applied research activities at Seneca. SCILS is one of Seneca’s newest initiatives and is funded by the Natural Sciences & Engineering Research Council of Canada (NSERC). “SCILS provides the opportunity to exercise our collective academic and industrial strengths in specialized areas, while collaborating with colleagues who bring experience in their own respective fields,” said Dr. Frank Merante, a PhD in biochemistry and a professor and principal scientist with SCILS. “It also enables us to contribute to an array of applied research projects with industry partners, while engaging students in cutting-edge activities.” Since inception SCILS has worked on nine applied research projects with local small and medium sized life science companies in Ontario, engaging eight faculty principal investigators and 16 student research assistants. “One of the big advantages of the NSERC support is our ability to expedite requests and engage with industry partners by saying, ‘We can work with you. We can start on this date. We have this amount of funding available,’” said Paola Battiston, Chair, School of Biological Sciences & Applied Chemistry. “It’s nice to be able to get a quick response back to potential partners, avoiding delays.” Applied research areas of focus at SCILS are life sciences diagnostics and cosmetic science.

SCILS’ life sciences diagnostics expertise supports companies developing products for metabolomics testing, biochemical diagnostics, immunodiagnostics and molecular diagnostics, used both in clinical and industrial settings. Current projects include point-of-care diagnostic tests, such as lateral flow and dipstick assays for testing of foreign pathogens in food, and veterinary testing applications, among others. “For example, Kenota Health, based in Kitchener, wanted to express recombinant proteins in yeast,” said Tina Perricone, Research Manager, Applied Research, Seneca Innovation. “The resulting work with Seneca will facilitate the production of cost-effective peanut allergy tests.” Cosmetic science projects at SCILS supports companies seeking to develop safe and effective cosmetic products with consumer appeal through novel formulations and analytical testing for quality and stability. Everist Inc., is a Toronto-based venture-backed beauty essentials startup that has developed a patent-pending waterless haircare paste innovation. Seneca is supporting their work to develop an all-natural shampoo and conditioner. “Everist is going to market and seeing great success as an all-natural brand,” said Ms. Perricone. Barkev Keoshkerian, a Seneca professor and SCILS researcher, notes that as a participant in the applied research program at Seneca, he has had exciting opportunities to engage with innovative smaller companies that require preliminary research to validate their concept. “Working closely with a company and bringing a product to commercialization is very rewarding,” said Mr. Keoshkerian. “But the most rewarding aspect of these projects is to be a mentor to students, to help them learn about research, apply their learning and see the sparkle in their eyes as they begin to understand their future career potential.” biotech.ca

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Sanofi Delivers a Shot in the Arm for Canadian Biomanufacturing Sanofi fournit une contribution essentielle à la biofabrication canadienne

ABOUT SANOFI IN CANADA Sanofi is one of Canada’s leading investors in life sciences, research and development, manufacturing and distribution – working to discover new and better ways to address unmet medical needs. With a legacy that spans over 100 years, Sanofi in Canada played a key role in the distribution of insulin on a mass scale, the fight against diphtheria, the eradication of polio in North America, and smallpox around the world. Committed to serving global public health needs, Sanofi is expanding its manufacturing footprint and building on its research and development initiatives to make more lifesaving vaccines available to Canadians, adults and children worldwide. Jean-Pierre Baylet, General Manager Sanofi Pasteur Canada, is leading the Vaccine Business Unit for Canada. With over 20 years as part of the Sanofi global network, he has seen many changes in the vaccine industry and over the last few years he has witnessed a significant change in focus and investment in Canada. Here’s what he has to say about the future of vaccines. WHAT SHOULD WE KNOW ABOUT THE WORLDWIDE VACCINE MARKET TODAY? The market is evolving and changing at a rapid pace. COVID-19 has really shaken things up. It has attracted major investment. New technologies have been introduced. The overall public awareness on vaccination has increased significantly. Vaccine development, manufacturing and regulatory approval processes – the timelines have shrunk. Governments and industry players have worked in an incredibly fast and efficient way. Ultimately, it has changed the way we work and acted as a catalyst for new investments, partnerships, and strategic initiatives. CAN YOU TELL US ABOUT THE MOST EXCITING TRENDS IN VACCINES? Thanks to the unprecedented efforts and surge in investment from many actors

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À PROPOS DE SANOFI AU CANADA En tant qu’un des plus grands investisseurs du Canada en sciences de la vie, en recherche et développement, en fabrication, et en distribution, Sanofi s’efforce de découvrir de nouvelles et meilleures façons de répondre aux besoins médicaux insatisfaits. Avec un héritage qui s’étend sur plus de 100 ans, Sanofi Canada a joué un rôle clé dans la distribution de l’insuline à grande échelle, la lutte contre la diphtérie ainsi que l’éradication de la polio en Amérique du Nord et de la variole dans le monde entier. Engagée à répondre aux besoins mondiaux en matière de santé publique, Sanofi élargit son empreinte manufacturière et s’appuie sur ses initiatives de recherche et de développement pour offrir plus de vaccins qui sauvent des vies aux Canadiens, ainsi qu’aux adultes et aux enfants dans le monde entier. Jean-Pierre Baylet, directeur général de Sanofi Pasteur Canada, dirige l’unité commerciale des vaccins pour le Canada. Ayant œuvré pendant plus de 20 ans dans le réseau mondial de Sanofi, il a constaté de nombreux changements dans l’industrie des vaccins et, au cours des dernières années, il a assisté à un changement important en matière d’orientation et d’investissement au Canada. Voici ce qu’il a à dire sur l’avenir des vaccins.

Jean-Pierre Baylet, General Manager Sanofi Pasteur Canada/ directeur général de Sanofi Pasteur Canada

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QUE DEVRIONS-NOUS SAVOIR SUR LE MARCHÉ MONDIAL DES VACCINS AUJOURD’HUI? Le marché change et évolue à un rythme rapide. La COVID-19 a vraiment ébranlé les choses. Elle a attiré des investissements majeurs. De nouvelles technologies ont été introduites. La sensibilisation globale du public à la vaccination a augmenté de façon considérable. Les échéanciers des processus de développement, de fabrication et d’approbation réglementaire des vaccins ont diminué. Les gouvernements et les acteurs de l’industrie ont travaillé de manière extraordinairement rapide et efficace. En fin de compte, la situation a changé notre façon de travailler et a servi de catalyseur pour de

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New vaccine manufacturing facilities at the Toronto site.

Nouvelles installations de fabrication de vaccins sur le site de Toronto.

around the world, we should reap the greatest benefits during the coming years. We should see an acceleration in the number of novel vaccines coming to market. Those vaccines will tackle some difficult infectious diseases like Respiratory Syncytial Virus (RSV), a common infection of the lungs and respiratory system in newborns. Messenger ribonucleic acid (mRNA) technology has taken a giant leap forward. This technology is really promising for not only protecting people from COVID-19, but potentially many other illnesses in the future, including in Oncology, but it’s still early days. Sanofi is working on a couple of vaccines candidates that are anticipated to come to market upon successful clinical trial results. These include subunit protein vaccines that use recombinant technology to produce the vaccine antigen, a current influenza platform, for COVID19, and our own mRNA vaccine, in partnership with Translate Bio.

nouveaux investissements, partenariats et initiatives stratégiques.

WHAT IS SANOFI’S CONTRIBUTION TO SHAPING THESE NEW TRENDS? In Canada, we continue to build on our legacy with the $500 million (CAD) investment in 2018 and the recent $925 million (CAD) investment to build new vaccine manufacturing facilities at the Toronto site. This will ensure we continue to protect populations against diphtheria, tetanus, and pertussis. The new vaccine manufacturing facility announced in spring 2021 will produce an influenza vaccine to protect seniors and contribute to future pandemic preparedness efforts in Canada.

POUVEZ-VOUS NOUS PARLER DES TENDANCES LES PLUS INTÉRESSANTES EN MATIÈRE DE VACCINS? Grâce aux efforts sans précédent et à l’augmentation des investissements de la part de nombreux acteurs du monde entier, nous devrions récolter de plus grands avantages au cours des prochaines années. Nous devrions assister à une accélération du nombre de nouveaux vaccins mis sur le marché. Ces vaccins s’attaqueront à certaines maladies infectieuses difficiles comme le virus respiratoire syncytial (VRS), une infection courante des poumons et du système respiratoire chez les nouveau-nés. La technologie d’acide ribonucléique messager (ARNm) a fait un pas de géant vers l’avant. Cette technologie est vraiment prometteuse, non seulement pour protéger les gens contre la COVID-19, mais aussi potentiellement contre de nombreuses autres maladies à l’avenir, y compris en oncologie, mais elle en est encore à ses débuts. Sanofi travaille sur quelques candidats-vaccins qui devraient être commercialisés après avoir obtenu des résultats d’essais cliniques réussis. Ceux-ci comprennent des vaccins protéiques à sous-unités qui utilisent la technologie de l’ADN recombinant pour produire l’antigène du vaccin, une plateforme de grippe actuelle, contre la COVID-19, et notre propre vaccin à ARNm, en partenariat avec Translate Bio.

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QUELLE EST LA CONTRIBUTION DE SANOFI À L’ÉLABORATION DE CES NOUVELLES TENDANCES?

Globally, we have realigned and refocused our current research and development strategy to aggressively pursue mRNA-based next-generation vaccines. Our objective is to be a leader in mRNA vaccines by 2025. To accomplish this, we are investing €400 million annually over 5 years in a mRNA Center of Excellence and dedicating about 400 employees to this goal. In addition, we have also invested €490 million in the construction of a new Evolutive Vaccine Facility in France. This facility incorporates the latest technologies for agile vaccine manufacturing with the potential to produce multiple different vaccines at the same time, and pivot manufacturing to meet the needs of an urgent public health crisis. Beyond these investments, we are working to build a stronger public health ecosystem. This means we are working with the World Health Organization, the Bill and Melinda Gates Foundation, governments, and industry to develop and manufacture vaccines that respond to global needs. WHAT ELEMENTS CONTRIBUTE TO BUILDING A STRONG PHARMACEUTICAL AND BIOMANUFACTURING SECTOR IN CANADA? HOW DOES SANOFI CONTRIBUTE TO CREATING THESE CONDITIONS AS AN INDUSTRY LEADER? We must continue to establish collaborations with industry and government. We have been working with industry partners Translate Bio, AstraZeneca, and GSK, to develop new vaccine candidates, and lending our global manufacturing capacity and expertise to other companies to increase much needed COVID-19 vaccine supply. All three levels of government – Federal, the Province of Ontario and City of Toronto - came to the table with the largest financial contribution to biomanufacturing and life

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Au Canada, nous continuons de tirer parti de notre héritage, avec un investissement de 500 millions de dollars canadiens en 2018 et un investissement récent de 925 millions de dollars canadiens pour construire de nouvelles installations de fabrication au site de Toronto. Cela nous permettra de continuer à protéger les populations contre la diphtérie, le tétanos et la coqueluche. La nouvelle usine de fabrication de vaccins annoncée au printemps 2021 produira un vaccin antigrippal pour protéger les aînés et contribuer aux efforts de préparation à toute pandémie future au Canada. À l’échelle mondiale, nous avons réaligné et réorienté notre stratégie actuelle de recherche et développement pour approfondir de façon énergique les vaccins de prochaine génération à base d’ARNm. Notre objectif est d’être un chef de file en matière de vaccins à ARNm d’ici 2025. Pour ce faire, nous investissons 400 millions d’euro par année sur cinq ans dans un centre d’excellence en ARNm et nous consacrons environ 400 employés à cet objectif. De plus, nous avons également investi 490 millions d’euros dans la construction d’une nouvelle installation de vaccins évolutifs en France. Cette installation intègre les dernières technologies pour la fabrication de vaccins agiles, avec le potentiel de produire de nombreux vaccins différents en même temps, et permet d’adapter la fabrication pour répondre aux besoins d’une crise urgente de santé publique. Au-delà de ces investissements, nous travaillons à bâtir un écosystème de santé publique plus solide. Cela signifie que nous collaborons avec l’Organisation mondiale de la Santé, la Bill and Melinda Gates Foundation, les gouvernements et l’industrie pour assurer l’élaboration et la fabrication de vaccins qui répondent aux besoins mondiaux.

QUELS ÉLÉMENTS CONTRIBUENT À LA CRÉATION D’UN SECTEUR PHARMACEUTIQUE ET DE BIOFABRICATION SOLIDE AU CANADA? COMMENT SANOFI CONTRIBUE-T-ELLE À CRÉER CES CONDITIONS EN TANT QUE CHEF DE FILE DE L’INDUSTRIE? Nous devons continuer à établir des collaborations avec l’industrie et le gouvernement. Nous collaborons avec des partenaires de l’industrie, Translate Bio, AstraZeneca et GSK, pour l’élaboration de nouveaux candidats-vaccins, et nous prêtons notre capacité de fabrication mondiale et notre expertise à d’autres entreprises afin d’augmenter l’approvisionnement en vaccins contre la COVID-19.

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sciences in Canadian history to build a new vaccine manufacturing facility in Toronto because we all see the need to increase our capacity in Canada. Sanofi is uniquely suited to this undertaking, having cultivated a very talented group of scientists, engineers, and support staff with the skills required to deliver this new facility as quickly as possible. Also, investing in the next generation of scientists is a critical component of our contribution to shaping the future. Creating opportunities through our university co-op student program and the Biogenius high school STEM competition and grant, provides invaluable mentorship, networking, and funding opportunities to help students learn about and pursue careers in the field. WHAT MUST BE DONE TO STIMULATE VACCINE RESEARCH AND DEVELOPMENT IN CANADA SO THE COUNTRY WILL BE LESS DEPENDENT ON IMPORTING VACCINES FROM ABROAD? HOW IS SANOFI CONTRIBUTING TO THIS? Communication and relationship building with the public, government, and academic institutions is critical. Without these partnerships, it is not possible to secure the large-scale funding and talent pool required to operate in this market – the funding could go elsewhere along with the associated jobs. Our industry must work with government as well to ensure that the regulatory

Les trois paliers de gouvernement (le gouvernement fédéral, la province de l’Ontario et la ville de Toronto) sont venus à la table avec la plus grande contribution financière à la biofabrication et aux sciences de la vie de l’histoire canadienne pour construire une nouvelle usine de fabrication de vaccins à Toronto parce que nous voyons tous le besoin d’augmenter notre capacité au Canada. Sanofi est particulièrement bien préparée pour cette entreprise, puisqu’elle a regroupé des scientifiques, des ingénieurs et du personnel de soutien très talentueux possédant les compétences nécessaires pour bâtir cette nouvelle installation le plus rapidement possible. De plus, investir dans la prochaine génération de scientifiques est un élément essentiel de notre contribution au façonnement de l’avenir. Créer des occasions, grâce à notre programme d’étudiants d’enseignement universitaire coopératif et à notre concours et à notre bourse du programme Biogenius d’apprentissage STEM pour les élèves du secondaire, qui permettent d’offrir un mentorat, un réseautage et des occasions de financement inestimables pour aider les étudiants à apprendre et à poursuivre leur carrière dans le domaine.

QUE FAUT-IL FAIRE POUR STIMULER LA RECHERCHE ET LE DÉVELOPPEMENT DE VACCINS AU CANADA AFIN QUE LE PAYS SOIT MOINS DÉPENDANT DE L’IMPORTATION DE VACCINS DE L’ÉTRANGER? COMMENT SANOFI CONTRIBUE-T-ELLE À CET ENJEU? La communication et l’établissement de relations avec le public, le gouvernement et les établissements universitaires sont essentiels. Sans ces partenariats, il n’est pas possible d’obtenir le financement à grande échelle et le bassin de talents nécessaires pour évoluer dans ce marché; le financement pourrait aller ailleurs, ainsi que les emplois qui y sont associés. Notre industrie doit également collaborer avec le gouvernement pour s’assurer que l’environnement réglementaire respecte notre ambition partagée de bâtir un secteur de la biotechnologie robuste au pays. Pour que le Canada demeure un pays attrayant pour les investissements étrangers, les gouvernements fédéral et provinciaux doivent continuer à chercher de nouvelles occasions de collaborer avec l’industrie et ont besoin d’une stratégie de sciences de la vie à long terme. Si nous examinons le rôle des partenariats publics-privés, comme la Biomedical Advanced Research and

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environment meets our shared ambition of building a robust biotechnology sector domestically. For Canada to remain an attractive country for foreign investment the federal and provincial governments must continue to seek out new opportunities to collaborate with industry and need a long-term life sciences strategy. If we look at the role of public-private partnerships, like Biomedical Advanced Research and Development Authority in the US and the funding it provided for vaccine research and development during COVID-19, or the Ebola outbreak, this is necessary to ensure we respond with the utmost urgency and agility to new public health threats. Sanofi is committed to its Canadian operations. The vaccine research and manufacturing taking place here fills an important role in the Sanofi network, contributing millions of doses of essential vaccines annually for adults and children in 60 countries. Approximately $2 billion has been invested in the Toronto site over the last five years to renew infrastructure and adopt new technologies. We have a legacy here of impactful contributions to public health and we plan to build on it for many years to come. WHAT CAN MAKE CANADA MORE ATTRACTIVE THAN OTHER COUNTRIES WHEN IT COMES TO FOREIGN INVESTMENTS? COVID-19 has altered the dynamic in Canada. It has refocused government investment on life sciences. It has opened people’s eyes to the impact of immunization against infectious diseases. The calls to government from Canadians to secure vaccines against COVID-19, the relatively rapid rollout of vaccines across the country, and vaccination uptake among the population serves to demonstrate that Canada is serious about attracting investment and building greater domestic capacity now. HOW CAN SANOFI IN CANADA AND GLOBALLY LEVERAGE HIGH VACCINE AWARENESS TO BETTER FULFILL THEIR MANDATE? We are living through unprecedented times. We have a responsibility to help educate people, now that we have their attention, to help them understand how vaccines are made, what the regulatory approval process entails, and how safety and efficacy are scientifically established. We know how dangerous misinformation is, that is why we must continue to reach people with clear, concise, and scientifically supported information. We cannot fulfil our mandate if we do not have public trust in our pharmaceutical companies and our regulatory authorities. We take this very seriously. No matter the technological advances, nor the speed at which the industry is moving to deliver new vaccines, there is nothing more important than producing safe, effective and quality products.

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Development Authority aux États-Unis et le financement qu’elle a fourni pour la recherche et le développement de vaccins pendant la COVID-19, ou l’épidémie d’Ebola, nous constatons que de tels partenariats sont nécessaires pour nous assurer de réagir avec une urgence et une agilité hors pair aux nouvelles menaces pour la santé publique. Sanofi a pris un engagement envers ses activités au Canada. La recherche sur les vaccins et leur fabrication qui ont lieu ici remplissent un rôle important dans le réseau de Sanofi, contribuant à des millions de doses de vaccins essentiels chaque année pour les adultes et les enfants dans 60 pays. Environ deux milliards de dollars ont été investis dans le site de Toronto au cours des cinq dernières années pour renouveler l’infrastructure et adopter de nouvelles technologies. Nous avons ici un héritage de contributions percutantes pour la santé publique et nous prévoyons de nous appuyer sur ce dernier pour de nombreuses années à venir.

QU’EST-CE QUI PEUT RENDRE LE CANADA PLUS ATTRAYANT QUE LES AUTRES PAYS EN MATIÈRE D’INVESTISSEMENTS ÉTRANGERS? La COVID-19 a modifié la dynamique au Canada. Elle a recentré les investissements gouvernementaux dans les sciences de la vie. Elle a sensibilisé les gens aux répercussions de la vaccination contre les maladies infectieuses. Les appels au gouvernement des Canadiens pour obtenir des vaccins contre la COVID-19, le déploiement relativement rapide des vaccins à travers le pays et l’adoption de vaccins au sein de la population sont des éléments qui servent à démontrer que le Canada est un candidat sérieux pour attirer des investissements et renforcer sa capacité intérieure dès maintenant.

COMMENT LES ACTIVITÉS DE SANOFI AU CANADA ET À L’ÉCHELLE MONDIALE PEUVENT-ELLES TIRER PARTI D’UNE SENSIBILISATION ÉLEVÉE AUX VACCINS POUR MIEUX REMPLIR LEUR MANDAT? Nous vivons une période sans précédent. Nous avons la responsabilité d’aider à éduquer les gens, maintenant que nous avons leur attention, pour les aider à comprendre la façon dont les vaccins sont fabriqués, le processus d’approbation réglementaire nécessaire, et l’établissement de l’innocuité et de l’efficacité de manière scientifique. Nous savons à quel point la désinformation est dangereuse; c’est la raison pour laquelle nous devons continuer à communiquer aux gens des informations claires, concises et étayées par la science. Nous ne pouvons pas remplir notre mandat si nous n’avons pas la confiance du public envers nos sociétés pharmaceutiques et nos organismes de réglementation. Nous prenons cela très au sérieux. Peu importe les progrès technologiques et la vitesse à laquelle le secteur évolue pour livrer de nouveaux vaccins, il n’y a rien de plus important que de concevoir des produits sûrs et efficaces de haute qualité.

CREATING JOBS. DRIVING INNOVATION. For a world seeking to address the challenges associated with population growth and climate change, Canada’s biotechnology sector is developing game-changing solutions. Canadian biotechnology companies like AbCellera Biologics are creating hundreds of jobs for Canadians and attracting others to Canada.

Learn more at BIOTECH.CA

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Sherbrooke Biotech Pioneering Next Generation Immunotherapies for COVID Fight A QUEBEC COMPANY HAS HACKED THE IMMUNE SYSTEM OF CHICKENS TO DISCOVER AND ENGINEER THE NEXT GENERATION OF IMMUNOTHERAPIES, which it has enlisted in the fight against COVID-19 and other serious diseases. Immune Biosolutions Inc., with offices and labs in Sherbrooke, is spearheading the development of new technologies using very old immune systems. “We’re using the immune system of chickens to derive unique antibodies mainly against proteins that play key roles in different diseases,” explains chief executive officer Frédéric Leduc. “Basically we’re taking advantage of the 300 million years of evolutionary distance between chickens and mammals in general, and humans in the case of therapeutics, to generate high affinity antibodies that may

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not be possible using the classic animal models such as the mouse, the rabbit or even the llama,” he adds. The immune system of chickens derives very unique types of antibodies that are highly humanizable, so Immune Biosolutions is able to transform those chicken antibodies into human formats very quickly and efficiently. This provides a lot of flexibility as the company is able to derive both IgG1 classic monoclonal antibodies, plus new bispecific and multi-specific antibodies, says Dr. Leduc. Immune Biosolutions announced in March 2021 that it had received $13.44 million from the Government of Canada’s Strategic Innovation Fund (SIF) and $5 million from private investors to develop its immunotherapy antibodies to neutralize and eliminate COVID-19 and its variants. The urgent fight against the COVID-19 pandemic provided circumstances under which Immune Biosolutions

Basically we’re taking advantage of the 300 million years of evolutionary distance between chickens and mammals in general, and humans in the case of therapeutics, to generate high affinity antibodies that may not be possible using the classic animal models such as the mouse, the rabbit or even the llama completely pivoted to become a bio-pharmaceutical company, with financing from the federal government allowing them to move quickly in that direction, explains chief business officer Luc Paquet.

“In the last couple of years we’ve put together a very unique, extremely fast platform of discovery using the chicken immune system as a centrepiece. We already had unique processes from antigen design, up to even biomanufacturing of antibodies. So when COVID-19 started we were well positioned to use our platforms and address this need very quickly,” says Dr. Leduc.

Immune Biosolutions has partnered with a couple of companies to use its platforms, and incorporated many of its ideas into different programs for COVID-19 in an effort to derive as many types of antibodies as possible, and to try and develop a product quickly. “From the start, we wanted to make a cocktail of antibodies to make sure that our therapy would work for as many future variants as possible,” Dr. Leduc says. “Immunothereapies that are currently approved for emergency use are using a very classic approach of delivery, mainly IV administration. Introducing the antibodies in the bloodstream has limited effect in protecting against respiratory infections. And that’s where we thought we could improve the efficiency of immunotherapies in general for COVID-19, because the primary infection site was in the lungs where it initially replicates, and then it spreads elsewhere,” he explains. Immune Biosolutions aims to directly deliver antibodies in the lung utilizing a cocktail of neutralizing antibodies to act as a viral extinguisher. This cocktail works very well with any current COVID variants of concern, including the Delta variants, and has shown great efficiency in safety features in animal studies. A Phase I trial is expected to commence in the first half of September, likely in South Africa. “The main reason why we’re doing this Phase I in South Africa is because there are not enough patients right now in Canada for an efficient recruitment and our antibodies are working quite well against the South African variants,” says Dr. Leduc, who also notes that South Africa currently has low vaccination rates. It is anticipated the Phase I trial will last about two and a half months, with Phase II, likely on the international stage, to begin before the end of the fourth quarter of 2021. “We want to be in the countries where we’ll be able to recruit patients and have an impact on those patients,” he adds. Immune Biosolutions is also attempting to create safe and highly affinity humanized antibodies for other infectious diseases and oncology. “We have a couple of programs in terms of infectious disease. Some are early, still in discovery. Others are a little bit more advanced,” says Dr. Leduc. “Before COVID, we were focusing mostly on oncology. We have several programs that are targeting either new immune checkpoints or new cancer targets. We think the way forward is to take into account not just a single element, but building a combination of therapies to address some of the most difficult cancers that we are facing right now,” Dr. Leduc says. This includes breast and colorectal cancers, involving a combination of classic oncology immunotherapy, plus redirecting the immune system to try and eliminate as many cancer cells as possible, he explains.

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Building Resilient Healthcare Systems For A Post-Crisis Era

New initiatves support regenerative medicine discoveries with high potential impact for patients

La mise en place de systèmes de santé qui, au-delà de la crise, sauront être résilients De nouveaux programmes qui appuient la recherche en médecine régénératrice pourraient grandement améliorer la vie des patients

NEW REGENERATIVE MEDICINE DISCOVERIES, INCLUDING CELL AND GENE THERAPIES, WILL NEVER REACH PATIENTS without access to the funding, expertise and other specialized support that are required to move along the commercialization pathway. To address this need, CCRM, a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies, and Amgen, a global leader in the biotechnology industry, created a multi-year fund for early-stage regenerative medicine-based technologies and therapies to benefit patients and the health-care system. During the first wave of COVID-19, system leaders across the healthcare sector – from public health agencies to hospitals to community agencies to long-term care homes – confronted numerous interconnected challenges while they worked to manage and mitigate a massive and complex public health crisis. That crisis was exacerbated by health systems that were too often underfunded, underprepared and inflexible. The pandemic was a wake-up call as it exposed the fragility of

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SANS UN FINANCEMENT, UNE EXPERTISE ET LES FONCTIONS SPÉCIALISÉES NÉCESSAIRES POUR LES FAIRE AVANCER sur la voie de la commercialisation, les découvertes en médecine régénératrice, y compris les traitements à base de cellules et les thérapies géniques, ne profiteront jamais aux patients. Afin d’obtenir ces éléments essentiels, le CCMR (Centre pour la commercialisation de la médecine régénératrice), un chef de file de la mise au point et de la commercialisation de technologies issues de la médecine régénératrice, de traitements à base de cellules et de thérapies géniques, et Amgen, un chef de file mondial du secteur des biotechnologies, ont créé un fonds pluriannuel destiné à faire bénéficier les patients et le système de santé des technologies et des traitements naissants axés sur la médecine régénératrice. Au cours de la première vague de la COVID-19, les dirigeants de l’ensemble du secteur de la santé, qu’il s’agisse d’organismes de santé publique, d’hôpitaux, d’organismes communautaires ou d’établissements de soins de longue durée, se sont trouvés devant de nombreux défis connexes

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Canada’s healthcare system. Beyond the immediate need to address the ongoing impact of the coronavirus, policymakers and their collaborators are now also responding to supply chains under strain, cancer patients facing testing and treatment delays, ballooning surgical wait times for arthritis patients and other related challenges. This once-in-a-century crisis must be met with a once-in-a-century response, one that replaces fragile health care systems with systems that are more resilient: centred around the patient, drive by data, supported by enhanced prediction and prevention efforts and anchored by a collective commitment to permanent, positive change. Rather than a singular focus on cost containment, resilient healthcare systems measure and maximize patient outcomes by moving care upstream to better predict and prevent disease by designing and delivering patient-centred care, accelerating the adoption of technology and process innovation, and leveraging insights from “Big Data” analytics. As a global conversation around “health care resilience” begins to take shape, Canadian leaders from the public, private and not-for-profit sectors, begin to identify the areas of alignment and opportunity that will ensure the health systems emerging from COVID-19 will be stronger, more adaptable, and more resilient than those that came before. To bridge the gap from bench to bedside, the CCRM/ Amgen program identifies, develops and commercializes promising technologies and therapies arising from research. Projects with high scientific merit that demonstrate the greatest potential to have an impact in the industry, are developed by scientists and academics with established credentials and expertise. Regenerative medicine, including cell and gene therapy, harnesses the power of (stem) cells, biomaterials, molecules and genetic modification to repair, regenerate or replace diseased cells, tissues and organs. It has the promise of creating revolutionary new treatments for devastating and costly conditions such as heart disease, diabetes and cancer. “CCRM’s collaboration with Amgen to create this fund is a perfect example of how public-private partnerships can leverage resources and expertise to support development and commercialization, and change patients’ lives,” said Michael May, President and CEO, CCRM. “The regenerative medicine research ecosystem across Canada offers a rich discovery pipeline and it is ready for such a program.” “There are few places in the world that have clustered all the necessary resources and talent to drive regenerative medicine from the bench to the bedside. Canada has consistently led the way for decades,” said Alan Russell, Vice-President, Research, Amgen Inc. “Amgen is delighted to have the opportunity to partner with CCRM and leverage an extraordinary platform to benefit patients.”

lorsqu’ils ont dû gérer et atténuer l’importante crise de santé publique complexe suscitée par la pandémie. Le sous-financement, le manque de préparation et le peu de souplesse des systèmes de santé ont exacerbé la crise. La pandémie a ainsi sonné le réveil au sujet de la fragilité du système de santé canadien. Au-delà de la nécessité d’intervenir immédiatement face à l’incidence du coronavirus, les décideurs et leurs collaborateurs œuvrent aussi maintenant à régler la situation des chaînes logistiques, qui sont sous pression, à trouver une solution aux retards dans le dépistage et le traitement du cancer, à réduire le délai d’attente (qui a gonflé) pour les chirurgies articulaires et à résoudre d’autres difficultés. À une telle crise, d’une ampleur rare, il faut une réaction d’une ampleur tout aussi rare. La crise exige en effet que l’on remplace les systèmes de santé fragiles par des systèmes résilients, c’est-à-dire axés sur le patient, fondés sur des données, appuyés par des efforts de prévision et de prévention accrus et renforcés par un engagement collectif envers des changements positifs durables. Plutôt que d’avoir pour seul objectif la réduction des coûts, un système de santé résilient mesure l’effet des soins sur les patients et les maximise en les déplaçant en amont; il est ainsi plus facile de prévoir et de prévenir les maladies, grâce à une conception et à une prestation des soins axées sur le patient, à l’adoption plus rapide des innovations technologiques et en matière de procédés, ainsi qu’à l’exploitation des renseignements issus de l’analyse des « mégadonnées ». Alors qu’une conversation mondiale sur la « résilience des soins de santé » commence à prendre forme, les dirigeants canadiens des secteurs public, privé et sans but lucratif désignent un à un les domaines à transformer et œuvrent à définir les possibilités grâce auxquelles les systèmes de santé post-pandémie seront plus forts, plus souples et plus résilients que leurs prédécesseurs. Afin d’établir un pont entre le laboratoire et le lit du patient, le programme du CCMR et d’Amgen finance la mise au point et la commercialisation des technologies et traitements prometteurs issus de la recherche. Les projets méritoires sur le plan scientifique, qui présentent un potentiel supérieur d’avoir une incidence sur le secteur, sont ainsi mis au point par des scientifiques et des universitaires dont la feuille de route et l’expertise sont établies. La médecine régénératrice, y compris les traitements à base de cellules et les thérapies géniques, tire avantage de la puissance des cellules (souches), des biomatériaux, des molécules et de la modification génétique pour réparer, régénérer et remplacer les cellules, les tissus et les organes malades. En elle réside la promesse de traitements révolutionnaires, qui transformeront la vie des personnes atteintes de maladies du cœur, de diabète et de cancer, dont on connaît les ravages et les coûts. « La création collaborative du fonds par le CCMR et Amgen constitue un exemple parfait de la façon dont les partenariats

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This once-in-a-century crisis must be met with a once-in-a-century response, one that replaces fragile health care systems with systems that are more resilient: centred around the patient, drive by data, supported by enhanced prediction and prevention efforts and anchored by a collective As health system stakeholders look to move beyond ineffective and inefficient historical structures, creating opportunities to bridge siloes has never been more important. System leaders need to avoid the temptation to turn back the clock to a pre-COVID mindset – and instead commit to stretching beyond their usual norms and networks to work with a wide range of stakeholders to co-create more adaptive and resilient systems. The pandemic has seen an unprecedented array of partnerships emerging across the health system. COVID19 has been a once-in-a-century crisis. It must be met with a once-in-a-century, shared response, one that replaces fragile health care systems with systems that are more resilient: centred around the patient, drive by data, supported by enhanced prediction and prevention efforts and anchored by a collective commitment to permanent, positive change. Amgen has also entered into a multi-year partnership with Mila – Quebec Artificial Intelligence Institute. “AI is a powerful and innovative tool, and is affecting every step of drug discovery, from better understanding the biological mechanisms of disease and designing molecules to predicting clinical responses and safety profiles,” said Philip Tagari, Amgen’s Vice President of Research, Therapeutic Discovery. “We are eager to explore the synergies between Mila’s expertise and Amgen’s mission to serve patients as we continue to develop the next generation of innovative medicines,” stated Brian Heath, Vice President and General Manager of Amgen Canada. “More and more of Mila’s world-class AI experts have research interests at the intersection of AI and life sciences, recognizing the incredible potential of AI-driven solutions for healthcare and pharmaceutical R&D activities,” explained Stéphane Létourneau, Executive Vice President at Mila.

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public-privé peuvent mettre à profit une somme de ressources et d’expertise dans la mise au point et la commercialisation de traitements qui changent la vie des patients », avance le président et chef de la direction du CCMR, Michael May. « Une gamme de produits très riche est en cours de mise au point dans le vaste écosystème de la recherche en médecine régénératrice au Canada, et celui-ci est prêt pour un programme tel que le nôtre. » « Très peu de territoires dans le monde ont réussi à regrouper toutes les ressources et tous les talents nécessaires au passage de la médecine régénératrice du laboratoire au lit du patient. Le Canada fait figure de pionnier depuis des décennies », ajoute le vice-président à la recherche chez Amgen Inc., Alan Russell. « L’entreprise Amgen est ravie de pouvoir s’associer au CCMR afin de faire bénéficier les patients d’un programme extraordinaire. » Les intervenants du système de santé souhaitent désormais dépasser les structures inefficaces du passé, car créer des occasions d’éliminer les parois qui compartimentent les secteurs est plus nécessaire que jamais. Les dirigeants des systèmes doivent résister à la tentation de réadopter la vision pré-COVID et plutôt s’engager à aller au-delà de leurs normes et réseaux habituels afin de travailler avec tout un éventail d’intervenants, pour la création collective de systèmes plus souples et résilients. Tout un spectre de nouveaux partenariats a vu le jour dans l’ensemble du système de santé à la suite de la pandémie. La COVID-19 a causé une crise d’une ampleur rare. À une telle crise, il faut une réaction collective, d’une ampleur tout aussi rare. La crise exige en effet que l’on remplace les systèmes de santé fragiles par des systèmes résilients, c’est-à-dire axés sur le patient, fondés sur des données, appuyés par des efforts de prévision et de prévention accrus et renforcés par un engagement collectif envers des changements positifs durables. Amgen a aussi conclu une entente de partenariat avec l’institut de recherche en intelligence artificielle Mila (Québec). « L’IA est un puissant outil novateur, qui influe sur chaque étape de la recherche pharmaceutique, de la compréhension des mécanismes biologiques qui sont à l’œuvre dans les maladies à la conception de molécules et à la prévision des réactions cliniques et des profils d’innocuité », indique le vice-président de la recherche (découverte thérapeutique) chez Amgem, Philip Tagari. « Nous sommes impatients d’exploiter, dans la mise au point de la prochaine génération de traitements novateurs, les synergies entre l’expertise de Mila et la mission d’Amgen au bénéfice des patients », affirme le vice-président et directeur général d’Amgen Canada, Brian Heath. « Les experts en IA de stature internationale de Mila sont de plus en plus nombreux à explorer des sujets qui se trouvent à l’intersection de l’IA et des sciences de la vie, car ils mesurent bien l’incroyable potentiel des solutions fondées sur l’IA dans les activités de R.-D. de soins et de médicaments », conclut le vice-président directeur de Mila, Stéphane Létourneau.

Calgary is

CANADA’S MOST ADVENTUROUS LIFE SCIENCES CITY With over 110 life sciences companies calling Calgary home, the city is an active hub for life sciences innovation. Homegrown technologies are changing the face of healthcare. Syantra is revolutionizing breast cancer detection using artificial intelligence-derived algorithms. Circle Cardiovascular Imaging is changing the global conversation about heart and stroke care with their AIpowered visualization software. And this is only the beginning. Calgary’s life sciences sector is projected to spend $428 million on digital transformation by 2024. If you’re a bright mind or bright company solving global health challenges, Calgary is the place for you.

Learn more: calgarylifesciences.com

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Building Canada’s life sciences talent from sea to sea Développer les talents du secteur des sciences de la vie d’un océan à l’autre THE GOOD NEWS IS THAT CANADA HAS A WEALTH OF SCIENTIFIC DISCOVERY AND A BOOMING LIFE SCIENCES INDUSTRY. We are seeing unprecedented investment in the sector, and Canadian companies are rapidly scaling into strong anchors. Canada also has a top-tier post-secondary system that generates some of the top scientific talent in the world. But the challenge is that currently, there is a gap in scientists with the business experience to take innovative therapies to market, and to drive ventures through scale-up to commercialization. The industry is demanding business-minded leaders at a rate faster than our current pool can provide; and unless we ensure a pipeline of talent ready for the particular rigours of industry, Canadian life sciences companies will not be able to recruit the people they need to enable the industry to take its rightful place as a world leader. Bottom line: More than ever, we need to develop our own highly-qualified personnel here in Canada, ready to take on both the challenges and the opportunities now before the industry. Recognizing too that diversity is Canada’s strength, priority and particular focus must be given to closing the gender gap within Canadian life sciences leadership, and to building opportunities for under-represented groups. To address these challenges, a key pillar of adMare’s mission is to ‘Build Talent’ – and that’s where the adMare Academy comes in. Through our Academy, we have trained more than 260 alumni – 95% of whom are today helping build Canada’s life sciences industry. 36

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The BioInnovation Scientist (BIS) Program: Early career scientist training from the adMare Academy adMare’s BIS Program is focused on supporting early career scientists to build the business skills needed to commercialize discoveries. It is a one-of-a-kind, progressive online program designed to help transition strong bench scientist into leading innovators with the business expertise to increase the flow of novel technologies to market. Angela Zhou, Research Administrator with the Precision Medicine Initiative (PRiME) at the University of Toronto, reflects on her experience in the BIS program.

“Coming from a very basic science background, it was incredibly helpful to see the modules – everything from commercialization to leadership to communication – come together to support the drug discovery process.” -Angela Zhou

The Executive Institute: An adMare Academy program for life science leaders The Executive Institute is designed for life science executives who are further along in their careers. The program trains leaders to think in more complex and strategic ways to successfully scale their companies. “I’m a firm believer in supporting those who will be next in line

to shape our life sciences sector,” says Lucas Siow, Chief Executive Officer and Co-Founder of ProteinQure, after completing the program. “The Executive Institute is an excellent example of how we can be an integral part of the growing success of the Canadian life sciences industry both here at home and abroad.”

Find out more about how you can advance your career through the adMare Academy, and amplify your own contribution to building Canada’s life sciences industry from sea to sea by visiting: admarebio.com/admare-academy

LA BONNE NOUVELLE EST QUE LE CANADA EST RICHE EN DÉCOUVERTES SCIENTIFIQUES ET POSSÈDE UN SECTEUR DES SCIENCES DE LA VIE FLORISSANT. Nous assistons à des investissements sans précédent dans ce secteur, et les entreprises canadiennes se développent rapidement pour devenir des entreprises phares. Le Canada dispose également d’un système d’éducation postsecondaire de premier plan qui développe certains des meilleurs talents scientifiques au monde. Cependant, le défi actuel est le manque de scientifiques ayant l’expérience commerciale pour amener des thérapies innovantes sur le marché, et pour diriger des entreprises émergentes vers la commercialisation. Le secteur demande des leaders qui ont le sens des affaires à un rythme plus rapide que ce que notre bassin actuel peut fournir. À moins que nous n’assurions une réserve de talents prêts à affronter les rigueurs particulières du secteur, les entreprises canadiennes en sciences de la vie ne seront pas en mesure de recruter les personnes dont elles ont besoin pour permettre au secteur de prendre la place qui lui revient en tant que chef de file mondial. Plus que jamais, nous devons développer ici, au Canada, notre propre personnel hautement qualifié, prêt à relever les défis et à saisir les opportunités qui se présentent dans le secteur.

de premier plan possédant l’expertise commerciale nécessaire pour accroître le flux de nouvelles technologies vers le marché. Angela Zhou, administratrice de recherche au sein de Precision Medicine Initiative (PRiME) de l’Université de Toronto, revient sur son expérience au sein du programme BIS. « Venant d’un milieu scientifique de base, il a été incroyablement utile de voir tous les modules, de la commercialisation au leadership en passant par la communication, se réunir pour soutenir le processus de découverte de médicaments. » L’institut des sciences de la vie pour cadres supérieurs : Un programme de l’Académie adMare pour les gestionnaires en sciences de la vie L’institut des sciences de la vie pour cadres supérieurs est conçu pour les cadres des sciences de la vie qui sont plus avancés dans leur carrière. Le programme forme les gestionnaires à penser de manière plus complexe et stratégique pour développer leur entreprise. « Je crois fermement qu’il est important de soutenir ceux qui seront les prochains à façonner notre secteur des sciences de la vie », déclare Lucas Siow, Président-directeur général et cofondateur de ProteinQure, après avoir terminé le programme.

« L’Institut des sciences de la vie pour cadres supérieurs est un excellent exemple de la manière dont nous pouvons faire partie intégrante du succès croissant de l’industrie canadienne des sciences de la vie, ici et à l’étranger. » -Lucas Siow

Pour en savoir plus sur la façon dont vous pouvez faire progresser votre carrière grâce à l’Académie adMare, et amplifier votre propre contribution au développement du secteur canadien des sciences de la vie d’un océan à l’autre, visitez le : admarebio.com/lacademie-admare

Reconnaissant également que la diversité est la force du Canada, il faut accorder la priorité et une attention particulière à la réduction de l’écart entre les sexes au sein de la haute direction du secteur canadien des sciences de la vie, et à la création d’opportunités pour les groupes sous-représentés. Pour relever ces défis, un important pilier de la mission d’adMare est de « développer des talents », et c’est là qu’intervient l’Académie adMare. Grâce à notre Académie, nous avons formé plus de 260 anciens étudiants, dont 95 % contribuent aujourd’hui à développer le secteur des sciences de la vie au Canada. Le programme scientifique en bioinnovation (BIS) : Une formation pour scientifiques en début de carrière offerte par l’Académie adMare Le programme BIS d’adMare vise à aider les scientifiques en début de carrière à acquérir les compétences commerciales nécessaires pour commercialiser leurs découvertes. Il s’agit d’un programme en ligne unique et progressif, conçu pour aider les scientifiques de laboratoire à devenir des innovateurs

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ecosystem écosystème

Growing the Canadian biotech ecosystem together Développer ensemble l’écosystème canadien des biote AS A MEMBER OF BIOTECANADA, YOUR COMPANY BECOMES PART OF AN EFFECTIVE ADVOCACY and regulatory voice representing the collective interests of Canadian biotechnology industry. Membership provides the tools to help your business reach its full potential through government relations, communications, marketing, and membership services. Members can save up to $10,000 through our Cost Savings Program with discounts on lab equipment, conference registrations, leading industry publications and insurance. BIOTECanada is committed to the objective of ensuring that savings offered will at a minimum offset the cost of membership. Alpha Cancer Technologies is a private clinical stage biotechnology company with products under development in immunotherapy and immunooncology. The company’s drug products use their proprietary recombinant human alpha fetoprotein. AREV Nanotec Brands Inc. a life science development enterprise focused on phytomedicinal extraction of novel therapeutic approaches to infectious diseases and subsequent comorbidities via their proprietary extraction systems to identify promising small molecules that present novel mechanisms of action in human and veterinary science. Bold Therapeutics is a clinical-stage biotech company that was founded in 2018 by a team of biopharma industry veterans to develop and commercialize BOLD-100, a first-in-class antiresistance therapeutic. Bold Therapeutics’ lead development candidate is BOLD-100, a novel first-in-class anti-resistance therapy for the treatment of gastric, pancreatic, colorectal and other cancers in combination with existing anti-cancer therapies. BOLD-100 has demonstrated synergy in established preclinical models in combination with a wide variety of anti-cancer therapies including both traditional chemotherapies and targeted therapies including tyrosine kinase inhibitors and checkpoint inhibitors.

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BIOTECanada

À TITRE DE MEMBRE BIOTECANADA, UNE ENTREPRISE FAIT PARTIE INTÉGRANTE D’UN MOUVEMENT DE DÉFENSE ET DE RÉGLEMENTATION de l’industrie canadienne de la biotechnologie qui veille à l’intérêt collectif de ses membres. L’adhésion à l’association donne accès aux outils dont votre entreprise a besoin pour réaliser son plein potentiel : des services de relations avec les gouvernements, de communication et de marketing et des services généraux aux membres. Ceux-ci peuvent économiser jusqu’à 10 000 $ grâce à notre Programme d’économies de coûts, qui offre des rabais sur l’équipement de laboratoire, les inscriptions aux congrès, les grandes publications sectorielles et les assurances. BIOTECanada s’est donné pour mission de veiller à ce que les économies offertes correspondent au minimum au coût de l’adhésion. Alpha Cancer Technologies est une société fermée du secteur de la biotechnologie qui œuvre au stade clinique. Elle met au point des produits d’immunothérapie et d’immuno-oncologie, à partir d’une alpha fœtoprotéine humaine recombinante brevetée. AREV Nanotec Brands Inc. est une entreprise de recherche en sciences de la vie qui consacre ses efforts à l’extraction phytomédicinale effectuée au moyen de systèmes brevetés et destinée au traitement novateur des maladies infectieuses et des maladies concomitantes. Le but consiste à trouver de petites molécules prometteuses, dont les mécanismes d’action chez les humains et les animaux seraient originaux. Bold Therapeutics est une société du secteur de la biotechnologie qui œuvre au stade clinique et a été fondée en 2018 par une équipe de vétérans du secteur biopharmaceutique ayant pour projet de mettre au point et de commercialiser BOLD-100, un produit qui cible les cancers résistants, le premier de sa classe thérapeutique. Le principal candidat-médicament de Bold Therapeutics est en effet BOLD-100, un traitement novateur des cancers de l’estomac, de pancréas, colorectaux et autres, devant être administré en combinaison avec des traitements actuellement employés en oncologie. Selon des données de modèles précliniques, BOLD-100 agit en synergie avec des traitements du cancer très variés, notamment des chimiothérapies classiques et des thérapies ciblées, dont les inhibiteurs de la tyrosine-kinase et les inhibiteurs de points de contrôle immunitaires.

ecosystem écosystème

CBRE Limited (Coldwell Banker Richard Ellis) professionals utilize a powerful combination of market intelligence, relationships, and technology to build real advantage from your Canadian real estate. CBRE is a global, industry-leading provider of world-class workplace solutions for life sciences and biotech companies. Whether it is for a startup looking for bench space or an established company looking for their next location. Services include: • Laboratory Project Delivery • Lease Audit & Benchmarking • Laboratory Renewals • Laboratory Relocations • Subleasing & Dispositions • Portfolio Management • Property Acquisition • Needs Analysis

Les professionnels de CBRE Limited (Coldwell Banker Richard Ellis) s’appuient sur l’alliage puissant des connaissances sur le marché, des relations et des technologies pour renforcer les avantages que procurent les immobilisations canadiennes. CBRE est un chef de file mondial des solutions professionnelles destinées aux entreprises du domaine des sciences de la vie et des biotechs, qu’il s’agisse d’une jeune pousse à la recherche d’espace de laboratoire ou d’une société bien établie qui a besoin d’un nouvel établissement. Parmi ses services, il y a : • la réalisation de projets de laboratoire, • la vérification et l’analyse des loyers, • le renouvellement des baux de laboratoire, • le déménagement d’installations de laboratoire,

CCRM supports the commercialization regenerative medicine technologies, and cell and gene therapies, with strategic funding, dedicated infrastructure and specialized business and scientific expertise. By partnering with leading research institutions to launch new ventures, enabling industry by providing innovative contract development and manufacturing organization (CDMO) services, and scaling emerging companies by catalyzing investment, CCRM is accelerating the translation of promising technologies, processes and therapies into life-changing health outcomes for patients.

Le CCMR appuie la commercialisation des technologies de la médecine régénératrice, les traitements à base de cellules et les thérapies géniques au moyen d’un financement stratégique, d’infrastructures exclusives et d’une expertise spécialisée en sciences et en commerce. Il s’associe à des établissements de recherche de pointe, avec qui il démarre de nouveaux fonds de capital de risque, il fournit une aide au secteur sous la forme de services novateurs de sous-traitants de développement et de fabrication (CDMO) et il fait croître les nouvelles entreprises en générant des investissements. Ainsi, le CCMR accélère la transformation de technologies, de procédés et de traitements prometteurs en des résultats qui transforment la santé et la vie des patients.

Defence Therapeutics, a Canadian biotech Company focused on the development of novel and highly specific vaccines and antibody-drug conjugates targeting cancer and infectious diseases. The primary objective and business of Defence is the research, development and advancement of three main products using its proprietary Accum technology: • Dendritic Cell (DC) cancer vaccines using Accum (AccuvacTM). • A new protein-based vaccine formulation against COVID and infectious disease. • ADCs (Antibody Drug Conjugates) targeting various cancer. EVAH Corp EVAH Corp’s mission is to find better ways to feed the planet and improve the sustainability of the food chain by developing innovative solutions. EVAH is proud to be part of the global “one health”

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les opérations de sous-location à bail, la gestion de portefeuille, l’acquisition de biens, l’analyse des besoins.

Defence Therapeutics est une entreprise canadienne de biotech qui se consacre à la mise au point de vaccins et de conjugués anticorps-médicaments (CAM) novateurs et hautement ciblés dans le domaine de l’oncologie et des maladies infectieuses. Defence a pour principal objectif (et secteur d’activité) la recherche-développement, à l’aide de sa technologie brevetée du nom d’Accum, de trois grandes familles de produits : • des vaccins contre le cancer à base de cellules dendritiques (AccuvacTM), • une nouvelle préparation vaccinale à base de protéines contre la COVID-19 et d’autres maladies infectieuses, • des CAM qui ciblent divers cancers. EVAH Corp EVAH Corp a pour mission de trouver de meilleures façons de nourrir la planète et d’élaborer des solutions novatrices qui amélioreront la viabilité de la chaîne alimentaire. biotech.ca

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approach by improving the health of animals used for food directly linked to the future objectives of humanity. Indeed, contributing to a healthier world, with the use of responsible and sustainable prophylactic treatments for animals, is our primary source of motivation. EVAH Corp’s activities revolve around four main areas: • Identify and target promising animal health technologies that offer significant income potential. • Manage internal and external scientific collaborators in order to accelerate the pace of product development. • A clear development path for each technology, with the aim of maturing technologies that will meet a significant market need and / or that will be the first to be marketed. • Strengthen the value of the platform at a strategic level where negotiations with multinational animal health companies can take place to monetize our assets. Giiant Pharma inc. is a Montreal-based company founded by former Merck Frosst scientists. Combining experts in the field of gastroenterology and more than 25 years of experience in the field of industrial pharmaceutical research, Giiant Pharma aims at developing safer therapies for the treatment of inflammatory bowel diseases. JN Nova Pharma Inc. is a pre-clinical-stage biopharmaceutical company, focused on efficiently developing innovative treatments that address significant unmet medical needs. JN Nova’s lead product candidate, KG2019 is a novel anti-COVID-19 molecule. The company is collaborating with Canadian Government labs and Canadian academic centers to accelerate its COVID-19 therapeutic development. Modelis, leverages advanced drug discovery methods to reduce the time and resources it takes to repurpose existing treatments for rare genetic diseases. Their innovative approach repurposes proprietary and known molecules from their partners for a wide range of human disorders. Modelis’ is a high throughput solution to discovering new treatments for rare genetic diseases due to our research methodology that leverages patient genetic avatars and CRISPR. They leverage artificial intelligence/ machine learning and academic collaborations through their partner network to identify new mechanisms of

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L’entreprise EVAH est fière d’améliorer la santé des animaux élevés à des fins alimentaires, en cohérence avec les objectifs de l’humanité, et ainsi de s’inscrire dans la logique « une seule santé ». En effet, participer à la santé de l’ensemble du monde grâce à l’utilisation de traitements prophylactiques responsables et viables chez les animaux, constitue notre source de motivation première. Les activités d’EVAH Corp peuvent se résumer en quatre points : • Définir les technologies de santé animale qui sont prometteuses et ont un fort potentiel de création de revenus, puis s’y consacrer; • Assurer une gestion des ressources scientifiques internes et externes de façon à accélérer le rythme de mise au point des produits; • Préciser la voie de mise au point de chaque technologie, avec pour objectif de faire progresser celles pour lesquelles il existe un fort besoin au sein du marché ou qu’il serait possible de commercialiser rapidement; • Amener la valeur du programme à un niveau stratégique permettant des négociations avec les multinationales de la santé animale en vue de la monétisation des actifs. Giiant Pharma inc. est une société montréalaise fondée par des scientifiques ayant travaillé chez Merck Frosst qui ont plus de 25 ans d’expérience au sein de l’industrie de la recherche pharmaceutique. L’entreprise, qui regroupe des experts de la gastro-entérologie, a pour but de mettre au point des traitements plus sûrs des maladies inflammatoires de l’intestin. JN Nova Pharma Inc. est une société biopharmaceutique œuvrant au stade préclinique, dont le travail est axé sur la mise au point efficace de traitements novateurs destinés à répondre à d’importants besoins non comblés en matière de santé. Le principal candidatmédicament de JN Nova, KG2019, est une molécule novatrice de lutte contre la COVID19. La société travaille avec des laboratoires gouvernementaux et des centres universitaires du Canada à accélérer la mise au point de son traitement contre la COVID-19. Au moyen de méthodes sophistiquées de recherche pharmaceutique, Modelis adapte en un temps record et avec un minimum de ressources des traitements existants à des maladies génétiques rares. Sa démarche novatrice permet de donner une nouvelle vocation aux molécules brevetées de ses partenaires, ainsi adaptées à un large éventail de maladies humaines. La solution de criblage à haut débit de Modelis permet la découverte de traitements destinés aux maladies génétiques rares, grâce à une méthode de recherche qui tire parti des avatars génétiques et des locus CRISPR. L’entreprise

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action and rapidly translate our animal model findings into human clinical trials.

Molecular Forecaster Inc. is a Canadian, Montreal-based scientific software company. This team of chemists leverages their knowledge of chemical principles and integrating artificial intelligence techniques to develop their own high accuracy programs with unique, customizable features. Their user-focused platforms, FORECASTER and VIRTUAL CHEMIST, are used for drug discovery, metabolism prediction, combinatorial chemistry, and asymmetric catalyst design.

Nanology Labs Inc. is an IND-stage pharmaceutical company, spin-off from University of Toronto and located at JLabs Toronto. The company has developed a drug delivery platform technology, TERP, which is a safe and efficient polymeric-lipid nanoparticle system that can carry various therapeutic and diagnostic payloads (peptides, RNAs, chemo drugs and imaging agents) to different solid tumor tissues, including brain tumor and metastasis. Multimodal visualization agents designed to enhance image-guided high-precision cancer therapy including surgery, radiotherapy, and chemotherapy.

exploite l’intelligence artificielle, l’apprentissage machine et des collaborations universitaires au sein d’un réseau de partenaires pour définir de nouveaux mécanismes d’action et transformer rapidement les résultats des modèles animaux en essais cliniques sur humains. Molecular Forecaster Inc. est une entreprise canadienne établie à Montréal, qui se spécialise dans les logiciels scientifiques. L’équipe de chimistes qui la compose emploie ses connaissances des principes de la chimie, qu’elle associe aux techniques de l’intelligence artificielle pour concevoir ses propres programmes extrêmement fiables, dont les caractéristiques uniques peuvent être adaptées par le client. Ses programmes conçus pour les utilisateurs, FORECASTER et VIRTUAL CHEMIST, servent à la recherche de médicaments, à établir des prévisions métaboliques, à la chimie combinatoire et à la catalyse asymétrique. Nanology Labs Inc. est une société pharmaceutique qui en est à l’étape de la PNMR, née d’un laboratoire de l’Université de Toronto et située aux JLabs Toronto. L’entreprise a mis au point une technologie de livraison de médicaments dans l’organisme, appelée TERP. Il s’agit d’un efficace système à base de nanoparticules lipidiques-polymères qui peut transporter diverses charges thérapeutiques et diagnostiques (des peptides, de l’ARN, des agents chimiothérapeutiques et des agents d’imagerie) jusque dans différents tissus tumoraux solides, notamment les tumeurs cérébrales et les métastases. Des agents de visualisation multimodes conçus pour améliorer les traitements guidés par l’image en oncologie de haute précision, notamment les interventions chirurgicales, la radiothérapie et la chimiothérapie

Nanovista’s first product, CF800, is a liposome nanoparticle-based imaging agent that: • Helps cancer surgeons clearly identify tumor boundaries prior to and during surgery for a more complete removal of tumor tissue while preserving healthy tissue • Holds a strong scientific basis and demonstrated performance in animal studies • Contains components that are FDA-approved and shown to work with multiple imaging techniques • Is a long-lasting agent (2 weeks) compared to alternative agents that require multiple injections (minutes or hours) • Utilizes existing clinical infrastructure and 800nm fluorescence imaging systems, already adopted in most major cancer centres and quickly gaining widespread acceptance in surgical oncology

Le premier produit de Nanovista, CF800, est un agent d’imagerie à base de nanoparticules liposomiques qui : • Aide les chirurgiens-oncologues à clairement cerner la tumeur avant et pendant l’intervention et favorise ainsi le retrait complet des tissus tumoraux, ainsi que la préservation des tissus sains; • S’appuie sur un fondement scientifique solide et un rendement éprouvé au cours d’études sur animaux; • Contient des éléments autorisés par la FDA dont le bon fonctionnement dans de multiples techniques d’imagerie a été démontré; • A une longue durée de vie (deux semaines) par rapport à d’autres agents, qui exigent des réinjections (au bout de quelques minutes ou de quelques heures); • Est adapté aux infrastructures cliniques existantes et aux systèmes d’imagerie par fluorescence à longueur d’onde de 800 nm, déjà adoptés dans la plupart des grands centres de cancérologie et de plus en plus populaires en chirurgie oncologique.

Oak Bay Biosciences, Inc. is developing a best-in-class aptamer-based therapeutic for Stagardt disease, a genetic

Oak Bay Biosciences, Inc. travaille à mettre au point, à partir d’aptamères, un traitement de première catégorie de la

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ecosystem écosystème

disease that causes progressive and irreversible blindness. The molecule has potential to service a serious unmet need and to become a blockbuster ophthalmology drug. Pholoho Biotechnology specializes in the large-scale production of premium, natural and sustainable insectbased ingredients for the pharmaceutical and biostimulant industries. Using high-tech solutions, artificial intelligence, genetic improvement programs, Pholoho Biotechnology is restoring balance with nature. TENTECH ONE ™ technology is the result of a multitude of continuous experiments to optimize and automate our production. This know-how not only makes it possible to obtain optimized performance, but also to develop unique products at the cutting edge of technology. PreciThera Inc. is a biotechnology company committed to the development of therapies for rare bone diseases using the combined application of computational technology and a deep understanding of disease pathology. The company focuses on heterogeneous genetic disorders that primarily manifest in bone dysfunction. In depth understanding of disease mechanism will allow PreciThera’s targeted strategies to meaningfully impact both the skeletal symptoms as well as the extraskeletal issues found in these patients. Primary Peptides was founded to capitalize on the extensive knowledge of neuroscience and proteomics amongst its founders and collaborators. Primary Peptides has identified a series of key domains of disease related proteins and has designed lead compounds to either block the interactions of these disease related proteins, offering new therapeutic approaches, or degrade particular disease related proteins in the body. The Ripple Therapeutics’ Epidel® technology is founded on a discovery that drugs can be engineered into controlled release materials without the use of polymers or excipients. The proprietary prodrugs are new chemical entities (NCEs) that have unique properties that allow them to be processed into standalone drug delivery implants (e.g. intravitreal implants, micro/nanoparticles, etc.) or as coatings on medical devices.

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maladie de Stagardt. Cette maladie, d’origine génétique, cause une cécité progressive et irréversible. La molécule pourrait être la réponse à un important besoin non comblé et devenir un médicament vedette en ophtalmologie. Pholoho Biotechnology se spécialise dans la production à grande échelle d’ingrédients naturels durables de première qualité issus d’insectes à destination des industries pharmaceutique et des biostimulants. Grâce à la haute technologie, à l’intelligence artificielle et à des programmes d’amélioration génétique, Pholoho Biotechnology contribue à restaurer l’équilibre avec la nature. La technologie TENTECH ONE™ est le résultat d’une multitude d’expériences suivies visant à optimiser et à automatiser la production. Le savoir-faire acquis permet non seulement d’optimiser le rendement, mais aussi de mettre au point des produits uniques, à la fine pointe de la technologie. PreciThera Inc. est une société de biotechnologie qui s’est donné pour mission de mettre au point des traitements destinés aux maladies osseuses rares grâce à l’application combinée des technologies computationnelles et de connaissances approfondies en pathologie. L’entreprise axe ses efforts sur les troubles d’hétérogénéité génétique qui se manifestent principalement par un dysfonctionnement des os. Une compréhension approfondie des mécanismes pathologiques permettra à PreciThera d’élaborer des stratégies ciblées, qui auront une incidence importante sur les symptômes squelettiques, ainsi que sur les manifestations extrasquelettiques chez les patients touchés. Les fondateurs de Primary Peptides ont mis sur pied l’entreprise afin de tirer parti de leurs connaissances approfondies en neurosciences et en protéomique et de celles de leurs collaborateurs. Primary Peptides a choisi un ensemble de domaines cruciaux liés aux protéines pathologiques et a désigné les principaux composés qu’elle entend mettre au point pour soit inhiber les interactions entre ces protéines, ce qui constituerait une nouvelle approche thérapeutique, soit décomposer certaines protéines pathologiques au sein de l’organisme. La technologie Epidel® de Ripple Therapeutics s’appuie sur la découverte selon laquelle on peut modifier les médicaments de façon à maîtriser la libération des substances qui les composent sans utiliser de polymères ni d’excipients. Les promédicaments brevetés sont des substances chimiques nouvelles (SCN) aux propriétés uniques qui peuvent être transformées en implants de dosage de médicaments autonomes (p. ex. sous forme d’implants intravitréens, de microparticules, de nanoparticules, etc.) ou en revêtements pour instruments médicaux.

ecosystem écosystème

Sansero Life Sciences Inc. is a Canadianbased bioscience company developing novel medications for the evolving needs of patients and the future of mental health care. Sansero’s highly skilled and experienced research team uses advanced machine learning, diagnostics and metabolic pathway profiling to create psilocybin-based formulations designed to replace anti-depressants and ADHD medications with new pharmaceuticals that treat the complete neurological pathway. Scispot.io, a life science digitization and automation company, announces a no-code digital operating platform for ambitious life science leaders and scientists. The company’s mission is to create a digital life science ecosystem™ by powering over 10,000 small and medium companies (SMEs) by 2025 so that they can collaboratively fight diseases, develop cures, and solve humanity’s biggest problems. Scispot’s platform transforms biotech SMEs into modern digital companies and enables on-demand access to their data, resources, and external partners all in one spot. SeaGen Canada Seattle Genetics is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. Seattle Genetics is headquartered in Bothell, Washington, U.S.A. and has a European office in Zug, Switzerland

Sansero Life Sciences Inc. est une société bioscientifique établie au Canada, qui met au point des médicaments novateurs destinés aux patients ayant des besoins évolutifs, avec en tête l’avenir des soins en santé mentale. L’équipe de Sansero, composée de chercheurs très expérimentés et compétents, emploie l’apprentissage machine de pointe, les diagnostics et le profilage métabolique pour créer de nouvelles préparations à base de psilocybine conçues pour remplacer les antidépresseurs et les traitements du TDAH et traiter l’ensemble de la voie neurologique. Scispot.io, une société de numérisation et d’automatisation du domaine des sciences de la vie, présente une plateforme d’exploitation numérique exempte de code destinée aux dirigeants et aux scientifiques du secteur. L’entreprise s’est donné pour mission de créer un « ecosystem™ » numérique pour les sciences de la vie; elle souhaite équiper 10 000 PME d’ici 2025, afin qu’elles puissent collaborer dans la lutte contre les maladies, la recherche de remèdes et la résolution des grands problèmes de l’humanité. La plateforme de Scispot transforme les PME des biotechs en sociétés numériques modernes et leur offre l’accès sur demande à leurs données, à leurs ressources et à leurs partenaires, par l’intermédiaire d’un guichet unique. SeaGen Canada (Seattle Genetics) est une jeune société mondiale de biotechnologie. Elle met au point et commercialise de multiples traitements transformateurs ciblant le cancer, qui devraient avoir une incidence considérable sur la vie des patients. Seattle Genetics a son siège à Bothell, Washington (États-Unis), et des bureaux en Europe, plus précisément à Zug, en Suisse.

Spiderwort Inc. is developing a novel biomaterial that will offer new avenues in regenerative medicine. Using plant derived cellulose to create a variety of scaffold architectures. Currently, they are in the pre-clinical stage of this product and promising results demonstrate that this new biomaterial is highly biocompatible and induce angiogenesis (blood vessel generation inside the scaffold).

Spiderwort Inc. œuvre à mettre au point une biomatière novatrice, qui ouvrira de nouvelles voies à la médecine régénératrice. L’entreprise utilise de la cellulose végétale pour créer divers « échafaudages ». La nouvelle biomatière en est actuellement au stade préclinique, et des résultats prometteurs indiquent qu’elle a une vaste biocompatibilité et peut induire l’angiogenèse (la génération de vaisseaux sanguins dans l’échafaudage).

Ventus Therapeutics Ventus is discovering and developing novel small molecule medicines that target the innate immune system to treat autoimmune diseases, inflammatory diseases and cancer. Using two platforms, they expand the set of targets amenable to small-molecule medicines including targets which have never been drugged and others for which existing chemical matter leaves significant room for improvement.

Ventus Therapeutics Ventus travaille à la recherche-développement de petites molécules-médicaments novatrices ciblant le système immunitaire inné, afin de traiter les maladies auto-immunes, les maladies inflammatoires et le cancer. Au moyen de deux plateformes, l’entreprise élargit l’ensemble de cibles susceptibles de bien réagir aux petites moléculesmédicaments, qui inclut notamment des cibles qui n’ont jamais été soumises à des médicaments et des cibles pour lesquelles les substances chimiques existantes sont grandement insuffisantes.

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CANADA HAS A STRONG TRACK RECORD OF SUPPORTING AND CONDUCTING HIGH QUALITY BASIC RESEARCH in the ongoing quest to build a robust biotechnology sector. However, the goal of creating a thriving self-sustaining biotech start-up ecosystem remains elusive. Value creation for therapeutic biotech companies is not driven by discovery but rather through clinical development and market authorization. Many biotech start-ups continue to face major obstacles on the long product development journey to the goal of commercialization. The list of challenges hasn’t changed over the last 25 years: developing an innovative risk-tolerant culture, finding seasoned executive talent, hiring experienced personnel and access to early-stage capital. Vasomune Therapeutics Inc., a Toronto-based biopharmaceutical company founded in 2014, has recently demonstrated that overcoming these barriers and successfully transitioning to clinical development is

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possible. Driving the company’s approach is the belief that a biotech start-up needs to be supported by a flexible workforce with the appropriate skills and experience characteristic of the core functions of multidisciplinary drug development teams. Vasomune operates with a lean structure based on a semi-virtual organizational model consisting of core members in the Toronto head office and others working from locations across Canada, US, Europe and Japan. Vasomune has maintained its independence by financing the company largely through non-dilutive sources. This approach allows Vasomune to build a clinical stage company in Canada financed largely through corporate partnership and government grants. Recently, the company received funding notifications up to $2.8m from the National Research Council of Canada’s Industrial Research Assistance Program (NRC IRAP) and US $9.2m in Peer Reviewed Medical Research Program (PRMRP) grants

from the US Department of Defense to support the development of AV-001. Proof that Vasomune’s approach is working can be seen in the encouraging results the company has experienced pursuing a unique therapeutic strategy aimed at combating disease driven by dysfunctional vasculature. The host vascular response (HVR) is an important pathological process in a variety of disease states, including acute respiratory distress syndrome (ARDS), acute lung injury, acute kidney injury, cardiopulmonary bypass surgery, hematologic fever (Ebola, dengue fever), hematologic shock and sepsis. In response to trauma or infection, the HVR can become unconstrained, driving the loss of barrier function, inflammation, vascular leak and edema in critical organs that leads to organ failure and death. Vasomune’s lead clinical candidate, AV-001, is a novel synthetic Tie2 tyrosine kinase receptor agonist targeting a key regulatory protein expressed on the cell surface of endothelial cells in the vasculature. In healthy individuals, Tie2 is responsible for maintaining normal vascular function, endothelial stability and barrier defense against vascular leakage. In proof-of-concept animal studies, AV-001 significantly improved survival, reduced pulmonary edema and increased lung function compared to untreated animals in a lethal model of severe RNA viral infection. Importantly, AV-001 also increased survival independent of the type of viral strain and was also effective against PR8 (H1N1) and 2009 swine-origin pandemic H1N1 viral strains. The transitional journey for AV-001 was catalyzed following Vasomune’s founding at Toronto Innovation Acceleration Partners (TIAP) and initial funding through a corporate partnership with AnGes, Inc. The lead molecule was advanced over the last three years to a Phase 2 clinical candidate from the preclinical predecessor analogs originally discovered in

Dr. Dan Dumont’s academic lab at Sunnybrook Research Institute in Toronto. Meanwhile, an overlap between AV-001’s mechanism of action, results from translation studies and the role of vasculature dysfunction in COVID-19 disease progression led the company to prioritize the development of its drug as a treatment for hospitalized patients with severe COVID-19 disease including COVID-19-associated ARDS. Encouragingly, Vasomune’s therapeutic approach has the potential benefit of maintaining its effectiveness against new emergent strains, including the highly virulent Delta variant (B.1.617.2). In November 2020, the Company received IND allowance from the US Food and Drug Administration (FDA). A phase 1 first-in-human clinical study conducted on 48 healthy subjects and completed this year demonstrated AV-001 was safe and well tolerated following daily intravenous doses up to seven consecutive days allowing advancement to clinical studies in patients. Discussions with regulatory agencies regarding the design of a randomized, double-blind, placebocontrolled have now been finalized, with Phase 2a study of AV-001 for the treatment of hospitalized patients with severe COVID-19 disease slated to begin the fourth quarter of 2021. “We are tremendously pleased at the positive response from the clinical and scientific community for our novel therapeutic approach to treating severe COVID-19 disease and grateful for the financial support from the NRC IRAP and US Department of Defense PRMRP programs which has enabled acceleration of the clinical development of AV-001”, said Douglas A. Hamilton, President and CEO of Vasomune. “Results from the Phase 2a clinical study will determine if our therapeutic strategy of normalizing the vasculature can improve survival, reduce progression to mechanical ventilation and shorten hospital stays for patients with severe COVID-19 disease.” For more information on Vasomune Therapeutics, visit: www.vasomune.com. biotech.ca

Medicago’s made-in-Canada scientific innovation SINCE THE START OF THE COVID-19 PANDEMIC, governments, organizations, and people around the world have worked diligently to find solutions that will enable all of us to return to some sense of normalcy. In the case of Medicago, a Quebec-based biopharmaceutical company, the pandemic has served to accelerate research and development activities using its proprietary plant-based platform. Medicago’s aspiration is to create an infrastructure that will allow us to provide Canadians with a proven domestic solution to address the current COVID-19 pandemic as well as future pandemics. At the same time, Medicago is building the knowledge and capacity to achieve its mission of helping to improve public health worldwide using the power of plants. MEDICAGO’S HISTORY The story of Medicago is rooted in innovation and perseverance. What started in 1999 with an academic partnership and the out-licensing of technology between Laval University and Agriculture Canada, has evolved into Medicago’s position today as an integrated biopharmaceutical company of more than 500 people in Canada and in the United States. The organization is proud of its heritage and the role it plays fostering a healthy life science ecosystem and supplier network in both Quebec and across Canada. The teams at Medicago understand how the path to success is rarely a straight line. Over its decades of growth, Medicago has experienced challenges common to start-up biotech companies, but with the unwavering support of its partners, and perseverance of its teams, Medicago has achieved significant R&D milestones. MEDICAGO’S PLATFORM AND PLANT-BASED SCIENCE Certain plants can be highly efficient at producing proteins of varying complexity, and therefore can serve as bioreactors or mini factories to produce protein antigens to be used in vaccines and therapeutics applications. Medicago has developed the expertise to produce proteins in the form of Virus-Like Particles (VLPs) using plants. These VLPs mimic the shape and dimension of a virus, which aids in presentation and then processing by the immune system. Unlike some traditional vaccines, VLPs do not contain core genetic material, thus are non-infectious and do not replicate. Medicago’s plant-based production platform helps eliminate the risk of mutation during production. For example, this recombinant technology is important in the case of influenza as the vaccine is likely to genetically match the targeted strain with precision. Medicago has 46

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shown their plant-based platform can deliver researchgrade vaccine candidates in just 19 days, and clinicalgrade vaccine doses in 6-8 weeks post availability of a viral genetic sequence. DOMESTIC MANUFACTURING CAPACITY AND PANDEMIC RESPONSE Medicago has invested over $740M in Canadian research and development over the last 20 years and continues to invest in Canada’s pandemic response capabilities through a new manufacturing plant in Quebec City. Once built, this facility will be able to produce up to one billion doses of pandemic vaccines annually. The company broke ground on the facility in 2018, and it hit a significant milestone in December 2020 as it enclosed the greenhouse and main building. “With our new state-of-the-art facility, we hope to be ready to respond to health threats and aim to provide vaccines and therapies not only for people in Canada, but also beyond our borders,” says Nicolas Petit, Vice-President of Commercial Operations. Medicago has transformed through the COVID-19 pandemic and is now at a significant juncture in its history as it advances towards commercialization of its first products. “We are grateful to the Government of Canada, the Government of Quebec, our Shareholders and other partners for their ongoing support”, says Takashi Nagao, President and CEO of Medicago. “Medicago’s top priority is to be ready to partner with public health to respond to infectious disease threats by ensuring people have timely access to our vaccines.” As a pioneer of plant-based transient expression and manufacturing, Medicago offers a disruptive approach to help improve human health. With nearly 20 years of experience and wisdom behind it, Medicago is about to reach a significant milestone - the first plant-based vaccine for human use. A Canadian and world’s first.

Medicago, une innovation scientifique 100% canadienne DEPUIS LE DÉBUT DE LA PANDÉMIE DE COVID-19, partout à travers le monde, les gouvernements, les organisations et les individus ont travaillé sans relâche pour trouver des solutions destinées à nous permettre de retrouver une forme de normalité dans notre quotidien. Chez Medicago, société biopharmaceutique établie au Québec, la pandémie a conduit à l’accélération des activités de R&D d’un vaccin produit sur plantes. L’objectif final de Medicago est de créer une infrastructure qui offrira aux Canadiennes et aux Canadiens une solution éprouvée à l’échelle nationale pour lutter à la fois contre la pandémie actuelle de COVID-19 et contre les pandémies futures. Grâce aux nouvelles connaissances et aux capacités acquises au cours de cette période inédite, Medicago a réalisé sa mission : contribuer à l’amélioration de la santé publique dans le monde en s’appuyant sur la puissance des plantes.

L’HISTOIRE DE MEDICAGO L’histoire de Medicago se fonde sur l’innovation et la persévérance. Elle a débuté en 1999 à l’occasion d’un partenariat avec l’Université Laval et Agriculture Canada, et avec l’octroi de licences liées à technologie de production sur plantes. Au fil du temps, Medicago s’est assurée une place de choix comme société biopharmaceutique intégrée. Elle compte désormais plus de 500 employé(e)s au Canada et aux États-Unis. Medicago est fière de sa riche histoire et du rôle qu’elle joue dans la promotion d’un écosystème des sciences de la vie actif et d’un réseau de fournisseurs au Québec et partout au Canada. Les équipes de Medicago savent que la voie du succès est rarement constituée d’une ligne droite. Au cours des 20 dernières années, Medicago a su relever de nombreux défis, communs à l’ensemble des entreprises du secteur des biotechnologies en démarrage. Grâce au soutien indéfectible de ses partenaires et à la persévérance de ses équipes, Medicago a franchi des étapes importantes en matière de R&D.

LA TECHNOLOGIE DE PRODUCTION SUR PLANTES DE MEDICAGO Certaines plantes peuvent être très efficaces pour produire des protéines de complexité variable. Transformées en véritables bioréacteurs ou mini-usines de production de protéines, elles seront utilisées dans le développement de vaccins et de traitements thérapeutiques. Medicago a développé l’expertise nécessaire pour produire des protéines

à partir de plantes, sous la forme de Particules Pseudo-Virales (PPV) . Ces PPV imitent la forme et la taille d’un virus, ce qui facilite la réponse du système immunitaire. Contrairement à certains vaccins traditionnels, les PPV sont dépourvues de matériel génétique. Elles sont donc non infectieuses et sont incapables de se reproduire. La technologie de production sur plantes de Medicago contribue à l’élimination du risque de mutation pendant la production. Cette technologie recombinante est particulièrement importante dans le cas de la grippe, puisque le vaccin est susceptible de correspondre précisément à la souche ciblée. Medicago a de plus démontré sa capacité à produire des candidats-vaccins de qualité recherche en seulement 19 jours; ainsi que des doses de vaccin de qualité clinique de 6 à 8 semaines après l’obtention de la séquence génétique d’un virus.

CAPACITÉ DE PRODUCTION AU CANADA ET LUTTE CONTRE LA PANDÉMIE Au cours des 20 dernières années, Medicago a investi plus de 740 M$ dans la recherche et le développement au Canada et aux États-Unis. Les investissements continuent avec la construction d’une nouvelle usine de production dans la ville de Québec. Une fois celle-ci achevée, jusqu’à un milliard de doses pandémiques de vaccins pourront être produites chaque année. La construction de ce nouveau complexe a débuté en 2018 et elle a franchi une étape importante en décembre 2020 avec la finalisation de la serre et du bâtiment principal. « Grâce à notre nouvel établissement à la fine pointe de la technologie, nous serons prêts à réagir aux menaces à la santé publique au Canada, et au-delà de nos frontières », explique Nicolas Petit, vice-président, Opérations commerciales. Pendant la pandémie, Medicago s’est transformée. Alors qu’elle progresse vers la commercialisation de ses premiers produits, elle se trouve à un moment charnière de son histoire. « Nous sommes reconnaissants envers le gouvernement du Canada, le gouvernement du Québec, nos actionnaires et envers plusieurs autres partenaires pour leur soutien continu, précise Takashi Nagao, président et chef de la direction de Medicago. La priorité absolue de Medicago est d’être prête à s’associer aux organismes de santé publique pour réagir aux menaces liées aux maladies infectieuses, tout en veillant à ce que les gens aient accès à nos vaccins en temps opportun. » Véritable pionnière de l’expression et de la fabrication transitoires sur plantes, Medicago offre une approche novatrice et participe à l’amélioration de la santé humaine. Forte de plus de 20 ans d’expérience, Medicago est sur le point de franchir une étape importante avec la production du premier vaccin à usage humain produit sur plantes. Une première canadienne et une première mondiale.

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How Incubators Are Powering Canada’s Life Sciences Sector Les incubateurs : des moteurs pour le secteur canadien des sciences de la vie by Jennifer Hamilton, PhD, Early Innovation Partnering, Johnson & Johnson Innovation par Jennifer Hamilton, Ph. D., directrice des partenariats, innovations récentes, Johnson & Johnson Innovation

OPTIMIZING CANADA’S LIFE SCIENCES INDUSTRY IS A SOURCE OF PERENNIAL ANGST. Proposed solutions have included attracting international venture capitalists, recruiting experienced high-priced U.S. CEO’s and Board of Directors, establishing dual U.S. company locations, 48

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LA NÉCESSITÉ D’OPTIMISER LE SECTEUR DES SCIENCES DE LA VIE CONSTITUE UNE SOURCE D’ANGOISSE CONSTANTE. Afin de résoudre cette difficulté, on a cherché à attirer les capital-risqueurs, à recruter aux États-Unis des chefs de direction et des administrateurs chevronnés de

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enhancing tax credits, personal tax breaks and nudging federal granting funds towards commercialization. Now we have a taste of success, with companies like AbCellera, Zymeworks and STEMCELL building and growing in Canada for the long-run. To foster more of these stories of accomplishment, we feel we need to provide a nurturing environment for start-ups, including mentorship and incubators. In the past few years, several mentoring initiatives have been launched, including Creative Destructive Lab which now operates five Canadian locations, OBIO’s Capital Access Advisory Program (CAAP), Edmontonbased Innovation Masterminds (imYEG), and the Canadian Technology Accelerators (CTA), run out of Boston and San Francisco. These initiatives are specifically designed to help companies build and raise funds. Incubators are also an important resource for start-ups and come in many different flavours. Some offer free

grande valeur, à établir des entreprises à la fois au Canada et aux États-Unis, ainsi qu’à faire augmenter les crédits d’impôt et les allègements fiscaux et réorienter les subventions fédérales vers le processus de commercialisation. Aujourd’hui, alors que des sociétés telles que AbCellera, Zymeworks et STEMCELL se sont établies à long terme au Canada et connaissent la croissance, nous goûtons aux fruits de nos efforts. Afin de favoriser des réussites comme les leurs, il nous semble qu’il faut désormais offrir aux jeunes pousses un milieu accueillant, qui comprendrait des incubateurs et des possibilités de mentorat. Au cours des dernières années, on a démarré plusieurs programmes de mentorat, dont le Creative Destructive Lab, qui a actuellement des bureaux dans cinq villes du Canada, le Capital Access Advisory Program (CAAP) d’OBIO, le programme Innovation Masterminds (imYEG), à Edmonton, et les Accélérateurs technologiques canadiens (ATC), exploités à partir de Boston et de San Francisco. Ces

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space, some charge rent; some accept only on-strategy applicants, while others have time-limited cohorts and include mentorship and financial support. Governments of all levels and academic institutes have also been willing partners in the incubator world as it makes sense for regions that want to stimulate the economic potential of knowledge-based industries. This support has ranged from donating space to providing funding for infrastructure, staffing and equipment. SOME EXAMPLES OF INCUBATORS FROM ACROSS THE COUNTRY ARE BELOW. • Newfoundland: The Canadian government and Memorial University came together to found the Bounce Health Innovation and co-working space in 2018. • Alberta: A unique partnership was forged between the city of Calgary, the University of Calgary, and the governments of Alberta and Canada to repurpose former industry labs to form the Life Sciences Innovation Hub which offers shared equipment and lab space. Opening its doors in 2019, the site is built to host 20-40 life sciences companies. • Ontario: At McMaster University the Innovation Factory and Synapse Lifesciences Consortium work together to support life science start-ups in the region. • Quebec: Montreal has also seen some exciting incubator models. Concordia University’s District 3 Innovation Centre downtown was launched midpandemic to serve very early start-ups and local innovators. Nearby the TransMedTech Institute provides a nurturing hands-on environment for medtech start-up companies. Closer to the airport,

programmes sont précisément conçus pour aider les entreprises à rassembler et à obtenir des fonds. Les incubateurs constituent aussi une précieuse ressource pour les jeunes pousses, et leur fonctionnement varie : certains proposent gratuitement leurs espaces de travail, alors que d’autres les louent; certains axent leurs efforts sur les demandeurs correspondant à leur stratégie, tandis que d’autres forment des cohortes pour une durée limitée, à qui ils offrent mentorat et soutien financier. Tous les ordres de gouvernement de même que les établissements universitaires sont aussi des partenaires enthousiastes du monde de l’incubation d’entreprises, car ce type d’initiative convient aux différentes régions du pays qui cherchent à stimuler le potentiel économique des industries du savoir. Les aides vont du don de locaux au financement des infrastructures, de la dotation et de l’achat d’équipement.

VOICI QUELQUES EXEMPLES D’INCUBATEURS, SITUÉS AUX QUATRE COINS DU PAYS. •

•

Jennifer Hamilton, PhD, Early Innovation Partnering, Johnson & Johnson Innovation/ Ph. D., directrice des partenariats, innovations récentes, Johnson & Johnson Innovation

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Terre-Neuve : En 2018, le gouvernement canadien et l’Université Memorial se sont unis pour fonder l’accélérateur Bounce Health Innovation et son espace de travail collaboratif. Alberta : Un partenariat unique s’est constitué entre la ville de Calgary, l’Université de Calgary et les gouvernements albertain et canadien en vue de donner une nouvelle vocation à d’anciens laboratoires du secteur, qui forment désormais le Life Sciences Innovation Hub, offrant de l’équipement et de l’espace de laboratoire à partager. Ayant ouvert en 2019, le site est conçu pour accueillir 20 à 40 entreprises du secteur des sciences de la vie. Ontario : À l’Université McMaster, le catalyseur Innovation Factory et le Synapse Lifesciences Consortium collaborent au soutien des jeunes pousses qui œuvrent en sciences de la vie dans la région de Hamilton. Québec : Il y a aussi d’enthousiasmants modèles d’incubateurs à Montréal. On a fondé le centre d’innovation District 3 centre-ville pendant la pandémie, afin d’offrir des services aux très jeunes entreprises et aux innovateurs locaux. Non loin du centre-ville, l’Institut TransMedTech offre aux jeunes entreprises du domaine des technologies médicales un environnement de travail accueillant. Dans le quartier de l’aéroport, adMare BioInnovations (anciennement NeoMed) s’est installé dans un bâtiment conçu pour la recherche pharmaceutique, un don d’AstraZeneca. Le bâtiment accueille de jeunes pousses et des organismes de recherche sous contrat qui y agissent en symbiose. Colombie-Britannique : En C.-B., les programmes d’incubation sont nombreux. En voici quelques exemples. Le projet vancouvérois entrepreneurship@UBC offre aux nouvelles entreprises fondées par des étudiants en commerce ou en sciences un programme d’accélération

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the adMare BioInnovations (formerly NeoMed) is located in a purpose-built pharmaceutical building gifted by AstraZeneca, and is filled with start-ups and contract research organizations coexisting in a symbiotic relationship. • British Columbia: In BC there are many incubator programs. To note a few - Vancouver’s entrepreneurship@UBC provides a HATCH Accelerator Program with a 12+ month mentorship for new companies which have been formed by business and science students. The Praxis Spinal Cord Institute’s SCI Incubate program offers a virtual incubator for global companies tackling spinal cord injury and the UBC School of Biomedical Engineering has creatively started Canada smallest and mightiest incubator (2 companies) inside its walls. • Prince Edward Island: This province has reaped the benefits of its investment in “housing” new companies in the Canada-wide virtual incubator Emergence specializing in the bioscience and food sectors. Johnson & Johnson Innovation itself is also in the incubator business, recently celebrating JLABS @ Toronto’s 5th anniversary. It is one of the only corporate incubators with a site in Canada designed to house early-stage life science companies. Support from the province and local universities helped launch the site which provides laboratories, expertise, education and resources to a total of 88 companies across the pharmaceutical, medical devices and consumer sectors. KEY FIVE YEAR HIGHLIGHTS INCLUDE: • JLABS @ Toronto companies have cumulatively hired 605 full-time and 244 part-time employees creating jobs in the Canadian ecosystem • 59% of JLABS @ Toronto residents have advanced their R&D stage while within JLABS • $1.9B dollars in funding and deals have been raised by Toronto residents • JLABS @ Toronto held 358 events with over 26,000 attendees in 13+ cities across Canada A perfect example of the “Johnson & Johnson Innovation - JLABS effect” is Immune Biosolutions. This novel antibody discovery company already had a site in Sherbrooke, Quebec yet wanted to also join JLABS @ Toronto. As one of the site’s inaugural residents, they kept dual locations and leveraged Johnson & Johnson Innovation’s mentorship, industry connections and resources. This culminated in an alliance with Janssen Biotech Inc. The above examples are only a small list of the life sciences incubators coast-to-coast in Canada. In whatever form they exist, the facilities provide young companies with much needed exposure, mentorship, investor and business contacts, and a community for collaboration and innovation. They help solidify Canada’s life sciences future.

du nom de HATCH, assorti d’un mentorat de 12 mois et plus. Le programme SCI Incubate du Praxis Spinal Cord Institute consiste en un incubateur créé à l’intention des sociétés du monde entier qui s’attaquent aux traumatismes de la moelle épinière, et la UBC School of Biomedical Engineering, avec beaucoup de créativité, a démarré en ses murs le plus puissant des petits incubateurs (il ne compte que deux entreprises) du Canada. • Île-du-Prince-Édouard : La Province a récolté les bénéfices de ce qu’elle a investi dans « l’accueil » des nouvelles entreprises au sein de son incubateur virtuel pancanadien du nom de Emergence, spécialisé dans les secteurs des biosciences et de l’alimentation. Johnson & Johnson Innovation agit elle aussi dans le domaine de l’incubation d’entreprises et a récemment célébré le 5e anniversaire de JLABS @ Toronto. Il s’agit de l’un des seuls incubateurs d’entreprises ayant un site au Canada conçu pour accueillir les jeunes pousses du secteur des sciences de la vie. L’appui de la province et des universités locales ont contribué au lancement du site, qui comprend des laboratoires et offre une expertise, de l’enseignement et des ressources à 88 sociétés des secteurs pharmaceutique, des instruments médicaux et des produits grand public.

VOICI QUELQUES FAITS SAILLANTS AU SUJET DE CES CINQ ANNÉES : •

Les entreprises de JLABS @ Toronto ont, ensemble, embauché 605 employés à temps plein et 244 employés à temps partiel, créant ainsi des emplois au sein de l’écosystème canadien. • C’est depuis leur arrivée à JLABS @ Toronto que 59 % des résidents ont réussi à faire évoluer leur R.-D. • Les résidents ont obtenu des fonds et conclu des ententes à hauteur de 1,9 milliard $. • JLABS @ Toronto a organisé 358 activités, qui ont permis d’accueillir 26 000 participants, dans une quinzaine de villes un peu partout au Canada. Un parfait exemple de « l’effet Johnson & Johnson Innovation — JLABS » est Immune Biosolutions. Cette entreprise d’innovation dans le domaine des anticorps avait déjà un site à Sherbrooke, au Québec, mais souhaitait également s’installer à JLABS @ Toronto. Comptant parmi les premiers résidents du site, elle a aussi conservé ses locaux à Sherbrooke et a tiré parti du mentorat, des contacts sectoriels et des ressources de Johnson & Johnson. Cette relation a culminé en une alliance avec Janssen Biotech Inc. Les exemples ci-dessus constituent une courte liste des incubateurs en sciences de la vie établis d’un océan à l’autre au Canada. Quelle que soit leur forme, les installations offrent aux jeunes entreprises la visibilité, le mentorat, les investisseurs et les contacts d’affaires dont ils ont grandement besoin, ainsi qu’une communauté de collaboration et d’innovation. Les incubateurs permettent d’assurer aux sciences de la vie du Canada un avenir prospère. biotech.ca

BeiGene Brings Ground-Breaking Cancer Treatments to Canada INNOVATIVE, GROUND-BREAKING CANCER TREATMENTS IN RECENT YEARS HAVE GIVEN NEW HOPE TO PATIENTS AROUND THE WORLD, including in Canada. BeiGene (Canada) ULC of Mississauga, a fully owned subsidiary of BeiGene, Ltd., headquartered in Cambridge, Massachussets and Beijing, China, is a major contributor to those breakthroughs. “It’s brand new, and we’re building quickly,” says general manager Peter Brenders, who notes that BeiGene (Canada) ULC, which incorporated in 2020 and currently has ten employees, has begun to build a cross-Canada team. The stated vision of BeiGene’s parent company, co-founded in 2010 by U.S. entrepreneur John Oyler and Dr. Xiaodong Wang, a member of the U.S. Academy of Science and director of China’s National Institute of Biological Sciences, is to “transform the biotechnology industry, creating impactful medicines that will be affordable and accessible to far more cancer patients around the world.”

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The publicly-listed company, whose mantra is ‘Cancer has no borders. Neither do we.’, is developing new oral small molecules and monoclonal antibodies for solid tumour, immuno-oncology, hemato-oncology and immunology/inflammation cancer treatments. BeiGene has grown to more 6,000 employees in 16 countries and regions globally, including five continents. It has more than 14,000 patients around the world enrolled in clinical studies, with more than 90 clinical studies ongoing in 40 countries and regions. BeiGene has more than 20 filings accepted for seven approved products in more than 40 countries, including one product in Canada. That product is zanubrutinib, which markets under the brand name BRUKINSA®. Zanubrutinib was approved by Health Canada in March 2021 for use in the fight against a rare blood cancer known as Waldenström’s macroglobulinemia (WM), a non-Hodgkin lymphoma primarily found in the bone marrow sometimes in the lymph nodes and spleen, which usually impacts older people. In July 2021 it was also approved for

Canadians need solutions for cancer and we want to bring help, so we sought approval to sell here. treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. “Our product is a very specific oral molecule that targets a Bruton’s tyrosine kinase (BTK) receptor, so it inhibits that BTK implicated in the cancer,” explains Brenders. “This is the predominant product that we’re focused on, and there will be some other indications for that, all related to cancer. Zanubrutinib is being studied in a number of other indications and we’re seeking approval on those,” he adds. BeiGene is currently looking at next geneation immunolocology products for the treatment of solid tumours, including an anti-TIGIT product that is coming along quickly in clinical trials which it hopes to bring to Canada, says Brenders. BeiGene has also developed an anti-PD-1 cancer product, which the company has licensed out to Novartis Pharma AG to develop, manufacture, and commercialize in Canada and some other countries. “These products all come out of our pipeline – home grown innovations that were from our research labs and

we’re bringing those to the world. We think these reflect best-in-class science,” says Brenders. Instead of focusing primarily on classic big pharma markets in venues like the U.S. and Europe, the company’s leaders believe they have a responsibility to develop treatments to solve large unmet needs in cancer for patients globally, Brenders stresses. Canada is an important venue in that strategy. “The question always comes up, ‘Why Canada?’ This reflects BeiGene’s motto of no borders. Canadians need solutions for cancer and we want to bring help, so we sought approval to sell here. The timing of availability is actually a reflection on Health Canada in terms of the positive nature and the speed of their review, and how quickly they were able to evaluate and assess the safety and efficacy of BRUKINSA®,” explains Brenders. But it is also important to note that BeiGene is more than just a global company looking to invest in Canada, he stresses. “It’s Canadians helping Canadians. We will have employees located across the country and we’re working with our local health systems to find ways to best provide support and introduce our new treatments. Our goal is to bring the products that BeiGene develops here and if the health system wants to use them, then we’re more than willing to work with them on that,” says Brenders.

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Uniting for growth with Canada’s Food & Agri-Tech Engine Bioenterprise marks progress in connecting Canada’s agriculture and agri-food innovation system

Faire avancer la croissance grâce au Moteur des technologies agroalimentaires du Canada Bioenterprise fait des progrès pour unir le secteur de l’innovation agricole et agroalimentaire du Canada by Lilian Schaer for Bioenterprise, Canada’s Food & Agri-Tech Engine par Lilian Schaer pour le Moteur des technologies agroalimentaires du Canada de Bioenterprise

AFTER MORE THAN 15 YEARS OF HELPING ONTARIO START-UPS AND EMERGING COMPANIES IN THE AGRIFOOD SECTOR ALONG THEIR GROWTH PATHS, Bioenterprise started down the path of creating a national agri-food innovation ecosystem last year. That’s when the Guelph-based agri-food innovation accelerator launched Canada’s Food & Agri-Tech Engine in an effort to offer a single national platform of training, mentorship and financial support to start-ups, entrepreneurs, and growth-oriented companies across Canada. It was a major step towards turning the vision of Bioenterprise and its CEO Dave Smardon into a muchneeded reality. “Canada’s agriculture and agri-food innovation ecosystem is highly fragmented and under-funded, and it’s long been our vision to create an environment that is more collaborative, more cooperative, and more national,” says Smardon. Historically, most agri-food and agri-tech innovation support has been available through various accelerators, incubators, and government programs in different parts of the country. More often than not, that support was municipal, regional, provincial, or sector-specific in its focus, limiting collaboration and growth opportunities across Canada and internationally. It also meant that available funds were often spread out very thinly, few organizations had the resources and funding to make meaningful impacts, and skillsets in different parts of the country weren’t being used to their full potential. The 2017 Barton Report identified the agri-food sector as a pillar of Canada’s economic growth with the opportunity to become a trusted global leader in food exports. The federal Agri-Food Economic Strategy Roundtable also pointed to the 54

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L’AN DERNIER, APRÈS PLUS DE 15 ANS À AIDER DE JEUNES ENTREPRISES ET DES ENTREPRISES ÉMERGENTES DU SECTEUR AGROALIMENTAIRE EN ONTARIO à prendre de l’expansion, la société Bioenterprise s’est lancée dans la création d’un écosystème national de l’innovation en agroalimentaire. L’accélérateur d’innovations en agroalimentaire situé à Guelph a ainsi créé le Moteur des technologies agroalimentaires du Canada dans le but d’offrir une plateforme nationale unique de formation, de mentorat et de soutien financier aux entreprises en démarrage, aux entrepreneurs et aux sociétés en croissance de partout au Canada. Ce Moteur représente un grand pas dans la concrétisation de la vision de Bioenterprise et de son président-directeur général, Dave Smardon. « L’écosystème d’innovations agricoles et agroalimentaires du Canada est très fragmenté et sous-financé. Nous avions depuis longtemps le projet de créer un milieu collaboratif, coopératif et d’envergure véritablement nationale », explique M. Smardon. Dans le passé, les formes d’aide à l’innovation dans le domaine de l’agroalimentaire et de l’agrotechnologie étaient généralement offertes par divers accélérateurs, incubateurs et programmes gouvernementaux dans différentes régions du pays. La plupart du temps, elles avaient une portée municipale, régionale, provinciale ou limitée à un secteur, ce qui restreignait les possibilités de collaboration et les perspectives de croissance à l’échelle nationale et internationale. Cela signifiait également que les fonds n’étaient souvent que saupoudrés, que peu d’organisations avaient les moyens et les ressources nécessaires pour avoir une incidence significative et que les compétences dans différentes parties du pays n’étaient pas pleinement mises en valeur.

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immense growth potential of the sector in its 2018 report and underlined the need for a coordinated approach. Innovation is one of the key pillars for helping Canada achieve the goals outlined in those reports, believes Smardon, but that pillar must be supported by a wellresourced and well-connected national ecosystem. “Canada’s current ecosystem has been under-resourced, and therefore the capacity for any of the provincial initiatives to make a difference is highly limited - we operate like 10 different countries instead of with a single, focused approach,” he says. “If we are going to punch above our weight internationally, we have to solve this problem of the fragmented, siloed ecosystem - and that applies not just to agriculture but across all sectors of the Canadian economy.” The depth of the problem is illustrated by leading United Nations’ indicators that measure every country’s economic performance. Canada ranks a respectable eighth in the world for investment in agricultural research, for example, but only 20th - just ahead of tiny Slovenia - when it comes to moving innovations through commercialization into the market. One of the big reasons for that, according to Smardon, is the piece-meal make-up of Canada’s innovation ecosystem - a challenge the Engine is hoping to overcome by making it possible for like-minded organizations to collaborate instead of competing with each other. The Engine is open to businesses of all sizes, from start-ups and small and medium-sized companies right through to large multinationals. That diversity enables Bioenterprise to identify the most promising emerging innovations and entrepreneurs and provide them with the resources, support and networking connections to ensure commercial success. A particularly evolving focus is on sustainable innovation as consumers and global business are increasingly aware of the need to create a better, more sustainable future for the planet. Innovation in areas ranging from soil health, animal welfare and responsible resource use to sustainable packaging, renewable energy, eco-friendly ingredients and circular economy approaches to waste reduction is needed to increase the sustainability of food production. “This is already happening in countries like the Netherlands, Ireland or France, who are all known leaders in the innovation space,” he says, adding that ultimately, Canada should have organizations like Canada’s Food & Agri-Tech Engine across multiple sectors of the economy to collaborate and cooperate in achieving greater successes. “When you’re in a country as large as Canada, the engine model, which is virtual, is the right approach - and collectively, government, industry and other ecosystem partners can realize more benefit for their innovation investments,” he adds. Since launching the Engine last year, Bioenterprise now leads a growing national network of connected regional and

Le rapport Barton de 2017 a déterminé que le secteur agroalimentaire du Canada était un pilier de la croissance économique canadienne ayant le potentiel de devenir un chef de file mondial fiable de l’exportation alimentaire. La Table de stratégies économiques du Canada pour le secteur agroalimentaire a aussi fait ressortir l’immense potentiel de croissance du secteur dans son rapport de 2018 et a souligné la nécessité d’une approche concertée. L’innovation est l’un des piliers clés pour aider le Canada à atteindre les objectifs décrits dans ces rapports, estime M. Smardon, mais ce pilier doit être soutenu par un écosystème national qui dispose de ressources et de connexions suffisantes. « L’écosystème actuel du Canada manque de ressources. En conséquence, la capacité de toute initiative provinciale à changer la donne est très limitée. Nous fonctionnons comme dix pays différents au lieu d’adopter une façon de faire unique et ciblée », ajoute-t-il. Si nous voulons nous démarquer sur la scène internationale, nous devons renverser la fragmentation et le cloisonnement de l’écosystème – et cela ne vaut pas seulement pour l’agriculture, mais pour tous les secteurs de l’économie canadienne. » L’ampleur du problème se remarque dans les principaux indicateurs des Nations unies qui mesurent le rendement économique de chaque pays. Le Canada se classe bon huitième au monde pour ce qui est des investissements dans la recherche en agriculture, par exemple, mais il arrive seulement au vingtième rang – tout juste devant la Slovénie – pour ce qui est de la mise en marché des innovations. Selon M. Smardon, cela s’explique en grande partie par l’écosystème décousu de l’innovation au Canada, une situation que le Moteur espère corriger en permettant aux organisations aux visées similaires de collaborer au lieu de se faire concurrence. Le Moteur est ouvert aux entreprises de toutes les tailles, des jeunes pousses aux multinationales en passant par les sociétés de taille moyenne. Une telle diversité permet à Bioenterprise de déterminer les innovations émergentes et les entrepreneurs les plus prometteurs et de leur fournir les ressources, le soutien et les réseaux nécessaires à leur réussite commerciale. Les innovations durables font l’objet d’une attention particulière parce que la population et les entreprises mondiales sont de plus en plus soucieuses de créer un avenir meilleur et durable. Il faut de l’innovation pour améliorer la durabilité de la production alimentaire, que ce soit dans des domaines tels que la santé des sols, le bien-être animal et l’utilisation responsable des ressources ou encore pour ce qui a trait aux emballages durables, aux énergies renouvelables, aux ingrédients respectueux de l’environnement et à la logique de l’économie circulaire. « Des pays comme les Pays-Bas, l’Irlande ou la France avancent déjà en ce sens et sont connus pour être des chefs de file dans le domaine de l’innovation, indique M. Smardon biotech.ca

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provincial partners across research institutions, academia, mentors and experts, government, and industry. That includes creating 55 strategic partnerships, including with BIOTECanada; welcoming 77 new members; and cementing a presence in six regions Atlantic Canada, Quebec, Ontario, Manitoba, Alberta, and British Columbia. A team of 10 innovation advisors is available to support Canadian entrepreneurs from start-ups to established companies with expertise in food innovation, value chains, food and consumer markets, agri-food equipment and technology, primary agriculture and forestry, agribusiness, bioeconomy regulatory affairs, governance, investment, development and business strategies. Over 50 emerging and growth-oriented companies have received funding, mentorship, and business development support through programs like Investing in Business Innovation and SmartGrowth in Ontario, GreenShoots in Nova Scotia, Alberta Yield and Quebec’s AgTech Acceleration Program.

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en ajoutant qu’à terme, il devrait y avoir au Canada des organisations comme le Moteur des technologies agroalimentaires dans plusieurs secteurs de l’économie pour favoriser la collaboration et décupler les succès. « Dans un pays aussi grand que le Canada, un modèle comme le Moteur, qui est virtuel, constitue la voie à suivre – et, ensemble, le gouvernement, le secteur et d’autres partenaires de l’écosystème obtiendront un meilleur retour sur leurs investissements dans l’innovation », ajoute-t-il. Depuis le lancement du Moteur l’an dernier, Bioenterprise a pris les rênes d’un réseau national croissant de partenaires régionaux et provinciaux associés qui se compose d’établissements de recherche, du monde universitaire, de mentors et d’experts, du gouvernement et du secteur. Bioenterprise a noué 55 partenariats stratégiques, y compris avec BIOTECanada, a accueilli 77 nouveaux membres et a consolidé sa présence dans six régions du pays – Canada atlantique, Québec, Ontario, Manitoba, Alberta et Colombie-Britannique.

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The past year also saw the creation of a francophone innovation ecosystem involving Collège Boréal, ZoneAgTech, EcoFuel and the Canadian Space Agency, the launch of a Northern Ontario pilot agri-tech hub project and advisory committee, and development of a national science advisory committee with representation from universities, colleges and corporations across Canada. For members, partners and sponsors nation-wide, Bioenterprise offers opportunities to: • Connect with advisors, researchers, innovators, suppliers, investors and customers • Innovate to bring new products and services to market • Grow the food and agri-tech economy to leadership on the global stage For more information on Canada’s Food & Agri-Tech Engine or Bioenterprise programs and services, please contact Carla Berquó, carla.berquo@bioenterprise.ca or 519.821.2960 ext. 247 / 1.866.464.4524; www. bioenterprise.ca.

Une équipe de 10 spécialistes en innovation est à la disposition des entrepreneurs du Canada, tant des entreprises en démarrage que des sociétés bien établies, pour leur offrir des conseils en matière d’innovation alimentaire, de chaînes de valeur, de marchés d’alimentation et de consommation, d’équipement et de technologie agroalimentaires, d’agriculture et de sylviculture primaires, d’agro-industrie, de bioéconomie, d’affaires réglementaires, de gouvernance, d’investissement, de développement et de stratégies commerciales. Plus de 50 entreprises émergentes et en croissance ont bénéficié d’un financement, de mentorat et d’une aide au développement commercial par l’entremise de programmes tels qu’Investing in Business Innovation et SmartGrowth en Ontario, GreenShoots en Nouvelle-Écosse, Yield en Alberta, et la Zone AgTech au Québec. La dernière année a aussi donné naissance à un écosystème d’innovation francophone réunissant le Collège Boréal, la Zone AgTech, EcoFuel et l’Agence spatiale canadienne, le lancement d’un projet pilote de centre agrotechnique et d’un comité consultatif dans le Nord de l’Ontario, ainsi que la mise sur pied d’un comité consultatif scientifique national composé de représentants d’universités, de collèges et d’entreprises de partout au pays. Bioenterprise permet à ses membres, partenaires et parrains des quatre coins du Canada de : • entrer en relation avec des conseillers, des chercheurs, des innovateurs, des fournisseurs, des investisseurs et des consommateurs • créer des innovations pour mettre en marché de nouveaux produits et services • propulser l’économie de l’alimentation et de l’agrotechnologie en tête de peloton sur la scène mondiale. Pour tout savoir sur le Moteur des technologies agroalimentaires du Canada ou sur les programmes et services de Bioenterprise, veuillez joindre Carla Berquó à l’adresse carla.berquo@ bioenterprise.ca ou au 519-8212960, poste 247 ou au 1-866-4644524; www.bioenterprise.ca.

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Canada’s Biopharma Talent Engine Takes Leap Forward with CASTL-NIBRT Partnership SINCE COVID-19, CANADA AND THE WORLD HAVE RE-AWAKENED TO THE IMPORTANCE OF BEING MORE self-reliant in the manufacturing of vital drugs and vaccines to protect population health. Critical to meeting this challenge is the need for more skills, training and infrastructure. The Canadian Alliance for Skills and Training in Life Sciences (CASTL) is delivering on this economic demand by providing world-class training in biopharmaceutical processing that will result in a rich talent pool of individuals who are work-ready and prepared to enter, thrive, and meet the needs of the Canadian bioscience industry. Recognizing the growing need for technically skilled and trained individuals in biopharmaceutical manufacturing, CASTL has recently signed a commercial agreement with the National Institute for Bioprocessing Research and Training (NIBRT) in Ireland to be the exclusive provider of NIBRT licensed training programs in Canada. This formal partnership will support Canada’s talent needs in keeping pace with the expected growth of the biopharmaceutical manufacturing industry. CASTL is one of NIBRT’s five global partners joining a network of organizations in Australia, USA, China and Korea. NIBRT’s Global Partner Programme supports an international alliance of leading training and education organizations to help address the global shortage of a skilled biopharmaceutical manufacturing workforce. CASTL’s Executive Director Penny Walsh-McGuire said that CASTL is honoured to be the exclusive provider of 58

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NIBRT’s best-in-class training in Canada. With this partnership, CASTL is accessing more than a decade of expertise and innovation that will support and present a real opportunity for the growing bioscience industry. “NIBRT’s leading-edge programs and curriculum have proven to help power the talent development for some of the largest biopharmaceutical manufacturing companies in the world. Through this partnership, CASTL will now bring this value to Canada’s biopharma ecosystem,” said WalshMcGuire. “CASTL is committed to working with industry and academic partners across Canada in implementing technical skills and training solutions that are responsive to industry requirements.” CASTL will deliver NIBRT’s training designed specifically for the biopharmaceutical sector in Canada within CASTL’s three learning streams: New Skilling, Reskilling and Upskilling. As part of this partnership, CASTL will have access to NIBRT curriculum, collaborate on curriculum design, access the latest training courses, and establish a new Canadian biopharmaceutical skills and training centre based in Charlottetown. A global centre of excellence for training and research in bioprocessing, NIBRT develops and delivers state-of-the-art training and education programs for academic institutions and the world’s leading biopharmaceutical manufacturing companies. With world-class facilities in Ireland, NIBRT programs offers a unique combination of in-class and hands-on training, customized to meet the needs of

industry. They also offer comprehensive digital training through their NIBRT Online Academy (NOA). Remarking on the agreement, NIBRT CEO Darrin Morrissey commented, “The exciting plans for CASTL will help Canada address the shortage of a skilled workforce, which is a key bottleneck in global biopharma manufacturing. We are very much looking forward to helping CASTL support Canadian biopharma students and industry.” A CASTL industry partner and one of the leading Contract Development and Manufacturing Organizations in North America, BIOVECTRA Inc. accessed NIBRT’s online academy (NOA) curriculum to upskill nearly 100 recently hired employees at the Charlottetown, PE and Windsor, NS operations, who completed more than 700 courses. The integration of this high-quality online training content in their employee learning proved to increase productivity and drive manufacturing efficiencies while minimizing time away from production activities. Both BIOVECTRA employees and supervisors reported a high level of satisfaction with the NOA training, including 88% of supervisors reporting that the courses were useful for their direct reports and 95% of employees stating that they would recommend the NOA courses. Oliver Technow, CEO of BIOVECTRA and Chair of the PEI BioAlliance Board, said that NIBRT’s curriculum offered an excellent opportunity for employees to deepen subject matter expertise.

“Through CASTL’s partnership with NIBRT, BIOVECTRA and biopharmaceutical manufacturing organizations across Canada will have access to relevant training that is built to meet the needs of industry. Employees at BIOVECTRA have strengthened their knowledge base as a result of NIBRT’s programming and we intend to build this into our onboarding process for new hires.” Letters of support for this CASTL initiative provided by adMare BioInnovations, BioTalent Canada, BIOTECanada and Innovative Medicines Canada were important in demonstrating the national scope of the partnership with NIBRT. CASTL’s national skills and training network is being developed by the PEI BioAlliance, with support from the Government of Canada, the Future Skills Centre, and the Government of Prince Edward Island. Penny Walsh-McGuire said that CASTL is currently connecting with industry partners as well as universities and colleges across Canada that wish to become part of the national biopharma skills and training ecosystem. “Canada’s aspirations for growth in the biopharma sector, stimulated by recent unprecedented investments by our federal government and private sector companies, can only be achieved with through a well-supported partnership of academic and industry leaders. CASTL will facilitate this effort by developing and executing a robust and proven skills and training program for Canada.” For more information on CASTL, visit castlcanada.ca.

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A thriving life sciences sector in Canada needs to be nurtured and supported if we are to leverage and build on its recent successes Le secteur florissant des sciences de la vie au Canada doit être nourri et soutenu si nous voulons tirer parti de ses récents succès. by Peter van der Velden, co-founder and the Managing General Partner, Lumira Ventures par Peter van der Velden, cofondateur et associé directeur principal de Lumira Ventures

GLOBALLY, THE LIFE SCIENCES SECTOR HAS BEEN PARTOUT DANS LE MONDE, LES SCIENCES DE LA VIE FONT LES MANCHETTES DEPUIS LE DÉBUT DE LA MAKING HEADLINES SINCE THE OUTBREAK OF COVID-19. PANDÉMIE. L’intérêt porté par la grande majorité des gens à The interest of virtually everyone in their health and leur santé et leur bien-être s’est accru, à juste titre, de façon well-being has, rightfully, increased exponentially resulting exponentielle, ce qui a entraîné une hausse des in increased investments in healthcare innovation, both investissements dans l’innovation en santé, tant de la part des from the government and private investors. In 2020, life gouvernements que d’investisseurs privés. En 2020, les sciences was one of the only growth sectors within sciences de la vie ont constitué l’un des seuls secteurs ayant a Canada’s burgeoning innovation and venture capital connu une croissance au sein des écosystèmes d’innovation ecosystems. Financing activity in the sector reached a et de capital-risque en plein essor au Canada. Les activités de multi-decade high of $1.1 billion (via 89 deals), representing financement du secteur ont atteint un sommet des dernières 26% of all venture capital deployed in Canada. At the décennies, soit 1,1 milliard de dollars (89 ententes), ce qui same time, public market support for Canada’s biotech représente 26 % de tout le capital-risque investi au Canada. ecosystem was unparalleled. In early 2020, British Au même moment, le marché public a accordé un appui Columbia-based companies Aurinia Pharmaceuticals and inégalé à l’écosystème de biotechnologie du Canada. Au Zymeworks Inc., both achieved multi-billion dollar public début de 2020, les sociétés Aurinia market valuations, helping pave the way Pharmaceuticals et Zymeworks de Colombiefor the successful mid-year IPOs of two Britannique ont toutes deux atteint des more VC-backed companies, Ontariovalorisations de plusieurs milliards de dollars based Fusion Pharmaceuticals and sur le marché public, ce qui a contribué à Quebec-based Repare Therapeutics, and ouvrir la voie aux introductions en bourse the year-end IPO of British Columbiaréussies, en milieu d’année, de deux autres based AbCellera. These three IPOs were sociétés financées par capital-risque – Fusion not just the largest in Canadian biotech Pharmaceuticals de l’Ontario et Repare history, but they also led the IPO activity Therapeutics du Québec – ainsi qu’à celle for the entire ecosystem of Canadian d’AbCellera de Colombie-Britannique en fin venture-backed companies across all d’année. Ces trois introductions en bourse sectors. n’ont pas seulement été les plus importantes But sector milestones over the past 18 de l’histoire de la biotechnologie au Canada, months have been about so much more mais elles ont aussi présidé aux activités than financings. Perhaps most d’introduction en bourse de l’ensemble de importantly many of these companies l’écosystème des entreprises canadiennes fulfilled the promise of delivering Peter van der Velden, co-founder financées par capital-risque, tous secteurs innovative medical products with the and Managing General Partner, confondus. potential to markedly transform patient Lumira Ventures/cofondateur et associé directeur principal de Lumira Or, les jalons franchis par le secteur au lives, not just in Canada, but also around Ventures

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the world. mRNA COVID-19 vaccines that are the backbone of our drive back to a normal life were enabled by delivery technology from Precision NanoSystems. AbCellera’s product bamlanivimab was authorized under emergency/special use pathways in multiple countries to treat high-risk COVID-19 patients. In January, Aurinia Pharmaceuticals’ Lupkynis became the first FDA-approved oral therapy for lupus nephritis. These products are the result of years of work and investment, and they lay an incredible foundation for the rapidly emerging next generation of innovations, innovators and entrepreneurs from Canada’s world-class academic research institutions, hospitals and existing biotech enterprises. COVID-19 also engaged our entire community. It should not come as a surprise that life science VCs, entrepreneurs, academics and clinicians responded to the crisis quickly as these are deeply engaged people who are passionate about protecting and improving the health of Canadians. But what made this response so impactful was that it happened truly in partnership with governments. VCs, entrepreneurs, academics and clinicians responded to the call from governments by volunteering thousands of hours of their time to help the governments make better, more informed decisions with respect to vaccine acquisition, biomanufacturing and how to best leverage Canada’s expanding biotech ecosystem to provide accelerated pathways to products for patients. Examples of this collaboration included the Vaccines Task Force, the COVID-19 Joint Biomanufacturing Subcommittee and the allocation of capital from Government of Canada’s Strategic Innovation Fund to promising COVID-focused innovations, including those from Lumira portfolio companies such as Edesa Biotech and IMV Inc., and other Canadian companies including AbCellera, Medicago, Precision NanoSystems, VBI Vaccines, and VIDO InterVac. For Lumira Ventures, the past 18 or so months have been equally transformative. In virtually every dimension of our business, this period built on, and reflected, the strength of the platform we have been developing for the past decade. Some of the highlights include: • Back-to-back wins of the CVCA’s Western Region Canadian impact Deal of the Year Award for our investment and successful exits from Aurinia Therapeutics and Zymeworks which both achieved multi-billion dollar public market valuations thus allowing us to deliver $100+M in returns to our investors. • Securing FDA approvals for two products: Lupkynis™ by Aurinia and Cosela™ by G1 Therapeutics. Lupkynis™ is the first FDA-approved oral therapy for lupus nephritis, a condition that causes irreversible kidney damage and even death. Cosela is a first-in-class drug to reduce chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.

seulement liés au financement. Il est sans doute encore plus important que nombre de ces sociétés aient réussi à offrir des produits médicaux novateurs ayant le potentiel de nettement transformer la vie des patients, non seulement du Canada, mais du monde entier. Les vaccins à ARNm contre la COVID-19, desquels dépend notre retour à une vie normale, ont été rendus possibles par la technologie d’administration de Precision NanoSystems. Le bamlanivimab, un produit d’AbCellera, a été autorisé à des fins d’urgence ou des fins spéciales dans plusieurs pays pour traiter les patients à haut risque atteints de la COVID-19. En janvier, le médicament par voie orale Lupkynis d’Aurinia Pharmaceuticals a été le premier à être autorisé par la FDA pour traiter la néphropathie lupique. Ces produits sont le fruit d’années de travail et d’investissements, et ils servent d’assises fantastiques pour la prochaine génération d’innovations, d’innovateurs et d’entrepreneurs qui émergent rapidement des établissements universitaires de recherche, des hôpitaux et des entreprises de biotechnologie de classe mondiale au Canada. La COVID-19 a aussi eu pour effet de mobiliser toute notre communauté. Il n’est sans doute pas étonnant que les investisseurs de capital-risque, les entrepreneurs, les universitaires et les cliniciens du secteur des sciences de la vie aient réagi rapidement à la crise, car ils sont profondément engagés et ont à cœur la protection et l’amélioration de la santé de la population canadienne. Mais leur réponse a porté autant de fruits parce qu’elle a pu compter sur un véritable partenariat avec les gouvernements. Les investisseurs de capital-risque, les entrepreneurs, les universitaires et les cliniciens ont répondu à l’appel des gouvernements en donnant bénévolement des milliers d’heures pour aider les autorités à prendre des décisions justes et éclairées en matière d’acquisition de vaccins, de bioproduction et de stratégies pour tirer parti de l’écosystème biotechnologique du Canada en pleine expansion afin que la population ait accès rapidement à des produits. Cette collaboration a notamment mené au Groupe de travail sur les vaccins, au Sous-comité conjoint de la bioproduction et à l’allocation de capitaux du Fonds stratégique du Canada pour l’innovation à des innovations prometteuses contre la COVID-19, y compris celles d’entreprises du portefeuille de Lumira, telle Edesa Biotech et IMV, et d’autres sociétés canadiennes, dont AbCellera, Medicago, Precision NanoSystems, VBI Vaccines et VIDO InterVac. Pour Lumira Ventures, les 18 derniers mois ont été tout aussi transformateurs. Dans presque toutes les facettes de nos activités, cette période a permis d’amplifier et de montrer la puissance de la plateforme sur laquelle nous travaillons depuis dix ans, comme le montrent les exemples suivants : • Nous avons remporté deux fois de suite le prix Deal of the Year pour la région de l’Ouest du Canada remis par la Canadian Venture Capital and Private Equity Association (CVCA) pour notre investissement et nos sorties réussies d’Aurinia Therapeutics et Zymeworks, qui ont mené à la

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Completing 28 new and follow-on investments. Q1 of 2021 was a record period for financing activity in our portfolio, with ten of our companies (including 7 Canadian companies) raising over US$575M. • Completing three highly successful strategic trade sale exits and five public market realizations including – the IPO of our first Canadian digital health investment. With all that investment and exit activity and a pandemic in full swing, you might think that fund raising was far from a priority, but not so. In July of 2021 we closed on an oversubscribed Fund IV and a new fund partnered with Angelini Pharma to focus on CNS and Rare Disease. In aggregate, US$256M/C322M of new capital. Fund IV was meaningfully over-subscribed making it, to

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valorisation de plusieurs milliards de dollars des deux entreprises sur le marché public, ce qui nous a permis d’obtenir des rendements de plus de 100 millions de dollars pour nos investisseurs. Nous avons obtenu l’approbation de la FDA pour deux produits, à savoir le LupkynisMD d’Aurinia et le CoselaMD de G1 Therapeutics. Le Lupkynis est le premier médicament par voie orale à obtenir une homologation de la FDA pour traiter la néphropathie lupique, une maladie qui cause une atteinte rénale irréversible et même la mort. Le Cosela est le premier médicament de sa catégorie à réduire la myélodépression induite par la chimiothérapie chez des adultes atteints d’un cancer du poumon à petites cellules au stade étendu. • Nous avons réalisé 28 nouveaux investissements et investissements de suivi. Le premier trimestre de 2021 a été une période record pour les activités de financement de notre portefeuille, puisque dix de nos entreprises (dont sept canadiennes) ont amassé plus de 575 millions de dollars américains. • Nous avons réalisé trois sorties très réussies et cinq ventes sur le marché public, y compris l’introduction en bourse de la première société canadienne dans laquelle nous avons investi en santé numérique. Avec toutes ces activités d’investissement et de sorties et avec une pandémie qui bat son plein, il serait facile de croire que la collecte de fonds a été reléguée au second plan, mais ce n’est pas le cas. En juillet 2021, nous avons clôturé le Fonds IV sursouscrit et avons créé un nouveau fonds en partenariat avec Angelini Pharma qui se concentrera sur le système nerveux central et les maladies rares. Au total, cela représente 256 millions de dollars américains (322 M$ CA) de nouveaux capitaux. Le Fonds IV a été largement sursouscrit, ce qui en fait, à notre connaissance, le plus grand fonds institutionnel de capital-risque en sciences de la vie jamais amassé au Canada. Le fait que le Fonds IV ait la base d’investisseurs partenaires la plus équilibrée et la plus large de l’histoire de Lumira illustre sans doute très bien l’intérêt mondial accru pour l’investissement dans l’innovation biomédicale. Nos investisseurs proviennent de sept pays et comprennent

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the best of our knowledge, the largest institutional life sciences venture capital fund ever raised in Canada. The heightened global interest for investing in biomedical innovation is perhaps best evidenced by the fact that Fund IV has the most balanced and broadest limited partner investor base in Lumira’s history. Our investors come from 7 countries and include: family offices and family office foundations, funds-of-funds, governments, pension plans and strategic investors. Despite these successes, there is still much more to do if we are to leverage the current momentum to build a truly new generation economy that includes a strong life sciences component, if we are to ensure healthcare sovereignty, and finally, if we are to ensure that Canadians, and not foreign entities are the primary beneficiaries of the government’s substantial investment in basic healthcare-related science. Entrepreneurs and existing sources of capital cannot do this on their own. To achieve this, the chronic underfunding of Canadian life sciences innovation needs to be addressed with sustainable sources of domestic capital. Canadian pension plans, particularly those outside Quebec, need to truly be “Investing for Generations” and recognize that not only is the innovative life sciences sector a source for domestic economic prosperity but also that it is a high impact, high performance asset class that for the past decade has materially out-performed virtually all the other asset classes they have been investing in. Domestic governments need to view our healthcare ecosystem as an asset, rather than an obligation and a cost-centre, as this will be the key to leveraging it as an engine for economic growth and prosperity. The translation of healthcare innovation from Canada’s academic and hospital research centres needs to be nurtured and fostered. With this latter objective in mind we are proud to be the only VC manager in Canada to have donated part of their carried interest profits to 12 leading Canadian healthcare foundations. Finally, we need to continue to build on our successes by opening the window of opportunity and helping the next generation of Canada’s best and brightest healthcare innovators understand that their opportunity, and that of our country to be a leader in delivering impactful healthcare impact innovation, is not limited to the traditional career routes of “being a doctor, working in a lab or being an entrepreneur who starts a company”. To help with this objective, in 2021, we launched our Venture Innovation Partners (“VIP”) program. The VIP is an up to 12 month, fully immersive, internship with Lumira Ventures for students in the final year of their academic education. We believe that there are countless ways to contribute to our sector and as such the goal of the VIP program is simple – open doors, eyes and minds; create unparalleled access and connectivity; and encourage our best and brightest to find their own road forward in our sector.

des cabinets de gestion de patrimoine familial et des fondations familiales, des fonds de fonds, des gouvernements, des régimes de retraite et des investisseurs stratégiques. Malgré toutes ces réalisations, il reste encore beaucoup à faire pour tirer parti de l’élan actuel en vue de bâtir une économie qui sera véritablement de nouvelle génération et qui comprendra une forte composante des sciences de la vie si nous voulons assurer notre souveraineté en matière de soins de santé et, enfin, si nous voulons que la population canadienne, et non des entités étrangères, soit la principale bénéficiaire de l’investissement substantiel du gouvernement dans la science fondamentale liée aux soins de santé. Les entrepreneurs et les sources de capital actuelles ne peuvent y parvenir seuls. Pour y arriver, il faut régler le sousfinancement chronique de l’innovation dans les sciences de la vie au Canada en recourant à des sources durables de capitaux nationaux. Les régimes de retraite du Canada, en particulier ceux hors du Québec, doivent véritablement « Investir pour des générations » et reconnaître que non seulement le secteur innovant des sciences de la vie est une source de prospérité économique nationale, mais aussi qu’il constitue une classe d’actifs à fort impact et à haut rendement qui, au cours de la dernière décennie, a surclassé presque toutes les autres classes d’actifs dans lesquelles ils ont investi. Les gouvernements au pays doivent voir notre écosystème de soins de santé comme un atout, plutôt qu’une obligation et un centre de coûts. Il s’agit de la clé pour faire de cet écosystème un moteur de croissance économique et de prospérité. Il faut encourager et faciliter la mise en application des innovations en matière de soins de santé issues des centres de recherche universitaires et hospitaliers au Canada. Dans cet esprit, nous sommes fiers d’être le seul gestionnaire de capital-risque au Canada à avoir fait don d’une partie des bénéfices de son intérêt reporté à 12 grandes fondations canadiennes dans le domaine de la santé. Enfin, nous devons continuer à miser sur nos succès en tirant parti des circonstances favorables et en aidant la prochaine génération d’innovateurs les plus prometteurs et les plus brillants dans le domaine de la santé du Canada à comprendre que leurs options professionnelles, et la possibilité que notre pays devienne chef de file en matière d’innovation ayant une incidence dans les soins de santé, ne se limitent pas aux parcours professionnels traditionnels consistant à « être médecin, à travailler dans un laboratoire ou à devenir un entrepreneur qui fonde une entreprise ». Dans cette optique, en 2021, nous avons lancé notre programme VIP, pour Venture Innovation Partners, qui offre un stage entièrement immersif d’une durée maximale de 12 mois chez Lumira Ventures à des étudiants en dernière année d’université. Nous croyons qu’il existe d’innombrables façons de contribuer à notre secteur et, à ce titre, l’objectif du programme VIP est simple : ouvrir les portes, les yeux et les esprits; créer des relations et une connectivité sans précédent; et aider nos meilleurs éléments à forger leur propre voie dans notre secteur. biotech.ca

Innovative approaches to developing tomorrow’s medicine CANADA HAS A STRONG TRACK RECORD OF GLOBALLY RECOGNIZED EXPERTISE IN BIOLOGICAL SCIENCES which has really come to shine during the last 18 months. However, it takes more than science to build a global leader; it takes people, capital and action. This is what Amplitude has been focused on providing. Amplitude’s commitment to creating, building and growing globally competitive healthcare companies is based on a potent mixture of opportunity and experience. Canada’s fertile innovation ecosystem and its ability to produce enabling technologies represents an opportunity to develop world-leading medical technologies and therapeutic platforms. Based across the country, Amplitude’s team has considerable experience successfully investing to accelerate the growth of these companies and in supporting the 64

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entrepreneurial teams catalyzing these technologies to transform human health. “At Amplitude, we welcome every opportunity to nurture, support and work with world-class scientists thriving to develop new therapies in precision medicine,” says JeanFrançois Pariseau, a partner at Amplitude. And since its inception, Amplitude has done just that. Today, it has more than $300 million under management, a direct result of its innovative approach to investing in emerging precision medicine companies. But while Amplitude continues to play a significant role in scaling the Canadian healthcare ecosystem, it believes the virtuous cycle of growth involving the development of clusters with deep entrepreneurial, scientific, and financial capabilities is just beginning. To accelerate this cycle,

Amplitude is working across the ecosystem to encourage the development of more ambitious vision and strategies for the early-stage companies and entrepreneurs. “Companies with the strongest strategies and boldest vision will attract the talent and capital required to impact healthcare on the global stage,” says Jean-François. “Amplitude wants to see more of these ambitious and strategic entrepreneurs across the country. That’s why we’re looking to be more proactive in the development of this class of professional.” Amplitude believes that the skills required for “entrepreneuring” can be learned and that more can be done across the ecosystem to identify and foster the growth of individuals with entrepreneurial ambition. Acting on that philosophy, Amplitude is encouraging life science PhDs, postdocs and MDs with deep scientific know-how critical to this domain – but also with a passion for translating world leading science to make an impact on patient lives – to hone their entrepreneurial capabilities through the development of new ventures directly at Amplitude. “We’re reaching out to outstanding scientists, engineers and inventors all across the country who, while eager to remain rooted in health and life science, are keen to explore the dynamic and creative scientific impact available to them as entrepreneurs,” says Michael Mee, a principal at Amplitude. To attract these talented individuals, earlier this year Amplitude introduced the Amplitude Ventures Fellowship Program, a three-month virtual program in which successful applicants are immersed in Amplitude’s unique approach to venture creation and given the opportunity to hone the skills required to develop the vision and strategy required of a world class biotech from an initial scientific insight. Throughout the process, fellows are challenged to explore scientific concepts outside of their area of expertise; to develop hypotheses of what novel ventures could emerge; to quickly test those hypotheses to validate their potential value and impact on healthcare; and, ultimately, to confirm the feasibility of technological innovation required to underpin such companies with world-changing potential. The fellowship will accept six to eight fellows annually. The first six were accepted in June of this year and completed their fellowship in August. “The program is obviously still in its infancy,” says Michael, “but we were all very excited about how we pushed

“We’re reaching out to outstanding scientists, engineers and inventors all across the country who, while eager to remain rooted in health and life science, are keen to explore the dynamic and creative scientific impact available to them as entrepreneurs”

the fellows to think about the different types of platforms that could arise from new and emerging science.” In fact, the Amplitude team has already identified the kernels of potential new ventures. Over the summer, fellows had an opportunity to expand and define the alternative futures that could be enabled through the development and evolution of these kernels. “We were pleasantly surprised by the entire process,” added Michael, “not only by the positive reaction from the institutions we approached but also by the high level of people who applied. We received over a hundred applications, and the final choices were not easy. Clearly, the fellowship program is achieving what we hoped it would achieve.” Amplitude is also proud to participate in an acceleration program designed to assist pre-seed or seed-stage stage therapeutic, med-tech or digital health companies in Quebec. Operated by adMare BioInnovations (adMare), with the financial support of the province and the City of Montreal, the two-year program supports up to eight companies with up to $150,000 of in-kind customized adMare resources. The selected companies also have access to adMare’s infrastructure and resources such as discounted laboratory and office space, complimentary scientific and business support, mentoring and training. Amplitude was proud to serve as a program delivery and selection committee partner. Assisting and developing top science talent is one thing, repatriating talent back to Canada is another critical element of this broader effort, says Michael. Historically the United States and Europe were viewed to offer more attractive funding and future career opportunities – leading to a loss for Canada of both the scientists and the made-in-Canada intellectual property – but the tide is turning. “A key element to both building the Amplitude team and scaling the companies we work with is to seek out and recruit talent with exceptional international experience in company building, operating and investing,” says Michael. “Through our fellowship program, and in partnership with our companies and the broader ecosystem, we’re working to help Canada’s talented innovators – and their discoveries – take their rightful place on the world stage, rooted here at home.” biotech.ca

WE ARE DEVELOPING ANIMAL HEALTH TECHNOLOGIES WE ARE ANIMAL HEALTH THAT THEDEVELOPING WORLD NEEDS NOW AND INTO TECHNOLOGIES THE FUTURE, THAT THEAWORLD NOW AND INTO THE FUTURE, TO MAKE GLOBALNEEDS DIFFERENCE.

TO MAKE A GLOBAL DIFFERENCE.

EVAH Corp (EVAH standing for Evolution in Animal Health) is a Québec-based biotechnoloEVAH Corp (EVAH standing for Evolution in gy company that specializes in the health of Animal Health)The is acompany Québec-based food animals. also hasbiotechnoloan aquagy company that specializes in the health of culture division in Atlantic Canada.

food animals. The company also has an aquaculture division in Atlantic The global population willCanada. grow significantly over the next decades, driving demand for food

The population grow significantly even global higher. The health of will people, animals and the environment are interconnected, and that's over the next decades, driving demand for food where WHO's "One World One Health" concept even higher. The health of people, animals and comes in. the environment are interconnected, and that's where WHO's "One World One Health" concept This approach is particularly relevant in the comes in.

areas of food safety, the fight against zoonotic diseases (infectious diseases that can be transThis approach is particularly relevant in the mitted from animals to humans or from humans areas of food therabies fight against to animals, like safety, influenza, and Rift zoonotic Valley diseases diseases that can be transfever) and(infectious the fight against antibiotic resistance mitted animals humans microbes or from humans (which from occurs whentoresistant are to animals,after like influenza, rabies and Riftand Valley selected antimicrobial treatment fever) andbecome the fight against antibiotic resistance diseases harder to treat).

(which occurs when resistant microbes are selected after antimicrobial About 70% of the increasedtreatment food pro-and diseases harder to treat).from new duction become will have to come

technologies and innovations that About thefor increased proaddress70% the of need a regular food supply duction haveprotein. to come from new of healthywill animal

technologies and innovations that address need supply 66 fallthe | autumn 2021 for a regular BIOTECanada

World Health Organization's concept "One World One Health"

WHY ANIMAL HEALTH?

Founded in Québec, EVAH has 18 emplo in that province and in Atlantic Canada, m Given what's at stake and the urgent need to whom are women scientists. They are all respond to the current health crisis, the former togetherEVAH to become a Canadian lead Founded ing in Québec, has 18 employees WHY ANIMALand HEALTH? managers staff of Québec-based Prevtec animaland health, addressing gap in in that province in Atlantic Canada,a most of its sect Microbia are teaming up urgent again need to build Given what's at stake and the to a new, one hand, partnering academic in whom areon women scientists. They arewith all workinnovative platform. respond to the current health crisis, the former tions the scientific community ing together to and become a Canadian leader in and, o managers and staff of Québec-based Prevtec animal health, a gap in with its sector otheraddressing hand, partnering largeby,Animal H Microbia are specializes teaming up again build a new, EVAH in tothe research and on one hand, partnering with academic institucompanies. innovative platform. tions and the scientific community and, on the development of biologics to protect other hand, partnering with large Animal Health food animals infrom bacterialand disease, EVAH specializes the research companies. as an alternative to antibiotics. development of biologics to protect

food animals from bacterial disease, Wealternative are also developing microbiome-based as an to antibiotics. solutions to enhance the growth and perforof food animals, as well as a parasiticide We mance are also developing microbiome-based for farmed salmon will ensure sustainable solutions to enhance thethat growth and performance of food animals, aswild well salmon. as a parasiticide growth and protect for farmed salmon that will ensure sustainable growth and protect wild salmon.

WHO WE ARE

WHO WEisARE EVAH a Business and IP platform in Animal Health based in Canada. The team includes

Establishing

global

presence

req

EVAH is a Business and IP platform in Animal resources that SMEs don't requires have. EVAH is business with in selling Establishing a global presence Health based inpeople Canada. Theexperience team includes mitted to all three stages research that SMEs don't have. EVAH is of cominnovations, scientists with expertiseresources in business people and with experience in selling strategic planning mitted todevelopment: all three stages of research and assess developing health products. innovations, andindustrial scientistsanimal with expertise in efficacy pilot trials andassessment, safety testing, and development: strategic planning developing industrial animal health products. efficacy pilot trials formulation. and safety testing, and final product This collaboration will create intellecproduct formulation. This collaboration will create intellec-

tual property value for animal health

Once the technologies and innovations tualproducts property that valueare forinanimal health Once thegone technologies havedevelop high demand. throughand the innovations research and products that are in high demand. gone through the research and development phases, EVAH will partner with large pha

phases, EVAH will partner with large pharmaceutical companies that have the resourc ceutical companies that have the resources to obtain regulatory approvals and comme obtain regulatory approvals and commercialize products ize products worldwide.worldwide.

EVAH’s positioning in the know EVAH’s positioning is timely in isthetimely knowledge sector and will contribute tomorrow’s sector and will to contribute to global tomorrow’s g economy.economy.

From left to right: Michel Fortin, President & Chief ExecuFrom left to right: Michel Fortin, President Chief Executive Officer of EVAH Corp with Scientific Advisory & Comtive Officer of PhD, EVAH Corp with Scientific Committee: André Buret, John Brennan, PhD, PaulAdvisory Dick, André PhD,MSc. John Brennan, PhD, Paul Dick, DVM,mittee: MSc and JeanBuret, Szkotnicki,

To read more about EVAH Corp To read more about EVAH Corp please visit our website please visit our website www.evahcorp.ca

www.evahcorp.ca

DVM, MSc and Jean Szkotnicki, MSc.

biotech.ca

THE PANDEMIC FORCED CANADA TO RE-EVALUATE ITS BIOTECHNOLOGY SECTOR By George Nikopoulos, Chief Executive Officer and President of Mannin Research.

THE COVID-19 PANDEMIC HAS SHAKEN UP CANADA’S BIOTECHNOLOGY SECTOR - a shakeup that was sorely needed, providing a catalyst for change that was long overdue. When the pandemic arrived on our shores, it uncovered a troubling reality. Canada was unprepared for an event of this magnitude, lacking the trained people and the facilities to properly address the treatment challenges posed. As countries around the world shut their borders to contain the spread of the virus, many of Canada’s supply pipelines were cut off. Our system was not designed to withstand a disruption in global supply chains, and the pandemic drove home the importance of having a domestic chain of both supply and capacity. This started with personal protective equipment (PPE), and quickly manifested in vaccines, as countries with production capacity were keen on keeping what they could for their own populations before sending any abroad. Canada had only a relatively minimal capacity for

domestic vaccine production, and no capacity to generate the novel mRNA based vaccines. It became clear that addressing the needs of the pandemic required a collective effort in our industry, our governments and our people, in order to re-invest in a made-in-Canada solution. The Government of Canada responded with a huge increase in federal funds dedicated to the creation of biomanufacturing capacity. The last federal budget committed more than $3.7 billion over the next seven years to the biotechnology sector, an investment that is sorely needed to attract talent, train people and give them a place to work. This investment, and others like it, are making a difference. Prior to the pandemic, we at Mannin Research were developing novel therapeutics to treat vascular diseases, including glaucoma. Since our recombinant protein therapeutic was designed to target vascular endothelial cells in the host-patient, it could also serve as a therapeutic in George Nikopoulos, Chief Executive Officer and President of Mannin Research. infectious and inflammatory diseases.

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Furthermore, because the therapeutic is enhancing defenses of the host, rather than targeting a specific infectious agent, its efficacy should not be affected by the various strains, or variants of the coronavirus. Mannin has also pivoted its R&D and collaboration outlook to meet the need for made-in-Canada solutions for new therapeutics to treat patients with COVID-19. This means on-shoring as much of the supply chain as possible and utilizing Canadian-owned and controlled firms. First, we partnered with Cyclica to develop new drugs, and evaluate repurposed drugs, utilizing their proteome-wide, AI drug discovery platform. Cyclica, a Canadian company and global leader in drug discovery and development that is embracing the complexity of disease, helped accelerate our work and improve our chances of success. Through DNAstack, another 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 Canada’s Digital Technology Supercluster in Vancouver. This consortium of more than a dozen organizations and companies supports the development of a digital technology platform to provide near real-time monitoring of the virus’ evolutionary

strains, transmission patterns, mutation rate and drug targets. 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. Mannin’s experimental treatment moved quickly along the developmental pathway — and is showing promise. Our lead drug to treat Acute Respiratory Disease Syndrome in COVID-19 patients is a recombinant fusion protein that treats the patient, instead of directly targeting the virus. It is not a cure for COVID, but it strengthens a patient’s blood vessels and protects them against lung injury and breathing problems, inflammation and sepsis, and other infections that may cause the body’s organs to begin shutting down. It will also help keep COVID patients out of the ICU and off a ventilator. This therapeutic is slated to begin clinical trials in early 2022, while we build-out the capacity to manufacture it in Canada. This will enable our company to scale-up and meet the needs of Canadians, and also address 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 the evolving pandemic, and future pandemics. We also want to foster the ecosystem that helped bring our drug to this stage. This will pay dividends in the future by rebuilding the biotechnology sector as a truly collaborative space where competitors work together and share in each other’s successes. For example, small and medium enterprises (SME) in Canada could not succeed in moving to the scale-up phase without the rapid growth and “halo effect” created by other Canadian companies like Cyclica and DNAstack. The pandemic crisis has provided focus for our industry. It has made it easier for Canadian SMEs to connect, grow and accelerate drug development for the benefit of all Canadians. This is just the starting point. Mannin is on pace to double in size in the next six months, and then double again within a year. And we are not alone. By the time we reach the second anniversary of COVID-19’s arrival in Canada, there will be a significantly increased biotechnology footprint in Canada, with more investment from the private sector. 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. biotech.ca

knowledge connaissance

Canadian Commercialization Trends for Emerging Biopharma In a world seriously impacted both socially and economically by an ongoing global pandemic, governments quickly turned to the biotechnology sector for help in mounting a therapeutic response.

Tendances canadiennes de la mise en marché pour les sociétés biopharmaceutiques émergentes Les bouleversements tant sociaux qu’économiques causés par une pandémie mondiale qui perdure ont rapidement amené les gouvernements à miser sur le secteur de la biotechnologie pour les aider à trouver une solution thérapeutique. by Matthew Norton, General Manager, Commercial, Technology and Government Solutions, IQVIA Canada par Matthew Norton, directeur général, Solutions commerciales, technologiques et gouvernementales, IQVIA Canada

SEVERAL CANADIAN BIOTECHNOLOGY COMPANIES PLUSIEURS SOCIÉTÉS CANADIENNES DE BIOTECHNOLOGIE ONT RÉORIENTÉ LEURS EFFORTS DE HAVE PIVOTED THEIR TECHNOLOGY AND PRODUCT DÉVELOPPEMENT DE TECHNOLOGIES ET DE PRODUITS DEVELOPMENT, directing research into developing pour se consacrer à la recherche sur les vaccins et les vaccines and therapeutics to target COVID-19. Biopharma traitements contre la COVID-19. Les innovations innovation was viewed as the solution to defeating the biopharmaceutiques étaient perçues comme la clé de la lutte deadly COVID-19 virus, which was a major contributing contre ce virus mortel, ce qui a largement contribué au succès factor to the sector’s success during the past year. du secteur dans la dernière année. With three vaccines being approved for emergency use in Avec l’homologation en situation Canada and made available in record d’urgence et la mise en marché en un time, and several others poised to temps record de trois vaccins au Canada debut, public biopharma companies et avec l’arrivée prochaine de plusieurs large and small closed out the year in autres vaccins, les petites et les grandes positive territory. The NASDAQ sociétés publiques de Biotech Index increased 26% in value biopharmaceutique ont terminé l’année year-over-year, from 2019 to 2020. sur une note positive. L’indice NASDAQ The positive investment climate for Biotechnology a connu une biotechnology innovation was a augmentation de sa valeur de 26 % sur contributing factor in the surge in douze mois, de 2019 à 2020. Le climat valuations of Canadian biotechnology favorable aux investissements dans equities. It also contributed to a 36% l’innovation en biotechnologie a increase in the number of public contribué à la valorisation des actions companies to 85, with a collective de ce secteur au Canada. Il a aussi market cap of almost C$32 billion contribué à une augmentation de 36 % (US$25 billion), more than double the du nombre de sociétés publiques, qui 2019 total. [source: Section 9.5 Matthew Norton, GM for Commercial, sont maintenant 85, avec une PharmaFocus 2025 publication] Technology and Government solutions, IQVIA

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capitalisation boursière collective de

knowledge connaissance

Biotech and emerging biopharma (EBP) companies are at the root of early-stage drug development. Their performance, the environment in which they operate, and their relationship to other stakeholders in the health system plays a critical role in determining the future of many novel therapies and health technologies. EBPS ARE PUSHING THE BOUNDARIES OF SCIENCE TO DELIVER BREAKTHROUGH THERAPIES TO PATIENTS To speed up the time to market, EBP companies need to take advantage of new trial designs, new technologies such as artificial intelligence, new strategic partnerships, and other innovative strategies. They need to partner with those who understand their unique challenges and can provide them with innovative solutions so they can reach their milestones across the clinical to commercial journey. BIOTECH COMPANIES DEAL WITH UNIQUELY COMPLEX CHALLENGES Emerging biopharma and biotech companies have proven to be critical drivers of innovation, representing over 80% of early-stage research and over 70% of late-stage research globally. Despite this rapid growth, these companies face critical clinical and commercial decisions as they mature in the market. [see Table 1]

LES SBÉ REPOUSSENT LES LIMITES DE LA SCIENCE POUR ARRIVER À DES TRAITEMENTS RÉVOLUTIONNAIRES Pour accélérer le temps de mise en marché, les SBÉ doivent tirer parti des nouvelles façons de concevoir les essais, de nouvelles technologies telle l’intelligence artificielle, de nouveaux partenariats stratégiques et d’autres stratégies novatrices. Elles doivent s’associer à des entités qui comprennent leurs défis particuliers et qui peuvent leur fournir des solutions innovantes qui leur permettront d’atteindre leurs objectifs tant cliniques que commerciaux.

LES SOCIÉTÉS DE BIOTECHNOLOGIE SONT CONFRONTÉES À DES DÉFIS D’UNE COMPLEXITÉ UNIQUE

CRITICAL CLINICAL DECISIONS

COMMERCIALIZATION DECISIONS

Les SBÉ se sont avérées être des moteurs essentiels de l’innovation, étant responsables de plus de 80 % de la recherche en phase initiale et de plus de 70 % de la recherche en phase finale dans le monde. Malgré leur croissance rapide, ces sociétés doivent prendre des décisions névralgiques sur les plans clinique et commercial à mesure qu’elles se taillent une place sur le marché. [voir le tableau 1]

• WHICH DIRECTION SHOULD I TAKE THE ASSET?

• WHAT SALES CHANNELS SHOULD WE EMPLOY?

TABLEAU 1 : DÉCISIONS NÉVRALGIQUES QUE DOIVENT PRENDRE LES SBÉ

• WHERE CAN I SECURE FUNDING?

• HOW SHOULD WE ENGAGE PATIENTS?

• WHAT PARTNERS SHOULD I CONSIDER?

• SHOULD WE TAKE THE PRODUCT TO MARKET? OR LICENSE? OR SELL?

TABLE 1: CRITICAL DECISION AREAS FACED BY EMERGING BIOPHARMA AND BIOTECHNOLOGY COMPANIES

• HOW DO I OPTIMIZE BURN RATE? • WHAT VENDORS DO I NEED AND HOW AM I GOING TO MANAGE THEM?

• HOW DO WE GET OPTIMAL PRICE AND ACCESS? • WHERE SHOULD WE LAUNCH AND IN WHAT ORDER?

• WHICH OPPORTUNITIES SHOULD I PRIORITIZE?

• HOW DO WE TAKE THE PRODUCT TO MARKET?

• HOW CAN I MORE QUICKLY GET TO A VALUE DEFINITION POINT?

• HOW DO WE REACH THE RIGHT PRESCRIBERS AND PATIENTS?

Different EBP business models result in different levels of engagement in R&D and commercialization. Some EBPs concentrate on pre-clinical research and then license the product to a partner that will take the reins on the commercialization process. They may look to Big Pharma to provide continued clinical development, commercialization, and medical affairs support.

près de 32 milliards de dollars canadiens (25 milliards $ US), soit plus du double du total de 2019. [Source : Section 9.5, rapport PharmaFocus 2025] Les sociétés de biotechnologie et les sociétés biopharmaceutiques émergentes (SBÉ) sont à la base des premières étapes du développement de médicaments. Leur rendement, le milieu dans lequel elles fonctionnent et leurs relations avec les autres intervenants du réseau de la santé jouent un rôle crucial dans l’avenir de bien des technologies et traitements qui sont novateurs.

DÉCISIONS NÉVRALGIQUES DU POINT DE VUE CLINIQUE • QUELLE ORIENTATION FAUT-IL DONNER AUX ACTIFS? • OÙ EST-IL POSSIBLE D’OBTENIR UN FINANCEMENT? • QUELS PARTENAIRES FAUT-IL ENVISAGER? • COMMENT GÉRER LE TAUX D’ÉPUISEMENT DU CAPITAL? • QUELS VENDEURS SERONT NÉCESSAIRES ET COMMENT SERA-T-IL POSSIBLE DE LES GÉRER?

DÉCISIONS NÉVRALGIQUES DU POINT DE VUE COMMERCIAL • QUELS CIRCUITS DE VENTE FAUT-IL UTILISER? • COMMENT MOBILISER LES PATIENTS? • FAUT-IL METTRE LE PRODUIT EN MARCHÉ? ACCORDER UNE LICENCE? OU VENDRE? • COMMENT ARRIVER À UN PRIX ET UN ACCÈS OPTIMAL? • OÙ LANCER LE PRODUIT ET DANS QUEL ORDRE?

• QUELLES OCCASIONS FAUT-IL PRIVILÉGIER?

• COMMENT METTRE LE PRODUIT EN MARCHÉ?

• COMMENT FAIRE POUR ARRIVER RAPIDEMENT À UN POINT DE DÉFINITION DE LA VALEUR?

• COMMENT ATTEINDRE LES BONS MÉDECINS PRESCRIPTEURS ET LA BONNE PATIENTÈLE?

biotech.ca

knowledge connaissance

EBP GROWTH INITIATIVES Even though each biotech company’s business circumstances can be unique, they often share similar growth initiatives. Asset selection is the first pillar of growth. It is important to accurately interpret the commercial potential of various therapeutic areas and to pick those with the

Chaque modèle de SBÉ conduit à un degré d’engagement différent dans les efforts de recherche-développement et de commercialisation. Certaines SBÉ se concentrent sur la recherche préclinique, puis accordent une licence à un partenaire qui s’occupera de la commercialisation. D’autres comptent sur le soutien continu de grandes sociétés pharmaceutiques pour le développement clinique, la commercialisation et les questions médicales.

INITIATIVES DE CROISSANCE DES SBÉ Bien que la situation d’affaires de chaque SBÉ soit unique, ces entreprises partagent des stratégies de croissance.

1 Asset Selection 1

Business scaling up engine

Portfolio Management

Selection des actifs

3 Commercial Strategy 2

opportunity for the highest return with the help of databacked ROI evaluations. Companies should start with understanding the target country’s treatment landscape, looking at the disease area segmentation (comparing Rx Maturity to Criticality of Need). Subsequently, it is important to leverage other healthcare and commercial data to quickly perform asset valuation and ROI analysis (e.g., clinical success rate, commercial potential, development costs, and commercial cost).

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Gestion du portefeuille

Moteur de croissance de l’entreprise

3 Stratégie commerciale

La sélection des actifs est le premier pilier de la croissance. Il est important d’interpréter avec précision le potentiel commercial de divers domaines thérapeutiques et de choisir ceux offrant les meilleures perspectives de rendement à partir d’évaluations du retour sur investissement fondées sur des données. Les sociétés doivent commencer par se faire une bonne idée du paysage thérapeutique du pays cible. Elles doivent examiner la segmentation du domaine thérapeutique (en comparant la maturité des médicaments au caractère critique des besoins). Ensuite, elles doivent étudier d’autres données sur les soins de santé et le marché pour effectuer rapidement une évaluation des actifs et une analyse du retour sur investissement (p. ex., le taux de réussite clinique, le potentiel commercial, les coûts de développement et le coût de mise en marché). Le deuxième pilier de la croissance d’une entreprise est une bonne gestion du portefeuille, ce qui comprend la capacité de discerner les limites et les lacunes des perspectives de marché, l’affectation judicieuse des investissements au développement et à l’acquisition d’autres produits, et la maîtrise des risques à long terme afin de

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For the business to scale up, the second pillar of growth requires good portfolio management. This includes discerning pipeline growth limits and gaps; allocating investments wisely on additional product development and acquisition; and controlling long-term risks to achieve a sustainable revenue and profit growth. Key considerations in portfolio strategy include the limited growth of current in-market products, corporate targets to ensure target internal rate of return (IRR) and growth trajectory, timeline of product pipeline maturation, and considering expansion via acquisition. Portfolio management should align the quantitative assessment on the commercial potential of pipeline products with the growth trajectories to meet the corporate targets. The third pillar of growth, commercial strategy, involves choosing the right partnership model to enter specific markets and adding value to assets with emerging digital capabilities and collaborative business models. THE GROWTH OF EBPS IN CANADA CREATES AN ENORMOUS COMPETITIVE LANDSCAPE. EBPs must decide on the best approaches at each stage of the clinical to commercial journey in order to succeed. The formula for success can vary based on each company’s unique challenges. Biotech and Emerging Biopharma customers have a different set of needs to successfully develop, launch, and manage products over their lifecycles. Companies that succeed will require knowledge, data, and trusted partners to help them deliver innovative healthcare to patients.

parvenir à une croissance durable des revenus et des bénéfices. La gestion du portefeuille nécessite notamment de tenir compte de la croissance limitée des produits déjà sur le marché, des cibles de rentabilité interne et de trajectoire de croissance de l’entreprise, du calendrier de maturité des produits en développement, et de la possibilité d’une expansion par acquisition. La gestion du portefeuille doit aussi mettre en rapport l’évaluation quantitative du potentiel commercial des produits en développement avec les trajectoires de croissance pour atteindre les objectifs de l’entreprise. Le troisième pilier de croissance, soit la stratégie commerciale, nécessite de choisir le bon modèle de partenariat pour percer des marchés précis et d’ajouter de la valeur aux actifs grâce aux possibilités numériques émergentes et aux modèles commerciaux collaboratifs.

LA CROISSANCE DES SBÉ AU CANADA CRÉE UN VASTE PAYSAGE CONCURRENTIEL. Pour réussir, les SBÉ doivent décider de la meilleure façon de faire à chaque étape clinique et commerciale. La clé du succès variera en fonction des particularités de chaque société. Les clients des SBÉ ont chacun des besoins qui leur sont propres par rapport au développement de produits, à leur mise en marché et à leur gestion avec succès tout au long de leur cycle de vie. Pour réussir, les sociétés auront besoin de connaissances, de données et de partenaires de confiance pour les aider à assurer des soins de santé novateurs aux patients. biotech.ca

Jazz Pharmaceuticals Puts its Own Spin on Diversity as an Asset EVERY COMPANY WANTS A PERFORMANCE EDGE. JAZZ PHARMACEUTICALS HAS FOUND IT, in everything from product development to sales and marketing. It comes down to the same thing: their unique take on diversity. Diversity is an asset for all organizations. What sets Jazz apart is a holistic view. To Jazz, diversity goes beyond what meets the eye. It includes everyone’s backgrounds and histories – everything you can or can’t see. Embracing diversity can include the traditional focus on gender, ethnicity, race, sexual orientation, disabilities, etc. Here, it also means honouring the range of perspectives that people bring, and every employee’s circumstances – from the single parent juggling responsibilities of family and work to the employee acting as a primary caregiver for an ageing family member. Jazz is a global biopharmaceutical company, headquartered in Dublin, serving patients in nearly 75 countries. They have production facilities in Ireland and Italy, a development lab in Vancouver, and teams throughout North America and Europe.The company expanded its business operations into Canada four years ago, with the establishment of Jazz Pharmaceutical Canada Inc, at Mississauga, in Ontario. From the launch of Defitelio in hematology, Jazz’s Canadian operations now features five products, with three launches in 2021. Jazz Pharmaceuticals Canada has tripled in size over the last year, making the focus on diversity even more critical for recruitment and team building. Respecting and welcoming everyone’s differences adds to the collective strength of the company, says Arlene Ali, 76

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Senior Director, Medical Affairs at Jazz Pharmaceuticals Canada “We’re constantly looking to build diversity into our team, and harness that power,” says Ali, one of Jazz’s champions for diversity, equity, and inclusion in Canada. “It’s about a different way of working, bringing together people with diverse experiences, skills sets and roles to address an opportunity.” DELIVERING STRONG RESULTS Diversity and inclusion matter in business. It can create a better sense of community, foster a more positive culture, avoid groupthink when solving problems, and help people feel valued. There’s a growing body of evidence that diverse organizations are better positioned to deliver results. Paul Harper, Jazz’s Regional Sales Manager for Canada, says the company thinks about four aspects: diversity, inclusion, equity and belonging. Harper, also global co-chair for Jazz’s All Dimensions of Diversity group, explains that diversity is everything about your people – who they are in their range of identities, personally and professionally. “If diversity is the mix, inclusion is about how the different parts blend and equity is about giving everyone

Diversity and inclusion matter in business. It can create a better sense of community, foster a more positive culture, avoid groupthink when solving problems, and help people feel valued.

fair access to achieve success”, says Harper. “Different people may need different support to get there, and belonging is the extent to which people feel part of the team.” That’s the Jazz approach. EVERYONE HAS A VOICE This has long been a priority at Jazz, and in 2020 became more formalized. That’s when Jazz launched two global groups: All Dimensions of Diversity and Inclusion for Innovation. Their link to business advantages is clear. Jazz calls these groups “ConcERTos”. About 20% of the firm’s 3,000 people have signed up to be part of these Employee Resource Teams. That number keeps rising. The musical theme of ConcERTos is fitting. Harper makes an analogy between a diverse company and a successful band. Everyone has a part to play, and “the notes come together to create a harmony,” he says. In addition to the two ConcERTo teams, globally Jazz employees have created affinity forums for Black, female, Asian and LGBTQ+ employees, among others. Across the company, efforts to improve touch on everything from unconscious bias, to recruitment, to diversity in clinical trials. Progress in all areas is key. This isn’t a program but a mindset. At her major team meetings, Ali constantly talks about the Jazz culture and the concepts of diversity, equity, inclusion and belonging. Everything is related, she says. The tone starts from top down, and you see the impact from ground up. What’s the evidence that you have a truly diverse and inclusive culture? Ali sees it in daily collaboration within and across functions, and in the way people bring their true selves to work in order to flourish. “It’s creating an inclusive setting,” she says, “where all are willing to speak up and be heard, listen to others, build on each other’s ideas, and think holistically about what we’re trying to achieve for patients, our employees and our communities.”

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Bold Therapeutics: Defeating Cancer Drug Resistance

DESPITE SIGNIFICANT ADVANCES IN ONCOLOGY OVER THE PAST DECADE, DRUG RESISTANCE REMAINS A SIGNIFICANT CHALLENGE. Over time, almost all patients develop resistance to their treatments, rendering them less and less effective (‘acquired resistance’). In parallel, some cancer types and mutations are naturally resistant to certain types of therapies (‘inherent or intrinsic resistance’). Bold Therapeutics is addressing this unmet need in oncology with its first-in-class anti-resistance therapy, BOLD-100, which has the potential to significantly improve outcomes in a wide range of patients by defeating cancer drug resistance. Bold Therapeutics is a rapidly growing Vancouver-based biopharmaceutical company tackling some of the most difficult-to-treat cancer indications head-on. Founded in 2018, Bold is has already made substantial headway, including building a consortium of more than 50 international researchers studying BOLD-100, initiating a Phase 1b/2a clinical trial, and executing its first regional licencing deal for BOLD-100 with Hana Pharm Co. of South Korea. BOLD-100 is a first-in-class rutheniumbased small molecule drug with a unique multimodal pro-apoptotic mechanism-ofaction (MoA) effective against both sensitive and resistant cell lines. More specifically, BOLD-100 (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition; and (2) induces reactive oxygen species (ROS) which causes DNA damage and cell cycle arrest. Collectively, these effects 78

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result in cell death in both sensitive and resistant cancers. In a previously completed Phase 1a monotherapy study in 46 patients with advanced cancer, BOLD-100 was found to be safe and generally well-tolerated, with clear indications of biological activity. In October 2020, Bold initiated its second clinical study, a Phase 1b/2a study in advanced gastrointestinal cancers. BOLD-100-001 (clinicaltrials.gov/ct2/show/ NCT04421820) is an open-label, multicenter two-stage study designed to evaluate the safety and efficacy of

BOLD-100 in combination with FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) chemotherapy in patients with advanced gastric, pancreatic, colorectal and bile duct cancers. BOLD-100-001 has been enrolling patients at six clinical trial sites in Canada: Cross Cancer Institute in Edmonton, Alberta (PI Jennifer Spratlin); Princess Margaret Cancer Centre in Toronto, Ontario (PI Grainne O’Kane); Ottawa General Hospital in Ottawa, Ontario (PI Rachel Goodwin); Juravinski Cancer Centre in Hamilton, Ontario (PI Elaine McWhirter); and Jewish General Hospital and Royal Victoria Hospital in Montreal, Quebec (PIs Petr

Kavan and Jamil Asselah, respectively). By year-end 2021, Bold Therapeutics expects to complete the Phase 1b portion of the trial and move immediately into the Phase 2a portion of the trial, adding two sites in the United States (H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida and the University of California, Los Angeles in Los Angeles, California) and five sites in South Korea. “Bold Therapeutics is at a pivotal milestone as we complete enrollment in the final dose-escalation cohort in the Phase 1b portion of our trial,” said Jim Pankovich, EVP, Clinical Development at Bold Therapeutics. “Leveraging a seamless adaptive design, we look forward to immediately advancing into the Phase 2a portion of the trial where we will be rapidly enrolling and treating patients with advanced gastrointestinal cancers at sites all over the world including Canada, the United States, and South Korea. This study allows us to generate critical efficacy data in a range of different indications, all with serious unmet medical needs, and, in the near-future, we expect to initiate additional clinical trials in parallel that explore different drug

combinations and indications designed to demonstrate BOLD-100’s therapeutic versatility.” In addition to clinical progress, Bold Therapeutics continues to generate compelling nonclinical data in cooperation with its extensive global network of research collaborators. Existing data definitively shows that BOLD100 is pan-indication, demonstrating efficacy against a wide range of both solid and liquid tumors, and pan-class, capable of combining safely with a wide range of different with an ability to combine safely with a variety of existing therapies. Most recently, Bold Therapeutics demonstrated synergy in combination with protease inhibitors in the treatment of both sensitive and resistant models of multiple myeloma, another indication where drug resistance is a leading factor in disease progression. “BOLD-100 is a remarkable drug – and one where its story gets more scientifically interesting and more commercially exciting each and every day,” stated E. Russell McAllister, Founder and CEO of Bold Therapeutics. “Earlier this year, the FDA granted BOLD-100 an Orphan Drug Designation (ODD) in gastric cancer, adding to our existing ODD in pancreatic cancer – and we anticipate filing for a number of different Breakthrough Therapy Designations (BTDs) as clinical data becomes available later this year. We expect our pace of development to accelerate into 2022 as we complete a $30M Series B round and initiate additional clinical trials in parallel with our existing Phase 1b/2a trial, bringing an exciting new therapeutic option to physicians and patients with limited – and often ineffectual – treatment options.” Bold Therapeutics is planning a $30M Series B round to close in 4Q21. Interested accredited and institutional investors are encouraged to contact the company for more information. In parallel, Bold Therapeutics is seeking additional regional development and commercialization partners, with a particular focus on identifying potential partners in China and Japan. For more information on Bold Therapeutics, visit: www.bold-therapeutics.com

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Biologics: overview of recent judicial proceedings and decisions Produits biologiques : aperçu des récentes procédures et décisions judiciaires by Urszula Wojtyra, Partner, Barrister & Solicitor, Smart & Biggar par Urszula Wojtyra, Associée, Avocate, Smart & Biggar

THE LAST YEAR OR SO HAS SEEN A NUMBER OF PATENT AND PATENTED MEDICINE PRICES REVIEW BOARD PROCEEDINGS and judicial decisions relating to biologics, including biosimilars and vaccines. This article highlights a few of these decisions. BIOSIMILARS As of August 2021, Health Canada has authorized 36 biosimilars, based on 14 different reference products.1 Over half of these (20) were authorized in 2020. As of the July 15, 2021 update to Health Canada’s listing of new drug submissions under review, eleven further biosimilar submissions are under review. The Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) apply to biosimilars. Many of the authorized biosimilars were the subject of patent infringement actions either under the PMNOC Regulations, or pursuant to the Patent Act. While the majority of these actions were discontinued before trial, trials were held in actions relating to filgrastim and infliximab, discussed below. Additionally, litigation relating to adalimumab remains pending. FILGRASTIM: Pfizer’s filgrastim product, NIVESTYM (a biosimilar of NEUPOGEN), was the subject of the first decision on the merits under the amended PMNOC Regulations, which came into force in 2017. Pfizer was successful against Amgen; Amgen’s patent was declared invalid as obvious.2 Amgen discontinued its patent infringement actions against

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MÉDICAMENTS BIOSIMILAIRES En date du mois d’août 2021, 36 médicaments biosimilaires basés sur 14 produits de référence différents étaient autorisés par Santé Canada1 . Plus de la moitié d’entre eux (20) ont été autorisés en 2020. En date de la mise à jour du 15 juillet 2021 de la liste de Santé Canada des nouvelles présentations de médicaments en cours d’examen, 11 présentations de médicaments biosimilaires supplémentaires sont en cours d’examen. Le Règlement sur les médicaments brevetés (avis de conformité) (Règlement sur les MBAC) s’applique aux médicaments biosimilaires. Bon nombre des médicaments biosimilaires autorisés ont fait l’objet d’actions en contrefaçon de brevet soit en vertu du Règlement sur les MBAC, soit en vertu de la Loi sur les brevets. Bien que la majorité de ces actions aient été abandonnées avant d’arriver au tribunal, des procès ont eu lieu concernant le filgrastim et l’infliximab. Ces actions sont abordées ci-dessous. De plus, un litige relatif à l’adalimumab demeure en instance.

FILGRASTIM : Le produit à base de filgrastim de Pfizer, NIVESTYM (un médicament biosimilaire de NEUPOGEN), a fait l’objet de la première décision au fond en vertu du Règlement sur les MBAC modifié, entré en vigueur en 2017. Pfizer

1. Smart & Biggar LLP maintains a list of approved biosimilars here: https://www.smartbiggar.ca/insights/ biosimilars. Health Canada’s Drug Product Database can also be searched for biosimilar drug approvals by selecting the “Biosimilar Biologic Drug” checkbox. 2. Amgen Inc v Pfizer Canada ULC, 2020 FC 522, aff’d 2020 FCA 188, leave to Supreme Court of Canada denied.

EN CETTE DERNIÈRE ANNÉE, UN CERTAIN NOMBRE DE DÉCISIONS JUDICIAIRES ONT EU LIEU CONCERNANT DES BREVETS et des procédures du Conseil d’examen du prix des médicaments brevetés relativement à des produits biologiques, y compris des médicaments biosimilaires et des vaccins. Le présent article relate quelques-unes de ces décisions.

Urszula Wojtyra

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1. Smart & Biggar S.E.N.C.R.L, s.r.l. conserve une liste des médicaments biosimilaires approuvés ici : https:// www.smartbiggar.ca/insights/biosimilars. La Base de données sur les produits pharmaceutiques de Santé Canada peut également être consultée pour connaître les médicaments biosimilaires approuvés en cochant la case « Médicament biologique biosimilaire ».

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other pegfilgrastim biosimilar manufacturers, all of which have obtained notices of compliance. Pfizer has sued Amgen for damages for the delay in its market authorization caused by Amgen’s patent infringement action, also known as a “section 8” action pursuant to the PMNOC Regulations; this action remains pending.3 INFLIXIMAB: Longstanding patent litigation between Janssen and Hospira relating to INFLECTRA (a biosimilar of REMICADE) has recently been discontinued. Janssen was successful at trial in establishing that Hospira, as well as Celltrion and Pfizer, infringed a patent relating to the use of infliximab for the treatment of rheumatoid arthritis in patients, with the trial judge finding the patent valid and infringed. On appeal, the Federal Court of Appeal remitted issues of anticipation and obviousness for reconsideration back to the trial judge.4 In early 2021, the trial judge issued its decision on the reconsideration, again upholding patent validity.5 The parties discontinued the action and appeals before the appeal of the reconsideration decision was heard, and before the trial judge decided the quantification phase of the action. ADALIMUMAB: As of August 2021, adalimumab is the only biosimilar that remains at issue in patent litigation, in two separate sets of actions. One set of actions is believed to be the first biosimilar versus biosimilar patent litigation in Canada: Fresenius Kabi (markets IDACIO) and Samsung Bioepis (markets HADLIMA) are litigating whether HADLIMA infringes Fresenius Kabi’s patent, and whether the patent is invalid.6 The other set is patent infringement and invalidity actions between AbbVie (sponsor of reference biologic HUMIRA), and JAMP Pharma regarding its biosimilar SIMLANDI, under review by Health Canada.7 VACCINES In addition to biosimilar patent litigation, the past year saw Merck and Wyeth face off in a patent trial regarding three patents pertaining to PREVNAR 13, Pfizer’s 13-valent pneumococcal polysaccharide protein conjugate vaccine. Merck sought to invalidate Wyeth’s patents, as it believed

3. Pfizer Canada ULC v Amgen Inc and Amgen Canada Inc, Federal Court File No T-744-20. 4. Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research, 2020 FCA 30. 5. Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research, 2021 FC 42. 6. Samsung Bioepis Co, Ltd v Fresenius Kabi Deutschland GmbH, Federal Court File No T-2009-19, and Fresenius Kabi Deutschland GmbH v Samsung Bioepis Co, Ltd, Federal Court File No T-462-21. 7. AbbVie Corporation and AbbVie Biotechnology Ltd v JAMP Pharma Corporation, Federal Court Files T-557-21, T-559-21, T-560-21 and T-561-21; JAMP Pharma Corporation v AbbVie Corporation and AbbVie Biotechnology Ltd, Federal Court Files No T-572-21, T-573-21, T-577-21, and T-581-21.

a obtenu gain de cause contre Amgen et le brevet d’Amgen a été déclaré invalide pour cause d’évidence2 . Amgen a abandonné ses actions en contrefaçon de brevet contre d’autres fabricants de médicaments biosimilaires du pegfilgrastim, qui ont tous obtenu des avis de conformité. Pfizer a poursuivi Amgen en dommages-intérêts pour le retard de son autorisation de mise sur le marché causé par l’action en contrefaçon de brevet d’Amgen, également connue sous le nom d’action intentée en vertu de l’article 8 du Règlement sur les MBAC; cette action reste en instance3 .

INFLIXIMAB : Le litige de longue date sur les brevets entre Janssen et Hospira concernant INFLECTRA (un médicament biosimilaire de REMICADE) a récemment été abandonné. Janssen a réussi à établir que Hospira, ainsi que Celltrion et Pfizer, avaient enfreint un brevet relatif à l’utilisation de l’infliximab pour le traitement de l’arthrite rhumatoïde chez les patients, le juge de première instance ayant conclu que le brevet était valide et avait été enfreint. En appel, la Cour d’appel fédérale a renvoyé au juge de première instance les questions d’antériorité et d’évidence4 . Début 2021, le juge de première instance a rendu sa décision sur le réexamen, confirmant de nouveau la validité du brevet 5 . Les parties se sont désistées de l’action et des appels avant que l’appel de la décision de réexamen ne soit entendu, et avant que le juge de première instance ne décide de la phase de quantification de l’action.

ADALIMUMAB : Au mois d’août 2021, l’adalimumab est le seul médicament biosimilaire qui reste en cause dans des litiges en matière de brevet, dans le cadre de deux séries d’actions distinctes. Une série d’actions serait la première poursuite relative à un brevet de médicament biosimilaire contre un autre médicament biosimilaire au Canada : Fresenius Kabi (qui commercialise IDACIO) et Samsung Bioepis (qui commercialise HADLIMA) contestent la question de savoir si HADLIMA enfreint le brevet de Fresenius Kabi et si ce brevet est invalide 6 . L’autre série d’actions est constituée d’actions en contrefaçon de brevet et en invalidité entre AbbVie (commanditaire du produit biologique de référence HUMIRA) et JAMP Pharma concernant son médicament biosimilaire SIMLANDI, en cours d’examen par Santé Canada7.

2. Amgen Inc. c. Pfizer Canada SRI, 2020 CF 522, confirmé 2020 CAF 188, autorisation d’appel devant la Cour suprême du Canada refusée. 3. Pfizer Canada SRI c. Amgen Inc. et Amgen Canada Inc., dossier de la Cour fédérale no T-744-20. 4. Corporation de soins de la santé Hospira c. Kennedy Trust for Rheumatology Research, 2020 CAF 30. 5. Corporation de soins de la santé Hospira c. Kennedy Trust for Rheumatology Research, 2021 CF 42. 6. Samsung Bioepis Co, Ltd c. Fresenius Kabi Deutschland GmbH, dossier de la Cour fédérale no T-2009-19, et Fresenius Kabi Deutschland GmbH c. Samsung Bioepis Co, Ltd, dossier de la Cour fédérale no T-462-21. 7. AbbVie Corporation et AbbVie Biotechnology Ltd c. JAMP Pharma Corporation, dossiers de la Cour fédérale T-557-21, T-559-21, T-560-21 et T-561-21; JAMP Pharma Corporation c. AbbVie Corporation et AbbVie Biotechnology Ltd, dossiers de la Cour fédérale T-572-21, T-573-21, T-577-21 et T-581-21.

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that Wyeth would assert the patents against Merck’s 15-valent pneumococcal polysaccharide protein conjugate vaccine, V114, for which Merck filed a submission with Health Canada during trial. The Federal Court upheld the validity of the composition patent, including that the patent was neither obvious nor anticipated. However, the Court agreed with Merck’s proposed construction that the claims were limited to the 13 serotypes specified in the claims.8 In so doing, the Court rejected Wyeth’s position that the patent disclosed a “platform” for making multivalent pneumococcal polysaccharide protein conjugate vaccine. Wyeth’s appeal of the decision is pending. In April 2021, the Federal Court of Appeal rendered its first appellate decision relating to Certificates of Supplementary Protection (CSPs) in relation to the Minister of Health’s refusal to grant a CSP for GSK’s SHINGRIX.9 The Minister had found that SHINGRIX contained only one medicinal ingredient—a Varicella Zoster Virus (VZV) gE antigen—and that the adjuvant in SHINGRIX was not a medicinal ingredient. The Minister had also found that the patent at issue claimed a formulation of the antigen and the adjuvant, and therefore was not eligible for a CSP. The Federal Court of Appeal overturned the lower court decision, finding that the Minister’s interpretation and application of the CSP provisions to exclude patent claims directed to a formulation, “particularly the one at issue,” was reasonable. PATENTED MEDICINE PRICES REVIEW BOARD (PMPRB) While the coming into force of the amended Patented Medicines Regulations has now been delayed until January 1, 2022, they have been the subject of court challenges. Both the Federal Court10 and Quebec Superior Court11 held that portions of the Regulations relating to new price calculation provisions (including confidential third party rebates) are unconstitutional but dismissed challenges to the balance of the provisions relating to new price regulatory factors and the “basket” of comparator countries. Appeals of both decisions remain pending. PMPRB has also amended its Guidelines, the implementation of which are also delayed until January 1, 2022. A separate challenge to the Guidelines before the Federal Court likewise remains pending.12 In July 2021, the Federal Court of Appeal granted Alexion’s application for judicial review of the PMPRB’s decision finding that Alexion priced SOLIRIS excessively, overturning the Federal Court decision and remitting the

VACCINS L’année dernière, outre les litiges relatifs aux brevets de médicaments biosimilaires, Merck et Wyeth se sont affrontés dans le cadre d’un procès concernant trois brevets relatifs à PREVNAR 13, le vaccin polysaccharidique antipneumococcique conjugué 13-valent de Pfizer. Merck a cherché à invalider les brevets de Wyeth, la société croyant que Wyeth comptait faire valoir les brevets contre V114, le vaccin polysaccharidique antipneumococcique conjugué 15-valent de Merck, pour lequel Merck a déposé une soumission auprès de Santé Canada pendant le procès. La Cour fédérale a confirmé la validité du brevet de composition, notamment que le brevet n’était ni évident ni antérieur. Toutefois, la Cour a souscrit à l’interprétation de Merck, à savoir que les revendications étaient limitées aux 13 sérotypes précisés dans celles-ci 8 . Ce faisant, la Cour a rejeté la position de Wyeth selon laquelle le brevet divulguait une « plateforme » pour la fabrication d’un vaccin polysaccharidique antipneumococcique conjugué multivalent. L’appel par Wyeth de la décision est en instance. En avril 2021, la Cour d’appel fédérale a rendu sa première décision en appel concernant les certificats de protection supplémentaire (CPS) en rapport avec le refus du ministre de la Santé d’accorder un CPS pour le produit SHINGRIX de GSK 9 . Le ministre avait conclu que SHINGRIX ne contenait qu’un seul ingrédient médicinal, un antigène gE du virus varicelle-zona, et que l’adjuvant présent dans SHINGRIX n’était pas un ingrédient médicinal. Le ministre avait également conclu que le brevet en cause revendiquait une formulation de l’antigène et de l’adjuvant et qu’il n’était donc pas admissible à un CPS. La Cour d’appel fédérale a infirmé la décision du tribunal inférieur, concluant que l’interprétation et l’application par le ministre des dispositions relatives au CPS pour exclure les revendications de brevet visant une formulation, « particulièrement celle en cause », étaient raisonnables.

CONSEIL D’EXAMEN DU PRIX DES MÉDICAMENTS BREVETÉS (CEPMB) Bien que l’entrée en vigueur du Règlement sur les médicaments brevetés modifié soit maintenant reportée au 1er janvier 2022, celui-ci a fait l’objet de contestations judiciaires. La Cour fédérale et la Cour supérieure du Québec 11 ont jugé que les parties du Règlement relatives aux nouvelles dispositions concernant le calcul des prix (y compris les rabais confidentiels aux tiers) étaient inconstitutionnelles, mais ont rejeté les contestations du reste des dispositions relatives aux nouveaux facteurs de réglementation des prix et au « bassin » des pays de comparaison. Les appels de ces deux décisions sont toujours

8. Merck Sharp & Dohme Corp v Wyeth LLC, 2021 FC 317. 9. Canada (Health) v GlaxoSmithKline Biologicals SA, 2021 FCA 71. 10. Innovative Medicines Canada et al v Canada (Attorney General), 2020 FC 725.

8. Merck Sharp et Dohme Corp c. Wyeth LLC, 2021 CF 317.

11. Merck Canada Inc v Procureur général du Canada, 2020 QCCS 4541.

9. Canada (Santé) c. GlaxoSmithKline Biologicals SA, 2021 CAF 71.

12. Innovative Medicines Canada et al v Canada (Attorney General) of Canada,

10. Médicaments novateurs Canada et al. c. Canada (Procureur général), 2020 CF 725.

Federal Court File No T-1419-20.

11. Merck Canada Inc. c. Procureur général du Canada, 2020 QCCS 4541.

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matter back to the PMPRB for redetermination.13 The Court of Appeal expressed concern that the PMPRB had misunderstood its mandate as being aimed at reasonable pricing, price-regulation or consumer protection at large, rather than properly considering the excessive pricing provisions in the Patent Act as directed at controlling patent abuse. The Court of Appeal found that the PMPRB had, for the first time and without providing any reasons, imposed the requirement that SOLIRIS be priced lower than all seven comparator countries. This departure from the Guidelines was held as one of the most controversial parts of the PMPRB’s decision. The Federal Court of Appeal repeatedly stated that the PMPRB decision failed to explicitly or implicitly consider the applicable provisions of the Patent Act, and the Court of Appeal could not discern a reasoned explanation of how the PMPRB arrived at its decision. The Court of Appeal concluded that on redetermination, the PMPRB “is free to make whatever decision seems appropriate to it based on a reasonable interpretation of the legislation as applied to the evidence in the case. … In making its decision, the Board must ensure that a reasoned explanation is discernable on the key issues— the issues on which the case will turn and the issues of prime importance raised in the parties’ submissions.” One can expect that the reasoning of the Federal Court of Appeal in the Alexion case will be of interest in the appeals of the challenge to the amended Patented Medicines Regulations, and the challenge to the associated revised Guidelines. CONCLUSION It has been a busy year for biologics in the courts. We look forward to providing a future update on the pending appeals and ongoing litigation.

en instance. Le CEPMB a également modifié ses lignes directrices, dont la mise en œuvre est également reportée au 1er janvier 2022. Une contestation distincte des lignes directrices devant la Cour fédérale est également en instance12 . En juillet 2021, la Cour d’appel fédérale a accueilli la demande de contrôle judiciaire d’Alexion à l’égard de la décision du CEPMB, concluant qu’Alexion avait fixé un prix excessif pour SOLIRIS, infirmant la décision de la Cour fédérale et renvoyant l’affaire au CEPMB aux fins de réexamen 13 . La Cour d’appel s’est dite préoccupée par le fait que le CEPMB avait mal compris son mandat comme étant destiné à assurer des prix raisonnables, la réglementation des prix ou la protection des consommateurs en général, plutôt que de considérer comme il se doit que les dispositions sur les prix excessifs de la Loi sur les brevets visent à contrôler l’abus de brevets. La Cour d’appel a conclu que le CEPMB avait, pour la première fois et sans fournir de motifs, imposé l’exigence que le prix de SOLIRIS soit inférieur à celui des sept pays de comparaison. Cette dérogation aux lignes directrices a été considérée comme l’une des parties les plus controversées de la décision du CEPMB. La Cour d’appel fédérale a déclaré à maintes reprises que la décision du CEPMB n’avait pas tenu compte explicitement ou implicitement des dispositions applicables de la Loi sur les brevets, et la Cour d’appel n’a pas pu discerner d’explication motivée sur la façon dont le CEPMB était arrivé à sa décision. À la suite d’un nouvel examen, la Cour d’appel a conclu que le CEPMB « est libre de rendre toute décision qui lui semble appropriée en se fondant sur une interprétation raisonnable de la loi appliquée aux éléments de preuve [...] Pour rendre sa décision, le Conseil doit s’assurer qu’une explication raisonnée est discernable sur les questions clés, c’est-à-dire les questions sur lesquelles portera l’affaire et les questions de la plus haute importance soulevées dans les observations des parties » (traduction libre). Il est probable que le raisonnement de la Cour d’appel fédérale dans l’affaire Alexion présentera un intérêt certain pour les appels de la contestation du Règlement sur les médicaments brevetés modifié et de la contestation des lignes directrices révisées connexes.

CONCLUSION Il s’est passé beaucoup de choses dans les tribunaux cette année concernant les produits biologiques. Ne manquez pas notre future mise à jour sur les appels en instance et les litiges en cours.

12.Médicaments novateurs Canada et al. c. Canada (Procureur général), dossier de la Cour fédérale no T-1419-20. 13. Alexion Pharmaceuticals Inc v Canada (Attorney General), 2021 FCA 157.

13. Alexion Pharmaceuticals Inc. c. Canada (Procureur général), 2021 CAF 157.

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Therapeutic Drug With Pan-Corona Viral Neutralizing Properties Shows Promise for Ottawa Biotechnology Company JN Nova Pharma Médicament thérapeutique aux propriétés neutralisantes virales pan-corona: Par la Société de biotechnologie d’Ottawa, JN Nova Pharma JN NOVA PHARMA INC., A PRIVATE CANADIAN JN NOVA PHARMA INC., UNE SOCIÉTÉ BIOPHARMACEUTIQUE CANADIENNE PRIVÉE, DÉVELOPPE BIOPHARMACEUTICAL COMPANY, IS DEVELOPING un nouveau médicament thérapeutique prometteur contre la a promising novel COVID-19 therapeutic drug. COVID-19. JN Nova’s lead therapeutic molecule, JN2019, is a potent La principale molécule thérapeutique de JN Nova, JN2019, corona-viral neutralizing agent. It is active against all est un puissant agent neutralisant corona-viral. Il est actif emergent viral variants, acting via an enhanced ACE2 contre toutes les variantes virales émergentes, agissant via un decoy, to trap the virus and block its entry into the lungs leurre ACE2 amélioré, pour piéger le virus et bloquer son and other organs. entrée dans les poumons et d’autres organes. The molecular class of JN2019 also simultaneously La classe moléculaire de JN2019 remplace également replaces ACE2 function. This vital protective enzyme is the simultanément la fonction ACE2. Cette enzyme protectrice virus’ target in the lungs and it is lost on viral infection. vitale est la cible du virus dans les poumons et est perdue lors The action of ACE2 is to remove hypertensive AngII and d’une infection virale. L’action d’ACE2 est d’éliminer generate the protective peptide Ang1-7, which also exerts l’hypertène AngII et de générer le peptide protecteur Ang1-7, an immunomodulatory function on the body’s innate qui exerce également une fonction immunomodulatrice sur le immune system. système immunitaire inné du corps. Thus, JN2019 will be evaluated in patients to reduce Ainsi, JN2019 sera évalué chez les patients afin de réduire viral loads in the lungs and respiratory tract, to prevent la charge virale dans les poumons et les voies respiratoires, collateral damage from cytokine storms and to counteract de prévenir les dommages collatéraux causés par les the harmful effects of severe viral infection leading to acute tempêtes de cytokines et de contrer les respiratory distress syndrome (ARDS) effets nocifs d’une infection virale and acute kidney injury (AKI), which grave conduisant au syndrome de are serious consequences of severe détresse respiratoire aiguë (SDRA) et à COVID19 disease. des lésions rénales aiguës (IRA), qui While vaccines are effective in sont des conséquences graves de la reducing the pandemic’s ability to maladie COVID19 sévère. spread, potent variants are emerging Bien que les vaccins soient efficaces and JN2019 has the potential to be an pour réduire la capacité de accessible, rapidly administered propagation de la pandémie, des therapeutic intervention for people variantes puissantes émergent et that are infected by these escape JN2019 a le potentiel d’être une mutants, and those with existing intervention thérapeutique accessible higher risk co-morbidities. et rapidement administrée pour les “We will assess JN2019 treatment personnes infectées par ces mutants to prevent infected people from having d’évasion et celles qui présentent des to go to hospital and to prevent comorbidités à risque plus élevé. regression in the hospital into the « Nous évaluerons le traitement ICU,” says Dr. John Gillard, CEO of JN2019 afin d’éviter que les personnes JN Nova Pharma, which was founded infectées n’aient à se rendre à l’hôpital in 2020 and is headquartered in Dr. John Gillard, CEO of JN Nova Pharma / Dr, John Gillard, chef de la direction de JN et ainsi prévenir la régression de Ottawa, with another office in Nova Pharma l’hôpital vers l’USI », explique le Dr, John Montreal. 84

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“The candidate drug will be Gillard, chef de la direction de JN Nova Pharma, qui a été fondée en 2020 et evaluated to protect infected dont le siège social est situé à Ottawa, vulnerable populations, including avec un autre bureau à Montréal. those with cardiovascular, « Le médicament candidat sera pulmonary, nephrological and évalué pour protéger les populations diabetic conditions. These patients vulnérables infectées, y compris celles are particularly susceptible to atteintes de maladies cardiovasculaires, hospitalization and severe disease pulmonaires, néphrologiques et because the viral target, ACE2, plays diabétiques. Ces patients sont a protective role in the organs affected particulièrement sensibles à by these diseases and it is lost on l’hospitalisation et aux maladies graves viral infection,” Dr. Gillard adds. parce que la cible virale, ACE2, joue un Unlike other treatments given by rôle protecteur dans les organes injection, JN Nova is also preparing Dr. Nathan Yoganathan, Chief Scientific touchés par ces maladies et qu’elle est for the administration of JN2019 via Officer / Dr. Nathan Yoganathan, directeur scientifique perdue lors d’une infection virale », an inhaled aerosol spray. ajoute le Dr. Gillard. “People don’t like injections and IV Contrairement à d’autres traitements administrés par infusions, which are relatively inaccessible, so we are injection, JN Nova se prépare également à l’administration de developing the formulation of our agent into an accessible JN2019 via un aérosol inhalé. « Les gens n’aiment pas les inhalation device”, says Chief Scientific Officer, Dr. Nathan injections et les perfusions intraveineuses, qui sont relativement Yoganathan. inaccessibles, alors nous développons la formulation de notre “In addition to our Canadian investors and collaborators, agent en un dispositif d’inhalation accessible », explique le we have been strongly supported by Canadian funding directeur scientifique, Dr. Nathan Yoganathan. agencies and we are working very hard right now with « En plus de nos investisseurs, et nous travaillons en ce Canadian bio-manufacturing and CROs to rapidly develop moment avec la bio-fabrication canadienne et les ORC canadiens this technology and safely bring it to patients in 2022. To pour développer rapidement cette technologie et la présenter en help our citizens and residents - that is our goal,” Dr. toute sécurité aux patients en 2022. Aider nos citoyens et nos Yoganathan says. résidents, c’est notre objectif », dit le JN Nova has a network of academic Dr. Yoganathan. collaborators, including the Ottawa JN Nova travaille actuellement avec un Hospital Research Institute (OHRI). the réseau de collaborateurs scientifiques, dont Lunenfeld-Tannenbaum Research l’Institut de recherche de l’Hôpital Royal Institute at Mt. Sinai Hospital in Toronto Ottawa (IRHO) et l’Institut de recherche and McGill University, Montreal. Lunenfeld- Tannenbaum de l’Hôpital Mt. “These collaborations show the Sinai à Toronto et l’université McGill. Canadian scientific community can « Ces collaborations montrent come together to innovate and develop a comment la communauté scientifique ground-breaking therapy for patients canadienne peut s’unir pour innover et affected by COVID-19 and its mettre au point un traitement novateur complications” stated Dr. Kevin Burns, pour les patients touchés par la COVID-19 Director of Kidney Research Centre, et ses complications », a déclaré le Dr OHRI. “We are also evaluating the Dr. Kevin Burns, Director of Kidney Research Kevin Burns, directeur du Centre de potential of this molecule in a different Centre, OHRI / Dr Kevin Burns, directeur du recherche sur les reins de l’IRHO. « Nous dosage form to support people who have Centre de recherche sur les reins de l’IRHO évaluons également le potentiel de cette slow recovery from COVID-19,” explains molécule sous une forme posologique Dr. Gillard. différente pour soutenir les personnes qui se rétablissent JN Nova is working closely with its highly-experienced lentement de la COVID-19 », explique le Dr Gillard. Canadian Clinical Research Organization to plan for JN Nova travaille en étroite collaboration avec son conducting clinical trials in Canada and the United States. Organisation canadienne de Recherche Clinique, hautement “This particular medical drug will be developed for expérimentée pour planifier la réalisation d’essais cliniques au approval in Canada and in the U.S. and will become Canada et aux États-Unis. « Ce médicament particulier sera available in global markets where it has been approved,” mis au point pour fins d’approbation au Canada et aux says Dr. Yoganathan. États-Unis et sera disponible sur les marchés mondiaux où il a été approuvé », affirme le Dr Yoganathan.

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Okanagan Specialty Fruits Celebrates a Quarter Century of Dedication to Innovation Okanagan Specialty Fruits célèbre un quart de siècle de dévouement à l’innovation by Denise Briggs – Communications Manager, Okanagan Specialty Fruits Inc. (OSF) par Denise Briggs – Gestionnaire des ommunications, Okanagan Specialty Fruits Inc. (OSF)

WHERE DO YOU SEE YOURSELF IN FIVE YEARS? IT IS A FREQUENTLY ASKED QUESTION IN THE BUSINESS WORLD, but many could never even begin to contemplate where they would see themselves in 25 years. This is exactly what Neal Carter, President of Okanagan Specialty Fruits Inc. (OSF), has been reflecting on as the company celebrates its 25th anniversary this October. “I started OSF in 1996 with my wife, Louisa, in Summerland, British Columbia. We were passionate about reducing food waste and boosting apple consumption,” explains Carter, who was already an apple and cherry orchardist when he started the company and whose family has been farming since 1908. “It’s certainly been quite the journey and I’m amazed at how far we’ve come. The past few years have been extremely rewarding as we’re finally seeing our dream become a reality with the commercialization of Arctic® apples.” A vertically integrated company, OSF specializes in the development, growing, processing, and marketing of novel tree fruit varieties developed through bioengineering and other molecular tools. OSF’s flagship product is its Arctic apple varieties, which maintain their just picked freshness, flavor and color after slicing. With the help of bioengineering, OSF has successfully silenced the polyphenol oxidase (PPO) enzymes that make apples brown when they are sliced, bitten, or bruised – ensuring more apples are eaten and fewer are wasted. This offers valuable benefits for all members of the apple supply chain, from grower to consumer. For over 30 years Carter worked with numerous crops as a bioresource engineer around the Neal and/et Louisa Carter globe in over 50 countries. It was 86

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OÙ VOUS VOYEZ-VOUS PROFESSIONNELLEMENT DANS CINQ ANS? C’EST UNE QUESTION FRÉQUEMMENT POSÉE DANS LE MONDE DES AFFAIRES, mais nombreux sont ceux qui pourraient cependant ne pas avoir la moindre idée d’où ils se voient dans 25 ans. C’est précisément à cette réflexion que Neal Carter, président d’Okanagan Specialty Fruits Inc. (OSF), s’est prêté alors que l’entreprise célèbrera son 25e anniversaire en octobre prochain. « J’ai fondé OSF en 1996 avec ma femme, Louisa, à Summerland, en Colombie-Britannique. Nous étions habités par l’envie de réduire le gaspillage alimentaire et d’encourager la consommation de pommes », explique M. Carter, qui était déjà pomiculteur et cerisier lorsqu’il a créé l’entreprise et dont la famille est dans l’agriculture depuis 1908. « Ce fut toute une aventure, et je suis le premier étonné de voir le chemin parcouru. Ces dernières années ont été extrêmement gratifiantes puisque notre rêve devient enfin réalité avec la commercialisation des pommes Arctic®. » En tant qu’entreprise verticalement intégrée, OSF est spécialisée dans la création, la culture, la transformation et la commercialisation de nouvelles variétés d’arbres fruitiers issus de la bio-ingénierie et d’autres techniques moléculaires. OSF peut compter sur un produit phare, ses variétés de pommes Arctic, qui conservent leur fraîcheur, leur saveur et leur couleur même après qu’elles ont été tranchées. Grâce à la bio-ingénierie, OSF a réussi à neutraliser les enzymes polyphénol oxydase (PPO) qui font que les pommes brunissent dès lors qu’elles sont coupées, croquées ou abîmées. Cette technique permet de s’assurer qu’on mange plus de pommes et, ainsi, qu’on en gaspille moins. Cela présente des avantages

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through this firsthand experience that Carter was considérables pour tous les membres de la chaîne d’approvisionnement des pommes, du cultivateur au persuaded that biotechnology can help agriculture meet consommateur. ever-expanding global food demands. As he pondered how Pendant plus de 30 ans, Neal Carter a travaillé sur différents to stop unnecessary food waste in the apple industry, he types de cultures en tant qu’ingénieur en bioressources, et ce, heard about research being done in Australia to turn off dans plus de 50 pays. Cette expérience de terrain l’a persuadé PPO in other crops. que la biotechnologie pouvait aider l’agriculture à répondre à “And the rest is history, as they say. Fast forward to la demande alimentaire mondiale, en constante augmentation. today and we currently have over 1,300 acres of Arctic Alors qu’il réfléchissait à la manière de mettre fin au gaspillage apple trees planted in our orchards in Washington State alimentaire inutile dans l’industrie de la pomme, il a entendu which consist of Arctic® Golden, Arctic® Granny, and parler des recherches menées en Australie pour désactiver les Arctic® Fuji varieties,” says Carter. “We’ve had some pretty PPO dans d’autres cultures. lofty goals and targets - we’ve delivered on a vast majority « Et le reste appartient à l’histoire, comme on dit. of them and exceeded expectations in many ways. It’s been Aujourd’hui, nous cultivons plus de 1 300 acres de pommiers pretty humbling to watch one idea turn into approximately Arctic plantés dans nos vergers de l’État de Washington, dont 2.6 million trees.” font partie les variétés Arctic® Golden, Arctic® Granny et As the company heads into its 25th year, it is also Arctic® Fuji », explique Carter. « Nous avions des objectifs et heading into its newest venture. The OSF science des cibles assez élevés, et nous avons atteint la grande department, located in Saskatoon, Saskatchewan, will now majorité d’entre eux et même dépassé les attentes à bien des be offering lab services to selected potential clients or égards. C’est une véritable leçon d’humilité que de voir une collaborators. The services will include micro-propagation, idée se transformer en quelque 2,6 millions d’arbres. » plant DNA extraction, DNA sequencing, DNA editing and À l’aube de sa vingt-cinquième année d’existence, other phenotype and genotyping assays. l’entreprise se lance également dans une toute nouvelle “OSF holds worldwide intellectual property rights in aventure. Le service scientifique d’OSF, situé à Saskatoon compositions and methods for regulating expression of (Saskatchewan), offrira désormais à certains clients ou polyphenol oxidase genes to control enzymatic browning in collaborateurs potentiels divers services, tels que la tree fruits and has successfully proven its bioengineering micropropagation, l’extraction de l’ADN des plantes, le expertise through the creation of Arctic apples varieties,” séquençage de l’ADN, le traitement des données d’une explains Dr. Muhammad Tahir, OSF’s Director of Research séquence d’ADN et d’autres essais liés au phénotype et au and Regulatory Affairs. “Many companies are forced to génotypage. look internationally for lab « OSF détient les droits de services, resulting in extremely propriété intellectuelle à l’échelle long turnaround times and higher mondiale sur les préparations et costs. Our highly skilled lab team les méthodes de régulation de is excited to now offer our services l’expression des gènes du to others, while delivering timely polyphénol oxydase visant à results with in-depth analysis, empêcher le brunissement including bioinformatics.” enzymatique des fruits de verger. The new venture, however, is not De plus, son expertise en bioan indication that the company is ingénierie a été clairement slowing down on developing its own démontrée par la création de tree fruits with novel traits, in fact, variétés de pommes Arctic », it is quite the opposite. explique le directeur de la “Our Arctic® Gala variety is recherche et des affaires currently going through the final réglementaires chez OSF, stage of deregulation and our Muhammad Tahir. « De Arctic® Honeycrisp variety is also nombreuses entreprises sont at the same stage of the process, obligées de faire affaire avec des while we continue to actively organismes à l’étranger pour develop other Arctic apple varieties. obtenir des services de laboratoire, We have also started research on ce qui entraîne des délais silencing enzymatic browning in d’exécution extrêmement longs et cherries,” says Dr. Tahir. “We’ve augmente les coûts. Notre équipe had a lot of success and we are Dr. Muhammad Tahir, Director of Research and de laboratoire hautement qualifiée excited about the prospect of Regulatory Affairs/Directeur de la recherche et des affaires réglementaires

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Neal Carter, President of Okanagan Specialty Fruits Inc.

using our expertise to help propel other ideas and businesses into the future.” Carter admits that being a trailblazer in the industry has come with many challenges and expects more 88

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se réjouit à l’idée de proposer désormais ses services à l’externe et de produire rapidement des résultats grâce à des analyses approfondies, s’appuyant notamment sur la bioinformatique. » Cette nouvelle avenue ne signifie toutefois pas pour autant que l’entreprise limite ses proches recherches sur de nouvelles caractéristiques pour les fruits de verger, bien au contraire. « Notre variété Arctic® Gala est actuellement en phase finale de déréglementation et notre variété Arctic® Honeycrisp en est au même stade. Nous poursuivons par ailleurs sans relâche notre travail autour d’autres variétés de pommes Arctic. Nous avons également entamé des recherches sur la neutralisation du brunissement enzymatique des cerises », précise M. Tahir. « Nous sommes fiers de nos succès et enthousiastes à l’idée d’utiliser éventuellement notre expertise pour aider à concrétiser d’autres idées, auprès d’entreprises. » Neal Carter admet, lui, que le fait d’être un pionnier dans le secteur fait en sorte qu’ils ont dû relever de nombreux défis, et il s’attend à ce qu’il y en ait d’autres, mais s’il avait un conseil à donner aux jeunes entrepreneurs en biotechnologie, ce serait de ne pas hésiter à voir grand. « La technologie ne cesse de nous étonner, et ses possibilités sont infinies. Le travail de notre industrie peut

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challenges ahead. But he says that if he could offer any advice to young biotech entrepreneurs it would be not to be afraid to think big. “Technology can do amazing things and the possibilities are endless. The work our industry is doing can truly make a positive impact in so many aspects and that makes all the challenges worth it,” he says. “The most exciting part is that Arctic apples are just the beginning here at OSF.” So, where does Carter see himself in another 25 years? “Definitely retired,” he joked. “My vision is to see Arctic apples differentiate themselves in the apple business and set a new standard for sliced apples. We will have broader germplasm that will not only be Arctic apples but other tree fruits also. But what inspires me most with OSF is our ability to truly make a difference with advancements in biotechnology and the collaborations our new lab services offering may bring. If we can all embrace the technology that will aid us to efficiently and sustainably produce the food we need to feed this planet we can make a powerful impact on the sustainability of both the environment and people across the world. I can’t wait to see what the next 25 years brings.”

vraiment jouer un rôle positif à bien des égards, ce qui fait que tous les défis en valent la peine », affirme-t-il. « Le plus excitant, c’est que les pommes Arctic ne représentent que le début de l’aventure OSF. » Alors, où M. Carter se voit-il lorsque 25 autres années auront passé? « Assurément à la retraite », dit-il sur le ton de la plaisanterie. « Mon objectif est de voir les pommes Arctic se démarquer dans le secteur de la pomme et qu’elles deviennent la nouvelle norme pour les pommes en tranches. Nous disposerons alors d’un germoplasme plus important, non seulement pour les pommes Arctic, mais aussi pour d’autres fruits. Toutefois, ce qui m’inspire le plus chez OSF, c’est notre capacité à faire une véritable petite révolution grâce aux progrès de la biotechnologie et aux collaborations que notre nouvelle offre de services de laboratoire peut apporter. Si nous pouvons tous adopter la technologie qui nous aidera à produire efficacement et durablement les aliments dont nous avons besoin pour nourrir cette planète, nous réussirons à avoir une incidence considérable sur la protection de l’environnement et des personnes dans le monde. Je suis impatient de voir ce que les 25 prochaines années nous réservent. » . biotech.ca

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Learn more at IQVIA.COM/CANADA or email canadainfo@iqvia.com © 2021. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries. 92 fall | autumn 2021 BIOTECanada

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Insights Magazine Fall 2021

Articles inside

AGRICULTURE

INVESTMENT/INESTISSEMENT A thriving life sciences sector in Canada needs to be nurtured and supported if we are to leverage and build on its recent successes

INDUSTRIAL BIOTECH BIOTECHNOLOGIE INDUSTRIELLE

ECOSYSTEM/ECOSYSTÈME Growing the Canadian biotech ecosystem together

TALENT How Incubators Are Powering Canada’s Life Sciences Sector

VACCINE NEWS DU NOUVEAU CÔTÉ VACCINS Sanofi Delivers a Shot in the Arm for Canadian Biomanufacuring

MESSAGE DU PRÉSIDENT ET CHEF DE LA DIRECTION

MESSAGE FROM THE PRESIDENT AND CEO