Biotechnology Focus April/May 2016

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

April/May 2016 VOLUME 19, NUMBER 2

Making Montréal a premier destination

for early stage

clinical trials

INSIDE:

Special Report:

From Student to Bioscience Entrepreneur

Publication Mail Registration Number: 40052410

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FEATURES

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contents

The unique Québec-based venture fund that boldly goes where other funds won’t (By Shawn Lawrence)

13

The crippling disease that turns tissue to bone Montréal-based Clementia Pharmaceuticals believes it has the means to put a stop to the rare disease known as FOP (By Shawn Lawrence)

April/May 2016 – VOLUME 19 – NUMBER 2

16

Mind The ‘Funding’ Gap

15 BIRON-Laboratoire medical, more than a Lab! A special report on an “old” new partner for your research and clinical projects (Compiled by Biron)

Q&A: Making Montréal an early stage clinical trial powerhouse

16

Q&A: Making Montréal a leading jurisdiction for early stage clinical trials Biotechnology Focus catches up with Québec chief scientist Remi Quirion, and the Executive Director and Chief Scientific Officer of RI-MUHC Dr.Vassilios Papadopoulos to discuss the Early Stage Clinical Trial Initiative (Compiled by Shawn Lawrence)

20 Centralized Image Management for Multi-Centre Clinical Trials Addressing the need for quality data collection in an area where technology is quickly evolving (By Julia Publicover)

DEPARTMENTS

SPECIAL REPORT: From Student to Bioscience Entrepreneur

6

Research news

8

Business corner

19 Calendar of events

6 Esperas Pharma Inc.

www.biotechnologyfocus.ca

Robert Merson highlights some of the factors that drive student scientists to cross over into the world of business, the tools that get them there and which bioscience entrepreneurs and companies will be key to the future of our sector (By Robert Merson)

IN EVERY ISSUE

30

The Last Word The Evolution of a Revolution (By Ulrich J. Krull) April/May 2016 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S note PUBLISHER/ EDITOR-IN-CHIEF SENIOR WRITER

Terri Pavelic Shawn Lawrence

CONTRIBUTING WRITERS

Julia Publicover

Robert Merson

Ulrich J. Krull

Director, Content & Business Development

José Labao

GRAPHIC DESIGNER CONTROLLER MARKETING MANAGER

Elena Pankova John R. Jones Mary Malofy

CIRCULATION DIRECTOR Mary Labao circulation@promotive.net Tel: 905-841-7389

Shining the spotlight on Canada’s early stage research ecosystem When it comes to biosciences, being early will give you your best shot at succeeding. This is an open ended statement, and for our purposes we mean it to be. As an example, this edition of Biotechnology Focus offers up several interesting stories about both companies and research initiatives where being early is the key ingredient to success.

First up, our senior writer Shawn Lawrence spotlights AmorChem, a unique Québecbased venture fund focused on increasing the commercial potential of innovations originating from universities and research centres in the province. What truly sets this fund apart from other venture funds is that it is fully dedicated to translational research or more specifically research in the early stages.

Next in our editorial lineup, there’s Robert Merson’s Special Report titled From Student to Bioscience Entrpreneur. This seven page report is more than just a case study on bioscience entrepreneurship, it’s also a celebration of what we are doing right to cultivate early stage company creation. This includes a rundown of many of the successful support systems and programs in place that are currently helping bioscience students become entrepreneurs. Finally, it covers five emerging companies who could very likely be key to the future of our sector.

And of course there’s our cover story, where various stakeholders in Québec have strategized a plan to turn the City of Montréal into a haven for early stage clinical trials. As Remi Quirion and Dr. Vassillios Papadopoulos explain in the Q&A article, the idea behind the Early Stage Clinical Trial Initiative is to lure potential sponsors in early (i.e. Phase 1), and to put themselves in a better position to attract subsequent clinical phases as well.

Finally, rounding out this issue, be sure to check out our innovator spotlight on Dr. Clarissa Desjardins and her company Clementia Pharamceuticals; and Julia Publicover’s piece on Centralized Image Management for Multi-centre Clinical Trials.

We hope you enjoy this issue as much as we enjoyed putting it together.

EDITORIAL ADVISORY BOARD Christine Beyaert, Cohn&Wolfe; Pierre Bourassa, IRAP, Montréal; Murray McLaughlin, Sustainable Chemistry Alliance; Ulli Krull, UTM; John Kelly, KeliRo Company Inc.; Peter Pekos, Dalton Pharma Services; Brad Thompson, Oncolytics; Robert Foldes, Viteava Pharmaceuticals Inc.; Gail Garland, OBIO; Barry Gee, CDRD; Bonnie Kuehl, Scientific Insights Consulting Group Inc.; Raphael Hofstein, MaRS Innovation; Roberto Bellini, Bellus Health; Peter van der Velden, Lumira Capital; Albert Friesen, Medicure Inc.; Ali Tehrani, Zymeworks Inc.

Biotechnology Focus is published 6 times per year by Promotive Communications Inc. 23-4 Vata Court, Aurora, Ontario L4G 4B6 Phone 905-727-3875 Fax 905-727-4428 www.biotechnologyfocus.ca E-mail: biotechnology_focus@promotive.net Subscription rate in Canada $35/year; USA $60/year; other countries $100/year. All rights reserved. No part of this publication may be reproduced without written consent. Publications Mail Registration Number: 40052410 Return undeliverable Canadian addresses to: circulation dept – 23-4 Vata Court, Aurora, Ontario L4G 4B6 National Library of Canada ISSN 1486-3138 \ All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

If you would like to order hard copy or electronic reprints of articles, contact sales@promotive.net

4 BIOTECHNOLOGY FOCUS April/May 2016

2016

Canada Gairdner Awards

Recognizing the world's greatest achievements in biomedical research since 1959 CANADA GAIRDNER INTERNATIONAL AWARDS RECOGNIZE INDIVIDUALS FROM VARIOUS FIELDS FOR SEMINAL DISCOVERIES OR CONTRIBUTIONS TO BIOMEDICAL SCIENCE

Dr. Rodolphe Barrangou

Associate Professor, Department of Food, Bioprocessing and Nutrition Sciences; Todd R. Klaenhammer Distinguished Scholar in Probiotics Research, North Carolina State University

CANADA GAIRDNER INTERNATIONAL AWARD

Dr. Philippe Horvath Senior Scientist, DuPont

CANADA GAIRDNER INTERNATIONAL AWARD

Awarded for establishing and characterizing CRISPR-CAS bacterial immune defense system

Dr. Emmanuelle Charpentier

Scientific member of the Max Planck Society, Director at the Max Planck Institute for Infection Biology; Professor, Umeå University

CANADA GAIRDNER INTERNATIONAL AWARD

Dr. Jennifer Doudna

Li Ka Shing Chancellor’s Chair in Biomedical and Health Sciences; Professor of Molecular and Cell Biology and Professor of Chemistry at UC Berkeley; Investigator of the Howard Hughes Medical Institute

CANADA GAIRDNER INTERNATIONAL AWARD

Dr. Feng Zhang

Awarded for development of CRISPR-CAS as a genome editing tool for eukaryotic cells

Core Member, Broad Institute of MIT and Harvard; Assistant Professor, McGovern Institute for Brain Research, Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology

CANADA GAIRDNER INTERNATIONAL AWARD

Dr. Anthony Fauci

THE JOHN DIRKS CANADA GAIRDNER GLOBAL HEALTH AWARD RECOGNIZES SOMEONE WHO IS RESPONSIBLE FOR A SCIENTIFIC ADVANCEMENT THAT HAS MADE A SIGNIFICANT IMPACT ON HEALTH IN THE DEVELOPING WORLD

Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health

JOHN DIRKS CANADA GAIRDNER GLOBAL HEALTH AWARD

Awarded for his many pioneering contributions to our understanding of HIV infections and his extraordinary leadership in bringing successful treatment to the developing world

Dr. Frank Plummer

THE CANADA GAIRDNER WIGHTMAN AWARD IS GIVEN TO A CANADIAN WHO HAS DEMONSTRATED OUTSTANDING LEADERSHIP IN MEDICINE AND MEDICAL SCIENCE THROUGHOUT HIS/HER CAREER

Senior Advisor, Public Health Agency of Canada; Distinguished Professor, University of Manitoba

CANADA GAIRDNER WIGHTMAN AWARD

Awarded for his groundbreaking research in Africa in understanding HIV transmission and his leadership at the Canadian National Microbiology Laboratory with pivotal roles in SARS, influenza and Ebola epidemics

Find out more about the work of the Gairdner Foundation and this year's laureates at www.gairdner.org

The Gairdner Symposia • Gairdner National Program • Gairdner Student Outreach Program • Gairdner Awardee Lecture Series

www.gairdner.org • @GairdnerAwards

R&D news Montréal Heart Institute researchers discover biomarker for diagnosing pulmonary hypertension

Left to right: Gaétan Morin, President and CEO, Fonds de solidarité FTQ; Luc Marengere, Managing Partner, TVM Capital; L’’honorable Denis Coderre, maire de Montréal; Caroline Fortier, CEO, Esperas Pharma Inc.; Dr. Gerald Batist, Scientific Director, Q-CROC; Vincent Poitout, Scientific Director, CRCHUM (CNW Group/Esperas Pharma inc.)

Esperas Pharma Inc. to begin clinical development of new anti-cancer product at major Montréal hospitals Montréal, QC – In partnership with the Québec Clinical Research Organization in Cancer (Q-CROC), Esperas Pharma Inc. is investing up to $7 million in a clinical trial that will give Québec patients first access to its promising new oral anticancer agent called ESP-01.

Esperas says it will develop ESP-01 in the province for the next three and a half years, in patients with advanced or metastatic cancer including metastatic triple-negative breast, colorectal or ovarian cancer.

The project will begin with a first-in-human clinical trial, to determine the safety and efficacy of ESP-01, followed by Phase 2 clinical trials, to be conducted at major Montréal hospitals: the Centre Hospitalier de l’Université de Montréal (CHUM), the Segal Cancer Center at the Jewish General Hospital (JGH) and the McGill University Hospital Center (MUHC). In time, other Québec centers may be added.

“We are pleased to collaborate with Esperas on this important clinical study,” said Dr. Gerald Batist, scientific director and cofounder of Q-CROC. “Through this partnership, we will realize our mission, which is to significantly improve the anti-cancer drug development ecosystem, to multiply pa6 BIOTECHNOLOGY FOCUS April/May 2016

tient treatment options, and to reduce the financial burden on the health care system through, in part, improvement of the clinical research infrastructure in Québec.”

Esperas Pharma Inc. was founded in April 2015 by a US$16.5 million financing led by TVM Life Science Ventures VII, a venture capital fund domiciled in Montréal, and coinvestor Fonds de solidarité FTQ. Esperas acquired the worldwide rights to develop and commercialize ESP-01 from Eli Lilly and Company (Lilly).

“The management team of Esperas Pharma Inc. is delighted to initiate the development of this anticancer medicine in Québec and to provide Québec cancer patients with first access to this promising development candidate,” said Caroline Fortier, CEO of Esperas Pharma Inc. “Furthermore, the company is proud to collaborate with the QCROC network and renowned centers such as the CHUM the JGH and the MUHC.” To see this story online visit http://biotechnologyfocus.ca/esperaspharma-inc-begin-clinical-developmentnew-anti-cancer-product-major-Montréal-hospitals/

Montréal, QC – During the annual meeting of the American College of Cardiology (ACC) held recently in Chicago, a researcher from the Montréal Heart Institute (MHI) presented the results of a Phase 2 clinical study demonstrating the safety of the PulmoBind biomarker and the ability of the PulmoBind tomography (SPECT) scan to clearly show abnormal results in patients with pulmonary hypertension.

The work of the team headed by Dr. Jocelyn Dupuis has led to the development of the first safe, sensitive and non-invasive molecular imaging agent designed for early diagnosis and monitoring of pulmonary hypertension. Dr. Dupuis was able to demonstrate that PulmoBind could replace the tests currently used in clinical trials to establish an early diagnosis and monitor treatment efficacy.

“This breakthrough brings great hope to patients with pulmonary hypertension because of the life-changing impact of benefiting from earlier treatment,” said Dr. Dupuis.

Pulmonary hypertension (PH) is a common, potentially life- threatening disease characterized by a progressive narrowing of the blood vessels in the lungs. It causes a gradual increase in shortness of breath,

R&D news which leads to significant disability. There is currently no cure. The development of effective medication is complicated by the lack of non-invasive tests that can screen for the disease at an early stage and monitor its progression. That is why this discovery gives so much hope to people with this disease.

PulmoBind is a new radiopharmaceutical product developed jointly by Dr. François Harel from the MHI’s Nuclear Medicine Department and Alain Fournier, PhD, a peptide chemist at INRS–Institut Armand-Frappier.

“There is currently no equivalent to PulmoBind capable of performing a functional imaging of pulmonary circulation. We take pride in this product for which we carried out all stages of development, from the basic research to its human application. We were able to achieve this using the stateof-the-art equipment at the MHI’s Nuclear Medicine Department,” explains Dr. François Harel, nuclear cardiology specialist.

According to Dr. Jean-Claude Tardif, director of the Montréal Heart Institute Research Centre and professor of medicine at Université de Montréal, “this discovery and the

development of PulmoBind by Dr. Jocelyn Dupuis and Dr. Francois Harel could truly change the lives of patients with pulmonary hypertension by improving early diagnosis and personalized monitoring.”

The project itself was backed by the CQDM and that organization says it is pleased with the results yielded by the project to date.

“We are extremely proud to have supported this project from the very beginning. We also salute the contribution of mentor Michael Klimas from Merck in the development of a positron emission tomography (PET) imaging version of PulmoBind. Results are very impressive and point to a bright future,” said Diane Gosselin, CEO of CQDM. It is expected that the results of this project will lead to a Phase 3 study extending three years and involving 350 patients across 10 centres in North America.

To see this story online visit http://biotechnologyfocus.ca/world-firstMontréal-heart-institute-biomarker-diagnosing-pulmonary-hypertension-discovered/

Dr. Janet Rossant wins Henry G. Friesen Health Research Prize Dr. Janet Rossant, a world renowned stem cell scientist and biologist, has been named this year’s winner of the Henry G. Friesen International Prize in Health Research.

The Friesen Prize, established in 2005 by the Friends of Canadian Institutes of Health Research (FCIHR) recognizes exceptional innovation by a visionary health leader of international stature. Dr. Rossant was recognized for her extensive scientific contributions to developmental biology and her international leadership in stem cell biology and policy-making.

Among her major scientific accomplishments to date, she demonstrated the origin of cells in the early embryo that can give rise to all tissues and the entire body of an intact animal, as well as the cells that give rise to the placenContinued on page 8

April/May 2016 BIOTECHNOLOGY FOCUS 7

Continued from page 7

Dr. Janet Rossant, PhD Photo: Janet Bedford

BUSINESS corner

Zymeworks completes M&A of CDRD spin-off Kairos Therapeutics

ta. This fundamental research informed the development of human pluripotent stem cells that have the potential to treat devastating degenerative diseases.

In addition to her role as former chief of research of the Research Institute at the Hospital for Sick Children (2005-2015), Dr. Rossant also directed the Ontario Stem Cell Initiative and served as scientific director of the Ontario Institute of Regenerative Medicine. In May 2016, she will become the president and scientific director of the Gairdner Foundation.

Born in Chatham, Kent (UK), Rossant obtained a BA at Oxford University and PhD at Cambridge University. She joined the professoriate at Brock University in 1977 and in 1985, came to the University of Toronto, first at the Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital and from 2005 at the Hospital for Sick Children.

As a public advocate, she has played a leading role in setting public policy regarding stem cell research. Her expertise in stem cell biology informed the scientific and ethical debate surrounding cloning and human embryonic stem cell research in Canada and the U.S. Dr. Rossant also had a major role in establishing guidelines for human embryonic stem cell research in Canada and beyond.

She has also received many distinctions including four Honorary Degrees, Fellowships in the Royal Society of London and Canada, 15 major national and international prizes, including Companion of the Order of Canada, the Michael Smith Prize, the Killam Prize and the Canada Gairdner Wightman Award.

Dr. Janet Rossant will deliver a public lecture this Fall in conjunction with the annual meetings of collaborating Scientific Societies and will also visit a number of Canadian universities and institutes.

The $35,000 Friesen Prize is awarded annually.

To see this story online visit http://biotechnologyfocus.ca/drjanet-rossant-wins/ 8 BIOTECHNOLOGY FOCUS April/May 2016

VANCOUVER, BC - Vancouver-based biotech Zymeworks Inc. says it has completed its merger and acquisition of Kairos Therapeutics, a CDRD spin-out company.

The new combined company will continue to be headquartered in Vancouver under the Zymeworks brand, creating one of the industry’s leading biologics drug discovery and development organizations.

Financial details of the merger and acquisition deal were not disclosed.

According to Zymeworks president and CEO Dr. Ali Tehrani, Kairos’ technology and pipeline will be integrated with Zymeworks’ research platforms.

“The completion of this merger is a transformative event for both Zymeworks and Kairos, and brings us closer to our goal of delivering life-changing medicines to patients who need better options,” he said. “Combining Kairos’ superior ADC (antibody-drug conjugate) technology with our platforms, scientific experience, and resources positions us as a clear leader in the field of biotherapeutics with tremendous potential to discover and bring forth new medicines.”

The proprietary next-generation ADC platform is based on novel toxin, linker, and sitespecific conjugation technology and could be synergistic with Zymeworks’ Azymetric™, AlbuCORE™, and EFECT™ technologies. More-

over, the Kairos platform has the potential to be a key enabler of personalized medicine as it allows for the development of therapeutics that target cancer with increased potency and efficacy, while reducing toxic side-effects.

As part of the acquisition, a number of Kairos staff will also join Zymeworks, including John Babcook, president and chief scientific officer of Kairos. He will join Zymeworks as senior vice president of discovery research.

“The Kairos team is excited to complete the merger with Zymeworks and bring together protein engineering, ADC, and bi-specific antibody technologies that will significantly enhance our ability to create innovative medicines that make a meaningful impact to lives of patients,” said Babcook. “We believe that by combining forces we will be able to expedite the development of a pipeline of best-in-class therapeutics. I also want to recognize the pivotal role CDRD played in enabling the development of this technology. Their platform is proving invaluable in creating and supporting a new generation of leading life sciences companies.”

To see this story online visit http://biotechnologyfocus.ca/cdrd-spinoff-company-kairos-therapeutics-merges-zymeworks/

BUSINESS corner Teralys Capital closes oversubscribed $375 million Venture Capital Fund of Funds

Montréal, QC - Teralys Capital reports its Teralys Capital Innovation Fund has closed at an oversubscribed $375 million amount.

The innovation-focused investor group currently manages over $1.6 billion in venture capital. This most recent fund of funds was created under the Government of Canada’s Venture Capital Action Plan (VCAP) in collaboration with the Government of Qué-

bec as well as leading Canadian and International institutional investors.

Teralys Capital Innovation Fund is backed

by Caisse de dépôt et placement du Québec, Fonds de solidarité FTQ, Investissement Québec, BDC Capital, Fondaction CSN, Fiera Capital, Lune Rouge, Bpifrance, National Bank of Canada, La Capitale, Desjardins Group and Consensus Business Group. Additionally, innovation-focused Canadian public

companies including Knight Therapeutics and OpenText Corporation are partners in the fund.

“Teralys Capital’s newest investment vehicle builds on the very same guiding principles at the core of our mission: (i) fostering the development of high potential innovative businesses across Canada; (ii) enabling profitable local economic development and job creation; (iii) while generating superior financial returns for all stakeholders”, said Éric Legault, managing partner at Teralys Capital.

Since its initial closing last year, Teralys Capital Innovation Fund has already completed 10 new fund investments and played a leadership role with venture capital managers such as Georgian Partners, iNovia Capital, McRock Capital, Information Venture Partners, White Star Capital, Persistence Capital Partners, Sofinnova Capital, Clarus Lifesciences and OpenText Enterprise Application Fund.

The Teralys Capital Innovation Fund is also leveraging its unique domain expertise and has made five additional direct investments in leading Canadian technology companies including Zymeworks, Lightspeed, eSentire and Luxury Retreats.

To see this story online visit http://biotechnologyfocus.ca/teralyscapital-closes-oversubscribed-375-million-venture-capital-fund-funds/

BARL awarded major research management contract HAMILTON, ON– Hamilton’s Bay Area Research Logistics (BARL) has been awarded an initial three-year contract to handle all of the Canadian clinical trial storage and distribution for GlaxoSmithKline Inc. (GSK).

The services to be provided include storing and distributing pharmaceuticals and vaccines for approximately 25 research trials on an ongoing basis.

The contract will enable BARL to expand its facilities by about 30 per cent and add more than two full-time employee equivalents to its current roster of employees.

“We’re proud that GSK has placed its confidence in us for management of its clinical trial storage and distribution in Canada,” says BARL business unit director Paul McCracken.

“We have an ambitious plan for the growth of our company, and this contract puts us in a good position to bring on even more new customers from across Canada and the U.S.”

BARL is a division of Bay Area Health Trust, which operates a number of enterprises designed to generate profits, used to support health care and health care research in Canada. Established in 2007 with one clinical trial, BARL now manages more than 75 trials for hospitals, universities, research institutes, pharmaceutical and biotech companies, and health clinics across Canada and internationally. Its clinical trial logistics work has involved shipping products to more than 25 countries.

GSK is one of the world’s largest researchbased pharmaceutical and healthcare companies. Ranked among the top 30 contributors to R&D in Canada across all industries, GSK invested $11 million into 71 active clinical trials involving 2,718 patients across Canada in 2015.

To see this story online visit http://biotechnologyfocus.ca/ barl-awarded-major-researchmanagement-contract/ April/May 2016 BIOTECHNOLOGY FOCUS 9

Venture Funds

| By Shawn Lawrence

Mind the ‘funding’ gap: Unique Québec-based venture fund BOLDLY GOES where other funds won’t

W

hen it comes to supporting its life sciences sector, the Québec Government has always been a trend setter. Whether it is facilitating new collaborations, setting business friendly policy, or even flexing its financial muscle, they have been an active partner in driving the industry forward.

The recently announced $20 million government commitment to AmorChem II, an early-stage life sciences fund managed

by Montréal-based venture capital firm GeneChem, is just another example of this out of box thinking that has become synonymous with the government’s support of the sector.

Like its predecessor, AmorChem I, the new fund is leveraged with not just public sector capital but also capital from industry partners.

Also like AmorChem I, the new fund is focused on increasing the commercial potential of innovations originating from Québec-based universities and research centres. Together, the two funds share the distinction of being the only venture fund in Canada fully dedicated to translational research.

For Élizabeth Douville and Inès Holzbaur, general partners with AmorChem L.P., the subsidiary holding company for both funds, watching the model evolve since it was first launched in 2011 has been exciting. Both agree that AmorChem I has done much to rejuvenate Québec’s startup ecosystem. With committed capital of $41.25 million, it has funded 24 new technology projects. The need for such funds was great they say.

“Following the financial crisis of 2008, the government recognized there was a lack of capital for early stage companies or that translational piece where startup companies emerge out of academia,” says Douville.

“AmorChem was created to address this challenge.”

10 BIOTECHNOLOGY FOCUS April/May 2016

The reasons that investing in translational research is crucial are many say both partners.

“In life sciences there’s always been a big financing gap when you go from academia and the more fundamental research based projects, to navigating that next step that leads to drug development,” explains Holzbaur. “Before AmorChem I, such a source of financing was non-existent because traditionally it’s an area not targeted by venture firms. It’s just too early in the game for them to get involved.”

“Most venture capital investors quite frankly like to see things when they’re in GLP talks or very close to the clinic,” adds Douville. “Occasionally they do one-off deals by extracting a technology out of academia and maybe

spinning a company around it. But never systematically the way in which we finance that early stage research, whether it’s In silico or In situ, or in the investigators lab.”

But for AmorChem, it’s an area right in their wheelhouse. Using a semi-virtual model, the goal of AmorChem is to take funded projects through to pre-clinical proof-of-concept with an end goal to either sell the projects to large

AmorChem: the only venture fund fully dedicated to translational research Preclinical Dev

Drug Discovery Research

Target ID

Target Validation

Hit to Lead ID

Lead Validation

Toxicity

IND

Pharmaco CMC Form

Clinical Development Phase I

Phase II

Phase III

University Research Funds Tech Transfer Offices Maturation Programs CECRs & NCEs

AmorChem Ventures

NEOMED BDC FSTQ CTI Genesys GSK Lumira Merck Bioscience Lumira Foreign Funds TVM Sanderling Versant-Inception

Translational Research

Adapted fromGilles Duruflé, 2012

Venture Funds

biotechnology or pharmaceutical businesses; or alternatively they bundle similar projects into new spin-out startups.

The projects are managed by AmorChem using a combination of resources.

For starters, much of AmorChem’s success comes down to having a unique perspective or understanding of the science behind the opportunities that they fund.

“We’re financial investors first and foremost obviously, so we have an understanding of what needs to be done to be able to create value in a project; but we’re kind of also known as the science geeks on the block so to speak. We all have our PhDs and so we understand the science behind the initiatives that we’re supporting which isn’t always true for many venture groups,” says Douville.

“We also have a team of project managers that are people who have had experience in pharma and in small biotech, driving the development of early stage projects,” adds Holzbaur.

Moreover, the AmorChem funds are structured very differently than traditional venture funds. This includes the subsidiary holding company that takes an exclusive license to the intellectual property of the technology and projects, and has the research contract with the universities and the investigators working on the project. As such, the holding company has been structured fiscally to collect the SR&ED tax credits from both the provincial and Federal governments, which

actually increases the non-dilutive cash the Funds can leverage.

“So with AmorChem I, the $41.25M which is the original LP investment into our fund, with the SR&ED tax credit, that figure climbs to the $52 to $53 million range,” says Douville.

They judge opportunities based on the merit of the science and its potential to be a good translational product. The selection criterion is that the technology must be highly innovative in its field, the principle investigator must be credible, the drug must fit an unmet need and the maturation plan must be feasible. Their portfolio is also strategically diversified across various disease indications.

“We’ve chosen not to limit ourselves because our potential partners all have different interests and needs. Additionally, we’re also been very good at selecting projects in technological or disease areas that maybe at the time hadn’t quite yet taken the pharma world

by storm, but thought that one day they might be significant. So it’s about meeting the needs of the industry while at the same anticipating them,” says Holzbaur.

Douville adds that in taking this approach, it’s all about increasing their shots on goal.

“So we’re investing in as many technologies, in as many different areas at least at the onset to sort of minimize the risk of failure.”

The manner in which AmorChem sources its opportunities has also evolved over time.

According to Douville, in the beginning, they were the ones who would do most of the legwork scouting local universities and investigator’s labs.

“We were very proactive to make ourselves known and we also had an existing network of academics that we knew from our work with GeneChem. It really was a combination of us going down the hallways of those universities and looking for those great opportunities, but also having some of those folks come to us through the tech transfer and commercial offices.”

She says that AmorChem uses a more systematic process now.

“That’s through a call for proposals, where the investigators and their tech transfer offices do much of the work we used to do, putting to us a definition of what the technology is, what’s the opportunity, its potential, and of course what they want to do with the money we give them.”

“We’ve chosen not to limit ourselves because our potential partners all have different interests and needs.

Additionally, we’ve also been very good at selecting projects in technological or disease areas that maybe at the time hadn’t quite yet taken the pharma world by storm, but thought that one day they might. “ — Inès Holzbaur April/May 2016 BIOTECHNOLOGY FOCUS 11

Venture Funds

A Québec-based portfolio diversified amongst universities UdeM McGill U Laval INRS CRCHUM ETS IRIC IRCM Waterloo Biotech

She says that this call goes out once a year, and they receive proposals not only from Québec, but now also from some of the other provinces.

“We’re putting our tentacles out there, invading Canada one province at a time,” says Douville.

Another more entertaining way that AmorChem sources its projects is through a special yearly event it hosts called KNOCK OUT™. Inspired by the popular television show Dragons’ Den, chosen researchers or contestants duke it out in front of a panel of seasoned biotech executives for the chance of landing a $500,000 AmorChem financing.

“We select the top five investigators that have submitted proposals to us, and get them

to pitch their business or technology opportunity in a five minute presentation with no slides in front of a panel of dragons. In this case they’re called heavyweights (the boxing analogy) and of course all of these opportunities are reviewed by us ahead of time.”

If there was a limitation to the existing AmorChem model, it was that it could not always invest as much as it would sometimes have liked to.

“Typically it’s $500k to $1 million that goes to each investment opportunity or the first feasibility financing,” says Douville. “Of course when we invest in a technology, we believe the results on which we are doing that investment are solid and sound, but the hypothesis, or commercial hypothesis, we want to test out whether the further validation of that technology in a more commercial track is tenable, and so that is why we limit the first financing to that amount.”

They add that if after that first financing, things look good and the technology looks solid, they’re always willing to back them again. But, as both Douville and Holzbaur explain, they will never have the amount of money needed to be able to take these technologies to the clinic.

While AmorChem II doesn’t address this issue entirely, it does expand AmorChem’s investment strategy significantly. With a target

“We’re at the stage where things are just budding, and we expect to start spinning out companies now in a very aggressive manner.”

— Élizabeth Douville 12 BIOTECHNOLOGY FOCUS April/May 2016

size of the fund set at $55 million, and $51.5 already committed via the Québec Government, the Solidarity Fund FTQ, Merck & Co., and other partners, the financing process is going to be a little bit different this time around the partners say.

“We’re not going to invest in 24 technologies, but instead we’re going to invest in 15 technologies only,” says Douville. She adds that that the focus will be on fewer feasibility projects to allow for more follow-on financing of the most promising opportunities.

“We’re going to limit the number of investments we do in the investigators labs, and we’re keeping quite a bit of money to be able to support the most promising of those technologies as they move along the development path. So basically, there will be bigger funds available for individual projects, not astronomically bigger, but big enough to have more bang for our buck.”

And again, because of SR&ED tax credits that $55 million will be leveraged by $19 million in additional non-dilutive funds.

In the end it comes down to moving that needle enough to make a difference, and seeing more deal flow and companies in the making. If AmorChem I shows any indications, it’s that they’re on the right path.

For example, in one successful case AmorChem was able to take one of its projects and strike a very significant collaboration partnership and option to sub license with Roche Pharmaceuticals at a total value of $108 million. The project was led by Dr. Pascal Chartrand of the University of Montréal and was based on the development of a small molecule development for an orphan disease called Type 1 myotonic dystrophy.

“The biology and chemistry both looked very tractable, so we were lucky enough to have competing interest in play and eventually Roche Pharmaceuticals emerged as the highest bidder and we completed that transaction in July, 2014. Based on a $500,000 investment, it was certainly very worthwhile,” says Douville.

In other cases, the projects invested in have provided meaningful enough results that AmorChem is now looking to launch companies around them. In fact according to Douville, there are six or seven such projects.

“We’re at the stage where things are just budding, and we expect to start spinning out companies now in a very aggressive manner,” she says.

To see this story online visit www.biotechnologyfocus.ca/mind-the-funding-gap-unique-Québec-based-venture-fundboldly-goes-where-other-funds-wont/

Innovators

| By Robert Merson

Special Report

From Student to Bioscience Entrepreneur Entrepreneurs are well worth celebrating as catalysts for economic growth; but the student bioscience entrepreneur deserves an extra level of recognition. These are individuals who can identify unique, high-risk opportunities and then tackle them head-on. Instead of trying to find a job; they start a company, and lead it.

T

he ICT sector has produced many successful student entrepreneurs over the last two decades. The Gen X and Millennial generations have been a driving force behind the boom in technology companies. A culture of “learning to code” has permeated down to primary schools, and student hack-a-thon’s are commonplace on university campuses.

The biosciences sector however has not seen the same rapid growth in technology entrepreneurs and start-ups. Perhaps it’s simply related to the longer development times and higher costs for products created through biological processes. Or perhaps it’s the increased regulatory requirements to ensure health and environmental safety for bioscience products. But the momentum for bioscience entrepreneurs has been shifting in recent years. Something has been happening that has begun to encourage more bioscience entrepreneurs to start their own companies and develop novel technologies that address unmet needs in the industry.

The purpose of this report is two-fold. First, we want to celebrate and recognize some of our most recent bioscience entrepreneurs, those who took the leap from student to Clevel bioscience executive. Second, we seek to identify and highlight some of the many support systems and programs which seem to be catalyzing the creation and development of successful bioscience entrepreneurs.

It still all starts in school Many in our field can relate back to a grade school science teacher or other similar role model who first got us hooked on science.

But it’s not enough to just have a love of the subject. Students want hands on experiences that not only further engrain their passion for science, but ones that also give the field a sense of purpose. Job shadowing is one example of how students can see first-hand the opportunities in the sector, but it’s the extracurricular activities that seem to be cited most often.

It’s the competition aspect that seems to seed the interest in entrepreneurship and the hands on problem solving that the students enjoy. The traditional science fair is nothing new, but there are two Canadian initiatives that can highlight how this traditional idea has been elevated to a passion filled extra-curricular activity (meaning they don’t do it for school credit anymore – they do it for fun!).

The Sanofi BioGENEius Challenge is a competition founded in 1993, when Toronto was preparing to host the BIO 1994 conference.

At the time it was Connaught Laboratories that partnered with Seneca College and the City of Toronto to recruit students who would showcase commercial applications of biotechnology. This was unlike any typical science fair, requiring an approved research proposal, direct engagement with industry mentors, and they even provided grant funding. The initiative was such a success that over the next few years it expanded across Canada, and in 1998 was picked up by the US-based Biotechnology Institute. The newly branded BioGENEius Challenge became somewhat of an “Olympics” of biotechnology student competitions, culminating every year around the international BIO conference. The impact for Canada has been tremendous, with currently 9 regional competitions held every year across Canada, and a national competition held in May. In 2009, with the founding of the McMaster University based Centre for Surgical Invention and Innovation, another student competition was established soon after; this time focused on robotics. As part of the Centre’s community outreach, it hosts an annual Innovation Nation Conference and Robotics Competition to engage high school and postsecondary level students in more engineering based problem solving. While there are other robotics competitions across Canada (e.g. First Robotics), this initiative was unique in terms of providing a showcase conference focused on the applications of robotics

Innovators specifically for the medical sciences sector.

By the time students are in University, a new level of competition has emerged. At the high school level, students are extremely dedicated and hardworking, but the primary motivation still seems to be to “have fun”. For university students however, these competitions are serious business. More valuable time is required, influential industry leaders and investors are involved, and often real money is on the line.

One of the most prestigious university level biotechnology competitions is iGEM (which stands for International Genetically Engineered Machines). Founded in 2004, this completion focuses on the applications of synthetic biology, and requires participants to have a good understanding of university level biology and biochemistry. The competition challenges teams to develop genetically engineered systems using standard biological parts (i.e. DNA sequences that encode a biological function). Many Canadian universities have teams that compete in this annual competition.

Universities are increasingly encouraging entrepreneurship The old saying used to be “you don’t go to university to get a job; you go to get an education.” If you wanted a career following your post-secondary studies, you may have alternatively been encouraged to go to a college. Now, entrepreneurial focused university programs are increasingly encouraging the philosophy that “university graduates should be creating jobs instead of seeking them.”

The University of Toronto seems to be one school that has aggressively been pivoting toward entrepreneurship over the past several years. The university has supported the launch of as many as nine distinct accelerators, each with unique objectives, but all supporting the growth of entrepreneurial ventures. As just one example, the Impact Centre and its Techno program, which mentors student entrepreneurs on how to start a company, boasts over 40 companies, the majority of which are in the bioscience space. In addition to these formal incubator programs with the university, the university’s affiliated teaching hospitals have also launched their own programs to support entrepreneurship and company creation. The Sunnybrook Research Institute for example has spun-off some of Toronto’s most recognizable medical technology entrepreneurs. Technology commercialization from the university and its affiliated hospitals, among other partners, is now managed by MaRS Innovation, an organization which also supports company

creation, and currently helps manage over 30 companies.

A more recent example is the 2015 launch of McGill’s X-1 Accelerator Program. This 10-week summer boot camp helps new entrepreneurs with the basics of developing a business plan, right through to pitching in front of investors. Although McGill has a history of mentoring nearly 1,000 start-up business teams since 2009 through its Dobson Cup competition, they and other institutions continue to introduce new programs to support entrepreneurs, with more programs focused specifically on supporting bioscience start-ups.

The University of Waterloo is probably the most well recognized institution historically for entrepreneurship. The university has prioritized co-operative training as a component of their degree programs for many decades, and boasts the largest post-secondary cooperative education program in the world.

This program has provided students with experience working in industry to complement their education. Professional Experience Year programs (or PEY’s) are available at other academic institutions, however they are not as well known or openly encouraged. Academic and regional accelerators are also readily available to Waterloo entrepreneurs, and the university is home to an active entrepreneurship community. While the Waterloo cluster has been typically labeled as ICT, there are also emerging bioscience companies coming from this region.

In terms of bioscience entrepreneurship, the best example of student networking groups is likely the Student Biotechnology Network in British Columbia. This group, which started in 2010, emerged primarily from the students at the University of British Columbia. While the focus is not specifically entrepreneurship, the group is dedicated to building a stronger network and capacity for students looking to engage in the biosciences community. The network links students with industry mentors who provide advice on careers in the biosciences sector, and it hosts events to build a stronger cluster of individuals dedicated to the sector. Not only has this network succeeded in its efforts, but they have attracted the interest of students from across Canada.

While student mentorship outside of BC is only a pilot program for 2016, they are assessing the feasibility of administering a national program.

Maybe university isn’t what you needed after all In 2011, Peter Theil (co-founder of PayPal and investor in other high tech start-ups) established the Theil Fellowship program, targeting

young entrepreneurs. This program provides a two year grant totaling $100,000 for students less than 23 years of age (the approximate age of a post-secondary graduate). Successful fellows either stop their post-secondary education, or skip it all together in order to achieve the programs primary objective – for young people to “build new things” instead of “sitting in a classroom.” In addition to the non-dilutive grant, fellows also receive support from the Theil Foundation’s network of founders, investors, and scientists to help build their companies.

Out of the 19 Theil Fellowships awarded for 2015, four were from Canada, with two of the individuals founding companies in the biosciences sector – Harry Gandhi, Co-Founder and CEO of Medella Health; and Cathy Tie, Co-Founder and CEO of Ranomics.

University educated or not – entrepreneurs still need help Beyond the realm of the university campus, entire regions have been building support systems to promote and foster entrepreneurship in the biosciences sector.

In Ontario, the investment in biotechnology incubators in the late 90’s, and the founding of the MaRS Discovery District in 2000 were early initiatives involving stakeholders from government, academia and industry, which helped to formalize innovation and the biosciences as priorities for the region. Now MaRS is just one node in a much larger Ontario Network of Entrepreneurs, which includes regional innovation centres across the province, and dedicated programs for supporting entrepreneurs and start-up companies.

Québec has undergone a similar transformation over the past 15 years, with investments in regional cluster initiatives, the establishment of regional incubators and provincially funded support programs.

Even federal programs have provided support to bioscience entrepreneurs through funding and technical expertise (e.g. NRCIRAP). The federal Centers of Excellence for Commercialization of Research (CECR) program has produced many national centers focused on commercialization in the biosciences sector. One of the most successful examples is the Vancouver-based Centre for Drug Research and Development (CDRD), which actually preceded the federal CECR program. By focusing specifically on drug development, CDRD has been helping Canadian research to secure more value within Canada.

Entrepreneurship workshops, business plan competitions, and innovation showcases have been popping up all across the country, and they all seem to be busy and over-subscribed.

New entrepreneurs are engaging with per-

Innovators spective entrepreneurs and more individuals are beginning to realize that entrepreneurship may be an option for them.

Perhaps most surprising has been the impact of foreign incubators and programs on stimulating entrepreneurship in Canada. The Indie Bio Accelerator program, which provides start-up funding and hosts incubation facilities in San Francisco, and Cork Ireland, has even enabled the launch of a Canadianbased start-up company (see profiled company Hyasynth Bio). The Canadian Technology Accelerator program has also helped Canadian bioscience companies expand into international markets (see profiled company Precision Nanosystems).

Canadian regions are recognizing that entrepreneurship is a critical factor to sustained economic growth, and while innovation based companies in general have been the focus, the biosciences sector is beginning to emerge as a high impact sector that cannot be ignored.

Mentorship is key Student mentorship is one thing, but for entrepreneurs starting a company, they rely heavily on experienced people to talk to. Being a CEO in the biosciences space can be a lonely job. Advisors are key at every stage of development, but what helps most is simply having someone who has shared a similar experience to run your ideas by.

Over time, mentors will come through advisory boards and investors, but a true mentor, who simply wants to give back and receive nothing in return, can still be hard to come by for early stage bioscience entrepreneurs.

Industry associations and regional bioscience organizations have been cited as facilitators of mentorship. While many organizations across Canada have established mentorship programs, the Ontario Biosciences Innovation Organization (OBIO) has taken this concept several steps further, actively supporting early stage bioscience entrepreneurs through their Pre-CAAP and CAAP programs.

These programs, the latter of which also received support from FedDev Ontario and the Ontario Government, directly engage early stage bioscience entrepreneurs, and provide them access to mentors at the pre-investment stage who help them to build their business, and then to investment mentors when they achieve a stage that they are ready to seek venture investment.

Building an industry – success is not dependent on the entrepreneur alone Entrepreneurs may build a company, but it takes many entrepreneurs to build an indus-

try. Regions and governments have recognized this, through strategic investments and programs that support commercialization of technologies, but economic policies also need to be aligned. Over the past decade the federal government has prioritized investments in the commercial development of research, while most recently the new government has reinvested in building capacity in Canada’s basic research. Support for small companies however still remains uncertain.

Now that we’re seeing a growing number of bioscience entrepreneurs, we need to make sure we’re supporting them to grow and thrive in Canada.

Bioscience entrepreneurs are skilled at identifying a market need and developing a technology solution to address that need.

When they achieve the milestone of developing a novel product however, we as a community need to support them to ensure that Canadians can access these innovative products and that the company can export its products to serve the global market. We as a community need to ensure that these companies can establish operations, grow employment, and sustain economic activities within Canada. If we truly want to celebrate the Canadian bioscience entrepreneurs, then we need to ensure that we support them in contributing to a vibrant biosciences industry in Canada.

While we have selected only a few companies to be profiled, there are several more companies that should be equally celebrated. These entrepreneurs and companies will be key to the future of our sector.

Mycodev Group, Fredericton, NB Dave Brown, Founder and CTO

Origins of the idea: During his undergraduate studies at the University of Alberta, Dave Brown says he “got the bug” for entrepreneurship after competing with the school’s iGEM competition team in 2012. This extracurricular activity was like a full-time job for members of his team, which included about eight students comprised of undergraduate level engineers, scientists and two business students. Under the mentorship of two professors, the University recruits an annual team of students who submit a project plan every April to compete against international teams at MIT each November. Brown’s team submitted a project as part of the entrepreneurship stream, which not only involved developing a novel technology from bacteria, but also required a full business plan and pitch to a panel of judges. The team won this category, and Brown was hooked as a bioscience entrepreneur.

Fresh off his win, Brown started investigating what he saw was an unmet need for chitosan. This is a biomaterial typically sourced from shrimp and crab shells, and used in medical applications including pharmaceuticals and wound care products. The problem with existing sources of chitosan was that the vast majority of the biomaterial was sourced directly from shell fish, and there was a grow-

Innovators ing concern from medical end users about the potential for allergic reactions and the high quantity of heavy metals that accumulated in shell fish. Brown identified that end users had a need for high purity chitosan that could consistently be reproduced.

Decision to create a company: Upon graduation, Brown returned to his family roots in New Brunswick, but there weren’t many opportunities for bioscience graduates. However, as a proud native of New Brunswick, he was committed to staying there and starting a company. He developed an idea to use large-scale fermentation of fungus for chitosan extraction. With this idea alone, he incorporated Mycodev Group, developed a crude website, and then began to receive inquiries from several U.S. based companies within the first week.

In his early days, Brown was able to secure some bench space with the Biorefinery Technology Scale-Up Centre at CCNB. With a bit of seed funding from the New Brunswick Innovation Foundation (NBIF), Brown received a research voucher to cover the cost of lab space. The only drawback was the 200km between his lab bench at CCNB and his home in Fredericton, so he ended up spending the summer camping out in a tent to ensure that he could stretch his development dollars as long as possible.

Support along the way: Brown freely admits that while he is passionate about the technology, he did not have the business background to scale his company. He was extremely fortunate to find a business partner during a presentation on his company to the local biotech community at a regular BIONB meeting. Brennan Sisk was in the crowd and soon after he became the company CEO. This partnership allowed Brown to focus his efforts on developing the technology, while Sisk led the corporate development, from sourcing financing to clients.

Mycodev secured office space in a Fredericton at the tech accelerator, Planet Hatch.

This organization not only provided the company with a dedicated office, but also provided start-up mentorship to the company. Funding was secured through a loan from ACOA, as well as a follow-on investment of $550K from the NBIF. The PondDeshpande Centre at UNB was also cited a source of support and early stage funding.

Possibly the most important support however came from the early customers themselves. Brown initiated discussions with prospective end users and engaged them directly in validating the early batches of chitosan that he was producing. With their feedback, he was able to refine his

fermentation process and ensure that his new customers were getting the high quality product that he had committed to.

Projected impacts of the company: Mycodev Group boasts a unique source for high purity chitosan with high consistency for each batch produced. The company is in a growth phase, currently recruiting new hires, and looking to expand beyond their current space. Their 10 year plan includes expanding to biopolymer products including nanoparticle chitosan and 3-D bioprinting scaffolds.

Their vision is to become a leading company in Canada’s biotechnology sector.

FINAL THOUGHTS ON OUR CULTURE FOR BIOSCIENCE ENTREPRENEURSHIP: Brown questions the limited number of bioscience entrepreneurs in Canada, when we seem to have a vibrant start-up culture in the information technology sector. “We’re missing a huge opportunity”, states Brown. “It’s unfortunate that so few individuals feel that entrepreneurship is an option for this sector.

We need to address this.”

Covina Biomedical, Halifax, NS Caitlin Pierlot, Co-Founder and CEO Brett Dickey, Co-Founder and CTO

Origins of the idea: Caitlin Pierlot was a relatively new addition to the technology team, having worked throughout her PhD on more of the fundamental sciences of biomedical research; but Brett Dickey was involved in the technology from the beginning, having spent over five years of his graduate training developing it. Both were researchers in Daniel Boyd’s lab at Dalhousie University’s School of Biomedical Engineering. It seems that Prof.

Boyd was a key mentor from the start, having previously founded a biomedical company in his native Ireland, and a second company, ABK Biomedical after being recruited to Canada. ABK Biomedical was also recognized for winning the inaugural BioNova BioInnovation Challenge competition in 2011.

Dickey however was no stranger to entrepreneurship, coming from an entrepreneurial family and having being involved in school co-ops and the early stages of another spin-off company during his undergraduate education. His graduate work in the Boyd lab focused on adopting the chemistry of an aluminum free, glass ionomer cement for use in orthopaedic applications. The goal of this research was always focused on commercializing the resulting technology.

Decision to create a company: After several years of research, funded through an Atlantic Innovation Fund (AIF) grant to the Boyd lab, Dickey had perfected the cement and it was ready for commercial testing and development. It was at this stage that Dickey decided that he preferred his lab-based work

Innovators on the technology, and recruited Pierlot (a post doc in the Boyd lab at the time) to become the company’s CEO. Covina Biomedical was established in the Fall of 2015, and it became the official commercial partner for the AIF funded research.

Concurrently, the annual BioNova BioInnovation Challenge competition was underway.

This competition, which attracts competitors from the academic and local business communities, provided an extra incentive for Pierlot to formalize a business plan and a pitch to potential investors. Despite considering themselves as one of the “greener” teams in the competition, they went on to win for best company and were granted a $45,000 prize.

Support along the way: Many other organizations provided support to help launch the new start-up company. Innovacorp, an early stage venture capital fund for Nova Scotia companies, provided grants through their Early Stage Commercialization Fund to help assess the regulatory and reimbursement requirements for the technology as well as some of the costs associated with patenting. Their Life Sciences Pre-Investment Program provided further support to the company in order to prepare it for investment. ACOA also provided a grant for Consulting Advisory Services, which was used to help the company develop a logo, value statements, and also refine their pitch.

Projected impacts of the company: The short term objectives for the company are focused on job creation and economic growth for the Halifax biosciences economy, and to continue to promote the ongoing translation of university research into industry. In the long term, the ultimate objective is to enhance the efficiency and efficacy of orthopaedic procedures, thereby improving patient outcomes and reducing the overall cost burden for the health system.

Final thoughts on our culture for bioscience entrepreneurship: Pierlot remarks that over the several years of her graduate and post-doctoral training, she has witnessed a visible change in the growing interest and support for bioscience entrepreneurship. Dickey notes that with limited opportunities for industrial employment in the bioscience sector in Atlantic Canada, there seems to be more of a shift in promoting entrepreneurship as a viable option for sustainable careers in the region. While the two are pleased that they are not unique among their peers, knowing others who are pursuing entrepreneurial bioscience ventures, they admit that they remain very much in the minority.

Hyasynth Bio, Montréal, QC Kevin Chen, CoFounder and CEO

Origins of the idea: Problem solving and biology seem to have been passions for Kevin Chen from early-on in his student career. During his undergrad at Queen’s University, he was team leader for the school’s iGEM competition team. He spent his summer after graduation working for Synbiota, where he was further exposed to the Do It Yourself (DIY) Bio community. In the fall, he began a Master’s degree at McGill University, but spent his evenings and weekends with a biohacker group he helped co-found called Bricobio. It was here where he met like-minded individuals and together they came up with the idea to use synthetic biology to produce THC, the chemical compound cited for the medicinal applications of marijuana.

Chen considers himself among a growing community of “hackers” and “DIY’ers”, which are common enough terms outside of the biosciences sector, but are progressively gaining acceptance within the biosciences community. The DIY-Bio community share a philosophy of open source environments, shared spaces, and learning through your peers; whereas biohackers go a step further to tackling specific problems with a biological solution, in a short period of time. A biohacker simply sees genetics or a biological interface as a traditional IT hacker’s software code. Chen and his peers have actually developed many ideas, and he remains well connected within this growing community of bio-innovators.

Decision to create a company: Hyasynth Bio was established, when the idea for developing THC using synthetic biology was accepted as a business proposal submission to the inaugural Indie Bio Accelerator program based in Cork, Ireland. Chen’s decision to take leave of his Master’s program for this venture was not encouraged by the institution. Nonetheless, Chen was committed, and with his colleagues they established the company’s start-up operations in an Indie Bio facility in Cork for the summer. The accelerator program provided the company with seed funding, lab space, and mentorship, which enabled the team to validate their technology, develop the business plan, and grow the company to a stage where it could attract seed investment.

And that is exactly what happened. The Ireland based venture capital firm, SOS Ventures provided a $500,000 seed investment in the company, and Chen was able to relocate the company’s operations back to Montréal.

He was also able to attract two additional angel investors, who each provided a small investment, but more importantly brought a valuable advisory capacity in specific areas of development.

Support along the way: Chen is highly complementary of the Montréal biosciences community. He continues to be actively engaged in networking events, and he’s been able to discuss his business with several investors. He’s also been working with the National Research Council who is supporting some of the company’s research, as well as Health Canada who are supporting the regulatory aspects of the company’s development activities. Given the sensitive regulatory nature of the company’s main product, Chen applauds Canada’s support for their research, stating that it’s much more difficult to acquire the required permits in other jurisdictions.

Chen selected a downtown location for his company, over other available incubation spaces throughout the region, as culturally this is where they enjoyed being. With facilities on the campuses of both Concordia University and UQAM, they have access to the appropriate space for their research, and they have experienced a growing support for bioscience entrepreneurs from these institutions.

Projected impacts of the company: The primary mandate for the company is to establish a controlled platform for medici-

Innovators nal cannabinoid usage. Currently, the only source for medical marijuana comes directly from the buds of the original plant material, with no real understanding as to how it should best be administered or used. This is particularly concerning when using cannabinoids for pediatric conditions. Hyasynth Bio is seeking to migrate the supply chain for cannabinoids to a controlled production with yeast, where purity and consistency of the end product can be ensured. Chen likens this process to the biomanufacturing of insulin, which was originally harvested from the pancreas of pigs, but soon transitioned to the controlled production of the compound using bacteria.

The impacts for Chen will not end with this venture. Chen is committed to expanding his interest in synthetic biology and to address new challenges in the future.

Final thoughts on our culture for bioscience entrepreneurship: Chen finds that while entrepreneurs are in no way unique to other technology sectors, they are under represented in the biosciences.

He feels that his team may be somewhat unique for the bioscience space in terms of their business style and young age; however, he would like to see many more people involved in building companies in the sector.

Medella Health, Waterloo, ON Harry Gandhi, Co-Founder and CEO Origins of the idea: Harry Gandhi has always had a passion for diabetes, recognizing the complexities of monitoring and management for this life-long disease. With both a family connection and a direct involvement in implementing a glucose monitoring system across a health system as part of a university co-op term, Gandhi knew early on that this was an area in which he wanted to make an impact. Surprisingly however, this was not his first start-up venture. He also founded a highthroughput genetic testing platform, which he says “failed for all the right reasons.” Based on this experience and his passion for diabetes, he developed the idea for Medella Health with two other students from the University of Waterloo. His co-founders Maarij Baig and Huayi Gao were all active in Waterloo’s entrepreneurship scene, and the team of three

began working together evenings and weekends, often prioritizing time for developing the technology in lieu of going to class – a decision that the University of Waterloo’s administration and professors were flexible to accommodate. Gandhi was actively involved in establishing a “biohacking” centre through a co-op term with the university, and Gao developed part of the technology platform as a 4th year design project. But after many months of development, the team decided that it required their full-time attention. This resulted in Gandhi dropping out of school to become the CEO for the new company, and Gao leaving the Master’s program that he had recently started.

Decision to create a company: The team knew that they had a strong infrastructure support system for starting a company; and they were dedicated to pursuing change in the chronic management of diabetes; but it wasn’t until they received their first real cash investment from winning a Fed-Dev Ontario sponsored business pitch competition, that they knew they had a company that would achieve a real impact. This became the force that drove the three founding bioentrepreneurs. They had no early visions of making lots of money, or any illusions of an easy lifestyle – they were simply driven by the goal of making an impact in healthcare, and they would dedicate the long hours required to achieve it.

Support along the way: The Velocity program at the University of Waterloo was essential to the company’s early success, offering access to equipment, lab space, and research mentors, all free of charge.

This program takes no share in equity from

start-up companies, and expects nothing in return. Federal grants were also helpful in seeding the company financially, but Gandhi cautions that early start-ups must avoid the trap of “grantrepreneurs”, that rely primarily on government assistance in lieu of focusing on developing their technology and attracting commercial interest. A Theil Fellowship also provided some early financing, but Gandhi stresses that the most critical support was not in the form of cash, but rather in accessing the required infrastructure and expertise to develop their technology.

Medella Health has since been recruited for relocation to California and other regions in the U.S., but the company is committed to keeping the technology development side in Waterloo, due to the three main pillars of technological support, that can’t be found clustered anywhere else in the world. These include: the Centre for Contact Lens Research which supports their underlying platform interface; the Center for Intelligent Antenna and Radio Systems which was also an early supporter of the Blackberry technology; and the Waterloo Institute for Nanotechnology which believes strongly in supporting young entrepreneurs.

Projected impacts of the company: In addition to the economic impacts of improving the GDP of the region, Medella Health is focused on achieving real impact for addressing the data collection problems in healthcare. Diabetes is a disease that once developed, stays with an individual their entire life, requiring regular monitoring and maintenance. Medella Health’s goal is to make this easy and seamless, shifting from a culture that is currently reactive to seeking treatment, to a culture that is proactive at monitoring and maintaining health. Over time this technology is expected to expand to other disease areas as well, facilitating data capture and analysis to achieve optimal health.

Final thoughts on our culture for bioscience entrepreneurship: “Entrepreneurship is not for everyone,” says Gandhi. “There are a lot of cheerleaders for entrepreneurship, but this doesn’t mean everyone should be doing it. It’s much harder than people make it sound, with minimum 60 to 80 hour weeks and no vacation.” Despite this caution, Gandhi praises the University of Waterloo, its supportive infrastructure and the many professors who often are asked to support student learning on their own time, because the student may have needed to miss classes to work on their technology or grow their company.

Innovators

Precision NanoSystems, Vancouver, BC James Taylor, Co-Founder and CEO

Euan Ramsay,

Co-Founder and COO

Origins of the idea: While this story begins with one individual, the origins for the company is really a convergence of four people with a novel idea – two professors and scientific founders, and two recently graduated PhD’s who became bioscience entrepreneurs. James Taylor came from a UBC engineering physics undergraduate background with a PhD in genetics, while his soon to be co-founder Euan Ramsay had a PhD and post-doc experience in the pharmaceutical sciences. Taylor also brought expertise in life sciences venture capital, which he acquired as Venture Capital Fellow with the Seattle-based Accelerator Corp. He was accustomed to the long hours of the entrepreneurial life style, working part-time in venture capital, while in tandem working towards his PhD at the Institute for Systems Biology.

It was during his PhD that Taylor met UBC professor Carl Hansen, an expert in microfluidics; and then upon his return to Vancouver that he met another UBC professor Pieter Cullis (also the Scientific Founder of CDRD), an expert in personalized medicine and nanoparticle systems. Taylor was recruited to CDRD to help set up a commercialization system that would impact personalized medicine. It was at CDRD that Taylor met Ramsay. The initial idea for the technology came from a convergence of the need in nanomedicines for improved manufacturing technologies from Cullis and the microfluidics expertise from Hansen.

Decision to create a company: With a novel idea in hand, Taylor started full-time at the company in June 2010, and convinced Ramsay to co-found the company shortly after. The technology is a significant leap forward in the way

nanomedicines are developed and manufactured and as such, the opportunity to accelerate the understanding of disease and the development of novel therapeutics was significant. To capture this opportunity Precision NanoSystems (PNI) was formed with the goal of being the global leader in this market place. PNI was initially funded through grant funds, by the founders, and through a commercial partnership. The PNI team rapidly developed their first products and by 2013 launched their flagship product, the NanoAssemblr Benchtop.

Support along the way: Despite the tremendous strengths in scientific, technical and business expertise on the start-up team, support from provincial and federal organizations was still critical to the success of the company. The company maintained a strong partnership with UBC and the UBCUniversity Industry Liaison Office and the technology and company was supported by an array of agencies, including: NSERC, CIHR, MITACS, Genome BC, and NRC-IRAP. Several other organizations were also supportive including the provincial and federal trade commissioners which helped the company establish a client base in foreign markets. As an example, the company participated in the Canadian Technology Accelerator program in both Boston and San Francisco, which helped them to establish clients among the large pharmaceutical and biotechnology companies, as well as with leading academic institutions.

The company now serves clients in over 20 countries, and has a highly energetic and dedicated team with an average age of 32 – further showcasing the young age of individuals involved with emerging bioscience companies. Precision NanoSystems was

recently recognized by Life Sciences BC as the 2016 “Growth Stage Medtech Company of the Year”.

Projected impacts of the company: Precision NanoSystems has established platform technologies and products that are enabling the acceleration of the next generation of drug development – nanomedicines. PNI’s technology is making drug development faster and easier, and is enabling the development of novel and powerful new therapeutic modalities. PNI is working with world leading biopharmaceutical companies, helping them to create some of the most exciting drugs under development today.

Final thoughts on our culture for bioscience entrepreneurship: Bioentrepreneurship is becoming much more acceptable with a noticeable growth in the Canadian biosciences sector. Taylor believes that “as physics and information technology have had a transformative impact on the last century; so the biosciences will have on this century”.

Robert Merson is a Certified Management Consultant and entrepreneur in the life sciences sector. He is an alumnus of the first Sanofi BioGENEius Challenge competition held in 1993/94; and he has served as a biotechnology industry mentor at the University of Toronto, New College for the past 14 years.

To see this story online visit www.biotechnologyfocus.ca/fromstudent-to-bioscience-entrepreneur

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Innovator

| By Shawn Lawrence

Clementia’s quest to stop the crippling disease that turns tissue to bone

I

magine a disease that slowly turns the muscles, tendons and ligaments in your body to bone, restricting your ability to move, speak, eat and breathe. It sounds like something unnatural or unreal, but while very rare, such a disease actually does exist.

It’s called fibrodysplasia ossificans progressiva (FOP), or as it was previously known, stone-man syndrome. For the approximately 2,500 people worldwide who suffer from it, there is no known cure. Not even surgery can correct it as tissue damage and injury from surgery trigger the disease to progress faster.

Perhaps most tragic of all is that the majority of those who suffer from FOP are children, many of whom will face having their lives cut short by the disease.

Dr. Clarissa Desjardins knows the stakes and she is hopeful that her company, Montréal-based Clementia Pharmaceuticals, is on the right course to finding a potential treatment.

It comes in the form of a repurposed drug called palovarotene. The compound, prior to its acquisition by Clementia in 2013, had been previously investigated as a possible treatment for emphysema or chronic obstructive pulmonary disease (COPD) by Roche Pharmaceuticals.

“It (Palovarotene) belongs to a class of drugs called retinoic acid receptor gamma (RARg) agonists and what makes it unique is that it selectively targets a pathway involved in cartilage and bone formation,” explains Desjardins. This is important she adds, as the new bone that occurs in FOP appears first as cartilage before becoming fully mature bone.

“The idea is if you can prevent the cartilage formation, you can prevent the growth of new bone,” she says.

Breaking it down further, Desjardins states that in people with FOP, the receptors (the ACRV1/ALK2) that are involved in the bone

morphogenetic protein pathway become overactive, which is why there is heterotopic ossification. In animal studies led by Drs. Maurizio Pacifici and Masahiro Iwamoto, Palovarotene was shown to stop this error message at its pathway source. Their published results were the reason that Clementia licensed palovarotene and established it as its flagship product.

“Prior to acquiring it, we were working with Roche on completely unrelated projects in personalized medicine when one of their senior executives basically pointed out this Nature Medicine paper published by scientists (Drs. Pacifici and Iwamoto) at Thomas Jefferson University on palovarotene,” she recalls.

“They said look at what these scientists have discovered, this drug that was in clinical trials for lung disease and was halted actually inhibits new bone formation in mouse models.”

Knowing her past track record for starting biotech companies including Advanced Bioconcept and Caprion Pharmaceuticals,

“The idea is if you can prevent the cartilage formation, you can prevent the growth of new bone.”

—Dr. Clarissa Desjardins

April/May 2016 BIOTECHNOLOGY FOCUS 13

Innovators

they suggested to Desjardins that she should create a company to take palovarotene back into the clinic.

“So I did, and we called it Clementia, derived from the Latin word for compassion or empathy.”

For Desjardins, the timing couldn’t have been more right. She says that a part of her was always searching for that next great opportunity.

“It’s what I’ve loved most about leading a biotechnology company. Everything makes a difference. Given the heroic fight of these individuals affected by FOP and the fact that no one has ever developed a drug for them, launching Clementia was an easy choice to make.”

In a short time, Clementia has continued to progress rapidly with the drug and the company is currently conducting Phase 2 and Natural History clinical trials at seven international sites. The trials include both adults and children with FOP.

“We are at the exploratory stage of clinical development now,” says Desjardins, “so we are testing a lot of different things like dose, duration of treatment, and timing of assessment, all of which are designed to inform a registrational trial.”

In late February the company hit a significant milestone with the trial, announcing that the 40th and last study participant had enrolled. According to Desjardins, the success of hitting this milestone was due in large part to Clementia’s ability to work hand-in-hand with the FOP community.

“FOP patient organizations and medical experts have been very supportive in their efforts to increase awareness of our trials, and we have a fantastic clinical operations team that organizes patient travel from around the globe to our seven clinical trial sites,” she says.

Clementia has also made significant headway on the regulatory front, which has helped to further facilitate clinical development of the drug. For example, in 2014 palovarotene

“Once you learn about FOP, it is impossible to forget. So a lot of people, including investors, are excited to help these individuals and are committed to rapidly vetting palovarotene in a robust development program for this overwhelming condition.”

— Dr. Clarissa Desjardins received Orphan Drug Designation from the FDA and Orphan Medicinal Product Designation from the European Medicines Agency (EMA). Additionally, the FDA also gave the drug Fast Track designation.

Financially, Clementia is very healthy as well. The company has raised US$92.5 million over the last two years, most of which came from a US$60 million mezzanine financing completed last June. The latter transaction represented the largest venture capital deal involving a pharmaceutical company in Canada last year. It’s a tell-tale sign that investors are taking notice of palovarotene’s promise.

“Once you learn about FOP, it is impossible to forget. So a lot of people, including investors, are excited to help these individuals and are committed to rapidly vetting palovarotene in a robust development program for this overwhelming condition.”

With sufficient resources to get Clementia through to the next stage and with the Phase 2 trial now completely enrolled, Desjardins says she is hopeful that results for the Phase 2 trial could be reported by the end of the year.

“Our next step is to incorporate the learnings of the Phase 2 and natural history studies into the design of a registrational trial and move us closer to our goal of providing a much-needed treatment for people in desperate need of one.”

To see this story online visit www.biotechnologyfocus.ca/ clementias-quest-to-stop-the-cripplingdisease-that-turns-tissue-to-bone 14 BIOTECHNOLOGY FOCUS April/May 2016

Special Report

Biron -

Laboratoire médical, More Than A Lab! An “old” new partner for your research and clinical projects

O

perating a medical laboratory for more than 60 years, Biron - Laboratoire médical has built a reputation for impeccable quality and ready accessibility.

Today, Biron offers to the medical community, clinical research groups and the pharmaceutical industry state-of-the-art facilities and, above all, a large number of advantages rarely found under one roof. Biron’s service offer stands out from those of its competitors for the size of the company and the vast array of related services.

Capacity and availability Biron’s automated laboratory allows it to carry out large-scale projects. We have the capacity to analyze large numbers of specimens. We operate 7 days a week, 24 hours a day. But what makes the biggest difference is that our specialists and personnel are readily available to accompany you in your project. If you have any questions, concerns or special requests, at Biron, you have quick access to the key stakeholders in your project.

More than a laboratory Operating a laboratory and performing tests is only one part of our service offer.

Biron also has its own fleet of couriers to ensure that the cold chain and chain of custody are respected. Our Customer Service Department of more than 40 agents is there to book your appointments. Our IT services are state-of-theart and allow results to be integrated directly into clinical files (in HL7 format).

It’s no coincidence that Biron was the first, and for now is still the only, private laboratory to file its results with the Québec Health Record (QHR). Lastly, a network of more than 100 service centres is available for projects involving ambulatory clients.

yond laboratory tests. That is why Biron strives to offer the technical facilities needed to conduct sleep studies or studies involving medical imaging, with all steps coordinated by the same team and carried out by dedicated specialists.

Expertise in special projects

Biron who?

For many years, our business priority has been to serve patients directly.

These patients, who can choose between free services in the public health network or paying services at Biron, are very demanding. Our operations meet their demands at all times, allowing us to serve clients in studies and special projects with confidence. In fact, we have always been involved in special projects. Whether we are participating in projects such as the CARTaGENE biobank project or a pan-Canadian bone marker project for a pharmaceutical product, our scientific and business teams deliver the results expected.

Unique services Research involving humans goes be-

Founded in 1952, Biron - Laboratoire médical is one of the business units of Biron Health Group. Together the units have more than 700 employees, most of whom are health professionals. Still owned by members of the Biron family, our organization is resolutely focused on the future. It goes all out to introduce innovations that are useful for the medical community, practical and readily available for patients, and always compliant with the most rigorous medical and ethical standards.

Lastly, Biron has all the required certifications and even surpasses patient safety standards, as demonstrated by its “accreditation with exemplary standing,” the highest distinction conferred

by Accreditation Canada.

April/May 2016 BIOTECHNOLOGY FOCUS 15

Clinical Trials

| Compiled by Shawn Lawrence

THE EARLY STAGE CLINICAL TRIAL INITIATIVE: Montréal’s first steps to becoming a clinical trial powerhouse The City of Montréal has aspirations of becoming a leading centre for conducting early stage clinical trials. Leading this charge is Montréal InVivo, the life sciences and health technologies cluster representing the Montréal area, who together with three of the region’s major research hospitals: the Centre hospitalier de l’Universite de Montréal (CHUM), the McGill University Health Centre and its Research Institute (RI-MUHC) and the Sainte-Justine University Health Centre (CHU); and other industry partners have established the Early Stage Clinical Trial Initiative, an ambitious plan to make the dream a reality.

In March, the Québec Government responded to this call for action, committing $5.3 million in funding over the next five years to implementing this initiative.

This month Biotechnology Focus catches up with Québec’s chief scientist and chairman of the Fond de recherche du Québec Remi Quirion, and the Executive Director and Chief Scientific Officer of the Research Institute of the McGill University Health Centre (RI-MUHC), Dr. Vassilios Papadopoulos to learn more about the initiative and what it means to the province.

Q

Biotechnology Focus: Tell us a bit about this initiative and why it was started?

Remi Quirion: Over the past 10 years, the model has changed a lot in terms of how big pharma and the biotech industry do business, and like other cities, Montréal has been impacted.

Specifically, we’ve seen investment in R&D stagnate and fewer companies conducting clinical trials here. Recognizing this trend, various stakeholders including Montréal InVivo went to work trying to find new niche areas where we as a region could specialize and one of the first areas we focused on was personalized medicine. The Québec government bought into this idea and invested heavily. This resulted in various companies both being created and coming to Montréal. Feeling we could still do more, we started strategizing and exploring other key areas that we could carve a niche for Montréal and Québec. We identified early stage clinical trials as an opportunity. For us the timing was very good because we were just opening two new state of the art hospitals in Montréal, the CHUM at the University of Montréal and the MUHC at McGill 16 BIOTECHNOLOGY FOCUS April/May 2016

University. Both hospitals were well equipped with clinical research facilities. Our thinking was we have the facilities, now we have to optimize their use. We also already had the clinical research experts needed. Next, we got together the research leaders at the CHUM, MUHC, Sainte-Justine Hospital (which is a children’s hospital), Montréal InVivo, the Fonds de recherche and began to develop a strategy. At this point Montréal InVivo took the lead role for this initiative focused on Phase 1 clinical trials, or first in man, through to clinical proof of concept. In January we moved ahead with this Early Stage Clinical Trial Initiative and then made a special ask to the Québec government for its support in the most recent budget and it was granted.

Dr. Vassilios Papadopoulos: As you know clinical trials are quite an important part of our business as an academic and science centre. The same goes for the other two academic and science centres, the Centre hospitalier de l’Universite de Montréal (CHUM) and the CHU Sainte-Justine.

Over the last three or four years there has been tremendous investment into the infrastructure of these hospitals and academic science centres. As an example,

Clinical Trials the McGill University Health Centre with funding from its public and private partners built and equipped a new, state-of-the-art research centre at the Glen Yards site of the new MUHC. This new centre of innovative medicine is fully equipped to run clinical trials.

This clinical research unit includes 50,000 sq. ft of space. I call it our research hospital in a hospital. At the University of Montréal, there is the CHUM. They built a fantastic facility with beds dedicated to clinical research. Both facilities are state of the art, this is what truly makes Montréal unique, two super hospitals or academic health science centres, which means they offer all the expertise possible in medicine today, with state of the art clinical and most importantly research dedicated facilities capable of conducting all stages of clinical trial research. Going from molecules to preclinical, to clinical and then following the patients for years to come.

Then there’s CHU Sainte- Justine which is currently being built and will also have a clinical research facility. As you can imagine, the government put $5 billion into all these hospitals and facilities, strengthening the research infrastructure for clinical research. So in meetings with Montréal InVivo, we started asking the big questions like how can all these assets be linked with industry and academia?

How can we take full advantage of these centres while at the same time serving the population of 5 million people in Montréal?

Montréal InVivo scanned the environment, talked to all the players involved and the one initiative that made sense to everyone was to focus on early phase clinical trials. We then had another series of meetings again initiated by Montréal InVivo where academics, industry, including both contract research organizations and pharma participated and essentially it was obvious that all parties were interested in going forward with an Early Stage Clinical Research strategy. The idea is if you can attract Phase 1, then subsequent clinical phases could also take place in Montréal.

Q

Why is Montréal an ideal place for these types of trials?

Remi Quirion: At the moment, I would be tempted to say that with the new hospitals that we probably have the best infrastructure in Canada for these types of studies. That of course will change quickly as others will have more or newer facilities. In terms of quality of academic science in the medical sector, certainly in terms of manpower, we are quite good as well. Of course, Québec has a relatively small patient population, and because of this there is already discussion that eventually if we want to be more competitive in this area, we’ll have to consider doing partnerships with, for example, cities like Toronto. I think to be more competitive, it would also be great to have partnerships with other centres in Québec including at Laval University in Québec City and in Sherbrooke...it’s in the making. In Québec City, they are starting to build a new hospital similar to the ones that we have in Montréal and hopefully it will be fairly easy to link up with them in due time.

Dr. Vassilios Papadopoulos: As I’ve mentioned, with the entire new infrastructure in place, the existing local expertise and talent, a strong CRO and pharma base here, we had all the elements in place to do pretty much anything in the clinical trial space. Everything was aligned. We just needed a voice to bring it all together and of course some money to back it. Montréal InVivo was that

voice, and various partners, especially government, have stepped up with the cash.

Q

Why focus on early stage as opposed to late stage clinical trials?

Remi Quirion: I think it’s similar to the strategy we took with personalized medicine. It’s a niche area and we want to be at the table before anyone else gets there. That would be one of the objectives.

A second objective or the hope is that if you start working with a company early, then if things go well, they are likely to continue to work with you on the other phases of their clinical trials and to do more of their business here in the future. You’re kind of locking them into a partnership early in the game. This is a way not only to bring clinical trials back to Québec, but also to keep them here.

It puts us in a better position for later stage clinical trials down the road as well.

Dr. Vassilios Papadopoulos: Being part of an academic medical centre, this is the area where you like to be. You want to be first in human because this is where the discovery translates first, it’s where you are able to make dramatic progress, and the big advantage is you can do this in very specialized areas with the necessary specialists. Moreover, we have the facilities now, we have the physicians and experts. But to focus in early stage clinical research you need to partner. The idea is if you start looking for something like rare diseases or even personalized medicine, it’s very difficult for one institution alone to recruit 10 to 15 patients. As such, if you’re trying to conduct a trial for 50 patients, you need multiple partners, or in our case, the three partner hospitals. Together, we can create a common initiative or hub that is able to provide our services as one entity to potential sponsors, whether it be from industry or other types of investigators. A part of this initiative is also to expose the population to the advantages of being enrolled in clinical trials. So we’re giving them first access to new molecules and technologies. That’s a big win for patients.

Q

In a sense with the early stage clinical trial initiative, you are also taking the first steps toward perhaps establishing which therapeutic areas you’re going to focus on in terms of future clinical trials?

Remi Quirion: Yes, and for example, we already know that we have expertise in cardiovascular disease with the Montréal Heart Institute, there’s a strong cancer network with many hospitals here in the province, but we’ll have to see where we want to focus, because first of all we don’t have the expertise in everything, and also we don’t have the budget or even the patient population to tackle everything.

Dr. Vassilios Papadopoulos: At the moment there are no real areas of disease focus for this initiative, although, I can tell you that there have been requests during discussions in cardiovascular disease, oncology, neuroscience, and mostly the areas of strength for the three institutions. There also have been discussions in areas that we are already conducting clinical trials in with industry.

April/May 2016 BIOTECHNOLOGY FOCUS 17

Clinical Trials

Q

How important is the industry or private sector component to this initiative?

Remi Quirion: In order for this initiative to be successful this needs to be done in partnership with the private sector. That would be the CROs, big pharma, biotech and medical device companies.

I would think probably the great majority of these studies will in fact be sponsored by the private sector. It could happen that sometimes the idea for a new use of a molecule comes purely from academia, and everything is funded on the academic side, but that will be the exception.

Dr. Vassilios Papadopoulos: I’m a strong believer in forging strong links with industrial partners. In fact, the research institute facility at the McGill University Health Centre was funded in part by the Canada Foundation of Innovation (CFI), and they are funded by Industry Canada. As such one of our mandates or obligations is to have our doors open to industry. We live in an ecosystem where academia will not do what industry does, but at the same time industry cannot do things by themselves. You have to find the right balance, and this is pretty much my job, finding that balance.

And this is what I like about this initiative is that around the table are the academics, the industry including pharma and CROs, and representatives from the Québec government. When all these people come together and find common points, I think something good can happen. It might not be easy and we will have obstacles as there’s nothing written in terms of rules or obligations, and we will have to make them up as we go along to see how we can make the ecosystem work. However, we need the industry and industry needs the academics. It’s about providing an environment, infrastructure, the legal frame, the ethical frame to be able to do it for the benefit of patients. We also need private contributions to complete the overall budget of operation. In the short term we are looking for $3 million over five years. These contributions will mainly be used to put in place a non-competitive collaboration platform to pool financial and human resources from different private partners to develop an outreach strategy for patients and healthcare professionals involved in clinical research.

Q

Do sponsors approach the hospitals for the trials or will the hospitals seek out the sponsors?

Dr. Vassilios Papadopoulos: It happens both ways. It used to be one way in the past, for years they would go to the specialist, the key opinion leader (KOL). Now we have both approaches, they will go to the KOL, or they will come to us for a physician referral.

Someone calls us for a trial in prostate cancer saying they would like to test this molecule, we have a number of physicians or experts in prostate cancer, and we present it to them and if they are interested they will take it over and we will help facilitate the process. Or they can approach the physician directly and still the trial will come to us because we have to take care of all the contractual, legal agreements, and also the site of the trial etc. to make sure the trial is done the way it’s supposed to be done.

18 BIOTECHNOLOGY FOCUS April/May 2016

Q

One of the promises made with this initiative is that it will make it faster and easier for sponsors to conduct their trials. Can you explain how?

Remi Quirion: By networking these various hospitals under a common umbrella, sponsors will no longer have to go to three different hospitals or draw up three different contracts for their clinical trials.

Interinstitutional agreements will have to be set up to facilitate this process. Essentially you will have one stop shopping that makes it much easier for the sponsor and because it’s all centralized, they have access to a larger pool of experts and clinicians, as well as a larger pool of patients.

Q

What’s the impact on the hospitals in terms of new jobs that will arise from this initiative?

Dr. Vassilios Papadopoulos: The projections say around 500 new jobs and these are based on the idea we will at least double the number of patients participating in early phase trials. We’d have to recruit more specialized experts, nurses, and analytical staff because if you run a Phase 1 trial you will need to do analytical work in terms of the molecules and analysis of what’s happening, as well as track the statistics. So there will be a number of jobs created directly associated with the trials, but also jobs indirectly created to cover the volume of work that needs to be done.

Q

Is five years enough time for this initiative to realize its potential?

Remi Quirion: It’s ambitious, but I hope so. Of course, doing clinical research is always quite time consuming. One of the advantages we have is the group of experts, in certain areas like cardiometabolic disease or neurosciences. Québec researchers have done a lot of these types of clinical research studies in the past. Maybe not necessarily early stage, but they know the process and how to run clinical studies, and that hopefully will help in fully realizing the objectives of this Initiative going forward.

Dr. Vassilios Papadopoulos: I think so. We really hope that five years will only be the beginning because if this works out it will continue to grow. The idea is we start with the three university hospitals and then after a few years perhaps expand the network to other hospitals in the Montréal area and even elsewhere. Overall I’m excited about this initiative, as are my colleagues at the other hospitals. We think the beginning will be tough, but we are confident that over time we’ll be able to work out the bugs and have success. At the end of the day, having the new drugs coming here and being tested here is a big win for our population and patients, and a big deal for every one involved.

To see this story online visit www.biotechnologyfocus.ca/qa-the-early-stage-clinical-trialinitiative/

CALENDAR MAY 2016 May 2-3

SEPTEMBER 2016 September 12-15

Tel: 905-667-8688 Email: labcon@csmls.org Web: http://labcon.csmls.org/en/

Bloom Burton & Co. Healthcare Investor Conference Venue: Toronto, ON 17 -21 new card:Layout 1 1/31/2013 July 9:09 AM Page 1 Tel: 416-640-7580 International Conference of Biochemistry & Email: bbloom@bloomburton.com Molecular Biology Web: www.bloomburton.com/conference/ Venue: Vancouver, BC Tel: 604 681 2153 x 109 May 9-10 Fax: 604 681 1049 OCE Discovery 2016 Email: IUBMB2016@icsevents.com Venue: Toronto, ON Website: iubmb2016.org Web: http://ocediscovery.com/home

May 11-12

48th Annual Canadian Mineral Analysts (CMA) Conference and Exhibition Venue: Sudbury, ON Tel. 705-670-5643 Fax. 705-670-3047 E-mail: ed.debicki@ontario.ca Web : www.2016cma.com

September 13-15 Biopharm America Venue : Boston, MA Web : http://www.ebdgroup.com/bpa/index.php

Agri Investment Forum Venue: Toronto, ON Tel: (587) 350-0067 Email: matthew@criticalpathgroup.com Web: www.agri-investmentforum.com

SRC101

May 25-26 Canada Talks Pharma 2016 Venue: Montréal, QC Tel: 1-514-564-3466 x 222 Email: Info@canadatalkspharma.com Web: https://canadatalkspharma.com/

JUNE 2016 June 5-9 Canadian Chemistry Conference and Exhibition Venue: Halifax, NS Tel: 613-232-6252 Web: www.csc2016.ca

June 6-9 2016 BIO International Convention Venue: San Francisco, CA Web: www.convention.bio.org/2016

June 14-16 Canadian Biosafety Symposium Venue: Montréal, QC Tel: 306-966-8496 Web: http://biosafety.icid.com

June 23 RESI (Redefining Early Stage Investments) Venue: Toronto, ON Tel: 617-600-0668 Email: resi@lifesciencenation.com Web: http://www.resiconference. com/#!mars-2016/qpp86

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Personalized medicine

| By Julia Publicover

Centralized Image Management for Multi-Centre Clinical Trials

P

ersonalized cancer medicine seeks to identify the right therapy, for the right patient and at the right time.

Imaging measurements are a key part of this personalization and need to be performed and analyzed with the highest level of precision and accuracy – this can include stratifying patients for appropriate treatment, designing image-guided treatments and evaluating response.

Clinical trials are used to bring new treatments forward and, increasingly, these are dependent on the growing variety of imaging studies and often include novel, untested imaging techniques. If these expensive trials are to be productive, it is critical that the imaging studies (both proven and novel) be performed with precision and accuracy.

To this end, the Quantitative Imaging for Personalized Cancer Medicine (QIPCM) group was created to help manage the emerging imaging needs of clinical investigators, and ensure they learn as much as possible from the imaging measurements, given the significant personal investment of the patients, the time commitment of the investigators, and the financial support of the funding agency.

QIPCM was established by Dr. David Jaffray, medical physicist and EVP of Technology and Innovation at the University Health Network (UHN) in Toronto. Dr. Jaffray saw the need for quality data collection and management in an area where technology is quickly evolving. With funding from the Ontario Institute of Cancer Research (OICR), Dr. Jaffray built a multidisciplinary team of physicists, oncologists, IT specialists and analysts—all with extensive imaging expertise—to solve the problems faced by clinical investigators.

“We have set up the QIPCM service and infrastructure to handle all aspects of the imaging data pipeline for a client,” says Dr. Ivan Yeung, medical physicist and physics lead of QIPCM. “Everything is about quality—quality assurance of the scanners and the data, robust anonymization and secure data handling, and expert analysis of the data using transparent, reproducible standards and 20 BIOTECHNOLOGY FOCUS April/May 2016

tools.” He adds that QIPCM provides end-toend quality assurance, workflow, and analysis services for imaging in clinical trials.

A clinical trial needs professional expertise to ensure a well-curated collection of imaging data. This expertise is needed right from trial inception— evaluating the performance of scanners located at multiple participating clinical institutions, and developing imaging protocols to ensure that the trial objectives are met and that the data from all sites is compatible and can be compared. Once data are collected, they must be handled according to government regulations while still being available to investigators at multiple institutions.

Standardized image analysis techniques for existing and emerging imaging biomarkers must be applied consistently. In some cases, custom tools need to be developed. The QIPCM team supports this through its internal development team.

QIPCM is uniquely- and expertly- equipped to provide this expertise and simplify workflow for classical trial structures. With support from CFI and The Princess Margaret Cancer Foundation, QIPCM is armed with a fast, flexible and easy-to-use computing platform for central image review where multiple trial in-

vestigators can securely and instantly review images by accessing them from anywhere in the world. This platform uses a central image repository and is built on the VMWareTM infrastructure that allows the specific investigator’s software to be globally available.

This management and central review for clinical trials is the technological and functional backbone of QIPCM. However, QIPCM’s strength is in their understanding of advanced imaging techniques such as dynamic, functional and molecular imaging. QIPCM’s Quality Team, equipped with quality assurance tools, including custom built Dynamic Contrast Enhanced (DCE) phantoms (manufactured by London-based Modus Medical Inc.), visits each institution participating in a trial to do a ‘deep dive’ into scanner performance.

Modern trials can include many novel endpoints and imaging procedures and QIPCM has the expertise to handle these challenges.

For example, the team has developed tools and quality measurements for standardization in PET-based hypoxia imaging (FAZA), including the development of a software tool to quantify the variation of hypoxia measurements in the presence of motion.

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Personalized medicine CT-PET images of pancreatic cancer patients with high (a) and low (b) FAZA uptake.

The absolute magnitude, even for ‘high’ FAZA uptake, is much lower than that in conventional FDG PET images. This prompted the QIPCM team to create a new method of analysis to properly quantify FAZA uptake in the pancreatic cancer patient study.

“The partnership with QIPCM is a key element to the success of our recent novel PETFAZA study in pancreatic cancer patients,” says Dr. David Hedley, medical oncologist at the Princess Margaret Cancer Centre and principal investigator of a study of hypoxia measurement in pancreatic cancer patients using PET-FAZA. QIPCM also works with other unique organizations in Ontario, including the Centre for Probe Development and Commercialization (CPDCTM) in Hamilton and CanProbeTM in Toronto, to bring novel imaging agents to the clinical research community.

“The quality of the molecular imaging agent is a critical part of quantitative imaging studies that is often overlooked”, says Dr. John Valliant of the CPDC. “Optimal development and exploitation of novel imaging agents requires that we have eyes on the entire pipeline to ensure we generate the highest quality data to learn as much as possible during a clinical trial.”

QIPCM seeks to understand technologies that will impact the field. The team has been involved in studies on both of the recently installed PET/MR scanners in the Province of Ontario. These unique systems combine the superb imaging contrast and resolution in MRI and molecular information provided

by PET. This combined scanner gives imaging researchers “the best of both worlds.”

To bring these on-line as valid instruments in clinical trials, it is critical to validate the

This research was originally published in JNM. Metran-Nascente C, et al. Measurement of tumor hypoxia in patients with advanced pancreatic cancer based on 18F-fluoroazomyin arabinoside (18F-FAZA) uptake. J Nucl Med. In Press. © by the Society of Nuclear Medicine and Molecular Imaging, Inc.

performance of the individual MRI and PET components, and to ensure simultaneous image acquisition of the two components will not interfere with each other.

Quantitative imaging promises potential benefits such as reduced trial size, detecting changes in disease or treatment earlier, and reduced bias in analysis. The Quantitative Imaging Network (QIN), which was formed by the National Cancer Institute (NCI) in the U.S., with the mandate to develop quantitative imaging methods and support clinical trials, brings together teams of imaging experts in North America who work with clinical trialists to define the nature of the imaging studies and drill down into the details of the procedure and analysis. The QIPCM is one of the first two Canadian sites to join the network to advance the science and tools of quantitative imaging.

QIPCM steps in to help serve as a rapid translation pipeline for these advanced quantitative imaging methods. Working in close cooperation with experts in the field—some of the people creating the new techniques and tools in the first place—QIPCM can help clinical trials access and make good use of these cutting-edge techniques as soon as they are available. This knowledge-translation-as-aservice approach is a distinguishing feature of QIPCM and cuts out potential years of delay and learning curves between physics innovations and clinical trial implementations.

For example, the emerging field of ‘radiomics’ applies advanced mathematical

algorithms and machine learning techniques to analyze subtle features within images. With these semi-automated approaches hundreds of features can be examined for thousands of patient images in a single study. QIPCM is preparing to support these novel algorithms through active support for trials and curating the clinical trial images for future analyses.

With a mandate to eliminate barriers to the adoption of quantitative imaging, QIPCM has emerged as a novel and highly valuable service that addresses many needs of clinical trials including equipment QA, protocol development, data anonymization, continuous quality control of data during accrual, centralized data storage with remote access, software tools, and image analysis. Currently, investigators from 21 clinical trials have engaged QIPCM and 17 data pipelines have been established with imaging institutions across North America. Ever increasing interest is pushing the program to expand support for clinical trials in all areas of medicine that employ imaging in one form or another.

Julia Publicover is Program Manager at QIPCM Techna Institute, University Health Network. She can be contacted by email at Julia.Publicover@ rmp.uhn.on.ca.

To see this story online visit www.biotechnologyfocus.ca/ centralizedimage-management-for-multi-centreclinical-trials/ April/May 2016 BIOTECHNOLOGY FOCUS 21

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| By Ulrich J. Krull, Professor of Analytical Chemistry and AstraZeneca Chair in Biotechnology

The Evolution Of A Revolution

D

efining the term biotechnology can be fraught with difficulty if trying to capture all possible points of connectivity. In the grand view, the word suggests application of technologies in the life sciences. It is noteworthy that the development of new technologies has had enormous impact in stimulating new perceptions in the sciences. The history of science is rich with examples; consider the altered view of the world as a consequence of the advent of the microscope, and then the telescope.

Consider what may now arise with the recent demonstration of the measurement of gravity waves as a new and unexplored window on the cosmos. The biotechnology revolution was grounded in tools that were captured from biological systems such as plasmid splicing and polymerase chain reaction. The future will be dependent on new tools, but not necessarily only by raiding the biological toolbox. So what might be in store for biotechnology?

It was not so many years ago that the world celebrated the completion of the human genome project (at least in its first iteration), and much was learned and continues to manifest. One of the most significant outcomes of the learning process was the realization that the genome would be only one part of a much more complicated story one that would eventually include proteomics and metabolomics, with such richness of information that it would be incredibly challenging to comprehend details and connections that underlie cause-and-effect.

We have enormous volumes of data from mass spectrometry, nuclear magnetic resonance, crystallography, gene sequencing and other characterization methods. How can this be processed to understand life processes, and how can the data lead to potential beneficial manipulations?

Interestingly, this richness of data is a problem common to many questions that are at the forefront of science. It exists in the challenge of the detection of gravity waves where incredibly small shifts in atomic position must be discerned on an overwhelming background of motions. It is confronted when sifting through data in the search for new particles at the Large Hadron Collider. It confounds the understanding of how strands of amino acids fold into functional proteins, and can seem insurmountable when population health data is considered in the prediction of outcomes of therapeutic treatments. These information rich initiatives rely on the determination of patterns, and it is this quantitative side of technology applied to life sciences that may hold tremendous promise for the next leap in the impact of biotechnology.

22 BIOTECHNOLOGY FOCUS April/May 2016

There is nothing novel about the suggestion of the relevance of computational methods and statistics as applied to biological processes. What has changed are the available tools, and the volume of data of good quality. Canadian science, industry and governments are converging on building massive computational capability, addressing the volume of data that can be processed and the speed of computations. Algorithms are continually created and refined to address better methods to search for patterns and relationships. The entire global science community is moving towards an age of shared data and open access. This is an exciting time, but will it be timely for biotechnology?

Biotechnology in its broadest sense continues to offer excitement in the minds of students, and rightly so. When one considers the constant stream of news about topics such as stem cell therapeutics, device technologies that are more compatible with biological hosts, rapid diagnostics for pathogens, tracking invasive species by environmental DNA signatures, improvements and adoption of biofuels and biomaterials, increasing productivity in agriculture, and a host of other developments, it seems obvious that such a cross-disciplinary subject with so much potential for impact should be a natural draw. There is demand for educational opportunities in biotechnology, but is there suitable analysis of gaps and needs to drive the discovery engine that leads to commercial opportunities? Are the programs that we offer students weighted to deter participation in quantitative mathematical applications of value to the subject? What about the many opportunities that derive from a consideration of a computational basis for biotechnology? For example, digital health, as a convergence of the digital revolution with the omics revolutions, and the development of “apps” as a rapid entry to entrepreneurship.

Biology has embraced aspects of chemistry with excellent synergy to support biotechnology. Computer science and the digital revolution remain more peripheral in the sphere of biology beyond data bases associated with genomics and proteomics. The opportunity is at hand for those who can navigate the cultures that seem to distinguish the biological, physical and mathematical science blocs.

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