Biotechnology Focus June/July 2018 by Promotive Communications

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

JUNE/JULY 2019 VOLUME 22, NUMBER 3

Ontario Companies Fill Marketplace Voids

Ontario edition

INSIDE:

Q&A with Todd Smith Publication Mail Registration Number: 40052410

Minister of Economic Development, Job Creation and Trade

24 Embracing the digital future: The challenges of managing information in life sciences Features 11 Taking AI to the next level Canada has become a leader in artificial intelligence research and development, the result of a combination of the efforts of universities, governments, large companies and start-ups. Artificial intelligence (AI) is a broad term that refers to computer systems being able to think independently with a human-like intelligence, making decisions based on the massive amounts of data that is fed into the systems. By Karen Ramlall

16 Q&A with Todd Smith, Minister of Economic Development, Job Creation and Trade There has never been a better time to invest in Ontario. Ontario has become a hotbed for artificial intelligence, regenerative medicine, advanced therapeutics, biomanufacturing and clinical trials. The Ontario Ministry of Economic Development, Job Creation and Trade (MEDJCT) is set to modernize the way government supports business. By Michelle Cornish

20 Ontario companies fill marketplace voids When it comes to research and commercialization in regenerative medicine and other advanced therapies, companies in Ontario are proving they have the innovative technologies and strong talent to compete globally. They are recognizing marketplace needs and striving to meet industry demands by developing new technologies, investing in the right capital projects, forming strategic partnerships and striving for overall excellence in the biotechnology sector. By Michelle Cornish

24 Embracing the digital future: The challenges of managing information in life sciences Managing information is critically important to life sciences companies. Creating new products can take years of trial and error and every step in the process must be documented thoroughly. As a result, organizations in the life sciences industry can benefit from incorporating enterprise information management (EIM) solutions that have a proven record of quality and a history of meeting regulators’ needs. By Ferdi Steinmann

27 Profiling terpenes in cannabis: How Canadian laboratories are overcoming analytical challenges The Canadian government’s decision to legalize the use of cannabis by adults for non-medicinal purposes in October 2018 presents an enormous opportunity for fully-licensed laboratories to establish and expand in support of the testing needs of this growing sector. By Jaclyn Thomson

29 2019 Gairdner and Killam awards announced Laureates for the prestigious Gairdner and Killam awards have been announced for 2019. This year marks the 60th anniversary for the Gairdner awards, the world’s most significant biomedical research award that comes with a $100,000 cash honorarium. By Michelle Cornish

Departments 7 Research News 9 Business Corner

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Innovative Ontario companies in the health sciences space

June/July 2019 BIOTECHNOLOGY FOCUS 3

www.biotechnologyfocus.ca

June/July 2019 | volume 22 | number 3

Contents

PERSPECTIVES 14 Harnessing the economic potential of stem cells As the regenerative medicine sector in Ontario continues to flourish, there is increased interest from investors and industry in the work being done by Ontario’s robust research community. By Krista Lamb

19 Why Ontario needs a network of early adopter health organizations The Government of Ontario is in the early phases of its transformation of Ontario’s health care system which includes the creation of Ontario Health and the establishment of Ontario Health Teams. A network of Ontario health organizations engaged with innovators as ‘early adopters’ will assess novel technologies’ ability to improve patient care and enhance health system efficiency. By Gail Garland

4 BIOTECHNOLOGY FOCUS June/July 2019

23 A place to grow and compete: seeding Ontario’s oncology innovation economy Cancer care is important to all Canadians but historically, our patients and local private industry have not harvested the benefits of our investments in academic research and discoveries. Commitment to the commercialization of Canada’s most promising innovations is needed in order to retain both intellectual property (IP) and talent pool, and ultimately move these innovations out of the lab to reach patients. By David O’Neill

30 Significant benefits ahead for Ontario life sciences Earlier this year, Life Sciences Ontario (LSO) released the 2019 sector report, “Accelerating Prosperity: The Growth Potential of Ontario Life Sciences”. The report evaluates the current economic contributions of the life sciences sector in Ontario and reveals its considerable growth potential when combined with a coordinated life sciences strategy. By Jason Field

Give kids like Jordan every chance to live better.

PUT YOUR MONEY WHERE THE MIRACLES ARE.

JORDAN, 14 SPASTIC DIPLEGIA PATIENT

Jordan started his life with a fight when he was born 12 weeks premature, but the fight didn’t end there. At age 1, he was diagnosed with cerebral palsy, and at age 7, his diagnosis evolved to spastic diplegia, which means he has an especially high level of tightness and stiffness in his lower body. Community donations raised through Children’s Miracle Network® fund the facility where Jordan receives physiotherapy, so he can not only walk, but enjoy his favourite hobby, running. Children’s Miracle Network raises funds and awareness for 170 member hospitals, 14 of which are in Canada. Donations stay local to fund critical treatments and healthcare services, pediatric medical equipment and research. Its various fundraising partners and programs support the nonprofit’s mission to save and improve the lives of as many children as possible. Find out why children’s hospitals need community support, find your member hospital and learn how you can Put Your Money Where the Miracles Are, at childrensmiraclenetwork.ca and facebook.com/ ChildrensMiracleNetworkCanada

ChildrensMiracleNetwork.ca

Give Today

to your local children’s hospital foundation

PUBLISHER’S note

PUBLISHER/ EDITOR-IN-CHIEF Group Publisher

Terri Pavelic J. Richard Jones

Writer

Michelle Cornish

CONTRIBUTING WRITERS

Ferdi Steinmann

Jaclyn Thomson Krista Lamb Karen Ramlall

Canada’s got Tech and Talent

Gail Garland

Canada is still a hotbed of technology and talent in the life sciences. On April 30th and May 1st, Canadian biotech companies and a multitude of investors from across North America convened in Toronto for the 8th annual Bloom Burton & Co Healthcare Investor Conference. The conference was an opportunity for many of Canada’s bigger and more mature biotech companies to showcase their technology and talent in front of an investor audience. The event kick-off started with the opening of the Toronto Stock Exchange and TSX Venture Exchange followed by two days of company presentations, one-on-one meetings and insightful panels. Event organizer, Brian Bloom remarked, “At the end of the day, this is all about investors, which is why 50 per cent of the people here are registered investors, we have almost 600 investors from Canada, United States and Europe.” Catering to a record number 1150 registrants who came to network and facilitate deals. This conference is a great lead in to the annual International BIO conference taking place in Philadelphia, PA. where 50,000+ one-on-one meetings will take place. The life sciences sector is fiercely competitive for tech and talent, Canada continues to punch above its weight. Whether it’s AI or Ontario’s Open for Business initiative, there has never been a better time for biotechnology in Ontario. In Taking AI to the next level, Karen Ramlall shows how Canada has become a leader in AI research and development, and we interview Minister of Economic Development, Job Creation and Trade, Todd Smith for his take on how the MEDJCT is modernizing the way government supports business in Ontario. Krista Lamb shows how the regenerative medicine sector in Ontario continues to flourish in her article Harnessing the economic potential of stem cells. Where there’s innovation, there must be early adopters. Ontario needs health organizations that continue to adopt novel technologies to optimize patient care as evidenced by Gail Garland in Why Ontario needs a network of early adopter health organizations. Canada’s most promising innovations need commitment to move them out of the lab and into patient’s lives, explains David O’Neill in A place to grow and compete: Seeding Ontario’s oncology innovation economy. This has never been truer for the cannabis industry. Jaclyn Thomson explains how fully-licensed laboratories are seeing opportunities to support the testing needs of this growing sector in Profiling terpenes in cannabis: How Canadian laboratories are overcoming analytical challenges. With all this growth, managing information remains critically important in the life sciences sector. Ferdi Steinmann expands on information management in Embracing the digital future: The challenges of managing information in life sciences. Lastly, Jason Field summarizes Life Sciences Ontario’s 2019 sector report in Significant benefits ahead for Ontario life sciences confirming Ontario’s considerable growth potential when combined with a coordinated life sciences strategy. The future of life sciences is in Ontario.

Jason Field

Enjoy!

6 BIOTECHNOLOGY FOCUS June/July 2019

David O’Neill

Director, Content & Business Development David Blondeau GRAPHIC DESIGNER CIRCULATION

Elena Pankova circulation@promotivemedia.ca

EDITORIAL ADVISORY BOARD Barry Gee, CDRD; Christine Beyaert, Roche Canada; Nadine Beauger, IRIC; Peter van der Velden, Lumira Capital; Jason Field, Life Sciences Ontario; John Kelly, KeliRo Company Inc.; Raphael Hofstein, MaRS Innovation; Gail Garland, OBIO; Albert Friesen, Medicure Inc.; Andrew Casey, BIOTECanada; Ulrich Krull, UTM; Peter Pekos, Dalton Pharma Services

Biotechnology Focus is published 6 times per year by Promotive Communications Inc. 21374, 2nd Concession Rd East Gwillimbury ON L9N 0H7, 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 department – 21374, 2nd Concession Rd East Gwillimbury ON L9N 0H7 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.

R&D news Focused ultrasound used to open the blood-brain barrier and clear toxic proteins in the brain

Dr. Vibhor Krishna (right) reviews a brain image with MRI technician, Brett Bryan as a part of a new clinical trial at The Ohio State University Wexner Medical Center. Toxic proteins called amyloids are associated with several incurable diseases. A new clinical trial at The Ohio State University Wexner Medical Center uses a non-invasive procedure to open the blood-brain bar-

rier. While the blood-brain barrier acts as a protective layer to shield the brain from infections or pathogens in the blood, it can also make it next to impossible to deliver therapeutics to the brain to treat neurode-

generative diseases such as Alzheimer’s. “While it’s protective and beneficial for day-to-day brain function, when we think about therapeutics, the blood-brain barrier poses a significant challenge,” said Dr. Vibhor Krishna, a neurosurgeon at The Ohio State University Wexner Medical Center. “The focused ultrasound procedure allows us to non-invasively access the brain tissue, so treatment can be administered straight to the site of pathology.” Through MRI imaging, doctors can target specific areas of the brain where amyloids exist. A helmet-like device then delivers 1,000 focused ultrasound waves that cause microbubbles in the blood which oscillate and open the blood-brain barrier. In this study, doctors aren’t delivering any medication. Instead, they hypothesize that once the blood-brain barrier is open, the patient’s own immune system may clear some of the amyloids. The procedure is performed three times at two-week intervals to allow for as much amyloid clearance as possible. Researchers are hopeful opening the blood-brain barrier may also apply to new treatments for brain tumors and epilepsy.

Aging seniors reap long-term health benefits from Edmonton-based artificial intelligence project Three Edmonton entities are combining forces to improve patient-centred interventions to support healthy aging. The project is a collaboration between Health City and Boehringer Ingelheim (Canada) Ltd. that uses artificial intelligence (AI) to examine data to predict frailty and its impact on chronic diseases like diabetes and heart disease. Edmonton AI and machine learning (ML) company, AltaML, will develop ML algorithms to combine data sets that will uncover predictions and patterns to answer key questions physicians are asking patients. The goal of the project is to enable healthcare teams to proactively identify patients who could benefit from individualized care such as fall prevention, medication review or social service interventions to mitigate frailty. “This is such a significant collaboration on so many levels for this city,” says Edmonton Mayor Don Iveson. “When I launched Health City in 2016, I knew that our region had the ability and opportu-

Edmonton Mayor Don Iveson nity to benefit from our world-class health research and innovative spirit. I am looking forward to more investment and jobs in this sector that result in economic prosperity for this region and ultimately impact the health and well-being of our citizens.”

Approximately one in four older adults are at risk of becoming frail and are at a greater risk for declining health, higher health care utilization, and loss of independence. Frailty is one of the most concerning realities of our aging population. “Our mandate is to drive economic development through innovation in the health sector in this region and this project is the first example of the kind of model we believe will do that,” says Health City CEO, Reg Joseph. “We’re excited that our partnership with Boehringer Ingelheim allows us to bring together this collaborative team from our vibrant health community to solve this very real challenge for our senior’s population, locally and nationally.” Including local organizations from the onset of the project lets them test their AI solutions in real-world situations, allowing them to eventually scale beyond the local region.

June/July 2019 BIOTECHNOLOGY FOCUS 7

R&D news First-of-its kind all-natural food preservative Tanzina Huq

A natural and clean label alternative to artificial preservatives will soon be available thanks to Chinova Bioworks. The Fredericton-based start-up’s mission is to replace unhealthy artificial preservatives in foods and beverages with natural mushroom chitosan. This alternative, called Chiber, is based on a fibre extracted from white button mushrooms that acts as an anti-microbial, protecting against bacteria, yeast, mold and pathogens. Chiber is the brain child of Tanzina Huq, co-founder and chief technology officer at Chinova Bioworks. The product has earned her the Outstanding Entrepreneur Award from Mitacs, a not-for-profit Canadian organization fostering growth and innovation in business and academia. “In light of recent efforts by Health Canada and the Food and Drug Administration to curb the use of artificial preservatives like sodium benzoate and sodium sorbate — which have been linked to health risks —

food and beverage companies are seeking natural alternatives,” Huq explained. “Our product offers an affordable, effective and flexible solution.” Mitacs will be recognizing five winners of the Entrepreneur Award for their work in turning their research into innovative businesses that impact the lives of Canadians. “Canada has exceptional talent and Mitacs is extremely proud to support young entrepreneurs in spring-boarding to market the next generation of innovations,” said Alejandro Adem, Mitacs CEO and Scientific Director. Huq’s initial goal was to reduce food waste and she “never imagined that the idea to develop a natural preservative would go this far”. Since launching in 2016, Chinova Bioworks has expanded to include 11 employees and is planning to extend Chiber to cosmetic applications by 2022. Chiber is launching in the U.S. in October 2019.

New clinical pathway for cancer patients leads to better outcomes and lower health care costs Researchers at the Helen F. Graham Cancer Center & Research Institute are improving quality of life, providing better health care outcomes and doing it all with lower costs to patients. The centre has developed a clinical pathway, called Supportive Care of Oncology Patients (SCOOP), that results in fewer visits to the emergency department, fewer hospital admissions and fewer readmissions when compared to a control group of similar patients during the first two years of the pathway. “The SCOOP protocol is a unique, early intervention tool shown to improve how we treat curative cancer patients effectively, safely and at lower cost,” said Nicholas J. Petrelli, M.D.,Bank of America endowed medical director of the Helen F. Graham Cancer Center & Research Institute. “Our experience would indicate that any group of patients at high risk for emergency department visits and hospital admissions could potentially benefit from this kind of approach.” The total cost savings for SCOOP patients was on average $1,500 per patient with a total cost savings of more than $319,000 for 207 SCOOP patients in 2018. Improvements included in the SCOOP pathway include introducing supportive and palliative care management early in the patient experience 8 BIOTECHNOLOGY FOCUS June/July 2019

Helen F. Graham Cancer and Research Center, Christiana Care Health Systems. Photo: Eric Crossan and including an electronic nurse navigation checklist to keep everyone on the same page. “What we have learned is that enhancing supportive and palliative care for patients being treated curatively seems to work as well as for patients with advanced disease,” said Chris Koprowski, M.D., MBA, associate service line leader for Cancer and director of Quality and Safety at the Graham Cancer

Center. “As far as we could determine from our review of the literature, the full scope of this approach was never before applied to patients with potentially curable cancers.” Initially developed for patients with potentially curable thoracic, colorectal or head and neck cancers, the protocol has been expanded to include patients with brain and hepatobiliary and pancreatic cancers.

BUSINESS corner ExCellThera announces collaboration with New York Blood Center Montréal based ExCellThera Inc., advanced clinical stage biotechnology company, delivers molecules and bioengineering solutions to expand stem and immune cells for use in novel one-time curative therapies for patients with hematologic malignancies, autoimmune and other diseases. Their lead therapy, ECT-001, combines the proprietary molecule UM171 with an optimized culture system. In its collaboration with the New York Blood Center (NYBC), ExCellThera will have access to NYBC’s clean room manufacturing facilities to produce ECT-001 to be used in clinical trials mostly in the U.S. “The New York Blood Center holds one of the world’s largest blood banks and has over 50 years of leadership in research and development, medical services and laboratory services. We are extremely pleased to enter into this multi-year agreement which will allow us to work closer together and leverage their leadership and exper-

tise in this specialized field,” said David Millette, Chief Operating and Financial Officer at ExCellThera. ExCellThera expects substantial scale-up in the production of ECT-001 to meet the needs of new clinical trials during these final phases

of clinical development. The FDA has granted ECT-001 orphan drug designation for the prevention of graft-versus-host disease and regenerative medicine advanced therapy designation in the treatment of hematologic malignancies.

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BUSINESS corner F-star expedites its transition to a wholly-owned portfolio strategy

Eliot Forser F-star, a leading clinical-stage biopharmaceutical company delivering tetravalent bispecific antibodies for a paradigmshift in cancer therapy, has pivoted to a wholly-owned portfolio strategy, creating greater value for shareholders over its former pure partnering model. The company is pursuing a protocol with its

lead clinical asset, FS118, the same as was planned with Merck. To promote tumor elimination, the FS118 is a bispecific antibody that leverages a unique mechanism of action that simultaneously inhibits PD-L1 and LAG-3-mediated inhibitory pathways, potentially reversing the immune system’s down regulation

in lymph nodes and at tumor sites. CEO of F-star, Eliot Forser said, “This new agreement reflects our pivot to building a wholly-owned pipeline, that allows for rapid progress into the clinic and secures greater long-term value from our products. With full rights to FS118, we have an opportunity to accelerate the development of this first-in-class medicine for a group of targeted cancer patients. We are also pleased to continue our long-term collaboration with Merck KGaA, Darmstadt, Germany by advancing assets from F-star’s Modular Antibody TechnologyTM into their pipeline.” Merck and F-star remain partners under other parts of the original collaboration, but with F-star retaining exclusive rights to develop and commercialize FS118 under the new agreement, F-star believes it can proceed faster, creating greater value for shareholders and patients. Under the terms of the new agreement, Merck has exercised its option for one discovery stage program and retains the right to option a secondary discovery program.

MJBizConNEXT explores future of cannabis industry This Jun. 12-14, the editors of MJBizDaily host MJBizConNEXT at the Ernest N. Morial Convention Center in New Orleans. MJBizConNEXT is an opportunity for cannabis business executives, lead cultivators and innovators to connect in a personal setting to further important industry discussions through peer-to-peer sessions for CEO’s, attorneys, cultivators and extraction scientists. “At MJBizConNEXT the pioneers and visionaries of the cannabis industry come together to look at the evolving future of cannabis and the drivers that are pushing it ahead,” said CEO and Co-Founder of MJBizDaily, Cassandra Farrington. “They are here to leverage technology, to meet and learn from their fellow peer executives, and to prepare for what’s to come as legalization lingers in the background and we pave the way to building a safe, regulated industry.” The event includes 250-hand picked exhibitors with interactive experiences showcasing the impact of innovation on plant production, energy efficiency, industry size 10 BIOTECHNOLOGY FOCUS June/July 2019

and community impacts. General session topics include: • Cannabis Evolution: Products, Cultivation, Extraction • Level Up: Next Steps for Your Business • On the Horizon: Emerging Markets and Trends • Money Matters: Investing in Cannabis • On the Radar: Innovations in Cannabis Technology • Future-Proof Your Business

The Hemp Industry Daily Conference, a one-stop source for key market information will be launching alongside MJBizConNEXT. This three-day conference is a deep dive into business opportunities, growing consumer demand for hemp and CBD and updates on regulations and legal developments. Learn more about the event and register here: https://mjbizconference.com/next/

AI By Karen Ramlall

ONTARIO

Taking AI

to the next level Using deep learning to accelerate drug discovery

Canada has become a leader in artificial intelligence research and development, the result of a combination of the efforts of universities, governments, large companies and start-ups. Artificial intelligence (AI) is a broad term that refers to computer systems being able to think independently with a human-like intelligence, making decisions based on the massive amounts of data that is fed into the systems. This decision-making superpower is being adapted to drive innovation in all parts of the life sciences continuum – from drug design and discovery, through manufacturing and into the clinic. Meet some of the Ontario companies that are using AI to accelerate the pace of discovery and development.

The lab of the future – that’s how the founders of Phenomic AI describe what they are building with the application of artificial intelligence to interpret reams of biological data faster and more efficiently. The company has developed AI-based techniques that quickly interpret large amounts of microscopic data to identify differences between cells and sort them into categories. These types of differences are hard to interpret by eye or with existing computational techniques. Phenomic AI’s software aims to understand how thousands of genetic mutations and drugs affect cell health. Scientists can navigate the data interactively and it has already led to a number of important insights in drug discovery programs. Traditionally, processing large datasets involves many steps. A researcher would have to segment every single cell in a screen, measure its parameters and use those measurements to produce statistical insights. At a minimum, this this can take two weeks to complete. Phenomic AI’s deep learning solutions automate this process. As soon as an experiment is completed, the results are uploaded to the cloud, automatically analyzed and the next day, scientists can explore and interpret the data. “We’re bridging the gap between the time it takes to gather the data and understand what it’s telling us,” says Oren Kraus, cofounder of Phenomic AI. The AI ecosystem in Ontario has also provided a particularly fertile environment for the company’s growth. “A combination of a large number of qualified scientists, high-quality machine learning programs to train students and investors who understand the AI space have provided a tremendous boost,” says Kraus.

Phenomic AI team

Biotechnology Focus / June/July 2019

ONTARIO

Sachin Aggarwal, Think Research’s CEO

Naheed Kurji, Cyclica’s President and CEO

An AI boost for health care decision making Each time a patient is admitted to hospital, a clinician must make a multitude of decisions about that individual’s care. Combine that with the continuous changes in drugs, technology and clinical evidence, clinicians face the challenge of keeping on top of all of these changes and using the information to make evidence-based decisions. Think Research is helping clinicians make decisions in this complex environment. “Care delivery is become more challenging,” says Sachin Aggarwal, Think Research’s CEO. “Think Research is marrying technology and clinical knowledge to help drive the best patient care by maximizing on the decision-making capabilities of clinicians.” Think Research’s AI platform works by capturing completed care decisions and linking them to patient outcomes at which point the platform’s algorithms can suggest the best approach to care. Specifically, each time a health care professional makes a decision, it provides a data point that is captured by the platform. This data gets linked to patient outcomes from their medical records. Once the input and outcomes are linked, the algorithms can start to suggest care decisions. Think Research is unique because it collects data that is highly detailed about the care decision-making process. Currently, most companies are trying abstract data from the medical records system. “Think Research uses data that comes from realtime decisions,” says Aggarwal. It also has access to a high quantity of data, which includes governments and hospitals across the country. This popu-

Biotechnology Focus

June/July 2019

Sheldon Fernandez, DarwinAI’s CEO

Think of Cyclica’s platform like a lock – the biological component for which the drug is being designed, and key – the drug. The knowledge-based approaches use a wealth of data about both the lock and key to form predictions about whether the key will work. lation level data gives the company a huge amount of diversity, variability and volume. Think Research’s platform is being used by thousands of clients and facilities and the company has big plans for expansion. “Humans are humans, regardless of where they live in the world and we believe that these decision tools are applicable everywhere in the world. We think we will be one of small number of players in the knowledge-based health care space,” says Aggarwal.

Polypharmacology: drug discovery for the future One protein, one disease, one drug. That is the classical approach to drug design. However, the challenge is that drugs do more than one thing when they interact with a cell or are tested in human beings. In addition to targeting the specific protein it is designed to turn off or turn on, a drug can interact with upwards of 300 off-target proteins. While this narrow approach gets you to a starting point, it does not adjust for the downstream risk that occurs when you introduce a drug into a complex biological system. In that challenge, Toronto-based Cyclica saw a huge opportunity. “The world of polypharmacology – that is all the targets that interact with one molecule – is the world that Cyclica feels

passionate about,” says President and CEO Naheed Kurji. The company is using a powerful combination of AI-based (knowledgebased) approaches, specifically machine learning and deep learning, to augment computational biophysics (applying computers to model and predict how drugs will interact with the core components of biology) to take a panoramic view of drug interactions with all the pieces of biology in disease development. By helping scientists understand this entire landscape, Cyclica’s approach can help scientists take precise steps in the right direction and decrease drug discovery time, says Kurji. Think of Cyclica’s platform like a lock – the biological component for which the drug is being designed, and key – the drug. The knowledge-based approaches use a wealth of data about both the lock and key to form predictions about whether the key will work. Combined with computational biophysics, scientists can gain insight into how the key is going to fit and whether or not it will open the lock. This year, Cyclica was named by Investment Ontario as one of the top 10 AI companies to watch and by Deep Knowledge Analytics as one of the top 20 global AI drug development companies. Their success is due in part to the research that is taking place at universities, hospitals and institutions like the Vec-

ONTARIO The challenge is that drugs do more than one thing when they interact with a cell or are tested in human beings. tor Institute, and, in the last few years, increasing commercialization of that research, Kurji says. “Toronto is now becoming the epicentre for AI in healthcare and drug discovery,” Kurji says.

Using AI to make AI smarter DarwinAI is using artificial intelligence to build artificial intelligence, explains CEO Sheldon Fernandez. The Waterloo-based company has developed a platform named Generative Synthesis, the result of years of academic research and was publicly launched in September 2018. The platform uses machine learning to observe a neural network (a type of deep learning), which

results in a deep mathematical understanding of the network. The results are used in two unique ways: • They explain how AI software has made a decision, known as explainable deep learning. While AI can perform exceptionally well, it is often difficult to explain why it has arrived at a specific decision. • The results have dramatically reduced the size of the neural network, while maintaining accuracy and reducing inference time (the time it takes to classify, recognize and process new inputs) To date, neural networks have been too large for some applications, such as consumer electronics. This breakthrough brings the potential of machine learning to these types of products.

“DarwinAI’s founders believe explainability is a critical first step towards ethical AI,” says Fernandez. “We need to understand how and why a machine learning system makes a decision before it can be aligned with a specific moral code.” From drug design and discovery to manufacturing and clinical administration, these companies are proving AI is here to stay.

Karen Ramlall is a freelance writer and communications professional, who specializes in health-related topics. She is able to translate complex health information into articles that are engaging and accessible to a wide range of audiences.

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Biotechnology Focus / June/July 2019

PERSPECTIVE

By Krista Lamb

ONTARIO

Harnessing the economic potential of stem cells Ontario institute fosters the province’s regenerative medicine sector As the regenerative medicine sector in Ontario continues to flourish, there is increased interest from investors and industry in the work being done by Ontario’s robust research community.

he Ontario Institute for Regenerative Medicine (OIRM) has been a key driver in catalyzing and strengthening these relationships to accelerate the translational pathway for advancing cell therapies into the clinic, and making technologies more attractive to investors. “This field promises to provide novel and innovative treatments

Biotechnology Focus / June/July 2019

for patients living with many devastating diseases by not just treating the symptoms, but the disease itself,” explains OIRM’s Vice President and Chief Operating Officer, Sandra Donaldson. “In addition, regenerative therapies present a tremendous opportunity for economic growth through company creation and manufacturing facilities

to support scale-up and scale-out of these therapies into the local and global marketplace.” Founded in 2014 with support from the Government of Ontario, OIRM has developed a successful partnering model in which the Institute plays a pivotal role in bringing the right partners together to support and advance promising technologies. This includes identifying other funding opportunities and collaborating with industry and academic institutions, both locally and internationally, to ensure long-term sustainability of projects and reduce the investment risk for each partner. These activities ensure investigators can access the knowledge and resources required to advance their technology but also prepare potential therapies for global adoption and increased visibility for commercial investment. These partnerships have allowed

ONTARIO OIRM to generate over $140 million in matched and leveraged funding since 2015. OIRM has invested just over $11 million in 48 research projects since 2015, including 11 clinically driven research teams (OIRM Disease Teams) focused on developing novel therapies in areas such as muscular dystrophy, heart disease and vision loss. These projects have led to the development of four new companies, including one of the largest series A investments ($225 million) in a biotech within Canada with the creation of BlueRock Therapeutics in 2016. Funding from the Institute has also resulted in new therapies moving into clinical trials in patients. In 2015, OIRM supported its first clinical trial investigating the safety of immunomodulatory cell therapy using stem cells in patients with septic shock. This Phase I study successfully concluded in 2017 and demonstrated the therapy was safe and well tolerated. With OIRM’s continued support this study will advance into a Phase II multi-centre study later this year.

OIRM’s Disease Team funding program has also supported two projects which are expected to enter clinical testing in 2019-2020. These studies involve the repurposing of an off-patent drug, metformin, to stimulate neural repair in children and adolescents with multiple sclerosis, and a study using stem cells derived from discarded burn tissue to bioengineer skin and promote wound healing following massive burn injury. “Ontario boasts a robust and thriving

stem cell and regenerative medicine ecosystem and is globally recognized as a powerhouse of fundamental research and discovery in this field,” says Donaldson. “The OIRM community is now over 260 members strong and represents a multidisciplinary network of researchers who are driving discovery and making Ontario a globally-recognized leader in this space.” Learn more about OIRM and its work at OIRM.ca.

“OIRM is driving innovation, building partnerships and catalyzing the growth of a strong and sustainable regenerative medicine ecosystem that will have meaningful impact on patients’ lives and the Ontario economy.”

Biotechnology Focus

June/July 2019

Interview

Q&A with Todd Smith

Compiled by Michelle Cornish

ONTARIO

Minister of Economic Development, Job Creation and Trade There has never been a better time to invest in Ontario. Several valuable assets exist in Ontario, making it a hotbed for artificial intelligence, regenerative medicine, advanced therapeutics, biomanufacturing and clinical trials. The Ontario Ministry of Economic Development, Job Creation and Trade (MEDJCT) is set to modernize the way government supports business.

Biotechnology Focus had the opportunity to interview Todd Smith, Minister of Economic Development, Job Creation and Trade recently about the MEDJCT’s mission and Ontario’s future in the fiercely competitive global life sciences landscape.

“Our vision is to work with all businesses, large and small, to ensure a stable and competitive economy that protects workers and creates jobs, opportunity and growth.” Photo printed with the permission of the Government of Ontario.

Biotechnology Focus

June/July 2019

Interview

ONTARIO Q: Noteworthy, the Ministry of Research and Innovation has undergone changes and is now under the MEDJCT. What is the vision for this new ministry? Our government’s number one priority is supporting Ontario job creators, by making our province an attractive destination for investment, for companies to scale and grow and for talent from around the world. We are making sure we have the programs in place to attract business investment and support job creation. And we want to create conditions for growth by cutting red tape and working across the government to lower the cost of doing business in Ontario.3 The MEDJCT is committed to making sure our academic and other research institutions are generating economic growth and supporting job creation. We are modernizing our programs and assessing their relevance in driving economic growth in areas of investment attraction, research and commercialization, entrepreneurship and talent. One of our other important goals is to ensure that our interests are well represented in all trade matters and negotiations to support the growth of new jobs and investment in Ontario.

Q: Ontario is a hot-bed for artificial intelligence, regenerative medicine, advanced therapeutics, biomanufacturing and clinical trials. This has led to the creation of valuable assets such as the Ontario Brain Institute, Ontario Institute for Cancer Research, Vector Institute and Ontario Institute for Regenerative Medicine, to name a few. How is Ontario leveraging these valuable assets? Ontario is fortunate to be home to a vast innovation ecosystem of world-class research institutes, commercialization centres, and universities and colleges.1 They’re constantly collaborating to keep science and technology on the bleeding edge, ensuring Ontario remains internationally competitive. This innovation ecosystem is clearly paying dividends when it comes to attracting foreign and domestic talent. Last year, we added more tech jobs in Toronto than the San Francisco Bay area, Seattle and Washington, D.C2., combined, and there are currently more than 60,000 life

We know that the best places to do business should also be the best places to live. sciences workers in Ontario. Our reputation as a global leader in sectors such as AI and life sciences is driving interest from companies around the world, and we want them to know we are open for business.

Q: Last year, Ontario invested in the

Sanofi vaccine manufacturing facility, how does this align with the mission of MEDJCT? Our vision is to work with all businesses, large and small, to ensure a stable and competitive economy that protects workers and creates jobs, opportunity and growth. We are focusing our efforts on ways to support businesses that have a direct impact — reducing red tape and regulatory burden and enabling a competitive environment in which businesses can thrive and create good jobs. We are making sure that Ontario is truly open for business. That’s why we are working hard on our new Open for Jobs Blueprint, which is designed to modernize the way government supports business. Business support programs will focus on four economic priorities: talent; research and commercialization; entrepreneurship and growth; and investment attraction. The Open for Jobs Blueprint is built on four key principles: 1. Accessible: programs will be userfriendly and more readily available to make applying for them easier 2. Fiscally responsible: programs will use competitive rounds and fiscally sustainable tools, with only projects that demonstrate the most value to taxpayers receiving support 3. Coordinated and scalable: programs will reduce duplications across minis-

tries and ensure that they respond to the needs of businesses; and 4 Effective: programs will be measured on impact and if they are delivering on their objectives.

Q: Life sciences is a fiercely competitive global industry, international collaboration plays a vital role. You recently came back from a trade mission to India where they have a strong footprint in pharmaceuticals and clinical trials. What were you looking to accomplish? Ontario is committed to attracting investments in manufacturing and research and development to improve the life sciences industry’s competitiveness and keep these high-paying, good-quality jobs here in the province. Promoting Ontario as an attractive jurisdiction for investment in key international markets will increase business opportunities that lead to job creation. By diversifying Ontario’s global trading partners and exports, we’re creating a climate conducive for business and economic growth. The India business mission was a great opportunity for me to bring Ontario’s open for business, open for jobs message directly to business leaders across sectors that demonstrate a high degree of trade and investment potential for Ontario. While in India, I met with over 40 companies, including some from the life sciences sector, including Novo Nordisk India Ltd. and Jubilant Life Sciences. I look forward to continuing a long and prosperous partnership between Ontario and India. Businesses choose the place that will offer them the best conditions to grow. In India, we delivered the message that Ontario is that place.

Biotechnology Focus

June/July 2019

Interview

ONTARIO Now experts from an array of disciplines, including across the life sciences industry, will gravitate to Ontario.9 Whenever that happens, innovation is close to follow. While pushing technology forward will always be a top priority, this unbelievable gift has opened the door to fostering exploration of the ethical and societal implications of emerging technologies, including the very hot-button topic of artificial intelligence.10

Q: We understand that you will be attending BIO2019 in Philadelphia, PA. What are the ministry’s goals at BIO? U of T Schwartz Reisman Innovation Centre. Image: Weiss/Manfredi.

“With over 1,900 life sciences companies in the province, it is important that our government creates an environment where they can thrive and create jobs.” Q: Ontario is attracting significant investments from industry. Recently Samsung launched global artificial intelligence centres and Toronto was one of the few selected locations. What made Toronto an attractive choice? Investment in the province has been growing, with major commitments from global powerhouses such as Samsung, among others. These investments can be attributed to Ontario’s reputation as a great place to do business, but also because of our abundance of highly-skilled talent. Ontario is better educated than any Organisation for Economic Co-operation and Development country, with 68% of Ontario adults possessing a post-secondary education.4 Toronto, specifically, is attractive because the University of Toronto (U of T) is among the best postsecondary institutions in the word. U of T is consistently ranked in the top 25 Global Computer Science Programs, and in the Top 20 Global Universities, according to U.S. News and World Report.5 Ontario also produces over 40,000 STEM grads per year.6

Biotechnology Focus / June/July 2019

Lastly, we know that the best places to do business should also be the best places to live. Toronto currently ranks #16 for quality of life word-wide, and Ottawa, #18.7 Successful companies want to be in places that are inherently attractive to their employees, so it’s no surprise Toronto has become a top choice for industry investments.

Q: In March, an impressive $100-million donation was given to the University of Toronto, to build the Schwartz Reisman Innovation Centre and create Canada’s largest university-based innovation node. This is an incredible opportunity and asset for Ontario. What will this mean for the Ontario life sciences industry? You know the ripple effect of throwing a pebble into a pond? Well this is a bowling ball. This landmark $100-million gift will power Canadian innovation and help researchers explore the intersection of technology and society – turbocharging advancements in how AI, biomedicine and other disruptive technologies can enrich lives.8

This year, the Ministry is focused on supporting all the great Ontario companies that will be attending BIO. With over 1,900 life sciences companies in the province, it is important that our government creates an environment where they can thrive and create jobs. BIO is a great opportunity to promote the excellent work Ontario companies are doing. It’s also a great opportunity for us to tell the world Ontario is open for business, and open for jobs. There has never been a better time to invest in Ontario.

References: 1.

https://www.investinontario.com/lifesciences 2. https://www.investinontario.com/spotlights/toronto-adds-more-tech-jobsseattle-bay-area-and-washington-dccombined 3. https://www.investinontario.com/lifesciences#talent 4. https://www.investinontario.com/whyontario#skilled 5. https://www.investinontario.com/whyontario#skilled 6. https://www.investinontario.com/whyontario#skilled 7. https://www.investinontario.com/whyontario#skilled 8. https://www.utoronto.ca/news/landmark100-million-gift-university-toronto-geraldschwartz-and-heather-reisman-will-power 9. http://urbantoronto.ca/news/2019/03/ gerald-schwartz-heather-reismandonate-100m-u-t-innovation-centre 10. https://www.utoronto.ca/news/landmark100-million-gift-university-toronto-geraldschwartz-and-heather-reisman-will-power

Perspective

Why Ontario needs a network of

By Gail Garland

ONTARIO

Early Adopter Health Organizations

he Government of Ontario is in the early phases of its transformation of Ontario’s health care system which includes the creation of Ontario Health and the establishment of Ontario Health Teams. The challenge of continuing to deliver the quality of health care that Ontarians deserve is well known. As the government embarks on its plan, Ontario Bioscience Innovation Organization (OBIO) has published a report, Achieving Impact Through Adoption of Innovative Technologies: Establishing Early Adopter Health Organizations as an Accelerator for Economic Growth in Ontario, which describes how the early adoption of novel health technologies can play a critical role in helping to deliver better quality care for patients. A network of Ontario health organizations engaged with innovators as ‘early adopters’ will assess novel technologies’ ability to improve patient care and enhance health system efficiency. Their engagement, feedback and procurement recommendations will provide our growing health science industry with a global launch pad. Ontarians stand to reap even more benefit as global technologies are attracted here to demonstrate their value and our economy will benefit as capital flows and jobs are created. In 2017, OBIO’s ‘Tackling the Anchor Company Challenge’ summit brought together industry, academic, government, health system and investment leaders to create a mandate of action to anchor and grow health science companies in Ontario. A key recommendation was to establish a network of early adopter health organizations as an ideal mechanism to create more opportunities for the adoption of innovative technologies. Subsequently, OBIO convened a steering committee of health system and industry leaders to develop a framework and further consulted with both health service providers and companies based on their first-hand experiences to understand what would make a network of early adopter health organizations most effective. While some health organizations have developed processes for engaging with

At OBIO’s 2019 Queen’s Park Advocacy Day. Pictured left to right: Amol Karnick, KA Imaging, Gail Garland, OBIO, Brian Courtney, Conavi Medical, Hon. Bill Walker, Minister of Government and Consumer Services, and Zach Fisch-Rothbart, CoHeatlh

innovators, the landscape is uneven. Even when two willing groups want to work together it is a challenge for both innovators and providers to engage with each other. Better organized U.S. hospital systems attract our promising technologies and the company soon follows. We need a straightforward way of allowing innovators to engage Ontario’s health system. For example, a network of early adopter health organizations can bridge the gap and create much-needed benefits for Ontario and Canada that are also far-reaching: Better patient care: Early adopter health organizations will be incentivized to seek out novel health technologies and, by directly engaging with innovators to help address these problems, clinical end-users can provide feedback that will further enhance and refine technology solutions to optimize the patient care experience and improve outcomes. Clear pathway to assessment, integration and adoption: A network of early adopter health organizations lowers barriers and ensures that successful technologies are known early, developed for maximum benefit to patients and are more easily deployed and purchased. Physician access to novel technologies: Designated early adopter health organizations will attract physicians who want access to the latest health technologies and will build on Ontario’s reputation as home to world-class physicians. Anchoring health sciences economy across Canada: Engaging directly with health organizations and being able to access the local market is essential to ensuring that Canadian health science innovators stay here and grow their companies here.

Attracting global health sciences industry & investment: The clear pathway that a network of early adopter health organizations presents is a signal to the world that Ontario and Canada are strong regions for investment. We will all benefit from having early access to the most innovative technologies anywhere in the world and the capital that will follow. Right now, Ontario can gain a firstmover advantage by becoming the first jurisdiction in Canada to empower the early adoption of novel health technologies. In addition, this early adopter model creates incentives for health organizations to partner with each other and with innovators, ensuring that both have “skin in the game”. An early adopter health organization network will pull innovation into our health care system, enabling improved care for patients and greater efficiency in the delivery of care while anchoring a growing health science industry here and bringing the world’s innovations to our doorstep along with capital to build Ontario into an international destination for the development of novel health technologies. Building a network of early adoption health organizations in Ontario to create pathways for novel health technologies is a timely mechanism with far-reaching benefits for Ontario, Canada and importantly, the world. Gail Garland is the President and CEO of OBIO, the Ontario Bioscience Innovation Organization.

Biotechnology Focus

June/July 2019

Innovation By Michelle Cornish

Ontario Companies Fill Marketplace Voids

hen it comes to research and commercialization in regenerative medicine and other advanced therapies, companies in Ontario are proving they have the innovative technologies and strong talent to compete globally. They are recognizing marketplace needs and striving to meet industry demands by developing new technologies, investing in the right capital projects, forming strategic partnerships and striving for overall excellence in the biotechnology sector. Ontario companies show they are the ones to watch in the life sciences and biotechnology space as they fill marketplace gaps and draw talent from around the world. Here are just four examples of Ontario companies excelling at meeting the innovative needs of the biotechnology sector.

Biotechnology Focus

June/July 2019

ONTARIO

Innovation

ONTARIO A marketplace gap exists for patients with diseases such as Parkinson’s disease, degenerative heart disease and autoimmune disorders that have few treatment options.

BlueRock Therapeutics

Recognizing that a marketplace gap exists for patients suffering with ailments such as Parkinson’s disease, degenerative heart disease and autoimmune disorders that have few treatment options, BlueRock Therapeutics, uses state-of-the-art technologies in cell biology and gene editing to create fundamentally new ways to treat these types of diseases. This new technology, the BlueRock CELL+GENETM platform, overcomes the limitations of current methods that rely on harvested primary cells to develop therapeutics. Where authentic cells enable cell replacement, restorative function, and disease reversal, engineered cells delivered in ways never before thought possible, enable therapies to treat previously intractable common and rare diseases. As noted on their website, BlueRock Therapeutics are “passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with few treatment options”. BlueRock Therapeutics’ authentic cell replacement projects currently underway in the neurology field include research on microglia for neurodegeneration, oligodendrocyte for demyelinating disorders and their lead project, dopaminergic neurons for Parkinson’s disease. BlueRock founders have demonstrated robust preclinical data for dopaminergic neurons

restoring motor function and increasing dopamine release as they mature. This project is expected to advance into clinical development by the end of 2019.

Centre for Commercialization of Regenerative Medicine (CCRM)

Mitchel Sivilotti, Chief Operations Officer for CCRM, a leader in developing and commercializing cell and gene therapies, and regenerative medicine-based technologies says, when it comes to the bio-manufacturing space, “There are a number of significant voids, but first amongst those is the affordability of current, highly manual manufacturing methods. Despite major advances in cell and gene therapy clinical efficacy, we have considerable labour costs and open manufacturing systems requiring large manufacturing infrastructure”. Sivilotti is hopeful that “economies of scale and the results of process optimization will begin to impact the cost structure in both autologous (cells and tissues derived from the patient) and allogeneic (donor) products in the near future”. From its inception, CCRM designed its Centre for Advanced Therapeutic Cell Technologies (CATCT) to address process scale-up and scale-out challenges by incorporating advanced cell therapy manufacturing technology. “Our programs include deep investment in viral vectors,

CAR-T, media development/optimization, and pluripotent stem cell expansion/ differentiation in 3D suspension culture bioreactors (to name a few),” says Sivilotti. “This experience ties directly to our clinical manufacturing facility, the Centre for Cell and Vector Production (CCVP), which has 10 ISO Class 7/Grade B clean rooms, including two dedicated to viral vector production. The CCVP can manufacture in accordance with a client’s current procedures or, together with the CATCT, provide access to process improvements designed to solve key challenges in scaled manufacturability, product yield and costs.”

“There are a number of significant voids, but first amongst those is the affordability of current, highly manual manufacturing methods.” — Mitchel Sivilotti, Chief Operations Officer for CCRM

Biotechnology Focus

June/July 2019

Innovation

ONTARIO “We are rapidly advancing our lead candidate from this proprietary platform, TBio-6517, to the clinic with the goal of achieving effective and durable outcomes for a greater number of cancer patients.”

Turnstone Biologics

Turnstone Biologics is a clinical-stage immune-oncology company leading the next generation of oncolytic viral therapies. In November 2018, they presented pre-clinical data supporting the development of a new therapeutic platform, Vaccinia, developed by Dr. John Bell and his colleagues at the Ottawa Hospital Research Institute and the University of Ottawa. This platform was developed to be potent, immune-stimulatory and highly selective. “This is an exciting time for Turnstone as we unveil another novel viral immunotherapy platform technology in our continued pursuit to develop transformative technologies that advance the treatment of cancer,” said Mike Burgess, MBChB, Ph.D., President, Research and Development at Turnstone Biologics. “We are rapidly advancing our lead candidate from this proprietary platform, TBio-6517, to the clinic with the goal of achieving effective and durable outcomes for a greater number of cancer patients.” The Vaccinia virus can be delivered systematically and is designed to target and kill cancer cells throughout the body, modulate the tumor microenvironment and stimulate both innate and adaptive immune responses. Key milestones for Turnstone Vaccinia include rapidly killing more than 80 per cent of cancer cells (in mice) across multiple cell lines while sparing normal cells, replicating in human lung, sarcoma, melanoma, ovarian, gastric and thymic tumor explants and demonstrated selective expression of its three encoded im-

— Mike Burgess, MBChB, Ph.D., President, Research and Development at Turnstone Biologics

munomodulators at the sites of tumors in preclinical models with no evidence of exposure in peripheral blood.

Octane Biotech

The bioengineering technologies and processes created by Octane Biotech are transforming the delivery of reversative medicine solutions and creating marketleading business opportunities for their global partner network. Octane CocoonTM, cell culture and tissue engineering systems producing living implants, is one of those technologies. Octane CocoonTM is a patient-scale cell therapy system that forms the core of a series of versatile cell and tissue therapy production systems that opens an array of clinical applications. It aims to answer key challenges facing autologous cell therapies as they reach the commercial stage, such as variability in call yields and

strict regulations once products are registered. Octane recently partnered with Lonza Group Ltd. in Switzerland to further develop and advance the technology. Timothy Smith, co-founder of Octane Biotech with Ian Grant, said, “As continuing shareholders and directors of Octane Biotech, we welcome the expanded engagement of Lonza to significantly accelerate and reinforce the role of the Cocoon™ system as a game changer in the autologous cell therapy manufacturing space. Since the inception of the company, the vision of our team has been to bring award-winning innovation to this sector, and we are confident that Lonza will excel in enabling these transformative therapies to reach more patients throughout the world.” Cocoon™ will be further developed with continued support from both Octane’s current site in Kingston, Ont. and their Maryland, U.S. research and development site. Ontario is the place to be when it comes to life sciences. Whether it’s innovative technology or an expansive ecosystem of partners, these Ontario companies are proving they have what it takes to succeed on a global level.

“Since the inception of the company, the vision of our team has been to bring award-winning innovation to this sector, and we are confident that Lonza will excel in enabling these transformative therapies to reach more patients throughout the world.” — Timothy Smith, co-founder of Octane Biotech

Biotechnology Focus / June/July 2019

PERSPECTIVE

By David O’Neill, PhD President, FACIT

A place to grow and compete:

ONTARIO

seeding Ontario’s oncology innovation economy Cancer care is important to all Canadians but historically, our patients and the local economy have not reaped the benefits of our investments in academic research and discoveries. Commitment to the commercialization of Canada’s most promising innovations is needed in order to retain both intellectual property (IP) and talent pool, and ultimately move these innovations out of the lab to reach patients. Local commercialization and the ability to compete with incumbent biotechnology hubs requires a coordinated strategy to position entrepreneurs for success. Academic scientists and trainees seeking to commercialize need industry connections and an appreciation of private sector investors’ perspective. Given that private markets prioritize established U.S. hubs, Ontario First capital, incubation and management are critical to grow entrepreneurial impact domestically. As part of the strategic solution, the Ontario Institute for Cancer Research (OICR) harnesses the Province’s high impact research and strengthens collaboration among its world-class, cancer research centres. FACIT – OICR’s commercialization partner, business accelerator and seed investor for oncology innovations – helps competitive companies grow roots by providing Ontario First capital, executive management and connections to its industry and investor network. FACIT and OICR’s joint mission is to lead Ontario’s oncology innovation economy, deriving tremendous local value from IP and benefitting patients with improved therapies and diagnostics.

Planting the seeds

It would be great if a large multinational manufacturing corporation in healthcare could call Canada home and give our science graduates and workers high quality jobs. The reality however, is a biotech version of RIM or Shopify has not been led by Ontario’s private sector and cannot be created by industrial policy. These anchor companies have been shown to arise organically from seedlings of a biotech ecosystem. Since inception, FACIT has invested $40 million into Ontario’s most promising biotech seedlings. With this spark, its portfolio of Ontario-based biotechs

Open for business: Ontario First capital helps achieve significant local impact.

has brought in $750 million+ in additional investment to the Province. By addressing the healthcare seed capital gap, FACIT has leveraged a $3-4 million annual operating grant and grown it to $100 million+ in assets under management. Further, FACIT has created/seeded some of the most successful Canadian biotechs, including Turnstone Biologics, Fusion Pharmaceuticals, and Triphase Accelerator.

Nurturing growth

A successful output of the FACIT-OICR commercialization model was showcased in January 2019, when FACIT and Triphase announced a historic $1 billion US partnership with Celgene for an OICR-discovered blood cancer therapy. The partnership represents the largest oncology licensing transaction for a preclinical asset in Canadian history, and the largest biotech asset transaction worldwide for academia/NPO. FACIT played an instrumental role in this partnership and led the global business development strategy. By investing $3 million in seed capital, FACIT put Ontario IP in an unusual position of strength to negotiate a transaction with maximum regional impact. Without access to this Ontario First capital, the IP would have been undersold to an international suitor, taking R&D jobs and real economic impact along with it. Through Triphase, R&D jobs, clinical trials and industrial development will stay in Ontario, benefiting both the economy and patients.

Reaping the benefits

From the industry-quality asset discovered by OICR’s Drug Discovery team to clinical development by local accelerator Triphase, the FACIT-TriphaseCelgene partnership solidifies a strategic ‘discovered & developed in Ontario’ pathway for cancer commercialization. This model reflects the collective efforts of multiple local stakeholders and receptors to accelerate innovation and capitalize on Ontario’s investments in research, education and healthcare, creating an emerging avenue for economic growth. Ontario is in a favourable position to build on this momentum and surpass these recent successes; however, dedicated Ontario First capital is necessary to keep the Province competitive. Fueling high-potential innovations into FACIT-OICR’s proven commercialization model will create R&D jobs, scale-up local biotechs and attract investment into the Province. Growing Ontario’s oncology innovation economy will ultimately deliver the best cancer care to its patients.

Learn how the FACIT-OICR commercialization model puts Ontario First in the fight against cancer. Visit facit.ca.

Biotechnology Focus / June/July 2019

Digital Future

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Embracing the Digital Future: The Challenges of Managing Information in Life Sciences

By Ferdi Steinmann

anaging information is critically important to life sciences companies. Creating new products can take years of trial and error and every step in the process must be documented thoroughly—not only to speed internal development, but also to satisfy the needs of external partners and regulators. As a result, organizations in the life sciences industry can benefit from incorporating enterprise information management (EIM) solutions that have a proven record of quality and a history of meeting regulators’ needs. These solutions offer features such as workflow management, version control and audit trails, which are critically important for complying with regulations. The need for information management platform solutions is increasing as new challenges face organizations within the life sciences industry. Competition is fierce, and companies are trying to balance the need to create innovative new products and research, while ensuring they carefully document every process and stay on top of regulatory compliance.

Biotechnology Focus

June/July 2019

It is a daunting task, but those who master it will have an edge over their competitors. Following are some of the key challenges life sciences companies must overcome if they hope to succeed.

Continued regulatory environment growth Life sciences companies are required to comply with a complex and growing set of regulations. These include: • GxP, which covers an array of compliance activities, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), designed to ensure medical products are safe and meet high quality standards throughout production. In Canada and the U.S. specifically, drug and health manufacturers must follow Good Manufacturing Practices (GMP), • Compounding standards governed by the National Association of Pharmacy Regulatory Authorities, and • ISO certification, which provides requirements and guidelines ensuring that processes and procedures in the manufacture of drugs are followed.

These regulations can vary from country to country, making compliance difficult to track for multi-national organizations. The regulations are also constantly evolving and organizations are mandated to keep up with these changes. For instance, one method of achieving this is through content management and digital solutions which are updated on a regular basis to ensure organizations have the proper regulations in place and are adhering to those regulations. Using a digital platform will assist these organizations to comply with any regulatory audits more efficiently.

Siloed information Too often, important information and documentation are kept within one functional area of a life sciences company. For example, in research and development departments, much of the information generated is stored in a silo application not searchable across the enterprise, limiting its capabilities. Since this information is not readily available, it can’t easily be accessed by other departments or combined with other data sets to generate new insights that could lead to improved processes.

Digital Future

trust between a life sciences organization and any patient advocacy group it works with is crucial. Patients may suspect that life sciences companies are trying to maximize their profits from their relationships with patient groups, so records must be kept of all interactions. Transparency is also important to patient advocacy groups, meaning any partnerships with life sciences companies need to have detailed documentation that can be accessed quickly if there’s a request for information. Privacy is also a major consideration in these agreements. Organizations that use secure digital solutions to generate and store their generic agreements can save time and offer better privacy to their partners. Ultimately, partnerships between life sciences companies and patient advocacy groups can be beneficial to both sides.

Patient rights are in the spotlight in many jurisdictions around the world and rules such as GDRP, HIPPAA and PIPEDA mean that clinical trials must be designed differently with granular security, privacy and policy management in mind. The increasing focus on the patient is resulting in more contracts, more regulatory reform and more minimum standards for clinical approvals. Tracking all of this puts an added strain on organizations within the life sciences industry. In order to handle all the documentation now required for clinical trials, they need modern digital solutions, enabling greater control over identifiable information and process management tools that follow legal requirements for consent management. This not only decreases the time it takes to generate contracts, but also makes it easier to track information and produce it for regulators or patients on-demand, boosting transparency and trust.

they’d prefer to use a third-party cloud provider. In some cases, a hybrid of both cloud and on-premise will exist. While many life sciences organizations have traditionally kept their information on-premises, the benefits of cloud-based solutions, especially when managing multi-stakeholder environments, are difficult to ignore. Today, building an onpremise solution can be costly–requiring significant up-front capital investment in hardware and software. It may also require more IT staff to install, maintain and monitor these systems on an ongoing basis. Moving deployments to the cloud removes much of the maintenance responsibility as well as the up-front hardware and software costs. It can also give life sciences organizations more flexibility in their deployment options—for example, scaling the tools to additional departments and users as required. Servicelevel agreements outline how the data should be stored and secured in order to fulfil regulatory requirements. With so much global attention on data privacy and security, having secure documents is a key requirement supported by cloud-based information management that provides secure access to these critical documents. In regulated industries, where multiple levels of stakeholders need to approve documents, appropriate cloud solutions provide secure sharing of information with internal approvals at the executive level as well as external partners and regulators. By setting up a secure cloud-based information management solution, regulatory managers working for life sciences companies can also get immediate updates on critical issues or follow-up on the status of documentation, even while travelling. With security concerns mitigated, working in the cloud can significantly reduce the time to complete regulatory approvals.

Continued debate over on-premise or in the cloud

Unified digital data drives efficiency and insights

Switching from paper-based submissions or exchanges with Clinical Research Organizations (CROs) or other third-party vendors to digital solutions isn’t the only technology consideration life sciences firms have to make. Once they decide to implement an EIM, they must decide whether to host it on their own premises, or whether

The rapid technological change in the life sciences industry is forcing the industry and, in particular, the regulatory teams to adapt and become more flexible, putting pressure on them to change their business models and personalize their products and services. For the industry, this means more data will be generated and

Increased focus on patient rights

Due to the immense pressure of adhering to regulations, life sciences companies are understandably risk-averse and can be hesitant to change processes or procedures that have worked in the past. However, paper-based workflows isolate information that could be important to other divisions and make keeping up with regulatory changes more difficult. While many organizations have started down the path of digitization, there’s still a long way to go if they truly want to make the best use of the information they generate and improve their processes.

More off-patent products More product patents are expiring, which means the industry is producing more generic products. Manufacturers of generics often rely on partnerships, with many teaming with patient advocacy groups, who are looking to boost access to more affordable medications for their members. These partnerships result in a significant amount of new and complex paperwork, outlining the details of the arrangements between the drug manufacturers and the advocacy groups. Establishing

Biotechnology Focus / June/July 2019

Digital Future

In research and development departments, much of the information generated is stored in a silo application not searchable across the enterprise, limiting its capabilities. stored. The pace of growth is only going to accelerate as medical devices with Internet of Medical Things (IoMT) capabilities come online. Whether it’s information from clinical trials, drug development or medical devices, companies need digital tools that not only can store, catalogue and analyze large data volumes, but also provide new insights. To create value now and in the future, life sciences companies should consider participating in data-centric platforms of care that will help improve individual health outcomes and reduce costs. Incorporating solutions with artificial intelligence (AI) can help life sciences firms

Biotechnology Focus / June/July 2019

make sense of this massive level of information they generate and lead to new discoveries that can streamline clinical trials, accelerate the development of new medications and increase supply chain efficiency. But these benefits can be realized only if organizations overcome their internal information silos and pool their structured and unstructured data together without compromising data integration and security. In this life sciences environment, digital platforms will provide the framework to create future value that is based on individualized outcomes and will be boosted by the industry’s ability to connect, com-

bine and share their data. An Accenture report estimates that by 2026, big data analytics leveraging machine learning algorithms will be generating approximately $150 billion in the medicine and pharmaceutical industry. To cope with the more complex regulatory environment they face today and capture important data that can lead to more profit and efficiencies tomorrow, life sciences organizations will need to begin re-examining their workflows and processes, so they can begin to prepare for the digital future–the Fourth Industrial Revolution.

Ferdi Steinmann is Global Industry Strategist, Life Sciences, at OpenText. With over two decades of experience in the healthcare, life sciences and pharmaceutical industries, he has tremendous insight into the way technology helps companies become successful.

cannabis terpene

Profiling terpenes in cannabis:

How Canadian laboratories are overcoming analytical challenges

he Canadian government’s decision to legalize the use of cannabis by adults for nonmedicinal purposes in October 2018 presents an enormous opportunity for fully-licensed laboratories to establish and expand in support of the testing needs of this growing sector. While not currently required under the latest quality control regulations issued by Health Canada, terpene profiling of cannabis products is expected to play an important role in helping suppliers meet consumers’ needs and preferences. Here, we consider the importance of cannabis terpene profiling and how laboratories can overcome the analytical challenges specific to this emerging field.

Terpenes in cannabis Terpenes are non-psychoactive components that give cannabis and its derived products their distinctive smell. Although these compounds are not psychoactive themselves, it is a widely-held belief of many cannabis users, and increasingly some parts of the scientific community, that specific terpenes in cannabis can create distinct or ‘enhanced’ experiences for users (1). These perceived differences are thought to arise from interactions between certain terpenes or terpenoids, phyto cannabinoids, and the endocannabinoid system. This so-called ‘entourage effect’ remains scientifically controversial, yet belief in the phenomenon persists among some groups of users and researchers. There is anecdotal evidence suggesting that some users associate cannabis chemovars derived from Cannabis indica – one of the two main species of the cannabis plant – with soporific or relaxing effects (2). The other, Cannabis sativa, is believed by some users to have uplifting

or energetic effects. While these perceived differences between the two main species of cannabis have not been proven, many users actively seek out specific chemovars of cannabis to produce a particular experience. A more complete understanding of cannabis terpene profiles and their link to users’ sensory experiences by characterizing the terpenes present in specific chemovars could, therefore, help to guide users’ choices. With the use of cannabis for medicinal purposes in Canada also expected to rise, sourcing material with a specific terpene profile is important for patients too. Research into the collective synergic effect of the terpenes present in cannabis is ongoing (3). However, it may be reassuring for patients to have reliable access to material with a specific terpene profile they are familiar with. For growers and suppliers, there is a commercial advantage in knowing the general terpene profile of the material they provide, whether this is for medicinal or non-medicinal purposes.

The growing market for cannabis products Characterizing a cannabis product’s terpene profile isn’t just important for those

involved in the supply of material that will be inhaled. New Canadian legislation paves the way for an expanding range of medical and nonmedicinal products containing cannabis-derived extracts, including concentrates, oils, and edible preparations. For many consumers, the appeal of these products is that they contain the same chemical components that are found in the plant material, and thus may be perceived to offer the same type of experience associated with smoking cannabis. To obtain these chemical components and include them in concentrates, oils, and edible preparations, terpenes must be isolated and extracted from cannabis. Avoiding contamination with other plant components such as waxes and chlorophyll can be challenging from a production perspective and requires a large amount of method development. Furthermore, the oxidative liability of specific terpenes, and the solvents involved in their re-addition to cannabis materials, can potentially be toxic when consumed through heat-based methods. This highlights the care that must be taken when re-adding terpenes to the final product. For businesses engaged in this sector, terpene profiling allows companies to fine tune their manufacturing processes to optimize the types and levels of terpenes in their products.

Biotechnology Focus

June/July 2019

cannabis terpene

Profiling terpenes in cannabis Profiling terpenes in cannabis is typically undertaken by gas chromatography-mass spectrometry (GC-MS). Many cannabis laboratories screen for 21 different terpenes, while some labs may test for around double this number to include additional terpenes that could play an important role in the proposed entourage effect. However, even with just 21 terpenes to screen for, the diversity of chemical and physical properties these molecules possess presents a significant analytical challenge. Terpenes commonly associated with cannabis typically fall into three broad families: monoterpenes (containing two isoprenoid units), sesquiterpenes (containing three isoprenoid units), and terpenoids (possessing additional functional groups). This chemical diversity means that these compounds possess very different volatilities. Sesquiterpenes, for example, are typically known to be less volatile than others. Obtaining good recoveries for these analytes can be more difficult when operating headspace analysis due to their low volatility within the autosampler and on the GC-MS column, and the potential for some terpenes to adhere to plant material in the test vial. Sample preparation workflows utilizing extraction can circumvent the latter issue, although careful optimization of solvent and extraction time is necessary. Monoterpenes, on the other hand, are highly volatile and retaining these analytes in the sample prior to analysis is challenging. This is especially difficult as the grinding technologies used for sample

Biotechnology Focus / June/July 2019

preparation steps can generate a substantial amount of heat which can contribute to pre-analysis volatilization and a subsequent loss of analyte. Consequently, sample preparation steps must be carefully designed to ensure consistent and reliable results. The use of sample grinding equipment with a chilling option, for example, could minimize loss of volatile terpenes. In addition, some laboratories have developed their own solutions to keep samples cold, such as using customized vial trays or headspace vial holders maintained at sub-zero temperatures. Given the broad range of analytes that must be tested, it is critical to use the same processes when preparing calibration standards as test samples. Furthermore, robust chromatographic separation must be balanced with practical chromatographic run times. As such, the selection of appropriate chromatography conditions, especially columns, is particularly important.

and guidance from industry experts. By supporting laboratories in this way, these valuable training initiatives lay the foundations for higher quality cannabis testing and further growth in this field.

Conclusion The current challenges in cannabis terpene profiling not only highlight the importance of employing the most capable technologies, but also the need for the cannabis testing community to share and adopt best practice to overcome some of the issues presented here. Vendors of analytical instruments and consumables are engaging with stakeholders across the Canadian cannabis sector to develop complete workflow solutions that provide the terpene profiling and characterization information this growing market needs.

References 1.

E.B. Russo, Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. Br. J. Pharmacol. 163 (2011) 1344–1364. D. Piomelli, E.B. Russo, The Cannabis sativa Versus Cannabis indica Debate: An Interview with Ethan Russo, MD, Cannabis Cannabinoid Res. 1 (2016) 44–46. S. Blasco-Benito et al. Appraising the “entourage effect”: Antitumor action of a pure cannabinoid versus a botanical drug preparation in preclinical models of breast cancer. Biochem. Pharmacol. 157 (2018) 285–293.

Meeting the challenges of terpene profiling

The current challenges associated with terpene profiling reflect the fact that cannabis testing is a relatively nascent field that will be unfamiliar to many established laboratories. To enable accurate and reliable terpene profiling, cannabis testing laboratories not only require capable technologies, but also the training and familiarity with best practices to ensure these workflows are used in the most effective way. Instrument manufacturers are already supporting laboratories by bringing GC-MS systems to the market that offer high levels of accuracy, specificity, sensitivity, and operational reliability. In addition to making capable analytical solutions available for terpene profiling, some leading vendors of instruments and consumables, such as Thermo Fisher Scientific, are engaging with fully-licensed testing laboratories to provide educational resources to ensure these technologies are used effectively. The Thermo Fisher seminar series, at which this author was fortunate to speak, aimed to help laboratories in Canada develop optimized methods for cannabis testing through the dissemination of best practices

Jaclyn Thomson, director of research and development, Northern Vine Labs. Dr. Thomson is the Director of Research and Development at Northern Vine Labs, a leading cannabis testing facility based in Langley, BC. She received her BSc (Honors) from the University of Victoria, and her PhD from the University of British Columbia. Following her work in the NHP industry, Dr. Thomson joined Northern Vine Labs where she set up the 3rd party testing facility. She continues to manage the lab and its many moving parts, while simultaneously directing the R&D program where she works to enhance the scientific understanding of the properties of cannabis to better serve the cannabis industry.

awards

By Michelle Cornish

2019 Gairdner and Killam awards announced

aureates for the prestigious Gairdner and Killam awards have been announced for 2019. This year marks the 60th anniversary for the Gairdner awards, the world’s most significant biomedical research award that comes with a $100,000 cash honorarium. The winners were announced Apr. 2, 2019 at the Toronto Reference Library and a formal presentation of awards will take place Oct. 24, 2019. The 2019 Canada Gairdner International Award for seminal discoveries or contributions to biomedical science was awarded to the following five recipients: Susan Band Horwitz “for defining novel mechanisms of action and resistance of drugs of natural product origin, most significantly Taxol®, and promoting their use for treatment of cancer”. Ronald Vale “for the landmark discovery of the motor protein kinesin and pioneering the understanding of its mechanism of action in driving cellular movement processes including cell division and intracellular transport”. Timothy A. Springer “for discovery of the first immune system adhesion molecules, elucidation of their roles in antigen recognition and leukocyte homing, and translation of these discoveries into therapeutics for autoimmune diseases”. Bruce Stillman and John F. X. Diffley “for their pioneering research on the eukaryotic DNA replication cycles including

From left to right: Keith W. Hipel, André Blais, Lynne Viola, Yoshua Bengio, Stephen W. Scherer

initiation, regulation and responses to DNA damage”. The 2019 John Dirks Canada Gairdner Global Health Award for outstanding achievements in global health research was awarded to Vikram Patel “for his world-leading research in global mental health, generating knowledge on the burden and determinants of mental health problems in low- and middle-income countries and pioneering approaches for the prevention and treatment of mental health in low-resource settings”. The 2019 Canada Gairdner Wightman Award for a Canadian scientist exhibiting outstanding leadership in medicine and medical science throughout their career was awarded to Connie Jean Eaves “for her pioneering work and leadership in the study of hematopoietic, mammary and cancer stem cells and her dedicated advocacy for early- career investigators and women in science”. The Killam Awards, established in 1967 and awarded by the Canada Council for the Arts, also grant laureates a prize of $100,000 each. The award recognizes the

From left to right: Susan Band Horwitz, John F. X. Diffley, Bruce Stillman, Ronald Vale, Timothy A. Springer, Vikram Patel, Connie Jean Eaves

career achievements of eminent Canadian scholars and scientists actively engaged in research in industry, government agencies or universities. The 2019 Killam Award winners are: In natural sciences, Yoshua Bengio, a deep-learning pioneer from the Université de Montréal, considered one of the world’s foremost experts in artificial intelligence. André Blais, Université de Montréal, for social sciences. Blais is a worldwide expert in electoral studies and has examined the behaviour of parties and electors in 25 elections across five countries. In engineering, Keith W. Hipel, University of Waterloo, for his global interdisciplinary research from a systems engineering perspective on the development of conflict resolution, multiple criteria decision analysis, time series modelling and other decision-making methodologies for addressing complex system-of-systems problems. Stephen W. Scherer, University of Toronto, for health sciences. Through his research at The Hospital for Sick Children, Scherer has revolutionized our understanding of the human genome and contributed ground breaking insight into disease mechanisms and evolution when his group co-discovered gene copy number variation as a common type of variation in DNA. Lynne Viola, University of Toronto, for her work in the humanities as a leading scholar of Soviet Union history. She is recognized around the world as the premier archival researcher of the Stalinist era with a research focus on the mass repression in the 1930s. Nominees for 2020 Gairdner and Killam award recipients are now open. Deadlines for nominees are October 1, 2019, and June 15, 2019, respectively.

Biotechnology Focus

June/July 2019

Perspective

ONTARIO

By Jason Field

Accelerating growth for Ontario life sciences Traditional manufacturing and production industries that have historically fuelled economic prosperity are facing significant headwinds on growth, difficulty in retaining investment and attracting new capital.

Biotechnology Focus

June/July 2019

Projected 10-Year Life Sciences Direct Jobs Outcomes 140,000

4.2% CAGR

130,000 Direct Jobs

120,000 110,000

+31,000 jobs

1.5% CAGR

100,000 +14,600 jobs

90,000

Status Quo

for sustained growth of the life sciences sector in Ontario. The report looks to other successful life sciences jurisdictions for best practices that can be applied in Ontario, without reinventing the wheel. Key enablers of growth for a life sciences sector include: access to capital, attraction of experienced talent, a collaborative sector ecosystem and a competitive environment for companies. If Ontario’s life sciences sector follows similar trends experienced in other advanced life sciences jurisdictions, the potential exists for Ontario to experience significant economic benefits as a result of an accelerated growth in the life sciences sector.

Considerations for Ontario: • Increasing the level of certainty within the public policy environment for the life sciences sector with legislated strategies. Certainty can enable greater business investment, attraction, and growth. • Reviewing and prioritizing policy and

2027f

2026f

2025f

2024f

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2018f

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80,000

2012

arlier this year, Life Sciences Ontario (LSO) released the 2019 sector report, “Accelerating Prosperity: The Growth Potential of Ontario Life Sciences”. The report evaluates the current economic contributions of the life sciences sector in Ontario and reveals its considerable growth potential when combined with a coordinated life sciences strategy. Present day – we have an economy that is growing at an increased pace and a labour force growth that is slowing due to baby boomers exiting the labour market and a talent shortage. Ontario needs to shift the source of growth towards high-value services sectors that can create highpaying, good-quality jobs. The report demonstrates how the life sciences sector could be part of this progression. The life sciences sector makes notable contributions to the provincial economy. Through capital investments and operations, the life sciences sector directly contributes employment, tax revenue and value-added gross domestic product (GDP) to the economy.. The economic contributions of the life sciences sector in Ontario results in nearly $60 billion in GDP contributions and supports 191,294 jobs. While the sector itself has grown and has shown resilience in times of economic downfall, more can be done to capitalize on this dynamic sector. Lack of sufficient capital hinders the ability of companies to commercialize their innovations and scale-up in Ontario, leading to companies seeking capital in other jurisdictions and leaving Ontario and Canada. The report calls for a holistic approach to address these challenges and create the conditions

Potential Growth (with Life Sciences Strategy)

program options to help bridge the commercialization gap. Work with all ecosystem actors to catalyze the conditions for competitiveness and success on the global stage. • Increasing awareness of public policy initiatives and the range of support available for start-ups and entrepreneurs in the life sciences sector. Promotion of the investment climate and that Ontario is “open for business” • Measuring and reviewing policy programs to ensure desirable outcome. Establish baseline, evaluate outcomes, and reallocate resources if necessary. To read the full report, please visit: http://bit.ly/2019SectorReport

Dr. Jason Field is President and CEO of Life Sciences Ontario, a notfor-profit, member-driven organization advancing the success of Ontario’s life sciences sector.

Biotechnology Focus delivers critical Canadian news and insights, trends and reports, from R&D to business.

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Biotechnology Focus June/July 2018

Articles inside

2019 Gairdner and Killam awards announced

RESEARCH NEwS

why Ontario needs a network of early adopter health organizations

Profiling terpenes in cannabis: How Canadian laboratories are overcoming analytical challenges

Ontario companies fill marketplace voids

Embracing the digital future: The challenges of managing information in life sciences

Q&A with Todd Smith, Minister of Economic Development, Job Creation and Trade

Harnessing the economic potential of stem cells

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