Biotechnology Focus February/March 2018

February/March 2018

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

VOLUME 21, NUMBER 1

Finding Our Way to a Cure: A Look at the Future of Innovation in Cancer Care

INSIDE:

Canadian biomedical engineers are bringing new advanced therapeutic products to Canadians Publication Mail Registration Number: 40052410

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FEATURES

contents February/March 2018 – VOLUME 21 – NUMBER 1

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Good Manufacturing Practices in Canada

Good manufacturing practices are critical as Health Canada maintains tight control of the sale of drugs in Canada.

(By Karen Friedman)

11

The top 5 Canadian biotech CEOs who elevate their companies These are the leaders that stood out and have captured the attention of the Canadian biotech investment community.

(By Michelle Currie)

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Finding Our Way to a Cure: A Look at the Future of Innovation in Cancer Care Key developments in the area of oncology that we can expect to see transformative and immediate changes.

(By Laura Shields)

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Canadian biomedical engineers are bringing new advanced therapeutic products to Canadians The regenerative medicine field is abuzz with the advancement of novel therapeutic products.

(By Peter Zandstra)

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Taking genome sequencing to the next level

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Toronto-based DNAstack sets their sights on connecting data, researchers and systems across the country to accelerate genomic discoveries.

(By Michelle Currie)

Finding Our Way to a Cure: A Look at the Future of Innovation in Cancer Care

23

Building Bridges in 2018 and Beyond to Accelerate our Life Sciences Sector

DEPARTMENTS

Challenges the life sciences community faces and how working together will ensure success.

(By Dr. Jason Field )

6

Research news

8

Business corner

28 Calendar of events

in every issue 24

Innovation for a cure (By Michelle Currie)

8 International partnership sets its sight on developing a cure for Alzheimer’s disease www.biotechnologyfocus.ca

aCROSS CANADA

29

The Last Word Machines are learning fast (By Raphael Hofstein )

February/March 2018 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S note PUBLISHER/ EDITOR-IN-CHIEF Writer CONTRIBUTING WRITERS

Terri Pavelic Michelle Currie Laura Shields

Karen Friedman Peter Zandstra Dr. Jason Field Raphael Hofstein GRAPHIC DESIGNER CONTROLLER

I am delighted to bring you the first issue of Biotechnology Focus in the year! Many thanks for your continued interest in our publication if you are joining us again – and if this is your first time to pick up an issue, welcome! To start off the new year we are highlighting the advancements that have been made here in Canada in the field of oncology, and the improvements biomarkers have made in our lives.

Our main feature has been written by Laura Shields, the director of medical strategy at Hoffmann-La Roche Limited, Canada, called Finding our way to a cure: a look at the future of innovation in cancer care. She brings us an informative viewpoint about the key developments in the area of oncology and what we can expect to see in some of the most transformative and immediate changes for Canadians in 2018 and beyond.

Karen Friedman walks us through the good manufacturing practices in Canada and how to bring a drug product to market in her article Good manufacturing practices in Canada. Elaborating on how Health Canada retains tight control over the sale of drugs in our country so that safety and efficacy standards are met.

The countries most notable industry leaders who have stood out from the back are shed in the light of Michelle Currie’s article The top 5 Canadian biotech CEOs who elevate their companies. Put together with the help of some leading Canadian biotech analysts and investors, come check out who was the cream of the crop!

Peter Zandstra takes us through the changes in the regenerative medicine field and the advancement of novel therapeutic products in his article Canadian biomedical engineers are bringing new advanced therapeutic products to Canadians to illustrate the future of the field.

The art of genome sequencing is exposed with Michelle Currie’s innovator article on Marc Fiume, the CEO of DNAstack Taking genome sequencing to the next level.

Allowing our readers to hear about his company’s innovative genomic cloud platform that was recently launched to better connect researchers on their journey to accelerate genomic discovery.

Dr. Jason Field delights with his piece Building bridges in 2018 and beyond to accelerate our life science sector that discusses the challenges we face and the disconnect between industry and government that hinder the life sciences sector.

In our Across Canada section we are featuring the Ottawa region and the advancements in research and care applied to the field of infectious diseases in Across Canada: Innovation for a cure.

Lastly, we have Raphael Hofstein giving his expose on how Machines are learning fast as the global pharma industry is undergoing dramatic transition from its quest for blockbusters to the design of precision based medicine.

Thanks for joining us again and hope you enjoy the read!

4 BIOTECHNOLOGY FOCUS February/March 2018

MARKETING MANAGER

Elena Pankova John R. Jones Melisa Sukhdeo

CIRCULATION DIRECTOR Mary Labao circulation@promotivemedia.ca Tel: 905-841-7389

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. 1-226 Edward Street, Aurora, ON L4G 3S8, 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 – 1-226 Edward Street, Aurora, ON L4G 3S8 National Library of Canada ISSN 1486-3138 All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

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

CALL FOR NOMINATIONS THE REMARKABLE INDIVIDUALS AND COMPANIES RECOGNIZED THROUGH THE GOLD LEAF AWARDS ARE GREAT EXAMPLES OF THE CORE STRENGTHS OF CANADA’S BIOTECH ECOSYSTEM.

2017 WINNERS Importantly, Canada’s global biotech success is founded in its ability to advance scientific innovation by

COMPANY OF THE YEAR: enGene Inc.

leveraging a diverse and vibrant ecosystem comprised

EMERGING COMPANY OF THE YEAR (HEALTH): Turnstone Biologics

of individuals, companies and institutions located in every province across the country. It is this strength that establishes Canada’s biotech industry as a leader in developing the solutions that will help address the global social and economic challenges emerging from

EMERGING COMPANY OF THE YEAR (AGRICULTURE/ INDUSTRIAL): CO2 Solutions Inc. INDUSTRY CATALYST: Dr. Ilse Treurnicht

population growth and a changing climate.

ECOSYSTEM BUILDER: Bioenterprise Corporation

From left to right

From left to right

• Ms. Carol Hughes – Member of Parliament, Assistant Deputy Speaker NDP Representative of the Health Research Caucus • The Honourable Kelvin K. Ogilvie, Senator - Past Chair of the Health Research Caucus • The Honourable Judith Seidman, Senator - Incoming Senate Representative of the Health Research Caucus • Andrew Casey, President and CEO BIOTECanada • Dr. John Bell, Founder Turnstone Biologics • Dr. David Stojdl, Founder Turnstone Biologics • Mr. John Oliver, Member of Parliament Oakville - Chair of the Health Research Caucus

• Andrew Casey, President and CEO BIOTECanada • Dr. Anthony Cheung, President and CEO enGene • Donald Olds, President and CEO NEOMED

NOMINATIONS DUE JUNE 15, 2018

BIOTECH.CA

R&D news Implanting a cure to type 1 diabetes

The University of British Columbia and Vancouver Coastal Health are testing a radical way to cure diabetes. The researchers are implanting pancreatic cells grown in a lab from embryonic stem cells to replace ones previously damaged. The hope is that the implanted cells would mature and multiply to eradicate the reliance on insulin and everyday monitoring of blood sugar via finger pricking.

The trial could involve about 10 or more people in Vancouver with a severe form of type 1 diabetes, in which a person’s immune system attacks the pancreas, degrading or eliminating its ability to produce insulin.

The team received a grant from the Stem Cell Network of Canada for $500,000 to implement these treatments. Currently, they have only implanted one person, but intend to implant more in the coming weeks. Participants will be followed for two years to see if the implanted cells mature into insulin-producing beta cells and other cells capable of controlling a person’s blood sugar, and whether there are significant side effects.

The implants are part of a larger clinical study by ViaCyte that plans to test the cellreplacement therapy on approximately 40 patients between the US and Canada. ViaCyte has developed a technique for coaxing the embryonic cells along a path to become mature pancreatic cells. The company has also developed for the clinical trial, a protec6 BIOTECHNOLOGY FOCUS February/March 2018

tive packet – smaller than a VISA card – that will be implanted just beneath the skin. The packet’s membrane will allow blood vessels to permeate inside so that oxygen and other nutrients will stimulate them to differentiate further. The researchers expect some of the cells will become beta cells, which sense blood sugar levels and release insulin when needed.

As well as these packets, other smaller “sentinel” packets will be implanted and taken out at an earlier stage to evaluate the condition and the development of the cells inside.

With the intention to prevent the participants’’ bodies from rejecting the units, they will be taking immunosuppressants.

This, however, makes the patients more susceptible to other infections and is therefore only being clinically tested on people who have a particularly dangerous form of type 1 diabetes.

The procedure for implanting the cells, performed by a team led by Dr. Garth Warnock, a UBC surgery professor, is similar to transplanting clusters of beta cells, known as “islets,” from deceased donors – a treatment pioneered at the University of Alberta. If this clinical study is successful, it could be a promising lead to a cure for type 1 diabetes.

To see this story online visit https://biotechnologyfocus.ca/implanting-a-potential-cure-for-type-1-diabetes/

Researchers are shaking things up – literally Scientists have discovered a way using techniques traditionally used by seismologists that monitor vibration as a way to measure cell properties. Seismologists use this technique to study the Earth and characterize its deep structure. Scientists have now dubbed this technique in congruence with cells, cell seismology.

Elasticity is a fundamental part of healthy cells. As sickness and disease develop, more rigidity tends to progress – a tumour becomes more solid; Atherosclerosis and vascular aneurysms begin with elasticity loss; and endothelial cells release transmitters that cause the vasoconstriction or vasodilation of blood vessels are just a few examples.

With simple equipment consisting of a standard microscope, micropipettes and a high-speed camera, the researchers developed a revolutionary method of observing in real time the displacements and forces present in mouse oocytes.

According to Greg FitzHarris, a researcher at the CRCHUM, Université de Montréal professor and one of the project’s collaborators, “with this new cellular imaging method, we will be able to investigate new mechanisms involved in cell division during embryo formation”.

The vibrations can then be measured using displacement-tracking algorithms by using noise correlation techniques – what seismologists use to measure earthquakes and the composition of subterranean rocks.

This innovative cell elasticity mapping technology is clearing the way to many practical applications in biology and medicine, whether for cancer, pathogen-induced infection, scarring or tissue engineering.

To see this story online visit https://laboratoryfocus.ca/researchersare-shaking-things-up-literally/

R&D news Hamilton researchers unearth new way to diagnose early-onset coronary disease

Dr Guillaume Paré McMaster University researchers develop a test that is five times better at predicting and more accurate than the current method of diagnosing early coronary disease (CAD) in young adults.

Until now, there are not many ways to determine if someone has CAD. One of the only ways was to test for a rare genetic defect that factored only into some cases. However, Paré and his team at the Population Health Research Institute of McMaster and Hamilton Health Sciences (PHRI) have discovered that when they test for multiple genetic variations they’re able to predict early CAD in five times as many patients than the current test.

The results were published in the American Heart Association’s journal Circulation: Cardiovascular Genetics.

Heart disease is the leading cause of death globally. The most ordinary form is coronary artery disease, which occurs when the blood vessels to the heart narrow or harden. Most people can decrease their risk by not smoking, being physically active, maintaining a healthy diet and body weight, and controlling cholesterol, blood pressure and blood sugar.

There are rare instances where high blood levels of “bad” cholesterol (LDL) occur and result in a genetic defect called familial hypercholesterolemia. People diagnosed with this defect are at a higher risk for early-onset heart disease – early to mid-forties. One of the issues is that many patients with early-onset heart disease do

not have the defect to be diagnosed by the standard test.

Paré and his team at PHRI, along with researchers at Laval University in Quebec City, Quebec, developed the multi-gene, or “polygenic” risk score based on 182 genetic differences related to CAD. They then compared polygenic risk scores between study participants with and without early-onset heart disease.

They found that the polygenic risk score predicted one out of 53 cases of early-onset heart disease, compared to one in 256 for the single genetic test. Additionally, none of the patients with high polygenic risk scores had the rare genetic defect for familial hypercholesterolemia, that meant that the current testing method would not have identified them.

Study participants included 30 patients from the heart clinic at Hamilton General Hospital and 96 patients with early-onset heart disease enrolled in the UK Biobank study. The researchers also included in the study 111,283 UK Biobank participants without early-onset heart disease.

The study was funded by the Canadian Institutes of Health Research, a Canada Research Chair in Genetic and Molecular Epidemiology and a CISCO Professorship in Integrated Health Biosystems.

To see this story online visit https://biotechnologyfocus.ca/ hamilton-researchers-unearth-newway-to-diagnose-early-onset-coronarydisease/

Theralase improves delivery schedule of anti-cancer vaccine to eradicate brain cancer Theralase Technologies Inc. improves the delivery schedule of its proprietary anti-cancer vaccine that will increase its efficacy in the eradication of brain cancer.

The anti-cancer vaccine was evaluated in a rat glioma (RG2) animal model, a recognised model of Glioblastoma Multiforme, which is a deadly form of brain cancer. It was created by exposing RG2 cells to patented stressors outside the body. This was then injected into rats to delay the progression of brain glioma tumours.

In Theralase more recent research, rats were vaccinated twice and then exposed to brain tumour induction. Another four vaccinations were given post brain tumour induction.

This data demonstrates that the optimized delivery timetable – six vaccinations versus two vaccinations – indicated a substantial increase in the survival of animals from 35 per cent to 87.5 per cent.

Theralase is in the process of developing two separate clinical treatment paths for patients who have been diagnosed with GBM to safely and effectively destroy the tumour with minimal side effects.

In the first phase of the GBM clinical study, the participant will receive primary treatment, such as surgical debridement, temozolomide (an oral chemotherapy drug) and/or radiation therapy. They will then receive the vaccine created from the patient’s own tumour cells to stimulate the body’s immune system to destroy residual GBM cancer cells.

During the second phase, the participant will receive an intravenous injection of Rutherrin, a patented PDC (TLD-1433) drug formulation combined with transferrin, to then activate it via laser light somewhere between 8 to 24 hours after injection. This time is necessary to allow the drug to cross the blood-brain barrier and be absorbed into the cancer cells.

Additional PDT and/or radiation treatment would then occur to destroy any residual tumours, as required, followed by the Theralase vaccine.

There are an estimated 24,000 new cases of malignant gliomas diagnosed in the US annually, with more than 14,000 deaths. Most patients do not survive beyond 2 years postdiagnosis.

To see this story online visit https://biotechnologyfocus.ca/theralase-improves-delivery-schedule-of-anticancer-vaccine-to-eradicate-brain-cancer/ February/March 2018 BIOTECHNOLOGY FOCUS 7

BUSINESS corner BC biotech company AbCellera receives $1-M non-dilutive funding CQDM and Brain Canada announce a $1 million non-dilutive funding to AbCellera and the University of British Columbia. AbCellera will also be contributing $450,000 to the project, which will expand and apply its state-ofthe-art microfluidic antibody discovery platform for the detection of function-modifying antibodies against G-protein-coupled receptor (GPCR) targets.

The CQDM support was made possible by the financial contributions of five of its industrial members, including GSK, Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, Pfizer, and Sanofi. These contributions underscore their commitment

to driving innovation that can expand the accessible target space of antibody-based therapeutics, the fastest growing class of drugs.

AbCellera, started in Carl Hansen’s laboratory at the University of British Columbia in 2012 has become a reputable name in antibody discovery from natural immune repertoires. AbCellera’s microfluidic single-cell screening platform allows for deep profiling of natural immune responses with an unmatched combination of throughput, speed, and assay capabilities.

This funding will allow AbCellera to further expand its leading capabilities for antibody discovery against high-value complex mem-

brane proteins that have proven intractable by conventional approaches, including hybridoma, phage and yeast display. The continued collaboration between AbCellera and the University of British Columbia is a model example of how public-private partnerships can efficiently translate cutting-edge research into practical applications to accelerate the discovery and development of new therapies for patients.

To see this story online visit https://biotechnologyfocus.ca/bcbiotech-company-abcellera-receives1-m-non-dilutive-funding/

International partnership sets its sight on developing a cure for Alzheimer’s disease

Dr. Donald Weaver Ink has marked the page signing a deal between the Krembil Research Institute and French multinational pharmaceutical company, Servier, for the development of a potential disease-modifying drug for Alzheimer’s disease.

This strategic research partnership agreement with Toronto-based company Treventis Corp., a company founded by the director of Krembil, Dr. Donald Weaver, is to co-develop a lasting treatment.

8 BIOTECHNOLOGY FOCUS February/March 2018

Studies are already underway at the University Health Network (UHN).

As part of the collaborative agreement, researchers from both countries will be targeting two key proteins that have been identified with memory loss – tau and beta-amyloid.

Weaver’s team has been working on a therapeutic strategy for near two decades to slow or stop this degenerative disease.

Currently, there are no disease-modifying treatments on the market to prevent or stop

the progression altogether. Alzheimer’s disease affects over 564,000 people in Canada and is expected to rise to a distressing 937,000 by 2031.

In 2013, Treventis was awarded $4.7-million in funding from the prestigious Wellcome Trust to investigate compounds, with the hopes of designing a drug that can safely and effectively treat people with chronic neurological dementias, such as Alzheimer’s. Funding from the Wellcome Trust, a British-based independent charity, is extremely competitive, difficult to obtain, and is traditionally awarded to researchers in the U.K. Some of the donors and contributors to the advancement of this research are the Brain Campaign, Alzheimer Society of Canada, Canadian Institutes of Health Research, The W. Garfield Weston Foundation, Bright Focus Foundation, and the Krembil Foundation.

As part of the agreement, Servier will fund all research costs and maintain worldwide rights to develop and commercialize drugs advanced during the partnership, while the Toronto researchers set to discover a candidate for a phase I clinical trial.

To see this story online visit https://biotechnologyfocus.ca/ international-partnership-sets-itssight-on-developing-a-cure-foralzheimers/

BUSINESS corner Croda International acquires Nautilus Biosciences

Croda International acquires Nautilus Biosciences Canada Inc. The two companies already have a proven track record of successful collaborations during the past six years developing specific applications for skin care and hair care, as well as crop care.

Croda intends to establish Nautilus as a Croda Centre of Innovation for Marine Biotechnology at the existing base at the University of Prince Edward Island. Through this acquisition and associated patents, Croda will utilise Nautilus’ innovative science for applications across all its market sectors.

This location is ideal for biotechnology research and has already attracted and facilitated partnerships with many other biotechnology-based companies. Nautilus has exclusive global access to the Marine Microbial Library which is based at the University of Prince Edward Island.

Nautilus was founded in 2007 by professor Russell Kerr, and together with its worldclass scientists focuses on using marine microbial biodiversity to discover novel actives and materials.

Roy Francis, executive director of the PEI BioAlliance adds, “Croda’s investment in Nautilus and Prince Edward Island is a great return on everyone’s commitment. It’s how a cluster works.”

Celgene Corporation merges with Juno Therapeutics for $9-B Celgene, a biotech giant, has merged with and acquired Juno Therapeutics and their leading blockbuster drug cancer therapy in one of their largest deals ever. For a total of $9 billion, Celgene will pay $87 a share in cash for those not already owned by this corporation.

Celgene and Juno have been collaborating since June 2015 under which the two companies would leverage T cell therapeutic strategies to develop treatments for patients with cancer and autoimmune diseases with an initial focus on CAR T and TCR technologies. In April 2016, Celgene exercised its option to develop and commercialize the Juno CD19 program outside of North America and China.

Juno develops cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T-cell (CAR T-cell) receptor technologies to genetically engineer

T-cells to recognize and kill cancer. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date.

This acquisition will position Celgene to become a preeminent cellular immunotherapy company with a platform to be at the forefront of future advances. JCAR017, a pivotal stage asset, with an emerging favourable profile in DLBCL, is expected to add approximately $3 billion in peak sales and significantly strengthen Celgene’s lymphoma portfolio, and JCARH125 will enhance Celgene’s campaign against BCMA (B-cell maturation antigen), a key target in multiple myeloma.

To see this story online visit https://biotechnologyfocus.ca/ celgene-corporation-merges-withjuno-therapeutics-for-9-b/

Aurora Cannabis buys out CanniMed in largest pot deal yet Two of Canada’s largest producers of cannabis have struck a deal after months of negotiations and a hostile takeover bid. The board of directors and the special committee of the CanniMed board have agreed to support a new offer made by Aurora for the acquisition of all of the issued and outstanding shares of CanniMed not owned by Aurora.

“We are very pleased to have come to terms with CanniMed on this powerful strategic combination that will establish a bestin-class cannabis company with operations across Canada and around the world,” says Terry Booth, CEO of Aurora.

The new offer for CanniMed is approximately $1.1 billion based on Aurora’s implied share price of $12.65. The maximum amount of cash available under the amended offer will be $140 million, and the number of Aurora shares to be issued will be between approximately 72 million and 84

million. Assuming maximum cash elections, each CanniMed shareholder would receive $5.70 in cash and 2.9493 Aurora shares.

Brent Zettl, president and CEO of CanniMed, adds, “A testament to the great team at CanniMed, this transaction clearly confirms that the company has been highly successful in becoming a preeminent global leader in the medical cannabis industry.

In this leadership position, CanniMed has provided invaluable education, resources, support and relief of symptoms for thousands of patients served around the globe.”

Despite CanniMed filing a law suit against Aurora earlier this year, this deal provides the optimum outcome for both companies.

To see this story online visit https://biotechnologyfocus.ca/auroracannabis-buys-out-cannimed-in-largestdeal-yet/

To see this story online visit https://biotechnologyfocus.ca/ croda-international-acquiresnautilus-biosciences/ February/March 2018 BIOTECHNOLOGY FOCUS 9

Best Practices

| By Karen Friedman

Good Manufacturing Practices in Canada

H

ealth Canada maintains tight control over the sale of drugs in Canada by applying the Food & Drug Regulations (1) to all involved parties. In order to bring a drug product to market, a manufacturer must provide evidence to Health Canada on drug safety and efficacy, and demonstrate that processes planned for production are consistent with the regulations. Enforcement of the regulations is not limited to the pre-approval phase.

After receiving approval, license holders must continue to ensure that all parts of their supply chain operate in compliance with Health Canada regulations.

Logistic partners including importers, distributors and wholesalers are required to operate in compliance with the Good Manufacturing Practices (GMP) section of the regulations when working with drug products so that procedures in place do not adversely affect the quality of drugs.

The GMP is broad in scope and covers numerous areas of responsibility such as building design, sanitation practices, distribution records/inventory control, record keeping and testing of products where necessary before they are made available for sale. One important aspect of GMP requirements is the stipulation that all procedures involving drug products are performed according to written procedures and are to be performed by qualified and trained personnel at all times. For some groups in the supply chain, this high level of accountability

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may not be achieved without significant updates to operational procedures or investments in additional staffing or equipment.

The term “GMP” is recognized worldwide as the quality standard for drug products. However, how companies receive certification from their local regulatory bodies vary throughout the world. In some regions, GMP regulations have been enacted by a federal authority, but the actual approval of GMP compliance is not managed by that same authority, and instead, certification is provided by third-party auditors (for example the FDA in the United States).

Health Canada has a unique system whereby evidence to demonstrate GMP compliance is approved directly by Health Canada before facilities are permitted to carry on activities with drug products. This pre-review system of GMP evidence may pose a barrier to entry for some groups looking to get into the drug product business, and is a frequent hurdle for importers wishing to bring drug products into Canada for further sale.

Up until a few years ago, Health Canada’s efforts in GMP regulation and compliance were focused primarily on drugs in finished form. However, over time it became evident that regulating starting materials, otherwise known as active pharmaceutical ingredients (API) were also a crucial part of the process of ensuring the quality of finished drugs.

Health Canada therefore made a significant update to the GMP regulations in 2013 by expanding their scope to include API

sources. Given that a large proportion of API sources are located abroad, the recent adjustment to the GMP regulations has resulted in an increased regulatory burden for Canadian importers of drug products and manufacturers of drug products; particularly if they are sourcing API from numerous foreign facilities.

Challenges for the drug supply chain with respect to GMP compliance may rise as the trend toward outsourcing and increased use of third-party distribution centres continues.

It remains the responsibility of the drug product license holder to ensure that all locations involved in bringing their drugs to market in Canada are GMP compliant. Planning for GMP compliance at early-stages of negotiations with contractors can assist with minimizing delays and interruptions in supply chains and production of drug products in Canada.

References: 1. Branch, Legislative Services. “Consolidated Federal Laws of Canada, Food and Drug Regulations.” Legislative Services Branch, 4 Jan. 2018, laws.justice.gc.ca/eng/ regulations/c.r.c.,_c._870/index.htm Karen Friedman Consulting provides registration services for pharmaceutical and natural health products in Canada.

To see this story online visit https://biotechnologyfocus.ca/good-manufacturing-practices-in-canada/

top 5

| By Michelle Currie

The top 5 Canadian biotech CEOs who elevate their companies

They are industry leaders who have stood out from the pack, and whose tenacity is extremely admirable. They have captured the attention of the Canadian biotech investment community and are the cream of the crop as Chief Executive Officers on the Canadian biotech scene from all around the country. With the help of some leading Canadian biotech analysts and investors, we’ve put together a list of who we think the Top 5 CEOs who elevate their companies are.

The criteria for making the list: They are CEOs who have delivered in the past and are with companies where they have a chance of delivering in the future. They aren’t necessarily leading the biggest companies, but rather, they qualify because they are the best leaders.

Dr. Clarissa Desjardins

Cameron Piron

Dr. Clarissa Desjardins is a co-founder of Clementia Pharmaceuticals and has been the president since its inception in 2010 and chief executive officer since 2012. Her company is a clinicalstage biopharmaceutical company that develops disease-modifying treatments for patients suffering from debilitating bone and other diseases. Clementia’s lead product candidate, palovarotene, an oral small molecule that binds and activates retinoic acid receptor gamma and prevents abnormal new bone formulation for the treatment of fibrodysplasia ossificans progressiva and multiple osteochondroma is now in phase III and phase II/III trials for two separate indications. This past September, she joined the board of directors of Bellus Health Inc., bringing with her a wealth of knowledge, as she has an exceptional track record for building successful biotech companies. Clarissa has received multiple awards that exemplify great leadership and made her a natural choice for this year’s list of top CEOs.

Cameron Piron is an industry-recognized leader and innovator in imageguided surgery. Although he is not a CEO, he has made a profound impact as a co-founder and president at Synaptive Medical – a company that is breaking ground with advanced medical devices, medical imaging and information science. Their BrightMatter technology combines surgical planning and navigation, robotic digital microscopy and informatics to create a family of devices to obtain patient data and retrieve it when needed the most. Recently integrated into hospitals in the United States, this technology is evolving to meet healthcare needs. Prior to co-founding Synaptive Medical, Cameron was president and co-founder of Sentinelle Medical, another medical device company that grew to over 200 employees and over $20 million in revenues before being acquired by Hologic Inc. in 2010.

February/March 2018 BIOTECHNOLOGY FOCUS 11

top 5

Dr. Ali Tehrani

Carl Hansen

Lloyd Segal

Dr. Ali Tehrani is a co-founder, president and chief executive officer of Zymeworks Inc., and an obvious choice for this year’s list. He has been an integral part of the success of Zymeworks, which continues to partner and flourish at a dizzying rate. The company’s lead clinical candidate, ZW25, is a Azymetric bispecific antibody that targets two distinct domains of the HER2 receptor resulting in multiple differentiated mechanisms of action. In 2017, the company reported results from the dose escalation portion of its ongoing phase I clinical trial, that expressed encouraging tolerability and anti-tumour activity. They made their sixth global pharmaceutical partnership with Janssen, along with Merck, Lilly, Celgene, GSK, and Daiichi Sankyo, and provided a licence to Janssen to develop multiple bispecific antibodies in a transaction worth up to US$1.45 billion. Building on the ferocity of the staff, this company has quickly risen and doesn’t seem to be stopping anytime soon.

Carl Hansen started AbCellera working out of his laboratory at the University of British Columbia in 2012.

He is the president and CEO of this privately held biotech company that provides enabling technologies for the discovery and development of monoclonal (mAb) therapies directly from natural immune cells. AbCellera’s lead technology is a proprietary single cell antibody discovery platform that provides researchers the opportunity to rapidly identify mAb therapeutic candidates from the natural immune repertoires of any species. This past year they launched an antibody research collaboration with GSK, and have established numerous collaborations with pharmaceutical and biotechnology companies working at the forefront of antibody drug discovery.

Lloyd Segal, a veteran biotech executive, president and CEO of Repare Therapeutics was another indisputable choice for this list. Lloyd is an entrepreneur-in-residence at Versant Ventures, and from 2010-2016 was a managing partner at Persistence Capital Partners, a leading healthcare private equity investor. He held CEO roles at Caprion Pharmaceuticals, which he co-founded, Advanced Bioconcept and Thallion Pharmaceuticals, and has served as a director of several public and private corporations in the U.S. and Canada.

Repare is developing new, precision oncology drugs for patients that target specific vulnerabilities of tumour cells.

Its approach assimilates insights from several fields of cell biology including DNA repair and synthetic lethality. Their platform combines a proprietary, highthroughput, CRISPR-enabled gene editing target discovery method with high resolution protein crystallography, computational biology and clinical informatics. The company secured an enormous US$68 million in early-stage financing in a deal co-led by Versant Ventures and Boston’s MPM Capital, and backed by U.S. drug giant Celgene Corp. and Canadian investors Fonds de solidarité FTQ and BDC Capital.

Honourable Mentions:

There was no shortage of great candidates for this year’s top biotech CEO picks. After so many outstanding nominations, it was hard to narrow it down to just five. Here are some of the honourable mentions who just missed the cut:

Roberto Bellini

Richard Glickman Arun Menawat

Sammy Farah

Anthony Cheung

David Main

President and CEO of Bellus Health

Founder and CEO of Aurinia Pharmaceuticals

President and CEO of Turnstone Biologics

President and CEO of enGene Inc.

President and CEO of Aquinox Pharmaceuticals

CEO of Profound Medical

To see this story online visit www.biotechnologyfocus.ca/top-5-canadian-ceos-elevate-companies/ 12 BIOTECHNOLOGY FOCUS February/March 2018

Cancer

| By Laura Shields

Finding Our Way

to a Cure:

A Look at the Future of Innovation in Cancer Care

F

or most of us, the start of a new year is a natural time to reflect on our progress as individuals. We take stock of the lives we’ve lived, the advances we’ve made, the impact we’ve had on those around us and the steps we need to take in the year ahead to achieve our goals.

For the Pharmaceutical and Biotechnology industry, the start of the new year is much the same. Standing at the doorstep of 2018, many of us who have spent our lives trying to advance healthcare around the globe believe that we are at a point in our careers, where science is progressing at a rapid rate.

In fact, some of us would venture that science is progressing at a rate that is outpacing our ability – as healthcare providers, as governments, as payers and as hospital institutions – to integrate these cutting-edge advances into clinical practice. While this reality poses significant challenges, as a pharmacist and as the Medical Strategy Director within a research-driven pharmaceutical company, I have to admit that it’s exciting to be on the threshold of so many unprecedented discoveries and novel treatment approaches for some of the world’s most devastating diseases.

The field of biotechnology is rich with discoveries that will have a dramatic impact on Canadians in 2018 and beyond. However, there are three key developments in the area of oncology in which we can expect to see some

February/March 2018 BIOTECHNOLOGY FOCUS 13

Cancer

We are also seeing the emergence of third-party molecular information providers, such as Foundation Medicine Inc., an organization that has partnered with Roche to offer genomic tests to provide physicians with information about a tumour’s unique genomic profile based on an interrogation of over 300 genes.

14 BIOTECHNOLOGY FOCUS February/March 2018

of the most transformative and immediate changes. These include: • the expanded role of diagnostics to optimize treatment choice; • the adoption of histology-agnostic treatment approaches; and • the next phase of true precision medicine

Expanded Role of Diagnostics In recent years, the use of diagnostic tests within the Canadian cancer care setting has become an increasingly important practice, particularly for guiding treatment decisions and optimizing the patient’s chances for positive outcomes. In fact, it’s estimated that nearly 70 per cent of all treatment decisions today involve a pathology and/or laboratory investigation.

While the role of predictive biomarker testing has already been well established for some time in certain tumour types (such as HER2 in breast cancer or EGFR and ALK in lung cancer) we are witnessing the emergence of two trends that could further enhance patients’ care and their experience with our healthcare system. These include the ability to simultaneously look beyond a single biomarker through genomic profiling, and the viability of liquid/blood-based biomarker testing.

In 2018 we can expect to see a continued shift among healthcare providers to rely more on comprehensive genomic profiling to map

each patient’s unique genomic profile to identify alterations across hundreds of genes known to be relevant in the development and progression of cancer. This broad approach optimizes the use of the available tumour tissue and provides physicians with the most comprehensive information to help guide their treatment selection. There is particular value in this approach for patients who have exhausted all standard treatment options or for those with rare forms of cancer with limited known effective treatment options.

Canadian institutions, like the British Columbia Cancer Agency, University Health Network in Toronto and The Jewish General Hospital in Montreal among many others, have already begun to demonstrate international leadership in this area with their in-house testing platforms and world-class genomic research programs. We are also seeing the emergence of third-party molecular information providers, such as Foundation Medicine Inc., an organization that has partnered with Roche to offer genomic tests to provide physicians with information about a tumour’s unique genomic profile based on an interrogation of over 300 genes. These external services provide options for institutions that may not have the internal capabilities to offer such testing services and for patients who are looking for more comprehensive diagnostic information. All of these efforts are striving to rapidly expand treatment options

Cancer Recently, two chimeric antigen receptor (CAR) T-cell therapies were approved in the United States, ushering in the next wave of personalized cancer care.

These therapies involve the genetic engineering and reinfusion of a patient’s own T-cells to fight their unique cancers. by matching patients with approved targeted therapies, immunotherapies, and clinical trials based on their tumour’s molecular profile.

The second emerging trend in the space of predictive biomarkers is blood-based testing, which offers physicians a less-invasive testing mechanism for cases, in which there is insufficient tissue available for analysis. This may also prove to be a better option when a traditional tissue biopsy is not feasible due to tumour location, when a patient is in poor health, or when a physician and/or patient simply prefer a non-surgical option. In addition to supporting initial treatment choice, blood-based testing may also offer physicians the potential for continued monitoring in the future, resulting in earlier detection of disease progression and an assessment of resistance mutations to inform subsequent lines of therapy.

A Change in Mindset Further to the evolution of diagnostic technologies, the increasing prevalence of targeted medicines is fundamentally challenging the way cancer research is conducted. We are no longer seeing only large randomized Phase III studies measuring overall survival for drug development, but more novel trial designs, including basket and umbrella studies, as well as smaller Phase II designs to measure the safety and efficacy of a drug. These new study approaches are aimed to accelerate scientific advancement and are addressing the challenges that exist when the prevalence of a particular molecular alteration is so limited that traditional trials seeking a large bolus of patients simply aren’t feasible.

In a basket trial, the impact of a single treatment across a spectrum of tumour types harbouring a particular alteration can be investigated. In contrast, umbrella trials inverse the approach, where multiple treatments are studied in patients with a common tumour type but who are stratified by molecular subtype.

Close to home, the Canadian Profiling and Targeted Agent Utilization (CAPTUR) trial sponsored by the Canadian Clinical Trials Group in partnership with several pharmaceutical companies and academic institutions across the country is a combined basket/ umbrella study enrolling patients of all cancer

types who are stratified into different arms of the study to receive treatments based on the genomic profile of their tumours. Studies like CAPTUR will fundamentally shift how physicians view cancer, forcing them to look less at the type of cancer (e.g., breast, lung, colorectal) and focus on the molecular structure of the tumour.

This histology-agnostic approach is one that is also gaining traction with regulatory authorities around the globe. In fact, the U.S. Food and Drug Administration (FDA) recently approved a PD-1 inhibitor to treat patients with any cancer type, provided their tumours were unresectable or metastatic and classified as microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR). This approval represented a significant departure from the traditional evidence requirements expected from a regulatory body and opens the door for further discussions and opportunities in other countries.

The Realization of True Precision Medicine The final development, which seems like a natural extension of our evolving mindset around the use of diagnostics and targeted medicines in oncology is our view regarding how medicines can be engineered to offer truly individualized treatments to patients.

Though personalized medicines and immunotherapies are no longer considered ‘new’ in the rapidly evolving clinical landscape, the emergence of two types of truly bespoke cancer therapies marry these concepts to create what many consider a bold step in our quest to cure cancer.

Recently, two chimeric antigen receptor (CAR) T-cell therapies were approved in the United States, ushering in the next wave of personalized cancer care. These therapies involve the genetic engineering and reinfusion of a patient’s own T-cells to fight their unique cancers. While approved in specific hematologic cancers today, researchers are also exploring these therapies in many solid tumours and the hope remains that they will offer a whole new way to think of treatment in cancer.

Still in its infancy, the second area of significant research is personalized cancer vaccines developed and manufactured for

an individual patient based on the molecular profile of their tumours. Where off-the-shelf cancer vaccines have failed in the past, there is hope that these custom, uniquely tailored vaccines, in combination with checkpoint inhibitor therapies will succeed in transforming cancer care.

Close In closing, while it’s easy to become discouraged by the often necessary hurdles required to integrate transformative products into current clinical practice, I would argue that there has never been a more exciting time for those of us who have built a career in the biotechnology industry; and I would argue that there has never been a more exciting time for those of us who have waited for a cure to cancer – a disease that has ravaged many of our families and has taken many of our friends and loved ones.

The reality is that science will continue to outpace clinical practice. But the promise of these discoveries can be realized if we – as stakeholders within the healthcare system – are willing and open-minded to collaborate on solutions, especially as we look at the impact personalized medicines can have in therapeutic areas beyond oncology, offering meaningful solutions to an infinitely greater number of patients, enabling them to live longer, healthier lives.

Laura Shields is a Director of Medical Strategy at Hoffmann-La Roche Limited.

To see this story online visit www.biotechnologyfocus.ca/finding-waycure-look-future-innovation-cancer-care/ February/March 2018 BIOTECHNOLOGY FOCUS 15

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| By Peter W Zandstra

Stem Cells

Canadian biomedical engineers are bringing new advanced therapeutic products to Canadians

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he regenerative medicine field, which includes cell and gene therapies (CGTs), is still abuzz with the fall approvals of three CGTs by the U.S. Food and Drug Administration: Novartis’ Kymriah, Gilead/Kite Pharma’s Yescarta and Spark Therapeutics Inc.’s Luxturna.

At the Cell and Gene Therapy World conference in Miami, Florida (January 22-25), many of the talks were either about the approved treatments or congratulating the industry on these significant milestones.

Reni Benjamin, of Raymond James Financial, reminded delegates that the pharmaceutical industry is also feeling confident about CGTs. Acquisitions in 2017 were worth billions: Gilead acquired Kite for $11.9 billion, Takeda bought Ariad for $5.2 billion and Roche acquired Ignyta for $1.7 billion. As the conference was just getting underway, the news was announced that Celgene is buying Juno Therapeutics for $9 billion.

Illustrating the future of the field are the more than 1,300 currently open clinical trials listing stem cells (from sources other than blood) as the primary therapeutic,1 the 1,000 clinical trials in gene therapy,2 and clinical trials involving chimeric antigen receptor (CAR) T-cells (a type of immune system cell) accounted for around half of clinical trials in 2016.2 As such, global investment in the CGT and regenerative medicine industry is booming. For example, public and private investment in immuno-oncology has grown to $1.5 billion.2 When it comes to gene therapies, the forecast for the year 2025 ranges from $4.3 billion to $10 billion2 due to recent advances in the understanding of genetic disease, and innovation in genetic engineering tools. Altogether, it is estimated that the regenerative medicine industry will explode to a valuation of up to $20 billion by the year 2025.3

February/March 2018 BIOTECHNOLOGY FOCUS 17

Stem Cells

Where does Canada sit in terms of being an innovator in these advanced therapeutic technologies?

Let’s start with the good news. Canada is a prominent force in this emerging global field.

We have a strong backbone of Canada-based researchers who are recognized scientific leaders, and a robust system for the development of highly-qualified personnel through Canada’s universities. We have also benefited from strategic investments in research, collaborative networks and infrastructure, and are developing a deep understanding of how to translate these advanced therapies from the bench to the bedside.

One way to sustain Canada’s leadership position is to nurture the right skills and education within our borders. Encouraging STEM (science, technology, engineering and mathematics) education from a young age is a necessary first step. Extending STEM-based education with biomedical engineering programs at the university level is a good strategy for supporting the growth of Canada’s CGT and regenerative medicine industry.

Biomedical engineering – where engineering design principles and mathematics are applied to medicine and biology, allowing students to make significant contributions to improving human health by finding new diagnostic or therapeutic solutions – is an area Canadian universities are increasingly focusing on.

An illustration of how biomedical engineers are already impacting the regenerative medicine field can be found at the University of Toronto’s Institute of Biomaterials and Biomedical Engineering (IBBME) and at Medicine by Design. The 55-year-old IBBME fosters a multidisciplinary research community where students and investigators in engineering, medicine and dentistry collaborate to develop innovative solutions that address global challenges in human health. Their impact can be seen in the development of breakthrough biomedical devices and new biomaterial products.

Funded in 2015 with a generous federal grant, Medicine by Design builds on IBBME’s successful multidisciplinary model to conceive, create and test strategies to address critical problems in regenerative medicine.

By working across disciplines and generating and using emerging methods, like genome editing, computational modelling and synthetic biology, Medicine by Design is generating a deeper understanding of core biological concepts controlling stem cell fate, and devising new therapeutic approaches 18 BIOTECHNOLOGY FOCUS February/March 2018

that will improve health outcomes.

This successful approach is now receiving a significant boost in Vancouver, where the University of British Columbia (UBC) has launched a new School of Biomedical Engineering as a partnership between the Faculty of Medicine and the Faculty of Applied Science.

“UBC’s School of Biomedical Engineering is cultivating and inspiring the future problem-solvers of health care,” says Dr. Dermot Kelleher, Dean of the Faculty of Medicine.

“Biomedical engineers are helping to drive the industry forward and could hold the keys to commercializing new technologies and treatments. Creating this educational pipeline is critical as Canada continues to stake its claim as a leader in regenerative medicine, and as the full promise of this field comes to fruition.”

Moving from Education to industry CCRM, a Toronto-based leader in developing and commercializing CGTs and regenerative medicine technologies, understands how the intersection of engineering and medicine, introduced by biomedical engineers, can help provide the tools that will advance the industry now and into the future.

“At CCRM, we recognize that highly-trained personnel, including biomedical engineers, are in high demand on a global scale as companies worldwide expand their regenerative

Canada is a prominent force in this emerging global field.

Extending STEMbased education with biomedical engineering programs at the university level is a good strategy for supporting the growth of Canada’s CGT and regenerative medicine industry.

Stem Cells

medicine products,” says Michael May, PhD, president and CEO, CCRM. “CCRM aims to retain and attract the best and brightest who can create the technologies required to enable Canada to make a difference in solving the field’s commercialization challenges. In doing so, the Canadian regenerative medicine industry will be strengthened, creating opportunities for more research funding, a strong foundation for company creation, and stickiness for investors.”

One area where CCRM employs biomedical engineers is in its Centre for Advanced Therapeutic Cell Technologies (CATCT), a joint investment by GE Healthcare and the Government of Canada. Biomedical engineers work on process development strategies and solutions, and on projects involving reprogramming and engineering cells, immunotherapies and gene therapies.

Operational for over a year, CATCT was created to accelerate the development and adoption of cell manufacturing technologies that improve patient access to novel regenerative medicine-based therapies. The team introduces new technologies to solve emerging technical challenges and closes gaps in current and future workflows.

Moving from industry to adoption Our next challenge is to make certain that we have the people, technologies, processes and infrastructure to ensure Canadians have

equitable access to these potentially gamechanging therapies. Biomedical engineering programs are a start. Engineers are trained to look for efficiencies through cost reductions and improved technologies.

We need to build a Canadian innovation cluster that will attract talent and business expertise to capture the intellectual property developed in Canada and mobilize it for the benefit of Canadians.

We also need to work with government to position our health-care system as part of our competitive advantage. As Dr. May proposes, “If the provinces become early adopters of the medical products and therapies designed and tested in Canada, both patients and the economy would gain tremendously.”

A big part of getting to this step in getting to this solution is starting to look at health economic models that integrate therapeutic costs and savings from development through to long-term patent treatment costs.

Together, Canada’s companies, networks, researchers, start-ups and innovative centres are starting to deliver on the promise of regenerative medicine. With the technical know-how and a spirit of collaboration, biomedical engineers are a driving force in the country’s quest to lead the CGT and regenerative medicine industry into the future.

References: 1. U.S. National Library of Medicine. (2018).

ClinicalTrials.gov database.

Our next challenge is to make certain that we have the people, technologies, processes and infrastructure to ensure Canadians have equitable access to these potentially game-changing therapies.

2. CCRM. (2017). Advanced Therapies Investment Report.

3. FierceBiotech.com. (2010). Regenerative medicine could be $20B market in 15 years.

Professor Peter Zandstra is UBC’s Director of the School of Biomedical Engineering and Director of Michael Smith Laboratories. Zandstra’s research integrates engineering and biological approaches using computer modelling and strict control of the microenvironment (niche engineering) to develop a deeper understanding of the regulatory networks that determine stem cell fate.

To see this story online visit www.biotechnologyfocus.ca/canadian-biomedical-engineers-bringing-new-advancedtherapeutic-products-canadians/ February/March 2018 BIOTECHNOLOGY FOCUS 19

Innovator

| Michelle Currie

Taking Genome Sequencing to the next level

T

he world is opening up to the idea of genome sequencing. What was once a far-fetched idea is now beginning to materialize - and we are only at the tip of the iceberg. Information technology like Facebook, Google, Wikipedia and Uber are all prime examples of impactful software platforms that connect people with data that have set the stage for the next act.

When you look at where DNA sequencing began back in the 1970’s with the “Sanger sequencing method” as a process of determining the order of bases in the length of DNA, we’ve come a long way. But still, researchers are at the forefront of this revolution of gathering our personalized genetic information and using it to power the next generation of safer and more effective “precision” medicines.

This is where Marc Fiume and his team from DNAstack, a Toronto-based cloud genomics company, have their role to play. Started in 2014, the company began work with some exciting researchers from around Canada whose hot topics included autism and cancer research. But constantly they were told that the researchers just didn’t have enough samples to make sense of all the data they were collecting, and that they really needed a platform that would connect them with other researchers globally who found themselves in the same position. Inspired by the concept of Facebook, they decided to build their own platform where genetic research could transpire among researchers worldwide.

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Innovator

February/March 2018 BIOTECHNOLOGY FOCUS 21

Innovator “In the early days there were lots of interesting things you can learn just by looking at one genome,” says Marc Fiume, CEO and co-founder of DNAstack. “It was all about how can we look at a breast cancer gene to understand the mechanism by which cancer evolved in that location in that patient. It started off with a passion for visually debugging individual genomes but more recently it’s turned into cloud computing and sharing across thousands of genomes which helps us understand the mechanisms of disease more comprehensively.”

He refers to the lack of data access as “potentially keeping life-saving information in a basement server room” and is one of his biggest frustrations when it comes to genomic research. Unveiling the sequence of a genome is challenging, time-consuming and expensive.

Perhaps that is the reason why such a platform can no longer be just a notion, but become a mandatory tool so we can further our knowledge unified, instead of trying to connect the dots apart.

“If you look at the forecast for where genomics is going to be in 2025, we expect two billion humans to have their genomes sequenced. The amount of data that those two billion genomes will produce is more data than will be uploaded to a social media site like YouTube or Twitter. It is a tsunami of data that will be generated,” he says. “Part of what excites me is the challenge of applying computer science and machine learning in genomics to change the face of healthcare in the future.”

Genome sequencing is a lot like “decoding” of a foreign script or ciphering out a code of each individual’s personal genome. It is a long string of letters that forms a sort of molecular blueprint that is unique for each of us. These “strings” of letters are about six billion long, and currently, researchers are only grasping a very small per cent of what those letters represent. This is why the need for sharing information should be a necessity.

In an attempt to break this societal selfinflicted mold, Marc worked with Dr. Stephen Scherer from The Centre of Applied Genomics on the “Personal Genome Project Canada” to facilitate the publication of health and genome records online for free. The intention being that whether you are sick or healthy, it is incredibly useful personally and for the research community to have your genome sequenced.

Perhaps you have a predisposition to a potentially harmful genetic disease that you were not aware of before and could catch it before it starts, or if you are a carrier, or if you simply want to learn more about your ancestry. All of this is possible with genome sequencing.

While some may not be ready to have theirs 22 BIOTECHNOLOGY FOCUS February/March 2018

DNAstack recently launched their Canadian Genomics Cloud platform that is designed to better connect data, researchers and systems across the country to accelerate genomic discoveries and the implementation of precision medicine. published online, it could still be made available to you in the privacy of your own home.

Marc and Ryan Cook, the other co-founder of DNAstack, have both tried to decrease the unease attached to publicly airing one’s genome sequence by publishing their own. “It’s about empowering and making key decisions about their healthcare in a way that’s not scary and also to break down barriers about data sharing,” comments Marc.

There are now 56 genome researchers that are bearing it all for the world to see, and encouragingly are following up on some of the data that they have found.

“Genomics is a continuation of the desire we have to better understand ourselves. Precision medicine will just be an extension of that trend,” he adds.

It wasn’t always easy for Marc and the company though. They have had some hurdles along the way - as do many - who are breaking ground and exploring unfamiliar territory.

Conquering inertia is one of the hardest parts, and not one easily broken.

“Creating a culture that is accepting of new technologies allows us to create a vision,” Marc explains. “Helping the community realize that by securely and responsibly sharing information that we can make these discoveries faster and that there are significant underappreciated costs to not do it. We are leaving life-saving information in the basement server room throwing the baby out with the bath water.

Genomics has so far been disconnected from the greatest tool we have for sharing information – the internet – and we’ve seen how radical internet technologies like Google and

Wikipedia have changed our ability to discover and exchange information worldwide.”

DNAstack is located within JLABS at the MaRS Discovery Centre in the bustling downtown centre of Toronto; and with such a healthcare and energetically buzzing corridor – how could a young company like DNAstack go wrong?

“It’s such a collaborative space. I love it,” says Marc. “When we consider the impact that Toronto has in genomics, we punch way above our weight; and if you look at MaRS itself, you’ve got the Center for Applied Genomics just down the street, Sick Kids Hospital just across the street, Ontario Institute for Cancer Research, JLABS, Vector Institute, UofT. I haven’t seen a single city block that has so much expertise in genomics as the MaRS corridor. For us, being geographically close to world leading science allows us to feel a kind of energy that allows us to compete with other genomics hubs like Boston, San Francisco, and San Diego. That energy that everyone brings just keeps you going - definitely a driver.”

The Launch DNAstack recently launched their Canadian Genomics Cloud platform that is designed to better connect data, researchers and systems across the country to accelerate genomic discoveries and the implementation of precision medicine. It was invented by Canadian leaders with decades of experience in genomics, sequencing, cloud computing, software, security, and policy to democratize access to best-inclass infrastructure while respecting the unique national and provincial requirements for data privacy and security. Their aim is to service the needs of Canadian genome scientists from research institutions, clinical laboratories, pharmaceutical companies, hospitals, and industry.

“Most Canadian genome scientists have been at a systemic disadvantage because they lack access to powerful computational infrastructure they need to manage and make sense of exponentially growing data. They spend a significant amount of their time, money, and effort setting up bricks and mortar data centres when they should really be focused on science, not infrastructure,” Marc explains. “We think that this is going to massively improve our ability to collaborate and will massively reduce the wasted investment into local infrastructures that aren’t scalable for the future. The hope is to demonstrate that Canada now does have the capacity to do a precision medicine initiative at scale. Canada is really ready for this.”

To see this story online visit www.biotechnologyfocus.ca/taking-genomesequencing-next-level/

Life Sciences

| by Dr. Jason Field

Building Bridges in 2018 and Beyond to Accelerate our Life Sciences Sector 2017 was a year of paradox for Ontario’s life sciences sector.

W

e encountered significant roadblocks but we also experienced a surge of momentum.

There is a sense of optimism regarding the future of life sciences in Ontario, but an equal sense that there is much work still to be done.

The challenges we faced can largely be summed up with one phrase: a pervasive sense of disconnect between industry and government. It was a wake-up call when the federal government designed a supercluster strategy with no dedicated life sciences project – despite our status as one of Canada’s largest economic growth opportunities. We watched as other sectors – namely advanced manufacturing, aerospace, and IT – were bolstered with funding, programs, and publicity.

We faced challenges to drug pricing and IP policy that threatened to move us backwards globally, disrupting the marketplace and the balance of the life sciences innovation ecosystem – with potential negative impacts for Canadian patients. We saw government at all levels talk about innovation in life sciences – but with no clear vision for Canada’s life sciences sector. What does success look like and what is the roadmap to achieve it? In Ontario, we continue to wait for findings from the provincial life sciences working group that government and the private sector can act on together.

Despite this disconnect, our companies continued to gain momentum and recognition on the international stage. In fact, several Canadian companies – two based in Ontario – were flagged among the Top 20 Life Sciences Companies to Watch in 2018. According to PwC’s MoneyTree report, healthtech was the second biggest Canadian sector by deals and funding in Q3 of 2017 and is primed for continued growth in 2018. One look at the

roster we sent to JP Morgan last week tells the tale: our sector is continuing its strong and steady rise.

However, these successes have yet to translate into the kind of economic returns that the data tells us we’re capable of. We still lack that globally-significant, billion-dollar biotech success story that will propel us from middleweight to heavy hitter.

Representatives from all provincial political parties agree on the need for a coordinated strategy to get us there. To this end, we released our Blueprint for a Coordinated Ontario Life Sciences Strategy in December 2017. It lays out a comprehensive plan and recommendations for policymakers to accelerate the success of life sciences, with specific action around promotion of our sector, access to capital, talent growth, and support for innovation. The document is endorsed by leading provincial and national life sciences, health, and economic organizations.

At our Queen’s Park Day, we saw key representatives from these parties all in the same room, all agreeing that the Blueprint contains

core elements that we must work together to achieve – regardless of the outcome of the next provincial election.

Life sciences is bipartisan by its very nature. It touches on almost every facet of our sustainability and success as a province and nation: the food we eat, the health of our population and environment, our research and innovation capacity to solve intractable challenges, and the jobs and wealth that fuel our economic growth.

We must agree that these issues transcend politics. They will continue to exist regardless of who is in power. We cannot afford to have valuable progress derailed by a provincial election.

Currently at risk is the Provincial Life Sciences Working Group; it was first promised by the Minister of Research, Innovation and Science in 2015, and convened early in 2017.

With an election rapidly approaching, we are still waiting for its recommendations. How will we implement them without a coordinated strategy – including concrete goals – to measure them against?

We need to mend the disconnect between industry and government and across government ministries. We cannot achieve success by continuing to invest in world-class science and research while eroding intellectual property protection and the Canadian market for life sciences innovations.

This is why a pan-government life sciences strategy is so important. We must now find ways to work together if we are to secure our success. Our failure to do so will have longterm ramifications for the health and wealth of Canadians and our country’s place on the global stage.

Dr. Jason Field is President and CEO of Life Sciences Ontario, a not-for-profit, member-driven organization advancing the success of Ontario’s life sciences sector.

To see this story online visit www.biotechnologyfocus.ca/buildingbridges-in-2018-and-beyond-to-accelerateour-life-sciences-sector/ February/March 2018 BIOTECHNOLOGY FOCUS 23

| By Michelle Currie

Innovation

for a cure

The research and innovation coming out of Ottawa recently involving infectious diseases have truly been a gamechanger. For those who live with an infectious disease, such as HIV, it changes daily rituals and the general course of life.

24 BIOTECHNOLOGY FOCUS February/March 2018

T

he Ottawa Hospital is a very large research centre for infectious disease in Canada, and contributes to a phenomenal amount of clinical trial research as well as lab-based research that makes this location unique. Spearheading the Ottawa Hospital research team, Dr. Jonathan Angel, Head of Infectious Diseases, has run and is currently running a clinical trial that could make someone’s way of life a completely different ballgame.

Angel arrived at the hospital in 1995 and has since been involved in innovative studies regarding infectious diseases within the region. In the early days of his research, it was more about getting patients access to antiretrovirals so that they can save lives.

Across Canada

The big thing is it provides another option for people who have a physical or psychological aversion to taking pills.

Now, over two decades later it is more about optimal patient care and involving innovative approaches to treatment.

John Henry, a patient with HIV that is participating in one of the trials associated with Angel, spent three weeks cycling across Great Britain last summer – without the need to take a three-week supply of antiretroviral pills. Instead, he is receiving an injection every eight weeks that allows him some peace of mind and more freedom in his schedule.

“Replacing daily pills with something that is injected and slowly released into the body – it amazes me that it’s possible, but it works,” says Henry. “You’re free from pills, which is great if you go on vacation; and between the eight weeks, you actually forget that you have it.”

Like any daily medication, a pill or multiple pills per day is a sign that something is not in balance with an individual’s health. For Henry, a daily pill serves as a reminder that he has the human immunodeficiency virus (HIV). The disease interferes with the body’s ability to fight organisms that cause severe illness, which can potentially lead to acquiring some of those conditions that contend for an AIDS prognosis. Currently, there is no cure for this disease. At one point in the 1980’s, a diagnosis was considered fatal, but new hope has arisen with antiretroviral pills

and the continual influx of innovative information and research.

Henry is part of an international study that is being co-authored by Angel to determine if an injection given once every four to eight weeks would work as well as a daily antiretroviral pill to suppress the virus. The clinical trial is taking place in five countries, with fifty locations and nearly 300 patients.

The stipulations for the participants insist that they do not have any previous experience taking antiretroviral medication, to then be randomised as to whether an individual receives the four-week injection or the eight.

“In all the studies that have been done, everyone started with oral therapy,” says Angel. “The reason being twofold. One, to test if you had an adverse reaction or allergy to it, because something you give by mouth is going to last for a day or two, while an injectable is there for months. You want to make sure that someone is going to tolerate it well. The other thing is that it is better but not necessary to get levels of the drug or your body up to a certain level before you start injecting. It maintains the levels more evenly.”

Another patient in the study who began taking part in the trial in October 2014, Chad Raymond, comments, “I got a firm diagnosis two months before taking treatment. The

Dr. Jonathan Angel, Head of Infectious Diseases at The Ottawa Hospital and Associate Professor of Medicine at the University of Ottawa, led a study to find if an injection was as effective as a pill for controlling HIV. Photo: The Ottawa Hospital

February/March 2018 BIOTECHNOLOGY FOCUS 25

Across Canada

Patients receive two separate intramuscular injections of the antiretroviral drugs cabotegravir and rilpivirine in their buttocks. Tremblay explains that the drugs are released slowly into the patient’s system and last a full month or two months, depending on which schedule they are on.

Clinical Research Coordinator Nancy Tremblay takes blood samples from a patient as part of the clinical trial. Photo: The Ottawa Hospital

26 BIOTECHNOLOGY FOCUS February/March 2018

idea of doing injections appealed to me because of the infrequency of it. I was happy to get away from doing something on a daily basis, as I worried about missing a dose. So, an injection once every month was more appealing.”

The medical knowledge of the virus has made leaps and bounds in the past couple decades. Nancy Tremblay, a clinical research coordinator for the trial explains, “Years ago, a person had to take a handful of pills two to three times a day, and there were lots of side effects. That contributed to a lot of noncompliance, as some patients couldn’t tolerate the medication. So, we’ve progressed from that to one pill, once a day. It’s very effective with very few side effects if any – now injectables offer another option.”

Patients receive two separate intramuscular injections of the antiretroviral drugs cabotegravir and rilpivirine in their buttocks. Tremblay explains that the drugs are released slowly into the patient’s system and last a full month or two months, depending on which schedule they are on.

“The delivery method is not for everybody,” says Angel. “The big thing is it provides another option for people who have a physical or psychological aversion to taking pills.” He goes on to say the challenge will be who administers the drug once it is ap-

proved for by Health Canada. “Coming into a clinic to get your prescribed medication isn’t the answer. It’s fine when it’s during the trial, but afterwards, it is still not clear who will be trained to give the injections and where will they be done: doctors in their offices, pharmacists, or nurses visiting patients in their homes. While it is still a year or two before approval and they are commercially available, there are unique issues that will need to be sorted out.”

The people who are participating in the study will still have access to the drug after the conclusion of the clinical trial. Thus far, there have been no conclusive adverse reactions and patients seem quite happy with the procedure. Both men and women are involved in the study and are representational to who researchers see in the clinics.

There are other stipulations to participate in this study, but the drug is tolerable to switch to if clients are open to injection.

As well as this study, there are other more lab-based studies taking place within the hospital that focus more on the cure to HIV and are working with oncolytic viruses such as Maraba – which is also used in cancer immunotherapy.

The research group working with the Maraba (MG1) virus at the Ottawa Hospital have used several laboratory models of latent HIV-infected cells to discover that the MG1 virus targeted and eliminated those cells and left the healthy cells unharmed. Researchers are rapidly trying to move their studies from the lab to humans pending funding and approvals.

Until then, patients at The Ottawa Hospital, like Henry and Raymond, are contributing to and benefiting from this research – allowing this innovative region to potentially lead to a cure for HIV.

To see this story online visit www.biotechnologyfocus.ca/innovationfor-a-cure/

4th AnnuAl ICEAA CAnAdA Workshop professional development for Costing professionals and Managers

WhEn

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May 1 – 2, 2018

shaw Centre, ottawa

registration will soon open for the 4th Annual ICEAA Canads Workshop. this year’s event will bring together professionals from government, industry, and academic cost communities for an intensive 2-day program dedicated to developing the understanding and appreciation of using data-driven estimating and analysis techniques. our extensive program is designed to keep everyone from novice to seasoned professionals abreast of the latest developments in the field. We offer both training tracks to prepare new professionals for the pCEA and CCEA exams, and professional development tracks for experienced professionals and managers.

www.iceaa.ca/2018

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| By Rafi Hofstein, President & CEO MaRS Innovation

LAST word

Machines are learning fast

G

lobal pharma industry is undergoing a dramatic transition from a quest for blockbusters to the design of a precision medicine based drug design. Artificial intelligence is one of the most prominent elements that has been adopted as part of the transition from a fully integrated pharmaceutical company model of drug design to extensive interaction with smaller innovative R&D companies as well as academic institutions.

Artificial Intelligence (AI) is the activity devoted to making machines intelligent, and intelligence is that quality that enables an entity to function appropriately and with foresight in its environment (definition proposed by Nils J. Nillson, Stanford U.). Even though there are numerous definitions for AI, this one fits nicely into the goal of using machine learning for improving the rate of success in the design of novel and cost-effective therapeutics.

The main challenge regarding processing of big data is the need to process it in a meaningful and cost-effective fashion.

February/March 2018 BIOTECHNOLOGY FOCUS 29

LAST word

Our awareness of the impact of the AI revolution in drug discovery is already enormous and we’re only at the beginning of its adoption cycle.

One of the primary reasons that AI has such a great potential in drug development is that there is huge amount of health data available right now in the public health system. Clinical trials’ data, electronic medical records (EMR), genetic profiles and much more is the wealth representing the notion of BIG DATA in healthcare. The main challenge regarding processing of big data is the need to process it in a meaningful and cost-effective fashion. That is why training a machine to fulfill the task becomes so attractive. Selecting and adjusting the right algorithms is the first essential step but once it is in place, training machines to find optimal patterns between structure of “druggable molecules” and their optimal activity is within reach.

Canada has established a lead position in training of machines to learn how to perform complex tasks, in a relatively short period of time. Based on recent commitments to the space, it is expected that we will witness in the foreseeable future designs of novel and much more specific therapeutics with higher potency and lesser side effects.

The prospects are quite encouraging in light of the shift global pharma industry is adopting towards precision medicine. That shift will rely on sifting of patients’ medical records. Canadian AI machines are learning fast and are expected to become a key player in advancing academic concepts into standard and streamlined processes and organizations.

In Ontario, the University of Toronto has emerged as a world leading hub for research and entrepreneurship in this area. A potent combination of long standing academic research in conjunction with the adoption of machine learning methodologies have already proven to be game changing opportunities. Interactive approaches of computer science and medical research, combined with emerging best in class entrepreneurship programming and training is already yielding some fascinating fruits in the area of AI for drug discovery.

Companies like Structura Bio are taking the complex computational challenge of reducing noisy images from cryo-electron microscopes 30 BIOTECHNOLOGY FOCUS February/March 2018

into readable highly accurate 3D structures of proteins and are doing what used to take a server room filled with computers a week, in a matter of seconds. Similarly, Phenomic AI (a recently incorporated UTEST company) uses a technique called deep learning to analyze data from high-throughput phenomic screens to analyze cell and tissue phenotypes in microscopy data with incredible accuracy. It holds out the potential for eliminating human intervention in the assessment of all that data. In some cases, companies like Deep Genomics and Atomwise are going all the way by leveraging their respective AI technologies to become drug discovery engines themselves. Our awareness of the impact of the AI revolution in drug discovery is already enormous and we’re only at the beginning of its adoption cycle. Future advances in Canada will be buoyed further by strong academic and institutional foundations that have been put in place to assist Canada in sustaining this advantage. The Vector Institute, as an example, was established in 2017 in partnership with Canada’s largest companies and the Federal and Provincial Government’s to attract and retain world leading research talent and to promote cutting-edge research in the field.

Recently, partnerships have been established between the MaRS Innovation research healthcare ecosystem (UHN, Sickkids, Sunnybrook) with global players in the space of machine learning based drug design and developments. Partnerships with Schrödinger and Evotec have been established to capture the enormous potential of “fishing in the pond” of EMR’s rich source of unravelling the tissue/cellular architecture as a baseline for discovery of novel disease targets, which thereby establishes a mechanism for better drugs.

The field of AI in the service of medical research is still in its infancy, but the initial avalanche of results is already starting to give us an idea of the great potential that machine learning can offer to those embarking on advancing drug development. Reducing screening times, aiding new drug candidates and finding the most effective drugs for specific diseases at a speed that humans cannot achieve is compelling, and we believe that AI will increasingly become part of the medical landscape.

Once hurdles such as data standardized collection and storage as well as data privacy concerned are addressed, it is expected that we will witness an exponential inclination in the implementation of machine learning as a powerful tool in the design of more potent drugs with lesser side-effects. The FDA and Health Canada are encouraging pharmaceutical companies to join the choir.

To conclude, rephrasing from Eric Topol of the Scripps Research Institute (CNBC, May 2017), “The potential of artificial intelligence has probably the biggest impact of any type of technology on healthcare.”

Dr. Hofstein is the President and CEO of MaRS Innovation. He joined in 2009 after past positions that include CEO of Hadasit Bioholding, Israel.

To see this story online visit https://biotechnologyfocus.ca/ machines-are-learning-fast/ Got something to say? Please send your comments/letters to press@promotivemedia.ca

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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

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