Biotechnology Focus June 2011 by Promotive Communications

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

JUNE 2011 VOLUME 14, NUMBER 6

ONTARIO TACKLING WORLD HEALTH ISSUES

Ontario Deputy Minister of Research and Innovation

GEORGE ROSS

and President and Scientific Director of the Ontario Brain Institute

DONALD STUSS

Publication Mail Registration Number: 40052410

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contents JUNE 2011 – VOLUME 14 – NUMBER 6

By Dr. Mark Poznansky

Genomics

Genomics knowledge necessary to be able to improve the nitrogen use efficiency of crop plants.

IN THE MIDST OF THE GENOMICS REVOLUTION We are in the midst of a revolution in Genomics: a revolution that will rival the major changes that occurred with the advent of the steam engine and the automobile and the incredible changes in communications represented by information technologies. Reality check: Is that just fanciful thinking? Is it perhaps wishful thinking? Or is the sentiment real? Let’s start with some facts. A recent Batelle Institute report (published May 2011) stated that the Human Genome Project, which cost the American Taxpayer some $3.8 billion, has now resulted in over 300,000 jobs and a direct return on investment of almost $800 billion. Who says that you can’t make money in Biotech! There is an argument to be made that in fact we have only begun to scratch the surface of the Genomics Revolution. Coming back from the Davos World Economic Conference in 1998, then Financial Post Editor Diane Francis reporting on a presentation made by the President of Dupont, stated something to the effect that: Biotechnology (read Genomics) will change the world as we know it: a) It will change the way we understand and treat many diseases such as cancer, Alzheimer’s and Diabetes b) It will change the way we feed the world as we produce crops that are cheaper to grow and healthier to eat c) It will teach us about the environment and allow us to live in a more harmonious fashion with our environment

Ontario

A Spotlight on Innovation and Research in Ontario Ontario Minister of Research and Innovation Baycrest: Transforming the way people age Reshaping brain theory

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OICR-Big Ideas-Big Business

ONTARIO

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Samuel Lunenfeld Research, advancing neuroscience research in Canada

MaRS overview of Ontario’s neuroscience excellence

And each of these predictions are coming to pass. The Genomics Revolution has resulted in untold discoveries pointing to the genomic and molecular basis of disease. We now have incredible insight into many of the most devastating diseases known to man including a number of different cancers, diabetes, Alzheimer’s and heart disease, and we’ve made huge strides in conquering an important number of infectious diseases such as HIV/AIDS. The future will hopefully see the realization of personalized medicine – the right medication at the right dose for the individual patient. The Genomics Revolution has already changed our food supply in ways that few of us are aware. Over 80 per cent of the world’s supply of corn, soy, canola and cotton have been genetically modified to produce strains that are pest and/or pesticide resis-

tant allowing for greater yields, and therefore keeping prices down. The enzyme pathway to produce Vitamin A has been introduced into the rice genome, which is already resulting in a significant drop in infant blindness in parts of the developing world. The Genomics Revolution is now starting to address one of the earth’s most diverse and interesting life forms. Over 85 per cent of the earth’s Biomass is made up of microbes that populate and control the environment of every corner of the earth including the deepest levels of the sea. For example, it is startling to note that there are 10x more microbes in our bodies than there are human cells. It is also clear that microbes have evolved over billions of years to function as “protectors of the environment”. Much work is being done to understand Microbial Genomics and determine how we might use these microbes to help clean up the messes that we have introduced into the environment. The oil sands, pollutants from mining and from burning dirty fuels are good examples. The Ontario Genomics Institute (OGI) in partnership with Genome Canada and the Ontario Ministry of Research and Innovation, works to support Ontario’s world-renowned researchers in obtaining funding critical to their work and vital to enabling discoveries that bring immense benefits. We also work to assist in the commercialization of discoveries through our business development activities, and we also work to raise general awareness of genomics research, its importance and potential through educational outreach activities and public events. Life changing research is already taking place in Ontario. Here are just a few examples: sæDr. Tom Hudson is a leading cancer researcher recognized internationally for his work on the International HapMap Project, an effort to catalogue human genetic variation. In 2006, he became the founding President and Scientific Director of the Toronto-based Ontario Institute for Cancer Research (OICR), which is dedicated to research in prevention, early detection, diagnoses and treatment of cancer. Since OICR was founded, it has launched several large-scale programs including the One Millimetre Cancer Challenge, the Cancer Stem Cell Program, the Pancreatic Cancer Genome Project, the Terry Fox Research Institute/OICR Selective Therapies Program and the High Impact Clinical Trials Program. Dr. Hudson’s laboratory at OICR is involved in the study of genome variation that affects cancer predisposition, progression, and response to therapy. His main project focuses on the genetic architecture of loci associated with risk to colorectal cancer.

sæDr. Steve Scherer is a Senior Scientist at The Hospital for Sick Children (SickKids), Director of The Centre for Applied Genomics (TCAG) at SickKids, Director at the McLaughlin Centre for Molecular Medicine, University of Toronto, and Professor of Medicine, University of Toronto. He is best known for his contributions to discovering the phenomena of global copy number variation (CNVs) of DNA and genes as the most abundant type of genetic variation in the human genome. With his group at SickKids and TCAG, he has discovered numerous disease susceptibility genes, including defining CNV and other genetic factors underlying autism. sæDr. Aled Edwards is a structural biologist and Director and CEO of the Structural Genomics Consortium (SGC), an open access public-private partnership that identifies new targets for drug discovery and places all the information into the public domain without restriction on use. The SGC determines the 3D structures of human proteins of therapeutical relevance to diseases such as cancer, diabetes, and many other disorders. To date, over 1200 structures have been determined and four Ontario-based companies and one long-term project has spun-out of this research, providing 867 SME jobs over the last decade – another example of how genomics is helping create new jobs and money for the province. sæ Dr. Elizabeth Edwards is a professor in the Department of Cell and Systems Biology at the University of Toronto. Her research focuses on developing an understanding of how biological processes affect the fate of pollutants in the environment. She is currently heading up a project funded through Genome Canada, OGI and the province of Ontario that is sequencing and analyzing the genomes of many organisms to identify proteins with the potential to act as catalysts to transform wastes into useful bioproducts such as biofuel. Previous to this project and along with private sector partner Geosyntec Consultants, she developed a microbial culture that cleans up contaminated groundwater sites and that is sold world-wide. sæDr. Steven Rothstein, Professor at the University of Guelph, uses molecular genetics, biochemical and genomic information to understand problems in plant biology, which impact on the improvement of important crop plants. He has been involved in discovering new ways to get higher yields from Ontario corn, and more generally has worked towards uncovering ways to make crops resistant to environmental stresses like weather extremes. He is also looking at the economic and environmental cost of using large quantities of nitrogen fertilizer, specifically understanding the regulation of nitrogen metabolism with the long-term goal of generating the basic

sæ Dr. Paul Hebert, Scientific Director of the International Barcode of Life (iBOL) project at the Biodiversity Institute of Ontario, University of Guelph, is leading the iBOL project, currently the largest biodiversity project in existence. iBOL which unites researchers and biodiversity organizations from more than 27 countries, is working towards cataloging the world’s biodiversity by building a DNA barcode database containing DNA barcodes of more than 500,000 species. In addition to its importance in biodiversity, this work will greatly help: identify disease vectors; sift out marketplace fraud, such as mislabeling of foods; test animal feed purity; monitor climate change and detect invasive species. So, you can see, important, game changing work is already being undertaken in our backyard, but the best is really yet to come. We are just at the start of this most important of revolutions – the Genomics Revolution.

Dr. Mark Poznansky is President and CEO, Ontario Genomics Institute

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Biotechnology Focus / June 2011

12 & 26 FEATURES

Patenting Antibodies in Canada

When is the right time to patent? What does a properly drafted antibody patent entail? By Micheline Gravelle and Sie Lung Tjew

By Shawn Lawrence

Ontario and the Asia Opportunity China looks to Ontario’s Baycrest for best practices in senior care

By Kelly Connelly

Compiled by Biotechnology Focus and MRI

By Christopher Rogers

BY Shawn Lawrence

Innovations in aging and brain health The Baycrest model, translating science into practical application By Kelly Connelly

www.bioscienceworld.ca

The Ontario Brain Institute A nexus for brain disease research By Shawn Lawrence

The Ontario Network of Excellence A complete rundown of the 14 regional centres that make up ONE

The Science of Sharing The Structural Genomics Consortium: a public-private partnership to determine the three dimensional structures of human proteins

Ontario’s commercialization engine for cancer research Maximizing the commercial potential of cancer researchers both provincially and globally

One on One with Deputy Minister George Ross Biotechnology Focus sits down with Deputy Minister of Research and Innovation George Ross to discuss the current state of life sciences in Ontario and what lies ahead

Regenerative Medicine in Ontario How Ontario’s Stem Cell Initiative and the Centre for Commercialization of Regenerative Medicine are writing a new chapter in Ontario’s stem cell story

A Genomics Revolution Ontario Genomics Institute president and CEO Dr. Mark Poznansky discusses the impact of genomics in health related sciences By DR. MARK POZNANSKY

Photo Credit for cover and photos of MRI Deputy Minister George Ross and Dr. Donald Stuss goes to Johan Sorensen. Photo shoot was held at the SSTARR facility located at MaRS

JUNE 2011 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITERS

CONTRIBUTING WRITERS

Ontario’s at the forefront of tackling world health issues

Shawn Lawrence Christopher Rogers Bonnie Keuhl

Gail Garland

John Kelly

Kelly Connelly

Mark Poznansky

Micheline Gravelle

National Account Manager GRAPHIC DESIGNER CONTROLLER

Every year in preparation for BIO, Biotechnology Focus puts together a special issue that shines the spotlight on Ontario and its world class research community. It’s become an annual tradition of sorts, one we particularly enjoy, and it’s always good to know what’s happening in our own backyard. Some of what you might learn may surprise you. For example, did you know that the Ministry of Research and Innovation embarks on a yearly trade mission to Asia to expand our industry’s footprint overseas and that already these missions are leading to collaborative efforts both here and there? Or that Ontario was chosen over other provinces and countries as the home for an internationally recognized centre of excellence in brain research (The Ontario Brain Institute)? Or how about the fact that Ontario is also home to a world-leading centre for studying aging? This month’s publication also includes a one on one interview with Ontario Deputy Minister of Research and Innovation George Ross (featured on the cover with Donald Stuss) to get his take on Ontario’s plans for BIO this year. In our Q&A with the Deputy Minister, he also offered up some information on what the Government of Ontario is doing to strengthen the sector going forward. Commercialization remains a hot topic in and around the industry and in Ontario we have several commercialization engines in place to translate our science into practical application. The Ontario Institute for Cancer Research Commercialization Group is just two and a half years old, but already through its Intellectual Property Development Commercialization Fund, it has provided seed money to more than 16 projects, eight of which have been spun out into companies. Likewise, the Ontario Stem Cell Initiative’s Centre for Commercialization of Regenerative Medicine is taking world-class research in the area of regenerative medicine to another level. There’s also the Structural Genomics Consortium, a novel public-private partnership where academia and industry are able to overcome their differences and work together to determine the three-dimensional structures of human proteins. These are just some of the many stories we’ve packed into this issue. I can tell you that having the chance to speak with some of the province’s leading scientists is a humbling experience, but a rewarding one. What’s clear is that many of our success stories are growing from partnerships with other jurisdictions. Moreover, Ontario is using its technology know-how and its scientific strengths to build bridges globally. Best of all, we are sharing our innovations with the world and they in turn are coming to us for answers.

Terri Pavelic

Sie Lung Tjew Patricia Bush Elena Pankova John R. Jones

MARKETING MANAGER

Mary Malofy

CIRCULATION DIRECTOR

James Zammit

circulation@promotive.net

EDITORIAL ADVISORY BOARD Najla Guthrie, KGK Synergize; Pierre Bourassa, IRAP, Montréal; Brad Guthrie, Alberta Advanced Education and Technology; Carol Reynolds, Genome Prairie; Ulli Krull, UTM; John Kelly, Erie Innovation and Commercialization; Peter Pekos, Dalton Pharma Services; Brad Thompson, Oncolytics; Darrell Ethell, CanReg; John Hylton, John H. Hylton & Associates; Robert Foldes, Mentis Partners; Colette Rivet, BioTalent; Grant Tipler, RBC; Randal R.Goodfellow, P.Ag., Senior Vice President, Corporate Relations, Ensyn; Bob H. Sotiriadis, LLB,a partner with Leger Robic Richard; Dale Patterson, Genome Canada; Darcy Pawlik, Syngenta Seeds Canada Inc; Gail Garland, OBIO; Barry Gee, LifeSciences British Columbia Biotechnology Focus is published 10 times per year by Promotive Communications Inc. 24-4 Vata Court, Aurora, Ontario L4G 4B6 Phone 905-727-3875 Fax 905-727-4428 www.bioscienceworld.ca E-mail: biotechnology_focus@promotive.net Subscription rate in Canada $35/year; USA $60/year; other countries $100/year. All rights reserved. No part of this publication may be reproduced without written consent. Publications Mail Registration Number: 40052410 Return undeliverable Canadian addresses to: circulation dept – 24-4 Vata Court, Aurora, Ontario L4G 4B6 National Library of Canada ISSN 1486-3138 \ All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

If you would like to order hard copy or electronic reprints of articles, contact Sandra Service 905-727-3875 x221 reprints@promotive.net ABC Membership Applied For.

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Intellectual Property

By: Micheline Gravelle, M.Sc. and Sie Lung Tjew, M.Sc.

Patenting Antibodies

in Canada Antibodies represent a significant slice of the biotechnology market. Global sales of monoclonal antibodies – for use as therapeutics, diagnostics or as reagents in research – totaled approximately $35 billion in 2008 and grew to $55 billion in 2010, wherein the top 5 brands had sales of over $5 billion each.

his remarkable growth is likely to continue given the increasing number of antibodies receiving market authorization by the various regulatory agencies. For example, the U.S. Food and Drug Administration approved4 new therapeutic monoclonal antibodies in 2009, while the European Medicines Agency approved a record-setting7. Even more telling is that over 200 antibodies were working their way through the various stages of a clinical trial in the United States in 2008. This upcoming flood of antibody products is likely to push global revenues to new heights. Manufacturers of innovative antibody products, like other segments of the pharmaceutical industry, must constantly guard against infringing products. Given the financial stakes involved, it is imperative that innovators protect their intellectual property as much as possible, for as long as possible, in order to realize the maximum return on their investment. Weakened patent portfolios from a lack of timely and sustained capital has been cited as one of the barriers to

6 BIOTECHNOLOGY FOCUS JUNE 2011

successful commercialization of biotechnology in Canada. A poignant reminder of the value of a properly drafted patent comes from a recent case in the U.S. In Centocor Ortho Biotech, Inc. v. Abbott Labs a jury award of $1.67 billion for patent infringement was overturned by a panel of the Federal Circuit when it found the antibody claims to be invalid. A patent fences off the invention so that others know where they may not trespass. The invention is defined by the claims which essentially gives the inventor or patent owner the right to exclude others from making, using or selling the invention for a limited period of time – which for most countries is 20 years from the filing date. The claims must be considered novel, inventive and useful over what has been disclosed in the prior art. The claims must also be sufficiently supported by the disclosure provided in the patent application upon filing. The disclosure must also fully and correctly describe the invention such that it would enable one of skill in the art to make and use the invention as claimed. In the recent decision of Re Immunex Corporation Patent Application No. 583,988 (hereinafter, “Immunex”), the Patent Appeal

Board (PAB), in seeking consistency with other common-law jurisdictions, adopted the principles established in U.S. and U.K. courts that an applicant may claim monoclonal antibodies immunoreactive with a specific antigen without an antibody having actually been prepared, provided that the antigen is a novel polypeptide that has been well-defined, for example, by its structure, formula, chemical name, or physical properties, or by depositing the protein in a public depository. Immunex’s patent application was filed on November 24, 1988, with claims directed to monoclonal antibodies immunoreactive with IL-1R polypeptides, as well as antibodies claimed in a product-by-process format. The antibody claims were originally rejected by the patent examiner because such an antibody had not been produced by the filing date. The main issue was whether these claims were sufficiently supported by the description. In addressing this issue, the PAB considered whether the claims were enabled, adequately described and had utility.

Enablement Methods for producing polyclonal antibodies have long been recognized by the Canadian Intellectual Property Office (CIPO) as sufficiently well-established such that they do not

Intellectual Property need to be described in detail to be enabling. Where an applicant had not prepared polyclonal antibodies at the time of filing, the description may still be enabling, provided that there is nothing peculiar about the antigen or any indications that would affect the likelihood of producing the claimed polyclonal antibodies by one skilled in the art. However, prior to Immunex, claims to monoclonal antibodies were rejected unless the applicant had prepared an antibody at the time of filing. Unfortunately, this practice was based on an old decision by the PAB in Re Institut Pasteur Application (hereinafter, “Pasteur”), which held that the basic hybridoma techniques for producing monoclonal antibodies were not sufficiently well-established in the mid-1980’s such that a mere reference to it would not be enabling. CIPO continued to apply this decision until January 2009 when the Manual of Patent Office Practice (MOPOP) was amended and CIPO acknowledged that monoclonal antibody production technology had become so routine that the protocol need not be described in detail to be enabling. Nevertheless, CIPO maintained that in certain circumstances,

possession of a working example was still pertinent to enablement, for example, where there were indications that suggest undue experimentation or undue adaptation of known procedures to overcome some difficulty in making a monoclonal antibody.9 In Immunex, the PAB found that there were two types of IL-1 receptors, Type I and Type II, which were antigenically different. However, the description in the application was only directed to a Type I receptor. Accordingly, the monoclonal antibody claims to any IL-1R polypeptide was not enabled across its scope since the task of isolating a Type II receptor for use as an immunogen would have been an undue burden. Fortunately for Immunex, the PAB was also of the opinion that the antibody claims would be enabled if they were appropriately limited to Type I IL-1R polypeptides and invited Immunex to make the necessary amendments to limit the claims to an antibody that binds to a Type I receptor. CIPO typically rejects the submission of post-filing data to support that the description was enabling at the time of filing. However, the PAB in Immunex was willing to

accept that post-filing data may provide an indication that the description was enabling since the claimed monoclonal antibody was produced without requiring undue burden by following a protocol very similar to the one described in the application.6 Enablement can still be an issue in Canada when the claims are directed to humanized antibodies. Claims to humanized antibodies were rejected in a recent case with the PAB citing the lack of a working example. In addition, it found that merely providing access to a mouse antibody would not have enabled the skilled person to make a humanized antibody from it given the nascent state of antibody humanization technology as of that application’s 1990 filing date. However, an argument can be made that producing humanized antibodies from a given mouse antibody would not be an undue burden today given the wide-spread use of this particular antibody technology.

Written Description Subsequent to the Pasteur decision,10 CIPO would reject claims to a monoclonal antibody as lacking a sufficient description unless an

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Intellectual Property antibody had been prepared at the time of filing. In the 2009 amendment to MOPOP, CIPO did state that where a monoclonal antibody was not prepared, the applicant was required to provide an explicit description of the epitope to which the monoclonal antibody binds, for example, in terms of a binding pocket defined by specific noncontiguous amino acids.9 In Immunex, the PAB held that the novel Type I IL-1 receptor was adequately described by the provision of a DNA sequence encoding such a receptor.6 In these circumstances, an applicant need not possess a monoclonal antibody immunoreactive with the novel polypeptide at the time of filing in order to fulfill the written description requirements. A working example may still factor into whether the written description is sufficient in cases where the antigen is complex or where the antigen, although novel, may be cross-reactive because it possesses an epitope common to a known antigen. In addition, claims reciting therapeutic or diagnostic antibodies, or claims reciting antibodies with special attributes, would require correspondingly detailed support.6 The position of the PAB on these issues was arrived at with guidance from seminal decisions in the U.S. For example, in Centocor, the Federal Circuit held that “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-a with A2 specificity, can result in a claim that does not meet written description even if the human TNF-a protein is disclosed because antibodies with those properties have not been adequately described”.5 In Noelle v. Lederman,7 the same court held that an applicant may not claim an antibody that binds to a genus of polypeptides if only one species of the genus has been described. In that case, claims to a genus of CD40CR antibodies were not supported sufficiently by simply describing mouse CD40CR antigen. In another U.S. case, it was held that an applicant may not claim a broad family of antibodies if the antigen is complex or poorly-defined and where the specification “teaches nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies”.

Utility In Immunex, the issue of whether the claimed monoclonal antibodies had utility was also addressed. The PAB held that it would have been 8 BIOTECHNOLOGY FOCUS JUNE 2011

apparent that an anti-Type I IL-1 receptor monoclonal antibody would at least be useful in assays for immunopurification of IL-1 receptor polypeptides.6 However, if the patent promises a specific result, such as monoclonal antibodies with therapeutic benefits against a particular disease, then the invention must accomplish that result in order to demonstrate utility. Evidence as to demonstrated utility can be provided during court proceedings as opposed to in the patent itself. However, the disclosure must at minimum make reference to a study demonstrating utility.

Synopsis Patent protection for novel antibodies should be sought as soon as possible in order to preserve their full commercial potential. However, applicants must take care to ensure that claims to antibodies are well-supported in the application. While it is preferable to have a working example in hand before filing, applicants may now be able to claim antibodies directed to a novel polypeptide in Canada without having produced one, provided that the target polypeptide is welldefined, for example, by its full amino acid sequence. Where a working example is produced without undue experimentation after the filing date, it may be used to argue that the specification was enabling. Sufficiency of support for antibody claims would benefit from prophetic examples and detailed protocols, especially where the technique used is not well-established, for example, antibody humanization, or where routine procedures were modified. For the purpose of providing support, monoclonal antibodies should be characterized as much as possible (i.e. epitope mapping, functional properties) before filing, especially if they bind to complex antigens. If you wish to claim a therapeutic use for the antibody then some evidence of therapeutic utility should be provided. The Immunex decision certainly is helpful to innovators of novel antibodies and finally puts Canada in line with other countries.

References: 1. Antibodies represented over 30% of the biotechnology market in 2008; see https://www.leaddiscovery.co.uk/ reports/1494/Monoclonal_Antibody_ Therapeutics_20092024. 2. http://knol.google.com/k/krishan-maggon/top-ten-monoclonal-antibodies2010/3fy5eowy8suq3/143#. 2. J.M. Reichert, “Monoclonal Antibodies as Innovative Therapeutics”, Current Pharmaceutical Biotechnology, 2008, 9:423-430. 4. http://www.ic.gc.ca/eic/site/trm-crt. nsf/eng/rm00395.html. 5. Centocor Ortho Biotech, Inc. v. Abbott Labs, 2010-1144 (Fed. Cir. Feb. 23, 2011). 6. Re Immunex Corporation Patent Application No. 583,988 (2011) 89 C.P.R. (4th) 34. 7. Noelle v. Lederman, 69 U.S.P.Q. 2d 1508 (Fed. Cir. 2004). 8. Eli Lilly & Co. v. Human Genome Sciences Inc, [2008] EWHC 1903 (Pat), aff’d [2010] EWCA Civ 33. 9. Manual of Patent Office Practice [MOPOP], ch. 17, available at http://www.ic.gc.ca/ eic/site/cipointernet-internetopic.nsf/ eng/h_wr00720.html. 10. Re Institut Pasteur Application (1995), 76 C.P.R. (3d) 206. 11. Re Sloan-Kettering Institute for Cancer Research Patent Appn. No. 2,072,017 (2009) 82 C.P.R. (4th). 12. In re Alonso, 88 U.S.P.Q. 2d 1849 (Fed. Cir. 2008). 13. Novopharm Ltd. v. Pfizer Canada Inc. et al., 2010 FCA 242. Micheline Gravelle, M.Sc. (Immunology), is a partner with Bereskin & Parr LLP and head of the firm’s Biotechnology & Pharmaceutical practice group. She is also a registered Canadian and U.S. patent agent. Micheline can be reached in Toronto at 416-957-1682 or mgravelle@ bereskinparr.com. Sie Lung Tjew, M.Sc. (Microbiology & Immunology), J.D., is a Student-at-Law at Bereskin & Parr LLP. He can be reached in Toronto at slungtjew@bereskinparr.com.

For more Intellectual Property information visit our COMMERCIALIZATION Web Portal at www.bioscienceworld.ca

Ontario

A Spotlight on Innovation and Research in Ontario 10 12

Ontario and the Asia Opportunity

The Structural Genomics Consortium Baycrest: A Centre for Excellence in aging Ontario Stem Cell Initiative and the Centre for Commercialization of Regenerative Medicine

Ontario Institute for Cancer Research Commercialization Group

Q&A with Ministry of Research and Innovation Deputy Minister George Ross

14 18 22

24 26

The Ontario Brain Institute

The Ontario Network of Excellence

30 32 34

Ontario’s Genomics Revolution Life Sciences Ontario OBEST and Commercialization Success

By Kelly Connelly

Mission to Asia

China looks to Ontario’s Baycrest for best practices in seniors’ care

Ontario

he world’s most populous country has asked Ontario’s leading academic health sciences centre in the care of aging adults to help it develop a best practices care model for its rapidly aging population. With over 1.3 billion people, China is grappling with a demographic time bomb that other countries around the world are also facing. The number of Chinese 60 and older is projected to reach 200 million in the next few years. By 2025, one in five people who live in urban areas will be seniors. After surveying the different seniors’ healthcare models around the world, Chinese officials have landed on Ontario’s doorstep and begun discussions with Baycrest to explore how the Toronto-based facility can help China develop the first dedicated health system for seniors.

Biotechnology Focus / June 2011

“Baycrest is excited by this extraordinary opportunity to do business with China and share our leading edge knowledge and expertise in seniors’ care,” said Dr. William Reichman, Baycrest’s president and CEO. The Ontario Ministry of Research and Innovation’s BIO Asia mission paved the way for the Baycrest-Beijing discussions about opportunities to develop a seniors’ hospital. This November, Baycrest will cohost a landmark symposium in Beijing with the Chinese Enterprise Hospital Association to share Ontario best practices in seniors’ care with Chinese government officials, and leaders of healthcare organizations and associations in China. “Based on the success of our 2010 BIO Asia mission, Ontario has been work-

ing with Chinese organizations to build China’s first state of the art hospital for seniors,” said Minister of Research and Innovation Glen Murray. “China doesn’t yet have the advanced infrastructure required for geriatric care, and Ontario is leading the way; our expertise in healthcare policy, aging care delivery, and technologies will be the basis for productive partnerships in the coming decades.” Ontario and Beijing have each contributed $200,000 to fund a feasibility study for the development of a seniorsfocused facility. The building is already constructed in Beijing’s most populated district Chaoyang, which has 3.2 million permanent residents. Baycrest’s executive team leaders were in China in April to visit with health officials and tour the area. Chinese officials have also visited Baycrest.

OICR GROWS IDEAS. LET US SHARE THEM WITH YOU.

The Ontario Institute for Cancer Research is translating cancer-related discoveries into commercial opportunities. We foster dialogue between researchers, investors and industry to accelerate innovation. We seed and spin out companies. We bridge the gap between academia and industry. Our work is leading to better care for patients and greater opportunities for the healthcare industry. Benefits of OICR Partnership: • Collaborate with world class talent • Access next generation genomics, bioinformatics, a full range of drug discovery capability (medicinal chemistry, biology), high-throughput screening, imaging, pathology, and early stage clinical trials • Opportunities for low risk investments leveraging translational resources including high-quality tumour Reply Card #4905

specimens and centralized ethics (IRB/REB) review to facilitate multi-centre clinical trials • Join forces with an experienced commercialization team with a dedicated seed fund focused on advancing projects to important milestones. Pharmaceutical, biotechnology and medical device companies enter into novel, long-term R&D partnerships to continue growing our ideas. Can we share one with you? For more information contact: Dawn Richards, PhD Senior Business Development Officer Dawn.Richards@oicr.on.ca Or visit us at: www.oicr.on.ca/commercialization

Funding for the Ontario Institute for Cancer Research is provided by the Government of Ontario

Innovative Leader

Compiled by Shawn Lawrence and MRI

Q&A

with Ontario Ministry of Research and Innovation Deputy Minister George Ross Biotechnology Focus: What is Ontario’s focus this year at BIO and why?

George Ross

Ontario

As a lead up to BIO 2011, we had the chance to sit down with Ontario’s Deputy Minister of Research and Innovation George Ross for a little Q&A to discuss his Ministry’s polices and programs in the life sciences and biotechnology space; and what’s in store going forward.

Biotechnology Focus / June 2011

Deputy Minister George Ross: The focus this year is on “Innovations in Healthy Aging”. Across the globe, health policy advisors, healthcare providers and industry leaders are seeking novel solutions to meeting the significant challenges of a rapidly growing aging population. In Ontario, the number of seniors is expected to double over the next 20 years. By 2031 there will be nine million seniors aged 65 or older in Canada — accounting for 25 per cent of the total population. Ontario has a great head start in tackling the issues of greying populations around the world, while bringing economic prosperity to our province. Our government has made significant investments into agingrelated initiatives, including our support for the stem cell research at Mount Sinai Hospital, neuroscience work at the Ontario Brain Institute, cognitive expertise at the Centre for Brain Fitness at Baycrest. But, it’s also the hard work of folks like Dr. St George-Hyslop at U of T, who discovered the Alzheimer’s gene that is putting Ontario at the forefront in brain research and treatment. Institutions like MaRS and Baycrest who are global leaders in pushing innovation related to brain disease have partnered to create Cogniciti a company already helping an aging population stay mentally fit and sharp. Ontario’s plan is to leverage these strengths and build partnerships be-

tween industry and academic leaders to promote and commercialize technologies, innovative products/services and research initiatives to our advantage in the aging sector marketplace. So, we need to tell the world about all that we offer about our position as an international leader in aging-related technologies, goods and services to address the need for novel solutions to meeting the significant challenges of a rapidly aging population worldwide.

BF: Can you give a rundown of the current Ontario life science landscape? GR: Canada’s stable political and economic environment has allowed us to come through the global financial crisis in recent years ahead of our competitors. While we’re not immune to the challenges being faced by the global research-based pharmaceutical industry, we are well positioned to take advantage of emerging opportunities. Life sciences will be transformed in the coming decade as innovative researchers and companies solve some of the toughest challenges facing healthcare today. Ontario is very well positioned to address these challenges. For example, our long standing investments in basic research and commercialization means that Ontario has best-in-class infrastructure with which to compete. Our cost advantage also distinguishes us from our competitors in North America. Over 1 million square feet and over $1 billion in new research facilities have been built

Innovative Leader

BF: The Ministry can be complimented on a number of gestures and initiatives that have shown that it is listening to industry beginning with a proper commercialization strategy. In your view, one year later how can Ontario be graded in this respect? GR: I’m pleased to report that MRI, together with its stakeholders and transfer partners has made significant progress. Just before last year’s BIO in Chicago, we launched Ontario’s $161 million Life Sciences Commercialization Strategy to help ensure that even more cutting-edge biomedical technologies are discovered and commercialized in Ontario — and manufactured here for sale around the world. It includes a $7 million one-time support for early-stage Ontario biotech firms delivered through the Investment Accelerator Fund that was created to address the immediate financing challenges of our biotech sector, a $21.4 million investment in the Health Technology Exchange (HTX) to help strengthen Ontario’s medtech cluster by providing early stage company financing, and incentives for multinationals to strengthen

their business cases for anchoring global development mandates in Ontario. On January 26, 2011, HTX announced an agreement to establish GE’s first global Pathology Imaging Centre of Excellence in Toronto. This facility officially opened in MaRS on May 31st. Planned collaborative research and development (R&D) partnerships will bring an additional $7.2M, for a total investment of $17.2M over the next 3 years. Other announcements are expected in the coming weeks. Moreover, we introduced a new province-wide clinical trials framework to help maximize Ontario’s share of global clinical trials activity. In this regard we are committed to streamlining ethics review and administrative processes for multi-centre clinical trials. The investments we’re making to improve the business climate in Ontario are resulting in new investments by industry that continue to solidify Ontario’s leading position in Canada as the go to place for conducting clinical trials. Through the Ontario Research Fund, the province committed $114.6 million to genomics and gene-related research through the Global Leadership Round in Genomics and Life Sciences (GL2). This one-time round of funding is supporting 19 large-scale, collaborative projects that aim to discover new therapies and technologies that are improving quality of life, as well as protecting our environment and biodiversity. The Ontario Venture Capital Fund is being professionally managed by Northleaf Capital Partners and is strengthening the Ontario venture capital ecosystem through its investments and activities. With 20 investors qualified to co-invest with the Ontario Emerging Technologies Fund and 21 deals approved or conditionally approved, this fund is realizing its goal to move money quickly into growing companies. The fund has so far committed $34.8 million to this portfolio, and is executing plans to continue to invest in these portfolio companies through follow-on financing rounds and selectively invest in additional companies.

BF: MRI’s strategy stresses the importance of enabling public/ private partnerships or funding models in the creation of interesting projects and new businesses.

Can you comment or elaborate on some of these initiatives that are making this strategy a reality? GR: Ontario has established a number of funds that co-invest with the private sector into promising new firms. The $205M Ontario Venture Capital Fund is a joint initiative between the Government of Ontario ($90 million) and leading institutional investors ($115 million) to invest primarily in Ontario-based and Ontario-focused venture capital and growth equity funds that support innovative, high growth companies. The $250 million Ontario Emerging Technologies Fund co-invests with qualified venture capital funds and other private investors directly into companies. In September 2010, this fund co-invested in two life-sciences companies: it invested with CTI Life Sciences Fund in NeurAxon Therapeutics and with the Business Development Bank of Canada in Natrix Separations. The Investment Accelerator Fund, a seed-stage fund, just completed a $7 million round targeting investments in life sciences. In these tight economic times sharing risk and developing open collaborative platforms is vital to success. The nature of R&D is changing, the world needs solutions now and Ontario is at the forefront of innovation by pooling resources together. So we are encouraging public-private partnerships on the global level like that of Dr. Aled Edwards at the Structural Genomics Consortium which emphasises openness in innovation and is helping make Ontario a global leader by creating “new research paradigms” that put our best foot forward to collaborate with the world in driving innovation. At the same time, we’re focusing our efforts internally by pulling together our hubs of innovation (i.e. the province’s 14 Regional Innovation Centres) into the new Ontario Network of Excellence (ONE). These centres ensure that anyone with a good idea will have access to experts in their own backyard who can help them build a strong business and secure financing to grow their companies and create jobs. Our hope is the ONE network will help better connect innovators, entrepreneurs and investors from around the province and the world.

Biotechnology Focus / June 2011

Ontario

since 2005. We have six medical schools including the University of Toronto, one of the largest in North America. Our 44 universities and colleges produce more than 35,000 graduates a year in mathematics, engineering and sciences. Ontario has strengths in oncology, neurology, cardiology, imaging, diagnostics, stem cells, informatics and clinical trials. The Ontario Institute for Cancer Research, led by Dr. Tom Hudson, is an innovative and collaborative research institute that focuses efforts on the entire spectrum of cancer issues from prevention to treatment. Ontario is home to MaRS which is located in Toronto’s Discovery District. It is the gateway to Canada’s largest concentration of scientific research, anchored by major teaching hospitals (Sick Kids, University Health Network), the University of Toronto and more than two dozen affiliated research institutes such as: The Population Health Research Institute (Hamilton), Robarts Research Institute (London), Thunder Bay Regional Research Institute, and the Ottawa Hospital Research Institute.

SGC

By Christopher Rogers

The Science of Sharing Structural Genomics Consortium A public-private partnership that offers “OPEN ACCESS SHARING”

Ontario

Dr. Aled Edwards

The Structural Genomics Consortium (SGC), led by Dr. Aled Edwards, has been around since 2002, but the kind of partnerships it drives feels new, even by today’s standards. Based at the University of Toronto with partners at the University of Oxford in the U.K., the SGC is funded through the Ontario Government’s Ministry of Research Innovation and private biotechnology and pharmaceutical companies, but the results of the consortium’s research is open and freely available; there are no patents.

Biotechnology Focus / June 2011

At the SGC, academic and industry scientists are able to overcome their differences and work together to determine the three-dimensional structures of human proteins and provide other valuable reagents to unravel the complexities of human biology. Edwards explained that in the late 1990’s as the human genome was being sequenced, it was becoming quickly apparent that the value of that information would be far greater if it was freely available for everyone to use rather than patented and sequestered in a company. It was a new paradigm to be sure. Edwards said it was prescient because, although often one hears that it’s impossible to commercialize without protection, a recent study of thousands of genes, some patented and protected, and some not (http://www. nber.org/papers/w16213) showed that the genes that were not patented led to many more commercial products than did patented ones. Edwards takes a similar view of the proteins in the human genome. In 1998, Ontario supported the first research in this area in the labs of Edwards and Cheryl Arrowsmith. From this effort grew the SGC, which was formed to make human protein structures available without patents and without restrictions on use. The funding for the SGC comes from the Ontario government, Genome Canada and the CIHR, the research charity the Wellcome Trust, the Swedish government, and the pharmaceutical companies GlaxoSmithKline, Merck and Novartis.

“We now are responsible, just the SGC labs, for one third of the world’s activity in human protein structure determination,” Edwards said. The team that was originally slated to determine the structure for just over 350 proteins accomplished that goal in no time, instead completing 450. Over the last four years the team was tasked with completing an additional 660 proteins and they’ve accomplished that goal too. “We make our reputation on hitting our milestones,” Edwards said. “That’s one of the reasons industry likes to work with us.” Edwards praises the Ontario government for supporting the SGC. He said the reason for the praise is because of the SGC has an unusual funding model (partnering with private pharma) that requires government funders to be innovative. “This could not have happened in the United States”, Edwards said. Ontario along with the CIHR and Genome Canada have been leaders in pushing the consortium forward. For Edwards, Ontario and especially the city of Toronto was perfectly positioned to spur this kind of organization with international collaboration. He said the collaborative society and multicultural setting of the province really give it an advantage. The partnerships with private pharmaceutical companies have also helped. Edwards explained that each time the team has extended the consortium they’ve received double the amount of funding from pharma, in millions of

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Ontario

For Edwards, Ontario and especially the city of Toronto was perfectly positioned to spur this kind of organization with international collaboration. He said the collaborative society and multicultural setting of the province really give it an advantage.

dollars of cash. “There’s very few deals that large,” Edwards said. “Especially because these companies don’t own anything.” “They don’t get proprietary knowledge - this isn’t a deal where they’re buying knowledge to own it - this is a deal where they’re contributing to this open access effort in order that this information becomes free.” This is really a new way of business in the bioeconomy that is being carved out by Ontario, according to Edwards. “We’re forever trying to be like Boston or like San Francisco, and by the time you think you’ve caught up, they’ve moved ahead and you’re still playing catch-up,” he said. “The open access model is a true case for Ontario creating a new way of doing business - not just doing business - but a new model.” The business model of the consortium is innovative but so is the research. Through protein research, the SGC is driving recognition for many rare diseases.

“Because we’re open access and are not driven by commercial needs, we can follow the science where necessary,” said Edwards. “And, over the last seven years we’ve been probably working on 200 proteins linked to rare diseases.” The SGC is also working with organizations like the Canadian Gene Cure Foundation and others in the U.S. to help drive progress in these areas. “ We’re starting to work and interact with the associations that are interested with genetic diseases both in Canada and the United States - to use what we’ve done to create research tools that can enable the world to understand why and how these diseases work so we can get to a cure faster. Those discussions are just starting now and we’re really quite excited about them.” The innovation in the field of rare diseases is exciting because of the existing partnerships with pharma. Rare diseases pose an unfortunate problem for many commercially oriented companies: there are often not enough people

with the disease to make it profitable to create drugs or tools to combat the condition. “I think that companies are intrigued with the possibility of working on these proteins. Of course, many people in the companies are passionate about helping patients. But in many of these diseases you don’t really know how to help. So, the more knowledge you have about these diseases and the mechanisms through which they work, the greater the chances of finding a strategy to generate a cure. And, the pharmaceutical companies would be delighted to participate in that - I’m confident.” The SGC model is unique and through its efforts the team has also helped to found two companies: 1DegreeBio and Harbinger Biotechnology and Engineering Corporation. Edwards said the group is in the process of recruiting a world-leading CRO to set-up a research hub in Toronto. “And we see many other commercial opportunities…” he said. “I firmly believe that in early stage drug discovery there’s going to be more opportunities for commercialization out of these open projects - and that we should be leaders in exploiting that in Ontario. It’s a big opportunity for us to make an impact in the precompetitive world in which you get industry funding up-front to do your science and then you build businesses off the knowledge and skills, not off patents.” Edwards said they’re also discussing other pre-competitive collaboration projects in areas such as parasitology - aiming to drive global collaboration among basic scientists and pharmaceutical companies to reduce duplication of effort in the area (for diseases such as malaria and tuberculosis). The team is also replicating the model in epigenetics. Edwards said that ultimately he thinks the real paradigm shift would occur by moving the precompetitive boundary for novel science to proof-of-concept clinical trials.

Biotechnology Focus / June 2011

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By Kelly Connelly

Innovative Leader

Baycrest A centre of excellence for innovations in aging

Ontario

Dr. William Reichman

Headquartered on a 22-acre campus in Ontario and fully affiliated with the University of Toronto, Baycrest is the global leader in developing and providing innovations in aging and brain health. Baycrest is unique in the world, combining a comprehensive system of care for aging patients, one of the world’s top research institutes in cognitive neuroscience, dedicated centres focused on mitigating the impact of age-related illness and impairment, and unmatched global knowledge exchange and commercialization capacity.

Biotechnology Focus / June 2011

The world is bracing for an unprecedented demographic shift that will see the number of persons aged 60-andolder grow by over a billion in the next 40 years. Those in healthcare science and innovation, including Baycrest, see a tremendous opportunity to help public and private stakeholders find solutions to the challenges of an aging population. Baycrest is quickly becoming a leader in developing technology-based solutions. The sprawling 1.2 million squarefoot campus in Toronto is driving innovation through a bold new organizational structure that strongly encourages commercialization opportunities for its science and care innovations through business partnerships. “Baycrest is evolving into a dynamic entrepreneur-centric model for translating science into innovation,” said president and CEO Dr. William Reichman. Baycrest plans to launch a new company that will introduce a comprehensive and uniquely competitive portfolio of aging-oriented products, goods, consulting and development services to the international marketplace. Companies and countries are now turning to Baycrest to help develop products and system solutions for the aging population. The entrepreneurial spirit is evident throughout this world-class academic health sciences centre. Creative ideas for “next” care products are being nurtured by entrepreneurs-in-residence in the Innovation, Technology and Design Lab. It’s the place where researchers and healthcare experts, and other types of professionals such as engineers and anthropologists, work collaboratively with in-house entrepreneurs, as well as partners from industry, to turn great ideas into revenue-generating product solutions for the marketplace. “We are building our considerable strengths to develop innovations and next practices that will consolidate our international reputation and attract to

our doorstep more of the world’s top neuroscientists, geriatric medicine specialists, educators and global partners,” said Dr. Anthony Melman, chair of Baycrest’s Board of Directors. One of Baycrest’s greatest strengths is its world-renowned cognitive science institute, the Rotman Research Institute (RRI). An international review panel of highly-respected scientists has ranked Baycrest’s RRI among the top cognitive science programs in the world, which makes it a “wonderful resource” for targeted brain fitness product development efforts with both governmental and private investors.

‘Ontario hotspot’ “Baycrest has the great advantage of being located in Ontario, which is a recognized global hotspot for brain innovation,” said senior scientist Dr. Randy McIntosh, vice-president of Research at Baycrest and RRI director. To enable Baycrest to fast-track its cutting edge cognitive science into therapeutic commercial products, the Ontario Ministry of Research and Innovation provided $10 million in matched funding with private philanthropy in 2008 to create the Baycrest Centre for Brain Fitness (CBF). The CBF’s mandate is to commercialize evidence-based technologies and interventions aimed at early detection and prevention of aging-related memory decline, repair and rehabilitation of function. One of the diagnostic prototypes is INCAS, a computer tablet testing platform that helps clinicians conduct neurological assessments of patients. The tablet-based interface is convenient for clinicians and patients and allows for more accurate and timely assessment of cognitive function. More recently, Cogniciti – a for-profit startup founded by the Baycrest CBF and Toronto-based MaRS Innovation to commercialize Baycrest’s expertise in cognitive training solutions – is devel-

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Innovative Leader

oping the next generation of cognitive diagnostic tools. The tools will help clinicians diagnose and treat agingrelated brain disorders with a greater degree of precision; an advantage that is expected to lead to more effective, individualized treatment interventions for patients. Baycrest’s Centre for Integrative Brain Dynamics – guided by senior scientist and vice-president of Research Dr. Randy McIntosh – is leading a team of international scientists to build the world’s first, functional virtual brain (www.thevirtualbrain.org). The project is a collaboration with 15 distinguished neuroscientists in 10 sites on three continents. The computerized model will deliver the first real, usable and open simulation of the human brain. For researchers, surgeons, neuroscientists and therapists, the virtual brain promises improved patient outcomes by letting clinicians simulate cognitive interventions – right from a Web browser. A world-class computing and neuroinformatics infrastructure enables Baycrest to take on these types of mammoth projects and create multi-institutional collaborations in local, national and international neuroinformatics projects – focused on the normal aging brain and the diagnosis and treatment of brain disorders. Scientist Dr. Stephen Strother is leading the neuroinformatics program by developing more effective ways to integrate and analyze neuroimages and related brain and clinical data. The Stroke Patient Research Recovery Database (SPReD), created at Baycrest under the auspices of the multi-institution Heart and Stroke Foundation Centre for Stroke Recovery, provides clinicians and researchers with comprehensive data sets, processing tools and predictive algorithms to help them learn more about the clinical and biological determinants of recovery from stroke. In the neuro education field, Dr. Sylvain Moreno, the lead scientist at the Baycrest CBF, is developing a virtual game product to improve intelligence, memory, decision-making, reaction time, attention and language skills. Future spinoffs may include gamebased cognitive training for adults and

Biotechnology Focus / June 2011

“Baycrest is evolving into a dynamic entrepreneur-centric model for translating science into innovation.” — Dr. William Reichman, president and CEO, Baycrest

possibly inter-generational cognitive training games to enable grandparents and grandchildren to participate in interactive games together.

Memory Link Innovative memory assistive devices are being developed and tested at Baycrest to help adults with a range of memory disorders. Baycrest’s Memory Link program is a powerful demonstration of how cutting edge brain science, in tandem with the latest handheld technologies, such as smartphones, can restore independence and confidence for adults with mild to severe memory impairment. Canada’s largest children’s rehabilitation hospital, Holland Bloorview Kids Rehabilitation, is currently adapting Baycrest’s Memory Link training protocols for teen clients with memory loss. The health sciences centre is also leading the first healthcare sector use of Cloud Services. It has partnered with Microsoft Canada and consulting company Orangutech to create a web-based environment for healthcare organizations to conveniently share electronic

documents, supported by the next version of cloud-based software. Known as eHealth2Share, it will serve as an online hub for healthcare electronic forms and workflow templates, best practices in patient care, clinical user groups, eLearning, international expert collaboration and shareware applications such as a Freedom of Information tracking system. To support Ontario’s Aging at Home Strategy, Baycrest has developed and scientifically evaluated an innovative online intervention / support program for caregivers in the community who are looking after loved ones with dementia. The website program replicates a face-to-face support group using video conferencing. In addition, it provides educational resources and information, a chat forum and e-mail link for group members and a healthcare professional. It’s an evidence-based intervention that yields the same positive outcomes as face-to-face support groups. The centre is now in the process of generating licensing agreement so that health service providers can adopt the program.

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OSCI and CCRM

By Shawn Lawrence

OSCI and CCRM:

ensuring Ontario’s regenerative medicine legacy lives on

Michael May

Ontario

It’s hard to believe it’s been 50 years since Drs. Ernest McCulloch and James Till of the University of Toronto and the Ontario Cancer Institute, first discovered stem cells. But Ontario can take credit for being a lot more than just the birthplace of stem cell research.

Ontario researchers have played a role in many other regenerative medicine breakthroughs from Dr. John Dick and his discovery of the first cancer stem cell, to Dr. Gordon Keller who was able to generate three types of heart progenitor cells from embryonic stem cells; or Dr. Andras Nagy for his discovery of a new non-viral method of creating stem cells from other cells of the body. When it comes to stem cell research and regenerative medicine, make no mistake, Ontario is a world leader. Much of Ontario’s success in regenerative medicine can be credited to its tightly knit regenerative medicine community. Every new discovery has forged an even tighter bond, encouraging collaboration and most importantly, the creation of a united front in the form of the Ontario Stem Cell Initiative (OSCI). “OSCI is about forming linkages and building on a collaborative environment in which we can make new research happen, bring new resources to the table to enable the translation of new treatments for disease,” explains OSCI director Janet Rossant. According to Rossant OSCI has three main goals: to promote better science by collaboration, promote international collaboration and to develop an economic base for regenerative medicine in Ontario “There is no question that stem cell Biotechnology Focus / June 2011

research and regenerative medicine are one of the frontiers of science. There’s huge potential for us to harness stem cells, whether they’re embryonic stem cells, induced pluripotent stem cells or adult stem cells. The ability to harness them to study disease, to understand disease better and to develop new drugs to treat disease will change the way we offer treatment to patients in the future. OSCI allows us to focus on this exciting new frontier in a more focused way. It allows the group better access to provincial funds and ensures that we’re working together, rather than against one another,” said Rossant The first step to forming OSCI was the establishment of The Ontario Human Induced pluripotent Stem (iPS) Cell Facility. Backed by seed funding from the Ontario Ministry of Research and Innovation, the facility is positioning Ontario at the cutting edge of the new technologies and applications in induced pluripotent stem cells. Momentum continued to build and today OSCI is a virtual network of over 60 stem cell scientists across multiple institutions in Ontario including the McEwen Centre for Regenerative Medicine at the University Health Network, The Centre for Stem Cells and Tissue Engineering at Mount Sinai Hospital, The Hospital for Sick Children Research Institute in Toronto, The Sprott Centre for Stem Cell Research in Ottawa, the Advanced Regenerative Tissue Engineering Centre, the McMaster Stem Cell and Cancer Research Institute in Hamilton, the University of Toronto and the University of Western Ontario. With the ability to collaborate and talk to each other, Rossant says OSCI has been able to avoid redundancy in research, but more importantly, the group has been able to build mega programs out of its research. “OSCI has allowed us to take things to a whole new level. Two examples of great projects facilitated through Ontario government financial support (Ontario Research Fund Global Leadership Program) and OSCI research collaboration include one led by Dr. Andras Nagy generating pluripotent stem cells and the other led by Dr. Mick Bhatia screening stem cells for molecules that can promote formation of

differentiated cells. Both of these projects have produced significant findings that likely wouldn’t have been possible without OSCI,” she said. In addition to facilitating innovative collaborative projects, new research funding has allowed the province to recruit researchers, international students, and post docs from abroad to its centres. “There are young scientists joining research institutes in London, Hamilton, Ottawa and in Toronto,” says Rossant. With the formation of OSCI, the whole has become greater than the sum of its parts.

CCRM: A new chapter in Ontario’s Stem Cell Story As mentioned, developing an economic base for regenerative medicine is one of the main goals of OSCI. So, if OSCI is about bringing Ontario’s regenerative medicine community together, then the Centre for Commercialization of Regenerative Medicine (CCRM) is about capitalizing on this collaborative success in the commercialization arena. It’s no secret that most of the intellectual property that comes out of academic institutions is often very early stage. CCRM has been created to prevent the premature creation of companies and licensing of technologies, and to take that IP and advance it through the product development stage in a capital efficient way. “Particularly, CCRM will work towards filling gaps in the pipeline from discovery to application and to provide the tools and targets to fill those gaps. CCRM recognizes the importance of large scale clinical trials with stem cells, but is focusing on enabling technologies that will allow stem cell research to really impact on disease therapies,” explains Rossant. In turn, the companies that traditionally steered clear are now finally realizing regenerative medicine is an extremely important area to invest. “Biopharma stands to benefit from the efforts of CCRM and advancements in the regenerative medicine. For example, our ability to make stem cells and specialized cell types from patients with many different forms of disease and grow those in petri dishes and grow those in large numbers allows us new tools to screen

OSCI and CCRM start new companies or to be licensed to existing companies. The end goal of CCRM is to create a critical mass of resources for company creation and product development, or an environment where the regenerative medicine industry can germinate, while at the same time supporting the entrepreneurial activities of researchers. “Through CCRM, we are building a network of receptors for their IP or for the companies that are created from their IP

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that will situate themselves in Canada. In some cases the IP will just go to one of our consortia partners because they’ve helped pay for it, they’re supportive and they need that technology. In other cases we’ll build companies around that IP with the idea that these companies will be viable in Canada. Ultimately, through CCRM’s efforts, we will bring entrepreneurs and young scientists to Ontario and over the long term, money, investment and capital back to the regenerative medicine community,” states May.

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Ontario

for new treatments, new diagnostics, new prognostics and new drugs to treat different diseases,” said Rossant. CCRM chief science officer Peter Zandstra explains that CCRM will concentrate its efforts on foundational bottlenecks. One example he gives is developing better ways to grow cells in large scale and more efficiently. “There are different resources that the community needs to accelerate translation, whether this is resources for characterizing cells, resources for producing those cells, or sources of disease specific models for high throughput drug development, these are just some of things we’ll be targeting,” he said. As such, CCRM will focus its effort on three platforms to start. Firstly around reprogramming and creating a library of patient and disease specific cell lines, secondly around cell manufacturing with an aim to produce clinical and commercial quantities of differentiated cells and thirdly biomaterials and tissue mimetics. According to CCRM CEO Michael May, what sets CCRM apart from other commercialization groups is that it provides resources (Ontario’s reputed stem cell community and generous funding), facilities (both academic and institutional), expertise (business and product development professionals) and a consortium of private companies or members ready to be receptors for new technologies produced through CCRM efforts. “There are few jurisdictions in the world that combine our expertise in stem cell biology, bioengineering and biomaterials. We think this is a unique translational model that leverages our academic facilities and resources. But those of us who have tried to move technology forward understand that technology push which we’re so comfortable with in academia, needs to be balanced by market pull. So we’ve built an industry consortium of 15 to 20 companies that are ready receptors for the Intellectual Property (IP) we’re moving forward. They can inform our decisions on where to focus,” he said. He adds that these companies are large and small, domestic and international, and they represent all aspects of the regenerative medicine industry. In terms of expertise and business leadership, CCRM’s board of advisors is heavily focused and dominated by seasoned industry veterans in regenerative medicine. They understand how IP might be packaged and positioned to

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Biotechnology Focus / June 2011

OICR

By Shawn Lawrence

Realizing the Commercial Potential of

Ontario’s Cancer Research

Frank Stonebanks

Ontario

The month of May was significant for Canada’s Ontario Institute for Cancer Research (OICR) as the organization announced investments in three new Ontario companies, TORCell Therapeutics, DLVR Therapeutics and Harmonic Medical. The launch of three new companies to market oncology technologies demonstrates the scope of OICR’s commercialization activity and the breadth of cancer research talent in Ontario.

Launched in 2005 by the Government of Ontario, OICR is an independent, notfor-profit organization that is taking on significant challenges in cancer research with multi-disciplinary, multi-institutional teams to tackle the incidence, diagnosis, management, and morbidity and mortality of cancer. OICR has invested significantly in translational research that will move new discoveries in prevention, detection and treatment of cancer directly from the bench to practical applications in patients.

Biotechnology Focus / June 2011

OICR has attracted more than $115 million of direct support for its innovation programs through partnerships with the Terry Fox Research Institute and five federal agencies. It has also helped generate more than $500 million in cancer research investment by international consortia partners. The Institute supports more than 1,400 investigators, clinician scientists, research staff and trainees located at its headquarters and in research institutes and academia across the Province of Ontario. It has key research efforts underway in small molecules, biologics, stem cells, imaging, genomics, informatics and bio-computing, from early stage research to Phase I clinical trials. But that is only half the story. At its inception, OICR created its own Commercialization Program and through its efforts, OICR has quickly established a reputation as a leader in the R&D commercialization domain. Heading up OICR’s commercialization arm is Frank Stonebanks. As chief commercialization officer, he oversees the Institute’s commercialization strategy, including management of its investment fund, the Intellectual Property Development and Commercialization Fund, and identification and development opportunities to collaborate with private equity and corporate strategic investors in oncology. He is charged with the task of not only maximizing the commercial potential of OICR’s extensive intellectual property (IP) pipeline, but also developing novel business models to bring this IP to market. “We serve anyone working in cancer in Ontario, in both the research and translational R&D area. This includes scientists doing discovery, Phase 1 and 2 clinical trials, or anyone who has compelling ideas and or intellectual property that can be converted into a

value proposition. It’s really about using novel business models to accelerate transformative early stage research and to support the most promising new approaches to fighting cancer by strategically investing in the very best technologies arising from Ontario’s outstanding research base,” says Stonebanks. Among these novel business models is an approach that Stonebanks says aligns public-private funding in creative ways where private capital can be invested alongside public capital to advance promising projects in the pipeline. In this way, the OICR Commercialization group is working to overcome a common bottleneck in the commercialization of innovative technologies, which is the scarcity of funding to support early stage applied research and development. The Intellectual Property Development and Commercialization Fund provides seed funding for late stage academic projects that meet specific market-oriented criteria. The Fund is unique in that it encourages partnership, but is also tailored to reduce risk and cost. It is intended to support cancer-related early-stage commercialization activities including: proof-of-concept, validation, standard operating procedures, market analysis, IP protection and acquisition. Just as important, it encourages collaboration between the public and private sectors. “Our vision for the Fund is the creation of a model of commercialization that is founded on collaborative working relationships among institutions, investigators, commercial partners and investors,” says Stonebanks, while adding that what the Fund encourages goes beyond just offering local researchers the chance to translate their research towards something commercializable. Specifically, the Fund enables and en-

OICR courages public-private partnerships. This could mean having the researcher(s) work directly with industry, spinning out a company or, alternatively, work with a private partner by in-licensing commercially viable IP from academic institutions in Ontario. Benefits of the IPDC seed funds accrue to partners on the public and private sides. “The technology gets funded, de-risked and the participating entrepreneurs gain access to OICR’s global commercialization team and its resources. At the same time, pharmaceutical, medical device and biotechnology firms looking to reduce their investment risk benefit through this innovative public/private partnership by having the chance to leverage investment alongside public dollars.” The IPDC seed fund has invested in more than 16 projects in just two and a half years, has lead to a major financing with two U.S.- based venture capital investors and eight of the projects have been spun out into companies including the three mentioned above. At the heart of this model is the com-

mercialization group team, the Institute’s in-house staff of experts and business executives who provide exceptional guidance and oversight to the commercial development of each project and in how to achieve the business of translating research discoveries into marketable products. These individuals or executives-inresidence provide valuable advice and assistance through our Entrepreneur in Residence program. “All you have to do is look at the people involved in the Fund, and their track record of success. We have a team that really know what they’re doing both at the micro and macro level. The team members have a lot of experience in structuring deal flow and management. They’ve built companies, done investments, been involved in companies small and large. They’ve been there and done that across the board,” explains Stonebanks. For these reasons, Stonebanks feels OICR’s commercialization group is perfectly positioned to provide a local solution to a global issue, translating great ideas into commercializable products. The environment that industry and the

financial community find themselves in today is a setting where risk investment has disappeared. The recent recession caused venture capitalists, other investors and industry to become even more risk adverse, accelerating a trend that was underway. What has been a challenge for industry however has become an opportunity for organizations like OICR. “Forward thinking translation-focused institutes like OICR that specialize in oncology, with an emphasis on commercialization, can fill a very big gap right now,” says Stonebanks adding that “somebody has to be willing to take the risks others don’t, and that’s where we enter the picture.” “What we’re offering is a shared model, where they (industry and the investor community) contribute capital along with public funds and receive options and advantages they would not otherwise have in return. By co-investing with OICR, external participants will gain access to cutting-edge oncology platforms, scientists and products emerging from Ontario universities and hospital-based research institutes.”

Every scientist in the world dreams of a “Eureka!” moment. McMaster’s Mick Bhatia had just that, when he and his team of researchers made a critical and life changing breakthrough: discovering how to make blood from human skin. Bhatia is the Canada Research Chair in Human Stem Cell Biology and director of McMaster’s Stem Cell and Cancer Research Institute in the Michael G. DeGroote School of Medicine. His discovery means that, in the foreseeable future, people needing blood for surgery, cancer treatment or treatment of other blood conditions like anemia will be able to have a patch of their own skin create blood for transfusions. It’s an amazing discovery with incredible possibilities. To learn more visit sccri.mcmaster.ca

Ontario

Inspiration to innovation

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Biotechnology Focus / June 2011

The Ontario Brain Institute

By Shawn Lawrence

The Ontario Brain Institute: A Nexus for Brain Disease Research

Dr. Donald Stuss

Ontario

Unlocking the mysteries of puzzling brain diseases such as Alzheimer’s, Parkinson’s, autism and schizophrenia has become a pressing need in the global community both economically and socially.

In Canada alone, one in four individuals will suffer from a brain disease in their lifetime and three times as many years will be lost to death and disability from brain diseases as those lost to either cancer or heart disease. While in Ontario, the economic impact of brain disease is estimated to be $39 billion annually as nearly one million Ontarians live with neurological disorders. The numbers tell a sobering tale. Recognizing the challenges inherent in these frightening trends, the government of Ontario through its Ministry of Research and Innovation committed $15 million to launch an Ontario Brain Institute (OBI) with an early emphasis on a joint initiative with Israel. The institute was to be a virtual research centre focused on improving patient outcomes in neurodevelopmental disorders (the growing brain) and neurodegenerative diseases (the aging brain). Almost half a year later, the OBI is solidifying its reputation as a nexus for collaborative efforts, with programs focused on bringing together Ontario’s leading scientists and clinicians drawn from the province’s universities, colleges, and hospitals together. And according to OBI president and scientific Biotechnology Focus / June 2011

director Dr. Donald Stuss, the timing for this initiative, and its location in Ontario couldn’t be any better. “The brain is the defining feature of humanity and there is no greater need than to minimize the effects of brain dysfunction, and maximize healthy brain abilities. Recent advances are allowing scientists for the first time to study all aspects of brain function, making possible fundamental insights into both healthy and diseased brains. Taken together, the time is right for a major new initiative in brain research and Ontario has the knowledge base, excellent scientists and experienced clinicians to lead this initiative.” According to Dr. Stuss, Ontario’s advantage is that it already has many of the intellectual assets in neuroscience that other countries seek. For example, Ontario-based clinical investigators and basic scientists are among the world’s leaders in research for Alzheimer’s disease, deep brain stimulation, brain imaging, computational and cognitive neuroscience, neurophysiology, and medical devices to aid patients with diseases of the nervous system. Dr. Stuss adds the province is also internationally competitive in genetics, molecular neuroscience; in the creation of simple model systems of brain disease; and in the study and prevention of stroke. “Canada is third to fifth in benchmarking indices in this field, and Ontario is the leader in Canada. So, having the heart of an international institute like this in Ontario just makes sense,” he said. The OBI model is the catalytic hub at the centre of a constellation of projects, explained Dr. Stuss. In its current role, OBI provides funding, fosters collaboration and facilitates industry engagement. In addition to linking the leading minds in Ontario’s 12 existing brain research centres, the Institute strives to operate on a global stage. “The idea is to foster research collaborations across institutions and disciplines and among basic and clinical scientists while including industry as a full partner not just domestically

but globally.” Additionally, OBI is backed by a Science Advisory Council (SAC) that will advise on the most relevant and pressing questions, monitor to ensure international competitiveness, suggest international inter-relationships and review achievement of milestones. Members are internationally recognized scientific leaders in a carefully selected spectrum of disciplines relevant to the goals of the OBI, drawn from the world’s major universities. “There is an increasing recognition that major breakthroughs in brain research will require collaborative efforts, for a true understanding of the brain will arise not from one discipline alone, but rather through experts from multiple disciplines working together. Having these international leaders on the Science Advisory Council (SAC) will bring to OBI a state-of-the-art knowledge about the science and initiatives around the world, and the successes and failures experienced by others. The OBI’s Science Advisory Council is a model that facilitates this international collaboration and breaks down silos, ensuring ever-greater gains in knowledge and clinical applications,” Dr. Stuss stated.

OBI commercialization model In addition to establishing integrated research projects around brain disease, OBI is also developing a model of commercialization by including industry in very early stages of discovery, creating an opportunity for scientists to focus on research and industry to be involved early enough in the process to discover potential products. An Industry Advisory Council (IAC) has been developed to provide valuable insight to commercialization pathways and realities associated with academic research. According to Dr. Stuss, the large multinationals the OBI has engaged to have representation on its Industry Advisory Council (IAC) include Pfizer, GSK, IBM, Medtronic with strong interest from Eli Lilly, Valeant (Biovail), Siemens and GE Healthcare. The OBI also has representation from SMEs such

The Ontario Brain Institute as Neuraxon, BKIN Technologies and HTx. The terms of reference for the IAC emphasize a committee responsibility that focuses on the goals of OBI, clearly extending beyond interests of members’ own companies. The OBI, with the assistance of the IAC, will also engage industry through company participation in its workshops that will determine the first OBI-funded projects and also, through its affiliation with the upcoming Ontario-Israel Roundtable that encourages global company-to-company partnerships. “This is a good example of the catalyst role the OBI can play. The OBI will not develop its own patents and licensing nor will it decide what to commercialize. The early involvement of industry in our model provides this opportunity directly to industry, minimizing several layers of engagement. The objective is to develop several levels of neuroscience industry, from SMEs to large multi-nationals, with job creation as a major objective. To ensure maximum science/industry collaboration, the chairs of each council will serve ex-officio on the other council.

focus on neurodegenerative or neurodevelopmental disorders,” he said. The OBI Board of directors, with advice from the Science Advisory Council and the Industry Advisory Council, will use these criteria to choose the initial Integrated Discovery System proposals based on the ideas put forward by Ontario’s brain science community. “The process has been bottom-up, with ideas suggested by the scientists doing the research on relevant brain

disorders. We have also involved discussion and consultation with patients and families with significant brain disorders through the neurological and mental health charities. Thus far we have received 32 proposals. In all, it is expected that 2-3 projects will be approved for funding. These are the initial steps in the development of OBI, working within the budget provided. In later years, other types of brain disorders will be included,” said Dr. Stuss.

project Determination

Ontario

In February and March 2011, Dr. Stuss met with more than 250 brain researchers in universities and hospitals across Ontario and was impressed to learn of the excellent and exciting research taking place. Following those meetings, OBI began the process of developing initial strategic research projects according to the following principles: Enhance Ontario’s excellence in brain research, especially in areas of strategic importance and impact; integrate across disciplines and institutions; address significant neurodegenerative and neurodevelopmental brain conditions; focus on clinical translation to improve diagnosis and treatment; and interface seamlessly with industry. OBI has since issued a call for proposals for planned workshops to determine which projects will receive precedence. The goal explained Dr. Stuss, is to shape a potential integrated research project on each workshop’s particular theme. “Preferred projects would have to maximize scientific, health and economic returns, represent the best science from across Ontario, maximize use of existing assets (scientific platforms, expertise), integrate research with clinical practice and industry receptors and

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Biotechnology Focus / June 2011

the Ontario network of excellence

the OntariO netwOrk OF eXCellenCe (One) Regional Innovation Centre — Ottawa & Eastern Ontario at OCRI the regional innovation centre at ocri (ric) was launched in november 2010. With a focus on ottawa and eastern ontario, the regional innovation centre provides a “one-stop shop” for clients to access all available commercialization programs and services in the region, regardless of sector. the ric, along with its partners, focuses on accelerating emerging knowledge based companies, assisting with innovation processes, nurturing the partnerships that support commercialization and connecting its clients with information, advice and funding opportunities to help them grow. the ric also helps drive investment into start up and growing companies across knowledge based industries by working to strategically expand the investment network. it strives to enhance the network of angel and other investors to foster coinvestment and larger syndication into high potential companies in the region. the ric also provides its clients with an access point into the larger ontario network of excellence. Here, companies have access to best practices from around the world, programs linking them to researchers and successful entrepreneurs, and assistance in accessing the funding and advice they need to take their ideas to market.

Website: http://investment.ocri.ca

OntariO

Elorin-Kingston

eLorin promotes the continued growth and prosperity of eastern ontario, in the region that includes the cities of Kingston, belleville and Quinte West as well as four counties: frontenac, Lennox & addington, Hastings and prince edward county. We work with multiple partners to foster a supportive innovative and entrepreneurial environment for start-ups, sMes and large businesses. several of our current clients are life science, biotechnology and medical device companies. With a primary focus to create a sustainable ecosystem developed through entrepreneurship and innovation, eLorin leverages: the expertise of its board of Directors; a strong regional nucleus of Universities and colleges; research hospitals; publicly traded member companies; and small & medium enterprises (sMes). We are a catalyst that engages the region’s business “captains” to work together. the eLorin region in eastern ontario boasts a diverse ecosystem that offers exciting opportunities in both rural communities and urban areas. eLorin also fulfills a visible advocacy role through the provincial Ministry of research and innovation’s (Mri) regional innovation centre (ric) mandate; and through the new ontario

network of excellence (one); we have many partners within the one network, increasing the strength of the programs and services that we can make available to our clients.

Website: www.elorin.info

Innovation Factory (iF), Hamilton innovation factory (if) is a not-for-profit regional innovation centre (ric), located in Hamilton, ontario and networked across north america, committed to building the province’s innovation community and helping entrepreneurs bring their new and innovative ideas to marketplace. funded by the ontario network of excellence (one), we are focused on strengthening the next generation of wealth and job generators. if connects and enables active collaboration between the communities of science, business, government, academia and finance to accelerate the innovation process and amplify the economic and social impact of important new ideas and discoveries. Whether a small start-up company located in a garage or a multinational company that has been a part of the fabric of Hamilton or the surrounding area for a century, innovation factory can help bring innovations to life. While most of our clients currently occupy the information technology and software industries, if also works with innovators in a range of sectors, including, but not limited to: advanced Manufacturing, advanced Materials and engineering, cleantech, communications and entertainment, Life sciences and Health care,and social innovations. offering a variety of programming and services, from multiple networking events each month, to placing executives-in-residence with our high potential clients, we provide a comprehensive range of supporting activities for entrepreneurs. our experienced advisors guide our clients every step of the way. at innovation factory, our mission is to create a relevant and impactful community of innovation that mobilizes a broad array of Hamiltonians to help innovative businesses in this region start, grow and succeed.

Website: www.innovationfactory.ca

Research Innovation Commercialization Centre (RIC)-Mississauga the ric centre links to the largest network of life sciences industry stakeholders in ontario. While ricc’s network extends across ontario, we cater to businesses and entrepreneurs in the peel region, which includes the cities of brampton, Missis-

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Genomics

By Dr. Mark Poznansky

In the midst of the Genomics Revolution

Ontario

We are in the midst of a revolution in Genomics: a revolution that will rival the major changes that occurred with the advent of the steam engine and the automobile and the incredible changes in communications represented by information technologies.

Reality check: Is that just fanciful thinking? Is it perhaps wishful thinking? Or is the sentiment real? Let’s start with some facts. A recent Batelle Institute report (published May 2011) stated that the Human Genome Project, which cost the American Taxpayer some $3.8 billion, has now resulted in over 300,000 jobs and a direct return on investment of almost $800 billion. Who says that you can’t make money in Biotech! There is an argument to be made that in fact we have only begun to scratch the surface of the Genomics Revolution. Coming back from the Davos World Economic Conference in 1998, then Financial Post Editor Diane Francis reporting on a presentation made by the president of Dupont, stated Biotechnology (read Genomics) will change the world as we know it: a) It will change the way we understand and treat many diseases such as cancer, Alzheimer’s and Diabetes; b) It will change the way we feed the world as we produce crops that are cheaper to grow and healthier to eat; c) It will teach us about the environment and allow us to live in a more harmonious fashion with our environment; And each of these predictions are coming to pass. The Genomics Revolution has resulted in untold discoveries pointing to the genomic and molecular basis of disease. We now have incredible insight into many of the most devastating diseases known to man including a number of different cancers, diabetes, Alzheimer’s and heart disease, and we’ve made huge strides in conquering an important number of infectious diseases such as HIV/AIDS. The future will hopefully see the realization of personalized medicine – the right medication at the right dose for the individual patient. The Genomics Revolution has already changed our food supply in ways that few of us are aware. Over 80 per cent of the world’s supply of corn, soy, canola and cotton have been genetically modified to produce strains that are pest and/or pesticide resis-

Biotechnology Focus / June 2011

tant allowing for greater yields, and therefore keeping prices down. The enzyme pathway to produce Vitamin A has been introduced into the rice genome, which is already resulting in a significant drop in infant blindness in parts of the developing world. The Genomics Revolution is now starting to address one of the earth’s most diverse and interesting life forms. Over 85 per cent of the earth’s Biomass is made up of microbes that populate and control the environment of every corner of the earth including the deepest levels of the sea. For example, it is startling to note that there are 10x more microbes in our bodies than there are human cells. It is also clear that microbes have evolved over billions of years to function as “protectors of the environment”. Much work is being done to understand Microbial Genomics and determine how we might use these microbes to help clean up the messes that we have introduced into the environment. The oil sands, pollutants from mining and from burning dirty fuels are good examples. The Ontario Genomics Institute (OGI) in partnership with Genome Canada and the Ontario Ministry of Research and Innovation, works to support Ontario’s world-renowned researchers in obtaining funding critical to their work and vital to enabling discoveries that bring immense benefits. We also work to assist in the commercialization of discoveries through our business development activities, and we also work to raise general awareness of genomics research, its importance and potential through educational outreach activities and public events. Life changing research is already taking place in Ontario. Here are just a few examples: • Dr. Tom Hudson is a leading cancer researcher recognized internationally for his work on the International HapMap Project, an effort to catalogue human genetic variation. In 2006, he became the founding President and Scientific Director of the Toronto-based Ontario Institute for Cancer Research (OICR), which is dedicated to research in prevention, early detection, diagnoses and treatment of cancer. Since OICR was founded, it has launched several large-scale programs including the One Millimetre Cancer Challenge, the Cancer Stem Cell Program, the Pancreatic Cancer Genome Project, the Terry Fox Research Institute/OICR Selective Therapies Program and the High Impact Clinical Trials Program. Dr. Hudson’s laboratory at OICR is involved in the study of genome variation that affects cancer predisposition, progression, and response to therapy. His main project focuses on the genetic architecture of loci associated with risk to colorectal cancer.

Genomics knowledge necessary to be able to improve the nitrogen use efficiency of crop plants.

• Dr. Aled Edwards is a structural biologist and director and CEO of the Structural Genomics Consortium (SGC), an open access public-private partnership that identifies new targets for drug discovery and places all the information into the public domain without restriction on use. The SGC determines the 3D structures of human proteins of therapeutical relevance to diseases such as cancer, diabetes, and many other disorders. To date, over 1200 structures have been determined and four Ontario-based companies and one long-term project has spun-out of this research, providing 867 SME jobs over the last decade – another example of how genomics is helping create new jobs and money for the province. • Dr. Elizabeth Edwards is a professor in the Department of Cell and Systems Biology at the University of Toronto. Her research focuses on developing an understanding of how biological processes affect the fate of pollutants in the environment. She is currently heading up a project funded through Genome Canada, OGI and the province of Ontario that is sequencing and analyzing the genomes of many organisms to identify proteins with the potential to act as catalysts to transform wastes into useful bioproducts such as biofuel. Previous to this project and along with private sector partner Geosyntec Consultants, she developed a microbial culture that cleans up contaminated groundwater sites and that is sold world-wide. • Dr. Steven Rothstein, professor at the University of Guelph, uses molecular genetics, biochemical and genomic information to understand problems in plant biology, which impact on the improvement of important crop plants. He has been involved in discovering new ways to get higher yields from Ontario corn, and more generally has worked towards uncovering ways to make crops resistant to environmental stresses like weather extremes. He is also looking at the economic and environmental cost of using large quantities of nitrogen fertilizer, specifically understanding the regulation of nitrogen metabolism with the long-term goal of generating the basic

Dr. Mark Poznansky is President and CEO, Ontario Genomics Institute

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I N T E L L E C T UA L P RO P E RT Y I N S T I T U T E O F C A N A DA I N S T I T U T D E L A P RO P R I É T É I N T E L L E C T U E L L E

C A N A DA

Ontario

• Dr. Steve Scherer is a senior scientist at The Hospital for Sick Children (SickKids), director of The Centre for Applied Genomics (TCAG) at SickKids, Director at the McLaughlin Centre for Molecular Medicine, University of Toronto, and professor of Medicine, University of Toronto. He is best known for his contributions to discovering the phenomena of global copy number variation (CNVs) of DNA and genes as the most abundant type of genetic variation in the human genome. With his group at SickKids and TCAG, he has discovered numerous disease susceptibility genes, including defining CNV and other genetic factors underlying autism.

• Dr. Paul Hebert, scientific director of the International Barcode of Life (iBOL) project at the Biodiversity Institute of Ontario, University of Guelph, is leading the iBOL project, currently the largest biodiversity project in existence. iBOL which unites researchers and biodiversity organizations from more than 27 countries, is working towards cataloging the world’s biodiversity by building a DNA barcode database containing DNA barcodes of more than 500,000 species. In addition to its importance in biodiversity, this work will greatly help: identify disease vectors; sift out marketplace fraud, such as mislabeling of foods; test animal feed purity; monitor climate change and detect invasive species. So, you can see, important, game changing work is already being undertaken in our backyard, but the best is really yet to come. We are just at the start of this most important of revolutions – the Genomics Revolution.

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Biotechnology Focus / June 2011

Life Sciences Ontario

Bonnie Kuehl, Ph.D. & John Kelly, Ph.D.

Life Sciences Ontario

The Voice of Life Sciences in Ontario

Ontario

Life Sciences Ontario Mission To represent and promote the benefits of life science technologies and encourage their commercial success including related organizations that support this community. We do this through advocacy, facilitation of economic development and promotion of our industry locally, nationally and internationally.

The life sciences sector in Ontario is diverse, ranging from pharmaceutical and biotechnology to agriculture (including livestock and plants), forestry, food and food processing, bioeconomy and the environment. This great diversity has lead to immense opportunity for the province, but has also lead to challenges in providing consistent messaging to policy makers and stakeholders, who in turn need to react to business, social and political realities. As each of us know, individual companies or groups have more limited influence and impact because they don’t represent a strong, collective voice. Life Sciences Ontario (LSO) was founded on the basis of providing a unified voice for life sciences in Ontario and has been recognized by the Government of Ontario as a key stakeholder in the future economy of the province. Life Sciences Ontario is not only impacting the directions and resolutions of public policy in Ontario but is also acting as a conduit between the many organizations in Ontario and the governments that operate in our space. This organization has the mandate to develop cross-sectoral connectivity across the province with the vision to provide opportunities for like-minded groups to act with one voice, ultimately contributing

to positive economic development and policy initiatives. It truly represents the life sciences community in Ontario with members of all sizes representing research, commercialization, support, manufacturing and production, and services sectors. Life Sciences Ontario is also collaborating across the many life sciences groups, including regional innovation centres (RICs), provincial industry groups, economic and business development groups, to address issues that are fundamental to the success of the province. This united effort will lead to an enhanced quality of policies and policy development for the sector. Each group and sector in life sciences has unique challenges, however, we also share common challenges particularly with the protection of intellectual property, regulatory, financial and investment challenges, and finally commercialization of the innovative products developed. In order to best represent the needs of our members, the LSO Board of Directors has executive level representation from across the province representing pharma, biotech, agriculture, food, and biochemistry, with direct linkages into the auto manufacturing and chemical sectors. With its expertise and strong leadership

LSO has been interacting with several government institutions and ministries to raise awareness of our common and diverse needs. By taking leadership in policy management, LSO is providing its members direct benefit and opportunity to be informed of key challenges (for example – increasing investment into the sector). This is done through communications and events designed to keep members at the cutting edge of industrial, policy and overall sector impact. Similar to the Autumn of 2010, LSO will be convening an investment summit in 2011, with the task of further supporting the economic vitality and health of the industry. LSO is working with the Ontario Government to have a deeper understanding of the economic importance of life sciences in Ontario. LSO will collaborate on an asset map of the breadth of the sector in Ontario. The community’s strengths will be analyzed, communicated, and showcased globally from these efforts. Future priorities for LSO to help align with Ministry priorities will be formalizing and enhancing a united voice for the community through collaboration with the many entities representing life sciences in Ontario; and forging strong relationships with Quebec to create a strong Ontario-Quebec corridor of life sciences that is globally competitive to the top jurisdictions in this space. Life Sciences Ontario provides stakeholders, including government, academia industry and NGOs a single entity to address significant and challenging matters and concerns. It adds value to its members by providing a united and loud voice to address the many issues that affect our industry today, making this sector more attractive to investment, corporate and plant localization, ultimately enhancing the profitability of life science companies in Ontario.

Biotechnology Focus / June 2011

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OBest

By Gail Garland, President & CEO of OBIO

COMMerCializatiOn suCCess OBest™ the ontario bioscience industry plan

Building Ontario’s Bioscience Industry and Ontario’s Economy

Ontario is home to world-class research which provides the raw ingredients for innovation, from a strong professional services sector to a highly educated work force, and is poised to take advantage of the knowledge economy. To be implemented over the next three years, OBEST completes the virtuous cycle (Figure 1) in which commercially successful companies turn Ontario’s sizeable investments in education ($22 billion in 2010) and R&D ($3.6 billion since 2004) into high-value jobs, anchor companies, the adoption and export of innovative healthcare solutions, and increased investment. Ontario companies are engaged in research and development of new therapeutics and products which promise enhanced opportunities for maintenance of health, through better diagnosis and treatment of illness. Approximately 100 small and medium-size companies are working on: stem cell therapies; cancer therapies; genomics; biomaterials; novel formulations; biosimilars; diagnostics; bioinformatics and devices. Approximately one third are engaged in early R&D; another third in clinical trials and the other third are either market-ready

With the global economy still in recovery two years after the economic downturn, Ontario’s bioscience industry and a universe of pan- Ontario stakeholders’ seized the opportunity to contribute to Ontario’s economic growth and developed a comprehensive, implementable plan for a vibrant biosciences industry. Developed by OBIO, the plan is named, OBEST (Ontario Bioscience Economic Strategy Team) and articulates industry’s collective mandate for sustainability, growth and long-term prosperity. In OBIO’s 2010 and 2011 industry status reports, senior industry executives described the constraints on their ability to develop and commercialize products. Issues confronting industry included difficulty raising external financing, finding technology partners and funding research. Industry executives recognized the need to develop a comprehensive bioscience industry plan if Ontario’s industry was to deliver on its full potential to provide innovative health care solutions and the concomitant economic benefits.

Figure 1. ontario bioscience econoMic enGine Government Investment in R&D and Education

OntariO

Adoption & Export of Healthcare Solutions

Anchor Industry & Spin-off Ventures

High-Value Jobs

Attract Investment

Biotechnology Focus / June 2011

or generating revenues. Most companies are private; pre-profit and employ fewer than 10 employees. Starting in the fall of 2010 and concluding early in 2011, over 200 stakeholders from across the province rolled up their sleeves and went to work as part of the OBEST project. Collectively, they dedicated more than 5,000 volunteer hours working in regional groups to advance a strategic plan which establishes industry’s goals, strategies and implementation tactics (Figure 2). Participants in this concentrated effort represented: universities, colleges, three levels of government, research institutions, hospitals, financial and capital markets, patient groups, pharma, bioscience companies and other industry stakeholders. Their concerted collaboration demonstrates the mutual interdependence of stakeholders in creating a plan for the industry to flourish. Consistent with OBIO’s operating principles, the OBEST process was open, transparent and democratic. An e-room provided participants with

Figure 2. obest strateGic process

Continued on page 38

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The Ontario Network of Excellence

Continued from page 28 sauga and the Town of Caledon. Mississauga is home to the third largest life sciences cluster in Canada with more than 375 companies employing approximately 24,800 people. Baylis Medical is a local success. Baylis Medical is a leading developer, manufacturer and supplier of high-technology medical devices for interventional pain management, interventional cardiology and radiology products. RICC has supported the growth of Baylis Medical through their Entrepreneur-in-Residence program, assigning a coach and mentor to provide them with high-level special guidance on commercialization of technologies.

Website: www.riccentre.com

Niagara Interactive Media Generator, Niagara Region Niagara Interactive Media Generator (nGen) is a hub for interactive digital media project and business development in the Niagara Region. As a new member of ONE, nGen has expanded its mandate via the Regional Innovation Centre (RIC) to include the support and development of the emerging industry clusters as identified in Niagara’s economic growth strategy. These industry clusters include digital media, health and wellness, green energy, and bio-products. Niagara has many unique competitive advantages perfectly suited to the emerging bio-economy. These include a longestablished agricultural and agri-food business infrastructure, institutional bioscience research, industry expertise drawn from a number of leading-edge companies, and abundant supplies of talent, water, energy and biomass. Collectively, these assets have helped attract businesses in a variety of growing sub-industries within the bio-products field such as waste-to-energy conversion, pharmaceutical product development and manufacturing, and industrial fermentation. As a part of the ONE network, nGen can align bio-products companies and entrepreneurs with valuable resources and services available in Niagara and Ontario. nGen facilitates networking, collaboration, prototyping, production and business development for the emerging industry clusters in Niagara. Its main activities revolve around mentorship, access to technology, projects, seminars, networking, and tenancy for digital media companies. It works to create an innovative business incubation and generation model to help jump-start and grow new enterprise.

Website: www.ngen-niagara.com

Ontario

We-Tech Alliance, Windsor, ON

WEtech Alliance is Windsor-Essex’s Technology Accelerator; an industry-led non-profit organization focused on driving the growth and success of Windsor Essex’s technology centric companies & entrepreneurs through leadership, connections and promotion. WEtech strives to identify, find solutions and foster the development of the technology industry in Windsor Essex by engaging companies in the technology and innovation sector, as well as companies who utilize technology. The WEtech mission is to nurture innovation and technology by providing the tools, programs, resources and support that entrepreneurs and technology-centric companies require for sustaining growth, development and success. Biotechnology Focus / June 2011

WEtech assists entrepreneurs in launching new ventures, providing education and networking opportunities to accelerate business growth for small-to-medium enterprises, and serves its members as advocates for the region’s thriving technology and innovation companies.

Website: www.wetech-alliance.com

MaRS Discovery District, Toronto MaRS Discovery District is a large scale, mission driven innovation centre located in Toronto, focused on building Canada’s next generation of technology companies. Opened in 2005, MaRS seeks to find a “better way to capture the commercial potential of Toronto’s $1 billion in annual science and technology research spending.” Since opening, MaRS has advised more than 1200 start-up companies on how best to commercialize their technologies. MaRS works closely with entrepreneurs in life sciences and health care; information technology, communications and entertainment; cleantech; advanced materials and engineering; as well as innovative social purpose businesses. The core “engine room” at MaRS is the Advisory Services group. Our advisors and associates assess our entrepreneurclients’ needs, work with clients to develop the best paths for their businesses and, ultimately, provide the support they need to reach their goals. MaRS also offers educational resources, including the Entrepreneur’s Toolkit, an online collection of articles, templates and workbooks, as well as in-person educational programs and lectures from thought leaders and industry associations. Through ONE, MaRS also provides free market intelligence to Ontario technology entrepreneurs, allowing them to make informed decisions about market size and industry opportunities. MaRS provides resources — people, programs, physical facilities, funding and networks — to ensure that critical innovation happens. MaRS stimulates, identifies and harnesses great ideas, nurtures their development and guides the transformation of those ideas into reality.

Website: www.marsdd.com/aboutmars/partners/ ontario-network-of-excellence/

Tech Alliance of Southwestern, London, ON TechAlliance empowers London and Southwestern Ontario’s tech-

nology sector. As a member of the Ontario Network of Excellence (ONE) we prepare today’s entrepreneurs to launch new ventures, provide education and networking opportunities to accelerate business growth for small-to-medium enterprises, and serve this community as advocates for thriving technology, life sciences and advanced manufacturing companies. Our Business Services team is here to help you start and grow your technology company and improve your chances for success. Our services are available to all start-up and early-stage companies and entrepreneurs in the region. Whether you have a company or just an idea, our in-house team of experienced analysts, advisors, and entrepreneursin-residence will work with you to understand your tech business and the challenges you face, and to help you access all the resources available to high-potential tech businesses in the area. TechAlliance also plays a major role

The Ontario Network of Excellence

Website: www.techalliance.ca

Innovation Guelph-Guelph Innovation Guelph is a social enterprise sponsored by the Guelph Chamber of Commerce and funded through the Ontario Ministry of Research and Innovation and MaRS. The mission of Innovation Guelph is to help enterprises start, grow and thrive. Innovation Guelph has a broad reach, but typically focuses on projects that fall into five sectors: advanced manufacturing and engineering, life sciences, clean tech, information technology and social innovation. Innovation Guelph does not offer funding directly, however, it aims to act as a clearinghouse and keep track of opportunities for private and public investment. Two examples are: Ontario Centres of Excellence: offers the potential for funding of private sector research needs by Ontario universities; and the Angel Investor Networks: if you are seeking private investment Innovation Guelph can assist in both connecting with and preparing for presentations to angel investor networks.

Website: www.innovationguelph.ca

Innovation Durham Northumberland-Whitby, Oshawa, Coburg The Innovation Durham Northumberland (IDN) is an industryled non-profit organization providing technology commercialization services contributing to the growth of both the Durham Region and Northumberland County. The IDN has three locations: Durham College Whitby Campus, University of Ontario Institute of Technology (UOIT) in Oshawa and the Northumberland Manufacturers Association (NMA) offices in Cobourg. The IDN provides innovators, technology based businesses, entrepreneurs and researchers with services and programs to help them innovate and gain a competitive advantage. The IDN will draw upon the resources of MRIs Business Acceleration Program (BAP) and the Ontario Centres of Excellence to deliver its program and services. Initially the IDN will focus on providing services to companies in the following sectors: Energy, information and communications technology (ICT), advanced manufacturing, and environmental products and services.

Website: http://www.innovation-dn.ca

The VentureLab, Markham VenutreLab is the York Region partner in Ontario’s Network of Excellence and is located in Markham, Canada’s high tech capital. The Regional Municipality of York has a long history of innovation in knowledge based industries and has signifi-

cant regional assets. It has a deep talent pool with close to 70 per cent of its adult population with post secondary degrees or higher and a strong entrepreneurial culture. VentureLAB realizes the significant value of education and learning in this knowledge-based economy. We strive to provide educational programs and encourage collaboration from this generation’s young entrepreneur’s right through the entire entrepreneurial life-cycle. VentureLab offers services to ICT and Life Science entrepreneurs in helping bring their technology to market. We have many strategic advantages including ventureLAB’s ability to connect with industry partners and to bridge relationships among the business, academia, science and government sectors.

Website: www.venturelab.ca

Communitech Technology Association Inc., Waterloo Communitech is a not-for-profit organization with close to 15 years of experience helping technology entrepreneurs in Waterloo Region grow their businesses. Recently, the organization expanded its focus to share its best practices, facilitate innovation and strengthen technology companies at a provincial and national level (driving the creation of the Canadian Digital Media Network.) In addition to seeding and growing young technology companies throughout the region, it is focused on connecting and bringing value to its 600+ members. It does this by way of numerous events, peer learning & development programs. From funded, mature companies to one-person start-ups, the organization works with hundreds of clients.

Website: www.communitech.ca

HalTech Innovation Centre, Oakville Halton Region, in partnership with Communitech Technology Association is establishing HalTech, Halton’s own Regional Innovation Centre (RIC). During this formation stage, Halton Region and Communitech will be providing a base level of business support services for the innovative community in the region.

Website: www.venturelab.ca

Northern Technology Alliance-North Bay, Sudbury, Thunder Bay, Sault Ste. Marie The Northern Technology Alliance which is a collaborative network of organizations from across the major centres in Northern Ontario designed to help clients commercialize their ideas. The Northern Technology Alliance is made up of members NORCAT (Sudbury), the Sault Ste. Marie Innovation Centre (Sault Ste. Marie), The Northwestern Ontario Innovation Centre (Thundery Bay) and Innovation Initiatives Ontario North (North Bay).

Website: www.norcat.org; www.ssmic.com; www.nwoinnovation.ca; www.iion.ca Biotechnology Focus / June 2011

Ontario

in the Southwestern Ontario Regional Alliance, a gathering of organizations striving to enhance our entrepreneurial community; members include TechAlliance, WORLDiscoveries, The Research Park (London, Sarnia-Lambton), Ontario Centres of Excellence (OCE), National Research Council of Canada (NRC), WEtech Alliance (Windsor-Essex). This unified approach enhances the collaborative element of TechAlliance’s service offerings and ensures we continue to work with innovative groups to promote a supportive network for business growth in London and Southwestern Ontario.

OBEST Continued from page 34

new industry partners, working with global pharmas on common regulatory and market access challenges and partnering with government to identify and meet the needs of future healthcare priorities. OBEST has delivered a road map for establishing biosciences as a key element of Ontario’s future economic engine and a solution to Ontario’s health care needs for innovation and cost effectiveness. With a plan in place, the bioscience industry, academia, government, healthSRC101 care providers and consumers can work effectively to make Ontario competitive abroad and an inspiring place to live, learn and work. I wish to receive/continue to receive a complimentary subscription to Together, we have created Yes No BIOTECHNOLOGY FOCUS the blueprint for growth and sustainability of a sector critiFormat Preference: print digital both cal to a knowledge economy. Signature:____________________________________Date: ___________________________ Implementing that plan together, Name:_________________________________Title: ____________________________________ we will create an environment for success, a critical mass of Company: ______________________________Dept: ___________________________________ commercial winners, where the Business Address : _______________________________________________________________ value of setting up a bioscience company and remaining in OnCity:_____________________________Prov: __________Postal Code: ____________________ tario is globally recognized. This Telephone: ___________________________Fax: ______________________________________ will be our shared legacy. meeting minutes, presentations and background reading materials. OBEST participants prioritized strategies which take a holistic approach to the sector and strengthen links among all participant groups. A strong focus exists for links between commercial companies and universities and research centres. As well, links are created with groups like the Structural Genomics Consortium and

emerging models such as the Center for Commercialization of Regenerative Medicine (CCRM). For example, CCRM brings together experts from several Ontario research institutes to accelerate regenerative-medicine research and development and create a commercialization pipeline that rapidly brings regenerative-medicine technologies to market. Other strategies focus on securing and retaining investment, attracting

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References: 1. Ontario Bioscience Industry Generated Recommendations for Sustainability and Growth in 2010 and Beyond; Ontario Bioscience Industry Generated Recommendations for Sustainability and Growth in 2011 and Beyond: www.obio.ca

About OBIO™ The Ontario Bioscience Industry Organization (OBIO™) is a private sector, membership-based organization that is Ontario’s leading advocate for the life science sector. OBIO™ is engaged in advocacy to enable the successful development and commercialization in Ontario of life science technology through investment, strategic alliances, stakeholder engagement and industry promotion. Our goal is to build a leading bioscience cluster in Ontario to deliver innovative products/services to a global market.

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Biotechnology Focus June 2011

Articles inside

A Genomics Revolution

The Ontario Network of Excellence

Ontario and the Asia Opportunity

The Ontario Brain Institute

Ontario’s commercialization engine for cancer research

Regenerative Medicine in Ontario

The Science of Sharing

Patenting Antibodies in Canada

One on One with Deputy Minister George Ross

Innovations in aging and brain health