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BIOTECANADA ECOSYSTEM REPORT

BECOMING A WORLD LEADING BIOECONOMY BY 2025

Canada’s biotechnology ecosystem has what it takes to become one of the Top 3 bioeconomies in the world by 2025.

www.biotecanada-ecosystem.com


BIOTECANADA ECOSYSTEM REPORT BECOMING A WORLD LEADING BIOECONOMY BY 2025

Canada’s biotechnology ecosystem has what it takes to become one of the Top 3 bioeconomies in the world by 2025.


SUMMARY EXECUTIVE SUMMARY 6

Why Does A Biotechnology Ecosystem Matter for Canada?

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What is at Stake?

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The Goal: Make Canada a Top 3 Global Bioeconomy by 2025

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Solutions for a Changing Planet

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Canada’s Biotechnology Ecosystem

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Becoming a World Leading Bioeconomy

CHAPTER 1 16

Modern Biotechnology

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Transformational Impact of Modern Biotechnology

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Canada’s Innovation Legacy

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Modern Biotechnology in Canada

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Economic Contribution

CHAPTER 2

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How Canada’s Biotechnology Ecosystem Works

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The Innovators

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Intellectual Property

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Start-Up Investors

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The Biotech Start-Up

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Business Support

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Growth Capital

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Mature Canadian Biotech Companies


CHAPTER 3 48

Key Components for a Globally Competitive Ecosystem

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People and Partnerships

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Financing

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Supportive Regulatory Environment

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Leadership

CHAPTER 4 68

A Vision for Canada’s Biotechnology Sector

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Leadership:

›  Goals and Metrics

›  Communication and Branding

›  Government Champions

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EXECUTIVE SUMMARY

As a first step in moving towards this objective, BIOTECanada has commissioned this paper to examine the current state of biotechnology in Canada, to uncover how Canada’s biotech ecosystem works, to ask industry leaders for their views on Canada’s biotech economy and to chart the key steps in reaching the Top 3 by 2025.

WHY DOES A BIOTECHNOLOGY ECOSYSTEM MATTER FOR CANADA? Global changes in human health, the environment, food security, economic fortunes, are dictating the need for nations to embrace the opportunity of turning 21st century knowledge into solutions for 21st century pressures. With biotechnology having played an integral role in human and planetary development for centuries before today, we have in our hands a tool able to protect and improve the long term sustainability and economic security for Canadians and fellow world citizens. Canada has a long and proud history in the development of modern biotechnology. From the discovery of insulin in 1922, the isolation of DNA by a Canadian scientist in 1943, the licensing of the first polio vaccine in 1955, the development of an early form of canola in 1974, the first Canadian biotechnology company founded in 1981, winners of the Nobel Prize in 1986 and, the first country in the world to grow commer-

cial biotech crops in 1995. From the world’s first biofuel jet test in 2012, to the recent contribution to development of a vaccine for ebola, and dozens of other milestones along the way. Canada has made its mark as a significant leader in the global ecosystem feeding biotechnology discovery and development. This leadership has enabled legions of opportunities for todays’ Canadian scientists, researchers, and entrepreneurs, to bring forward biotechnology products and quality of life for the world. With all of the expertise in the sector in Canada it is time to ensure Canada reaps the maximum advantage of what the expertise offers. Societal pressures demanding solutions for modernizing our economy, healthier citizens, environmental remediation, are at the forefront of public policy goals at all levels of government within Canada.

WHAT IS AT STAKE? The existing Canadian ecosystem of biotechnology discovery and development is world class. Dozens of emerging economies look to Canada to see what we have done to establish the early leadership recognized around the world. They are also building on what we have accomplished

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and ensuring their efforts outpace Canada as one of their primary competitors in this sector. We have too much at stake to not remain at the top of the world leading bio-economies. With public sector and private sector investment in biotechnology research and deve-


lopment at an all-time high, Canada has the next generation of economic modernization and growth at hand. With manufacturing, resource management, agriculture, health, chemistry and many other economic sectors facing increasing demands for improved outcomes, biotechnology crosses all sectors as a tool for true innovation. Given the billions of dollars from governments and industry being invested into biotechnology research and development, should we not be getting more in return? Canada should be better at leveraging existing knowledge and capacity to attract new levels of investment for the sector.

Can we level the playing field for Canadian entrepreneurs to compete for investment dollars? To keep the quality of life Canadians have enjoyed and established as one of the best in the world, Canada needs to embrace the game changing technologies for the future. From stem cell treatments, to vaccines preventing illness, to new manufacturing and industrial practices, to new technologies to manage resources and clean our environment and to allow Canada to keep feeding the world, biotechnology is the foundation for these solutions.

THE GOAL: MAKE CANADA A TOP 3 GLOBAL BIOECONOMY BY 2025 The OECD has defined the world bioeconomy as comprising one-third of the total world economy. This includes renewable biomass, and the integration of biotechnology across sectors. Predictions by the OECD for the future size and scope of the bioeconomy feature the vast potential of biotechnology impacting industry and primary production, quickly followed

by health. (OECD The Bioeconomy to 2030: Designing a Policy Agenda) To reach the Top 3 by 2025, BIOTECanada will launch an initiative to identify the additional policies and programs needed to ensure Canada’s biotechnology ecosystem reaches its goal. This initiative will draw together industry and government partners and stakeholders and focus on:

1. People and Partnerships 2. Finance 3. Supportive Regulatory Environment 4. Leadership BIOTECanada will build on the research and interviews conducted in preparing this paper to identify the policies and programs that will allow Canada to leverage and build on its current strengths to reach the Top 3 by 2025.

BIOTECanada believes by working together Canada’s biotechnology ecosystem - industry, academia and governments - can create one of the strongest and most successful biotech economies in the world.

“Canada has a long and proud history in the development of modern biotechnology” 7


EXECUTIVE SUMMARY

SOLUTIONS FOR A CHANGING PLANET The global population is exploding. By 2050 it will reach 9 billion people— tripling in less than one hundred years. Scientists, economists and world leaders are questioning how traditional industries like health care, agriculture, forestry, energy and manufacturing will keep pace with the growing demand for medicine, food and energy. Many of the answers lie in biotechnology. Biotechnology is changing the world and transforming industries around the globe. The scientific community’s expanding understanding of living organisms is creating a foundation for new game-changing applications that can solve some of this generation’s greatest challenges. Other nations are seizing this opportunity. They are creating biotech ecosystems to support the development of biotechnology and they are capturing the technologies that will transform their economies. Canada has a rich history as one of the world’s first biotech innovators. Canada now has an opportunity to build on this legacy and become one of the world’s most successful modern biotech regions by transitioning traditional industries into the new economy while drawing on the country’s considerable strengths: its investment in research, its world-class regulatory system and its strong business environment. Canadian advances in biotech research and development are already leading to innovative therapies that allow for the early identification, the prevention and even the curing of costly and debilitating illness and disease. Researchers at Western University have developed the world’s first HIV vaccine that is based on a killed whole HIV 1, much like the killed whole virus vaccines for polio, influenza and hepatitis A. Montréal-based Enobia Pharma Corp. has 10

developed a promising enzyme replacement therapy — asfotase alfa — to treat patients with hypophosphatasia, a severe genetic bone disorder that causes skeletal deformity, severe muscle weakness and organ damage, and that can be debilitating and, when developed in utero, often deadly. enGene Inc., in Vancouver has developed a highly flexible nucleotide (DNA and RNAi) delivery technology targeting mucosal tissues — technology that can be used to treat prevalent, chronic diseases of the gastrointestinal tract, lung and bladder as well as treat conditions such as diabetes, anemia and hemophilia. Immunovaccine Inc., a clinical-stage vaccine development company created 10 years ago at Dalhousie University, has used its patented DepoVax™ vaccine adjuvant platform to develop therapeutic cancer vaccines designed to stimulate the body’s immune system to destroy cancer cells in patients who have breast, ovarian and prostate cancer. Biotechnology is also transforming traditional Canadian industries like agriculture, aquaculture, forestry, mining, energy and chemical manufacturing, leading to the development of new products and applica- tions that are more environmentally friendly than their traditional counterparts. Okanagan Specialty Fruits in British Columbia has developed Arctic® apples - a non-browning fruit that has been modified to stop natural enzymatic browning, and is working on biotech solutions to make apples and other tree fruits resistant to deadly diseases. Prevtec microbia in Saint-Hyacinthe, Québec has developed Coliprotec an aid to preventing post-weaning diarrhea


in pigs - a disease caused by F4(K88)positive E. coli bacteria. Agrisoma Biosciences Inc. in Saskatoon has commercialized Resonance® carinata — an industrial oilseed mustard that has been genetically engineered to produce high-quality, vegetable oil for biojet and biodiesel fuel and that can be grown on semi-arable land. BioAmber in Sarnia was the first company in the world to commercialize bio-based succinic acid, which has a range of applications, including as a raw material for polyurethanes, coatings, adhesives, lubricants and sealants and as a replacement for petro-based ingredients in personal care products. Medicago in Québec City has developed a process to culture vaccines on tobacco leaves reducing the typical six-month vaccine development cycle to one month

and offering the potential to develop a vaccine and vaccinate a population before the first wave of a pandemic. CO2 Solutions Inc. in Québec City, the global leader in the field of enzymatic CO2 capture, has developed a technology to capture CO2 from large emission sources such as coal-fired power plants and aluminum refineries, eliminating the CO2 and creating new commercial products useable for environmental reclamation projects. The contribution of Canada’s biotech sector is both scientifically breathtaking and economically significant. Statistics Canada estimates in 2005 Canada’s biotech sector employed over 13,000 people and generated $4.2 billion in revenue. The Centre for the Study of Living Standards (CSLS) estimates that today biotechnology contributes $40 billion to the Canadian economy.

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EXECUTIVE SUMMARY

CANADA’S BIOTECHNOLOGY ECOSYSTEM Biotechnology starts with science. While large pharmaceutical, agriculture and chemical companies are introducing biotechnology to their portfolios, individual scientists in small private companies, universities, hospitals and public research agencies remain the backbone of biotech research and development in Canada. But to achieve success, science is not enough. Most biotech research and development takes 10 years or more to move from the laboratory to commercialisation - time required to refine the biological discovery, to evaluate its potential effectiveness, to determine its usefulness and to work through the long process, including clinical and field trials, needed to obtain regulatory approval. To survive this period of development - a period during which these biotech innovations generate no revenue - most biotech Innovators will require the support of business, financial, legal and regulatory experts. Together, these supports help Canada’s biotech ecosystem survive and grow. Dozens of industry leaders were interviewed for this report. They included executives in some of the most successful small and mid- sized life science companies in the country as well as experts in venture capital firms, investment banks, biotech incubators and accelerators, intellectual property law firms, pharmaceutical, agriculture, bio-chemical and bio-fuels companies and industry associations. Those interviewed are unwavering in their support for Canada’s biotech activities and see the potential for Canada to become one of the leading biotech jurisdictions in the world. They believe biotechnology can strengthen the Canadian economy through research, development and clinical activities, through investment op-

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portunities and through the manufacture and export of biotech products. Leaders spoke of Canada’s excellence in research and recognized that this and Canada’s many other strengths- its regulatory system, the National Research Council’s Industrial Research Assistance Program (IRAP) and the Scientific Research and Experimental Development Tax Incentive Program(SR&ED) - could be a calling card to attract investors and business leaders to Canada’s biotech community. Leaders were also clear that in order to reach the Top 3 by 2025, Canada needs to build on these strengths and focus on developing excellence in four main areas :    

1. People and Partnerships 2. Finance 3. Supportive Regulatory Environment 4. Leadership They believe Canada must attract more skilled entrepreneurs and managers to support biotech companies and continue to enhance collaboration across the biotech community. They also see the importance of ensuring financing is available to Innovators at key steps in the development of their technologies and the importance of Canada’s regulatory system being not just competitive with other jurisdictions, but being truly forward looking, anticipating new technologies. Finally, industry leaders spoke to the importance of Canada adopting a strong vision for its biotech economy with quantifiable benchmarks to determine if the sector is reaching its goals. The concept of Top 3 by 2025 is a direct reflection of these leaders’ perspectives of a vision for the industry.


BECOMING A WORLD LEADING BIOECONOMY Reaching the Top 3 by 2025 will not be an easy task and will require a focused, coordinated and sustained effort on the part of Canada’s biotech industry. All partners in the biotech community will need to work together to ensure Canada has a strong ecosystem that will support global leadership by 2025. As a first step, Canada’s biotech community must adopt a common vision for the biotech economy. To reach the Top 3 by 2025, BIOTECanada and leaders from across Canada’s biotech community must confirm, embrace and aggressively pursue this common goal. Reaching the Top 3 by 2025 will require broad support and participation from Canada’s biotech leaders. It will also require that Canada put in place the necessary programs and initiatives to support Canada’s biotech community as it works towards the Top 3 by 2025 goal. Industry leaders have identified the need for support in four key areas: People and Partnerships, Financing, Supportive Regulatory Environment, and Leadership. Under Leadership, BIOTECanada has identified a number of priority measures that will support Canada reaching the Top 3 by 2025 and will begin work on these immediately. These include: Goals and Metrics: Canada’s biotech community must establish specific goals and metrics to measure its success in reaching the Top 3 by 2025. Industry must agree on key indicators that will allow it to meaningfully measure its global competitive position in biotechnology today, in 2025 and at critical points in between. It must develop recommendations on how that data will be collected, with a goal of starting the collection of data for the 2015 calendar year.

Government Champions : The Canadian government has an important role to play in promoting Canada’s bioeconomy and should appoint a lead federal Minister for Biotechnology. This role would not only enhance efforts and programs already in existence, but should hold responsibility for promoting the biotech sector — to ensure biotechnology has a strong voice in domestic policy circles and is part of the international conversation about biotechnology. The lead Minister would also facilitate interdepartmental collaboration to facilitate policy development and align activities aimed at growing the bioeconomy in Canada. Provincial governments should also appoint senior ministers who can play a key role in promoting biotechnology in their economies and who can work together to ensure Canada’s biotech ecosystem ranks as one of the best in the world. Leadership : To support the Top 3 by 2025, BIOTECanada will launch the Top 3 by 2025 initiative. This initiative will identify the enabling policies, programs and activities needed to support Canada’s biotech community in reaching its goal. The Top 3 by 2025 initiative will build on the research and interviews conducted in preparing this paper and draw together industry and government to identify the People and Partnerships, Financing, and Regulatory initiatives needed to support Canada’s biotech community. BIOTECanada believes by working together Canada’s biotech ecosystem - industry, academia and governments - can create one of the strongest and most successful biotech economies in the world.

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CHAPTER 1: MODERN BIOTECHNOLOGY

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CHAPTER 1:

MODERN BIOTECHNOLOGY The global population is exploding. Since 1960 the world’s population has more than doubled from 3 billion to 7 billion people. By 2050 it will reach 9 billion — tripling in less than one hundred years. Scientists, economists and world leaders share a common concern. How can tradi-

tional industries like health care, agriculture, forestry, mining, energy and manufacturing industries that in many cases have reached their limits and are already taxing the environment — keep pace with the growing demand for medicine, food and energy ? Many of the answers lie in biotechnology.

“Many of the answers lie in biotechnology.”

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CHAPTER 1: MODERN BIOTECHNOLOGY

TRANSFORMATIONAL IMPACT OF MODERN BIOTECHNOLOGY Since the industrial revolution, consumer, industrial and health products have been largely chemical based. These products - petrochemicals, plastics and polymers, medicines, fertilizers, pesticides, textiles, adhesives, fragrances, cleaning productsrevolutionized the 20th Century health care, farming, energy and industrial manufacturing sectors. But new technologies are needed to solve the 21st Century’s problems. Biotechnology — the use of molecules and other building blocks derived from living organisms to create products and processes — is transforming traditional industries so they can develop more efficient and less environmentally damaging products and techniques, leading to healthier people and a healthier planet. Other nations are seizing this opportunity they recognize the future is here. They are actively supporting a thriving biotech economy within their borders. They are creating biotech ecosystems to support the development of biotechnology from the laboratory through to commercialization. And with that, they are capturing the technologies that will transform their industries and their economies, helping traditional industries adapt and maintain a competitive edge and building new sectors that leverage highly skilled and professional work forces. The United States is home to some of the world’s first and most successful biotech regions including Boston and San Francisco. Extensive programs such as pharma partnering, business accelerators, expert networks and investor roundtables have helped to support these and 18

“New technologies are needed to solve the 21st Century’s problems” many other biotech communities. The United Kingdom has gained a reputation around the world for its strength in biotech research and development. Their biotech industry is concentrated around Oxford University and Cambridge University — the home base of many Nobel laureates. Switzerland, home too many leading pharmaceutical companies, has strong biotech industries in Basel and Zurich. These are noted for developing biotech management talent and for their biotech exports. In addition to having strong individual companies, the Swiss biotech industry works actively to promote that country’s biotech sector. Israel has developed a biotech industry almost out of thin air. A strategic government decision in 1993 to create the Yozma fund, an international collaboration to bring venture capital money and expertise to that country’s innovation sectors, has led to numerous biotech start-ups and the creation of a strong, domestic venture capital community. Israel’s venture capital industry now has an estimated 70 venture capital funds and over 200 international funds actively invest in that country. Although it has a small population relative to many biotech countries, Belgium is seen as a global biotech leader due to its focus on clinical trials.


With its proximity to other leading European biotech nations, Belgium has been able to develop strong regional biotech clusters in each of Brussels, Flanders and Wallonia that continue to grow the industry.

Australia has fostered an expertise in developing biotech companies in the areas of oncology and neurology. Australia’s national biotech industry association has extensive programs to educate and support new biotech companies to develop and grow.

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CANADA’S INNOVATION LEGACY Canada has a strong history as an early biotech innovator. From insulin production in the 1920’s to SARS genetic decoding in 2003 - Canada’s early contributions to biotechnology have benefited millions here at home and around the globe. Connaught Laboratories One of Canada’s earliest forays into biotechnology is Connaught Laboratories and University Farms established in 1919 outside of Toronto. First renowned for its production of diphtheria and tetanus antitoxins, Connaught Laboratories went on to play a critical role in the development of large-scale insulin production methods in the 1920’s. The laboratory made many early contributions to biotechnology including conducting the original field trials on diphtheria toxoid, developing a pertussis vaccine, developing heparin, a blood anticoagulant, and producing penicillin during WWII. In the 1950’s work at Connaught helped Jonas Salk develop his polio vaccine in sufficient quantities to support clinical trials in the United States. Connaught also developed vaccines against influenza, measles and smallpox. Today, Connaught Laboratories continues to operate in Canada under the leadership of vaccine company Sanofi Pasteur. Canola Canola is one of this country’s first and greatest biotech successes. Canola was originally developed in Canada in the 1970’s using traditional breeding techniques. From there, canola has developed into Canada’s most valuable agriculture product generating over $7 billion a year in farm cash receipts. Today, almost all of Canada’s canola has been genetically modified, resulting in greater resistance and higher yields. While 20

many Canadian agriculture sectors are struggling to stay competitive, canola production and processing now contributes $19.3 billion to the Canadian economy each year and generates more than 249,000 jobs. Even today Canada remains a global centre for canola research and development, leading to further recent innovations such as high stability and high oleic acid canola, which reduces overall trans-fat intake from fried foods in comparison to substitutes and has changed the way many leading fast food service companies in North America fry their products. QLT Inc. QLT Inc. is a biotechnology company founded by University of British Columbia scientists in 1981. The company develops photodynamic therapeutic products drugs that are activated by exposure to light - with a focus on ophthalmology and dermatology products as well as cancer treatments and has been a training ground for many of Canada’s biotech leaders and entrepreneurs. Initially QLT’s research was focused on photodynamic anti-cancer drugs including Photofrin®, administered as a single injection, makes cells sensitive to ultraviolet light permitting them to be identified and then destroyed using lasers. Photofrin® was first approved in Canada in 1993 and has received approval as a treatment for bladder, oesophageal and other cancers. Photofrin® was eventually sold to Quebecbased Axcan Pharma Inc. Today, QLT is best known for the development of ocular products including Visudyne® - a photodynamic therapy for wet age-related macular degeneration, the leading cause of blindness for people over age 55. The FDA approved Visudyne® in 2000. At the time, Visudyne® was the largest ophthalmic product launch in his-


tory with sales of $150 million in the first 12 months. In 2001, as a result of Visudyne® sales, QLT was one of only 14 profitable biotech companies in the world. Cystic Fibrosis Discovery of the Cystic Fibrosis Gene by Dr. Lap-Chee Tsui Cystic fibrosis is a genetic disease characterized by the buildup of thick mucus that causes progressive damage to the respiratory system and chronic digestive system problems. It is the most common genetic disease affecting Caucasian populations. In 1989, researchers led by Dr. Lap- Chee Tsui at the Hospital for Sick Children (SickKids) in Toronto discovered the gene that causes cystic fibrosis - cystic fibrosis transmembrane conductance regulator (CFTR). Important to the understanding of cystic fibrosis, the CFTR gene was also the first disease-causing gene ever to be identified. After the CFTR gene discovery in 1989, Dr. Tsui set up a mutation database that today houses the collection of mutations in the CFTR gene and created a comprehensive map of chromosome 7, now known for its disease-causing mutations. STEMCELL Technologies Inc STEMCELL Technologies Inc is a biotechnology company that develops specialty cell culture media, cell separation products and ancillary reagents for life science research. It was created in 1993

Hematology/Oncology Research at the British Columbia Cancer Agency. Out of facilities in Vancouver, the U.S. and France, STEMCELL Technologies produces over 1,500 products (cell culture media, cell separation products, and instruments) that it sells to 70 countries around the world. From its beginnings as a way to raise funds for research and to ensure cancer researchers had the cell culture materials they needed, it has become one of the largest biotech companies in BC. BC Cancer Agency Genomics Science Centre Decodes SARS Virus. Scientists at the BC Cancer Agency’s Genome Sciences Centre played a critical role in managing and treating SARS following the 2002/03 global outbreak of that disease. SARS, which developed in China in 2002, eventually infected 8,000 people worldwide. Using its world- class equipment, including computerized high-speed gene sequencers, the Genome Sciences Centre worked with the National Microbiology Laboratory in Winnipeg, the University of Victoria and the BC Centre for Disease Control to investigate a coronavirus considered a leading candidate to be the SARS pathogen. The Canadian team successfully sequenced the gene of the coronavirus behind SARS in less than a week. Within a year, three potential vaccines were developed.

“Canada’s early contributions to biotechnology have benefited millions here at home and around the globe” 21


CHAPTER 1: MODERN BIOTECHNOLOGY

MODERN BIOTECHNOLOGY IN CANADA Drawing on this rich legacy, Canada now has an opportunity to become one of the world’s most successful modern biotech regions. Canada can transition its traditional industries into this modern biotech economy while drawing on its considerable strengths: its investment in research, its world-class regulatory system and its strong business environment.

pneumonia, high-risk populations and chronic diseases. The NRC partners domestically and internationally to develop novel and improved vaccines and enabling technologies. Rare and Orphan Diseases

Healthier People Advances in biotechnology research and development are leading to innovative therapies that allow for the early identification, the prevention and even the curing of costly and debilitating illness and disease. Disease Prevention and Vaccines Biotechnology plays a critical role as a preventative tool in health care, creating techniques to screen patients for predisposition to disease and developing vaccinations to prevent and/or treat illness and disease. The Public Health Agency of Canada estimates vaccines have reduced the number of cases of measles, rubella, polio and other illnesses in Canada by 99 percent. Research into new disease and disease strains continues. Researchers at Western University are working on the development of a vaccine for HIV. In a joint venture with Sumagen Canada Inc., Western University scientists have developed the world’s first HIV vaccine that is based on a killed whole HIV 1, much like the killed whole virus vaccines for polio, influenza and hepatitis A. This is the only HIV vaccine under development in Canada, and one of only a few in the world. Through its Vaccines Program, Canada’s National Research Council (NRC) is researching vaccines for influenza,

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Many Canadian medical biotechnology companies are also developing new treatments for rare or orphan diseases - diseases that affect a small population of people and have few, if any, effective therapies. Rare diseases are often genetic and often fatal. In these cases, new medical interventions focused on using gene technology to replace, repair or turn off defective genes can improve, and in many cases, prolong and save lives. Hypophosphatasia, a severe genetic bone disorder that causes skeletal deformity, severe muscle weakness and organ damage, can be debilitating and, when developed in utero, often deadly. Today there are no treatments for this rare disease. But Montréal-based Enobia Pharma Corp. has developed a promising enzyme replace-


“Canada can transition its traditional industries into this modern biotech economy while drawing on its considerable strengths” ment therapy — asfotase alfa — to treat patients with hypophosphasia. In 2013, researchers at Western University discovered a gene mutation that is linked to ALS — a rare progressive disease that affects motor neurons and kills 90 percent of patients within five years. Dr. Michael Strong and colleagues at the University discovered a mutation in a gene that appears inside of sick motor neurons. Ultimately, this discovery may prove to be a crucial link in the understanding of ALS and in identifying potential new treatments. Chronic Disease The majority of chronic diseases like schizophrenia, Crohn’s disease, diabetes, epilepsy and multiple sclerosis have existing medical treatments. However, biotechnology presents opportunities to develop advanced treatments that are more effective by designing medications that are better targeted to the individual patient and to the disease. Aquinox Pharmaceuticals, Inc., a clinical-stage pharmaceutical company in Vancouver, is developing anti-inflammatory drug candidates for bladder pain syndrome/interstitial cystitis affecting millions of people worldwide. Aquinox’ research targets “SHIP1”, a key regulator of an important cellular signaling pathway in immune cells that when present in lowered levels causes inflammation. enGene Inc., in Montreal, has developed a highly flexible nucleotide (DNA and RNAi) delivery technology targeting mucosal

tissues. This delivery technology can be used to treat prevalent, chronic diseases of the gastrointestinal tract, lung and bladder as well as provide systemic release of proteins from the gut to treat conditions such as diabetes, anemia and hemophilia. Cancer Cancer occurs when a cell’s genetic material becomes damaged or changed, producing mutations that allow cancer cells to grow uncontrolled. Biotech research is focused on identifying those defects and developing diagnostic tools and treatments to address the defective genes. New vaccines are under way to prevent certain cancers, while medical treatments are being developed with potentially curative effects. Immunovaccine Inc., a clinical-stage vaccine development company created 10 years ago at Dalhousie University, has used its patented DepoVax™ vaccine adjuvant platform to develop therapeutic cancer vaccines designed to stimulate the body’s immune system to destroy cancer cells in patients who have breast, ovarian and prostate cancer. Trillium Therapeutics Inc. in Toronto has the potential to be another Canadian success story. Trillium is the only company in Canada researching new therapies that will kill cancer stem cells. Listed on both the NASDAQ and TSE, Trillium recently completed a public offering generating $55 million for the next stage of research for innovative cancer therapies.

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All of these advances in biotechnology are leading the way to precision medicine, allowing medical interventions and treatments to be more targeted and more effective. With the ability to map patient genome, medical treatments can be customized based on a patient’s specific genetics and other information. This can lead to earlier diagnosis of disease, greater effectiveness of treatments and reduced complications for patients.

Okanagan Specialty Fruits (OSF) in British Columbia has developed Arctic® apples modified to stop enzymatic browning. OSF is also working on biotech solutions to protect orchards from deadly diseases including fire blight — which kills apple and pear trees and now requires antibiotic sprays — and apple scab — a common fungal problem that currently requires growers to spray susceptible varieties up to 10 times per season.

Healthier Planet Biotechnology is also transforming traditional Canadian industries like agriculture, aquaculture, forestry, mining, energy and chemical manufacturing, leading to the development of new products and applications that are more environmentally friendly than their traditional counterparts.

Prevtec microbia in Saint-Hyacinthe, Québec has developed Coliprotec, an aid to preventing post-weaning diarrhea in pigs caused by F4(K88)-positive E. coli bacteria. It is the first live bacterial vaccine for livestock production to have been fully developed and manufactured in Canada.

Food The world’s growing population will require farmers to produce 70 percent more food by 2050. Modern biotechnology can help meet this challenge by allowing farmers to grow more on less land. Using biotechnology, plant breeders can produce crops with improved insect, disease and weather resistance, higher yields and with better nutritional profiles. With reduced reliance on chemical pesticides and traditional land till practices, biotech crops can reduce soil erosion by 90 to 95 percent and can increase carbon sequestration by, on average, 29 percent. Today, Canada’s leading biotech crops include canola, corn and soybeans. But biotechnology’s reach is expanding beyond crop production into horticulture and livestock.

As demand for fish and seafood continues to increase, scientists are also using biotechnology to develop new techniques for managing marine production in environmentally sustainable ways. Through biotechnology scientists can identify and combine traits in fish and shellfish to increase productivity, improve quality and increase species resistance to illness and infection. Today, Prince Edward Island is home to the world’s first commercial-scale biotech fish egg facility. Aqua Bounty Technologies, Inc. has developed AquAdvantage® Salmon (AAS) includes a gene from the Chinook salmon, which provides the fish with the potential to grow to market size in half the time of conventional salmon. AAS is an environmentally sustainable alternative to current farmed salmon. Biotechnology is also leading to the identification and extraction of key ele-

“Biotechnology plays a critical role as a preventative tool in health care” 24


ments in marine vegetation for food and other uses. Acadian Seaplants Limited, a biotech company founded and based in Nova Scotia, is one of the largest independent manufacturers of seaweed products in North America. The company extracts components from seaweed to produce natural fertilizers and soil amendments, probiotics for animal and livestock feeds and a variety of products such as edible seaweeds, brewing agents and ingredients for dietary supplements, cosmetics and personal care products. Energy From the development of new sustainable fuels to the creation of new technologies that reduce the environmental impact of fossil fuel production, biotechnology is having a transformational impact across the energy sector. Agrisoma Biosciences Inc. in Saskatoon has commercialized carinata — a nonedible industrial oilseed mustard that has been genetically engineered to produce high-quality oil for biojet and biodiesel fuel. Resonance® carinata can be grown on semi-arable land ensuring no impact on food production. In 2014, Enerkem Alberta Biofuels—a second-generation biofuels company — launched a full-scale municipal wasteto-biofuels and bio-chemicals facility in Edmonton, Alberta. Their technology uses garbage instead of fossil fuels for the production of biochemicals and ethanol. During construction of the facility — one of the first commercial plants in the world built to produce renewable chemicals and advanced biofuels—more than 600 direct and indirect jobs were created.

Bio-Materials Biotechnology is also providing sectors like agriculture and forestry with new market opportunities, as plantbased feedstock replaces fossil fuels in the industrial and chemical manufacturing sectors. Woodbridge Foam Corporation, an automotive and industrial foam supplier headquartered in Mississauga, Ontario has developed BioFoamTM — the first mass production ready, plant-based polyurethane foam that substitutes renewable resources for petroleum in the manufacture of polyol. BioFoamTM can be used in a full range of automotive interior applications including seat frames, cushions and head restraints. BioAmber is an industrial biotechnology company producing a sustainable biobased chemical succinic acid — from liquid glucose derived from renewable agriculture feedstock. Until recently, the common method of succinic acid production on an industrial scale was petroleum-derived. BioAmber was the first company in the world to commercialize biobased succinic acid, which has a range of applications. Recently BioAmber was selected as the supplier of bio-succinic acid used to

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treatment options for solid waste, landfills, oil spills and CO2 emissions.

produce a new range of innovative, biobased polyurethanes for textile applications that Bayer MaterialScience has begun commercializing. Medicago in Québec City has developed a process to culture vaccines on tobacco leaves. This reduces the typical six-month vaccine development cycle to one month and offers the potential to develop a vaccine and vaccinate a population before the first wave of a pandemic. Given the importance of forestry to the Canada economy, it can be expected that a biotech tree designed to improve forest health will soon be on the horizon. The devastating effects of pests such as mountain pine beetle and emerald ash borer and of fungal diseases will need to be addressed through a variety of means, including biotechnology. Today, Canada ranks third in the world for the production of academic papers on forest biotechnology, with the University of British Columbia, the University of Alberta and Canada’s National Research Council leading the way. Bio-Remediation Biotechnology is also playing a critical role in bioremediation; providing new

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CO2 Solutions Inc. in Québec City, the global leader in the field of enzymatic CO2 capture, has developed a technology to capture CO2 from large emission sources such as coal-fired power plants and aluminum refineries. CO2 Solutions and Codexis Inc., of Redwood City, California have a collaboration agreement with Alcoa Inc. to capture CO2 from aluminum production operations and combine it with bauxite residue, a major aluminum industry waste product, both eliminating the CO2 and creating a new commercial product with applications in environmental reclamation projects. In Winnipeg, Trans Canada Bioremediation has developed microbial applications that use naturally occurring microorganisms to transform harmful substances into non-toxic compounds. Trans Canada Bioremediation offers their services to commercial food service operations, livestock facilities, automotive manufacturers, oil & gas companies and wastewater treatment plants


ECONOMIC CONTRIBUTION In addition to its social benefits, biotechnology offers Canada an opportunity to capture significant economic benefits as well. In the past several decades global economic growth has been driven by information technology. Going forward biotechnology will drive economic expansion by providing solutions to the problems plaguing both developed and developing economies including resource limitations, lower productivity and environmental concerns. And the value of the biotech sector will not rest solely in the sales of commercialized agriculture, industrial and medical biotech products. While this can be significant, there is also tremendous value inherent in the research and development work and in the clinical activities that lead to the development of biotech products in the first place. The last data on Canada’s biotech economy was collected in 2005. Statistics Canada estimated in that year Canada’s biotech sector generated $4.2 billion in revenue and employed over 13,000 people, 8,391 of whom were employed in private and public sector biotech research and development. These jobs represented highly skilled and educated individuals who in carrying on Canada’s legacy of re-

search excellence were ensuring that the scientific discoveries made in Canada had a chance to develop in Canada and to benefit this country’s provincial and national economies. While the Centre for the Study of Living Standards (CSLS) has estimated that Canada’s biotechnology sector now generates $40 billion in economy activity, there is no recent data on biotech’s contribution to Canada’s economy. This is of concern given the significant potential that biotechnology can offer to the country.

“In addition to its social benefits, biotechnology offers Canada an opportunity to capture significant economic benefits as well”

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HOW CANADA’S BIOTECH ECOSYSTEM WORKS Biotechnology starts with science. The vaccine for HIV, the use of soybeans to manufacture foam for car seats, Canada’s $7 billion canola industry - all of these truly transformative biotech innovations started with highly skilled Canadian scientists exploring new research avenues in their laboratories. But to achieve success, biotech innovations must travel a long road. Most biotech research and development takes 10 years or more to move from the laboratory to commercialisation. This time is required to

refine the biological discovery, to evaluate its potential effectiveness, to determine its usefulness and to work through the long process, including clinical and field trials, needed to obtain regulatory approval. To survive this period of development — a period during which the biotech innovations generate no revenue - most biotech Innovators will require the support of business, financial, legal and regulatory programs and experts. Together, these initiatives make up the ecosystem that helps Canada’s bio- technology sector thrive.

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THE INNOVATORS All biotechnology starts with an Innovator. While large pharmaceutical, agricultural and chemical companies are introducing biotech products and applications to their portfolios, individual scientists in small private companies, universities, hospitals and public research agencies remain the backbone of biotech research and development in Canada. In 2005, the most recent year for which data is available, there were 8,391 people conducting biotech research in Canada: 7,065 in the private and 1,326 in the public sector. The majority of biotech research was in the area of medicine and healthcare (87.3%), followed by agriculture (9.2%) and industrial applications (2.8%). 2 Today, biotechnology continues to be a truly national industry spread across the country. While research and development is often organized around major geographic hubs, today every province in Canada supports research and development in medical, agriculture and/or industrial biotechnology. Just some of these biotech research and development centers of excellence include: Greater Vancouver, which is home to 70 per cent of British Columbia’s life sciences sector, including 100 biopharmaceutical companies, 60 medical device manufacturing and distribution companies, and 30 bio-products companies. Cutting edge biotech research is being conducted in predominantly four life sciences areas : on-

cology, infectious diseases, neuroscience and regenerative medicine. Alberta, which has formed Alberta Innovates by realigning the province’s research and innovation systems to better compete in a global environment. The system encompasses four main areas: Bio Solutions, Health Solutions, Energy and Environment Solutions and Technology Futures which supports research and development in technology sectors, the commercialization of technology, the provision of business and technical services, and initiatives that encourage a strong science, technology and entrepreneurial culture in Alberta. Saskatoon, which is Canada’s largest agriculture biotech research center. Saskatoon hosts the University of Saskatchewan, Agriculture and Agri-food Canada’s (AAFC) Saskatoon Research Centre, including the Plant Gene Resources of Canada and the Canadian Animal Genetics Resources Program, and the National Research Council’s Plant Biotechnology Institute. Saskatchewan, which is home to between 30 and 40 percent of Canada’s agricultural biotechnology, supports over 400 research and technical positions and 700 supporting jobs in Saskatoon alone. As well, the University of Saskatchewan hosts VIDO-InterVac – a world class research organization working with national and international partners to develop vaccines for human and animal diseases. Manitoba, which boasts one of Canada’s

“In 2005 (...) there were 8,391 people conducting biotech research in Canada” 34


fastest growing biotechnology sectors and which has significant capabilities in biomedical research and development and in agricultural biotechnology. Manitoba is a global centre of excellence in infectious disease identification and management with activities concentrated in The Canadian Science Centre for Human and Animal Health, The National Microbiology Laboratory and The International Centre for Infectious Diseases. Sarnia, Ontario, which has become an important hub for industrial biotechnology. With large agricultural, petrochemical, and automotive industries already active in the region, Sarnia has the necessary industrial infrastructure and feedstock supply to support an industrial biotech sector. The Sarnia hub works closely with Western University — one of the leading institutions in Canada for research into biotechnology, including biomaterials, biochemical engineering, biomedical engineering, and green engineering — and with other research facilities including The Research Park — a joint venture of Western University, the County of Lambton, and the City of Sarnia. The Agri-Food and Innovation cluster in Guelph, Ontario, which is the second largest agriculture biotech cluster in Canada. The region boasts expertise in advanced agricultural sciences, bio-based materials and food and nutraceutical research. Guelph hosts over 30 research centres and laboratories and 70 companies working in the field of agriculture, food and life science. Guelph is also home to a number of biotech accelerators including Ontario Agri-Food Technologies, Soy 20/20, Guelph Partnership for Innovation, MaRS Landing, BioEnterprise and the Ontario BioAuto Council. As well, Guelph is home

to Guelph University — ranked seventh in the world for its impact on agricultural sciences – and Canada’s largest Network of Centres of Excellence — Advanced Foods & Materials Network — specializing in food and advanced biomaterial. The Greater Toronto Area, which is Canada’s largest medical biotech cluster and home to 163 biotech and life science companies, including the Canadian headquarters of many global pharma- ceutical and biotechnology firms. Toronto hosts more than 11,000 principal researchers and technicians at eight universities and colleges, nine teaching hospitals and private sector research facilities. The city’s Discovery District is the densest geographical center for research in the world and has been home to breakthroughs in areas such as breast cancer, cardiovascular disease, Alzheimer’s, and cystic fibrosis research. Montreal, which also hosts a life sciences hub with a focus on pharmaceuticals, health technologies, biotechnology and contract manufacturing/research. In total the sector supports 45,000 jobs in 600 facilities including 12,000 researchers and specialists in approximately 300 public research organizations in 2011. The region is internationally recognized in the areas of aging, neuroscience and mental health, cancer, cardiovascular and metabolic disease and genetics. The foundation for the success of both the Greater Toronto area and Montreal clusters was created in large part to the longstanding presence and leadership of multinational commercialized pharmaceutical and biologic companies located in these regions. Fostering partnerships with

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CHAPTER 2: HOW CANADA’S BIOTECH ECOSYSTEM WORKS

universities, hospitals and other research institutions, the leadership of the international commercial companies sought new models for research and development with world leading Canadian research organizations, creating a vibrant foundation for the industry to keep growing. Laval, QuÊbec, which hosts more than 80 biotech and health sciences companies employing more than 5,000 people. The city is home to the health sciences component of the Institut national de la recherche scientifique; The Quebec Biotechnology Innovation Centre, The National Experimental Biology Centre; and The Biotechnology Development Centre. New Brunswick, which is home to over 50 companies and 13 research institutions involved in biotechnology. New Brunswick boasts biotech clusters focused on natural resources, including forestry, fisheries, and agriculture, as well as health sciences. Nova Scotia, which is home to 50 life sciences companies employing over 1,100 people. Nova Scotia’s life sciences industry has close to 500 separate products competing in the global marketplace, most of which are functional foods/nutraceutical, pharmaceutical and agricultural products. Research and development is highly focused on marine biotechnology, making Nova Scotia an important biotech hub for aquatic biotechnology. Prince Edward Island, which hosts a small but important biotech hub with a focus on human, animal and fish health and nutrition, as well as on industrial biotechnology and bio-remediation. The PEI Bioscience Industry generates more than $100 million in sales and employs over 1,100 people.

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Newfoundland and Labrador, whose biotech companies, researchers, academic institutions, and government agencies have developed special expertise in marine biotechnology in relation to fisheries, aquaculture, and marine organisms in cold ocean environments and in human genomics.


“Today, biotechnology continues to be a truly national industry spread across the country�

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INTELLECTUAL PROPERTY Intellectual property is of critical importance to biotech researchers. It is the foundation on which scientists and early entrepreneurs are able to take their concept to commercialization. Today, unlike even 10 short years ago, small scale Innovators, universities and research institutes are conducting a large portion, if not the majority, of exploratory biotechnology research and development. Biological invention is highly complicated. It requires that many facets of a problem or idea be explored at the same time. Many of these research avenues will lead to areas for further exploration but many will lead to dead ends. The complexity, risk and high cost of this research means that no one organization can afford to take on a full research program internally. While chemical-based research and development was highly integrated and hosted in single companies, the realities of biotechnology innovation have, in a very short period of time, changed that model. The nature of biotech innovation has led to a new research and discovery model - one that is highly collaborative, that includes a diverse group of organizations and involves a multiple of partnership arrangements. The nature of biotech innovation has also changed the way in which Innovators and their partners use and rely on intellectual property (primarily patents and data protection) to develop successful commercial relationships. For many small biotechnology companies their primary asset is their patent; for medium sized biotechnology companies, their patents are fundamental drivers in the valuation and commercial promise of their business; and for universities and other publicly-funded research, patents offer the promise of licensing revenues for re-investment into their basic research activities and institutions. 40

The Association of University Technology Managers (AUTM) annual survey of University technology transfer officers demonstrates the importance of intellectual property to public research institutions. The AUTM Canadian Licensing Activity Survey: FY2013, which summarizes responses from 37 Canadian institutions, including universities, colleges, hospitals and research institutions, found that: - 68 new start-up companies were formed in FY2013 (+19.3% growth over prior year) - 92 (+37.3%) new commercial products were created by companies licensing university technology - $710 million (+30.3%) in net product sales were generated - $5.62 billion (+0.83%) in total research expenditures were made - 233 (+27.3%) new non-U.S. patent applications were filed - 240 (+34.8% U.S. Patents were issued Intellectual property protections become critical as a tool to protect the unrealized potential of research investments while the Innovator works through the development and regulatory approval processes. Intellectual Property is also, in many cases, the only asset a research company has and becomes fundamental in its ability to raise necessary start up and growth capital. At this stage, it is critical for an Innovator to obtain both patent and data protection to ensure that his or her discoveries are secured and can attract the further high risk investments that are required as the discoveries move towards clinical trials and regulatory approval Biotechnology Use and Development Surveys (BUDS).

2

Statistics Canada. 2005


“It is the foundation on which scientists and early entrepreneurs are able to take their concept to commercialization�

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CHAPTER 2: HOW CANADA’S BIOTECH ECOSYSTEM WORKS

START- UP INVESTORS Even in their start-up phase, biotech Innovators and the companies they form may require several million dollars to carry on early proof-of-concept activities. Start-up capital for small biotech companies often comes from the Innovators themselves or from their friends and families. After family and friends, many small Canadian biotech start-ups turn to Angel Investors for key seed funding - often as much as $500,000 or more. These early investments are high-risk - ultimately as few as 1 in 10 biotech innovations may succeed and, because biotech development is a multi-year process, the wait time for a return on investment is long. In addition to providing this important early-stage capital, Angel Investors may also offer managerial expertise and access to extensive industry networks that first time Innovators often lack. Angel Investors can also play a key role in connecting biotech companies with other sources of capital down the road. Government programs are another critical source of early biotech capital and funding. Through federal organizations like Genome Canada, the National Research Council, Sustainable Development Technologies Canada and the Canadian Institutes of Health Research, the Canadian government funds a significant amount of early stage biotech research.

In addition the government provides funding support through a variety of programs including the National Research Council’s Industrial Research Assistance Program (IRAP) and the Scientific Research and Experimental Development tax incentive program (SR&ED). The SR&ED is a federal tax incentive program for Canadian businesses of all sizes and in all sectors to conduct research and development in Canada. The SR&ED is the largest single source of federal government support for research and development and is one of the most generous research and development programs among OECD countries. The SR&ED provides businesses with cash refunds and/ or tax credits for their expenditures on eligible research and development work done in Canada. In 2010/11 the SR&ED amounted to $3.5 billion and represented 70 percent of the federal government’s funding for research and development. The IRAP provides early stage direct funding for research and development to small and medium-sized Canadian businesses and is the federal government’s largest research granting program. In 2010/11 IRAP funding equalled $237.3 million.3 The Business Development Bank of Canada (BDC) is also an important early

“Angel Investors can also play a key role in connecting biotech companies with other sources of capital down the road” 42


stage biotech investor - often taking a position in a company early in its development. The BDC has invested in dozens of seed-stage companies including many spin-offs from university and government research labs. The BDC is currently working with AccelRx, a drug development technology accelerator, to provide seed funding to new and emerging Canadian health sciences companies. BDC Venture Capital will be the main funding mechanism for companies created at Accel-Rx, with the intent to invest in up to three to four companies annually and with selected companies receiving a $500,000 convertible note from BDC Venture Capital. Natrix Separations, Inc. in Burlington, Ontario is a leading supplier of high performance, single use and multi-cycle disposable chromatography products for the life science, food, beverage and water markets. Their technology has worldwide applications in protein purification and other biological & industrial separations. Natrix Separations has used their ground-breaking technology to develop high value products for specific markets such as large-scale bioprocessing, smallscale bio analytics, food & beverage processing, and water treatment. Natrix Separations’ founders received $2 million in early stage funding from BDC Venture Capital and MDS Capital funding that was critical in allowing the company to stay and grow in Canada.

funding a significant amount of early stage research long before commercial viability is known. In 2013, the Canadian Cancer Society invested $38.3 million to fund the work of 268 scientists throughout Canada. In 2014/2015, Cystic Fibrosis Canada will fund more than $5 million in leading-edge research, supporting 48 research projects, 27 fellowship and student training awards and three Canadian Institutes of Health Research partnerships. Since its founding in 1948, The Arthritis Society has funded more than $185 million in basic and applied arthritis research. In 2014/15, the Society will invest $4.4 million towards their Research and Career Development Program and regional initiatives. In 2013, Crohn’s and Colitis Canada invested $5.2 million in research activities including the Genetics, Environmental, Microbial (GEM) Project, a Canadian-led international research study investigating the causes of Crohn’s disease. Jenkins Report

3

Patient groups and charitable foundations have a vested interest in finding treatments and cures for a number of chronic and rare diseases and are

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THE BIOTECH START UP Armed with a scientific concept and with the necessary intellectual property protections and start-up funding, a biotech Innovator must begin the complex and lengthy development and regulatory activities needed to establish the efficacy of his or her work. For this to happen, biotech Innovators will usually partner with business leaders who can champion the research and who can navigate the often complex biotech financing, legal and regulatory environments. By working together, researchers are able to focus on their Innovation while their business partners can put the support measures in place to move that transformational idea from the laboratory into a real world application.

Pairing Innovators with the necessary business supports is often a challenge. Biotech researchers work in all corners of the country - usually in small public and private laboratories and often on their own. While experts in their own scientific fields, Innovators are not always adept at promoting themselves or their innovations. Much like athletes, many are waiting to be “discovered”. This becomes the domain of professional biotech “scouts” and “talent agents” - experts who can be found in technology transfer offices, venture capital firms and large pharmaceutical, chemical and agricultural companies and whose job is to identify the Innovators, to track promising research and to council Innovators on when and how to take that first step towards commercialization.

BUSINESS SUPPORT At various stages in their development, most biotech Innovators and small biotech companies will require advice and support as they navigate their scientific discoveries through the biotech development process. This support can come from many different sources including university technology transfer offices, business incubators and accelerators, industry associations and the development arms of investment banks, venture capital firms and large pharmaceutical, agricultural and chemical companies. The support also takes many different forms including networking and business development opportunities, mentorship and training, legal support, and financing. The technology transfer offices at universities play an important role in brokering research, funding and collaborative 44

relationships between their academics and industry. The University of Toronto’s Innovations & Partnerships Office provides a single gateway for anyone looking for sponsored research and collaboration opportunities with the University’s research departments. The Office also negotiates, drafts, and signs all partnership agreements on behalf of the University’s researchers. The office enters about 2,000 partnership and funding agreements and manages $50 million in industry and leveraged funding every year. Canada’s federal government has also established a program to support the development of industry-led business incubators and accelerators.


Through the Networks of Centres of Excellence in Canada program, the government sponsors a number of Centres of Excellence for Commercialization and Research — non-profit organizations created by a university, college, non-profit research organization or company to match clusters of research expertise with the business community to stimulate new commercialization activities. The Networks of Centres of Excellence in Canada program also sponsors BusinessLed Networks of Centres of Excellence — large- scale collaborative networks headed by industry consortia that increase private sector investments in Canadian research, provide researcher training and accelerate the timeline involved in translating research into commercial products and services. Working with support from the federal and provincial governments, the biotech industry has also established a number of biotech incubators and accelerators across the country, many in association with the Networks of Centres of Excellence in Canada program. The Quebec Consortium for Drug Discovery (CQDM) is a pre-competitive research consortium based in Montreal that is jointly funded by the federal BusinessLed Networks of Centres of Excellence program, the Quebec government and 8

large pharmaceutical companies: Pfizer Canada, AstraZeneca, Merck, Boehringer Ingelheim, GlaxoSmithKline, Eli Lilly Canada, Novartis Pharma Canada and Sanofi Canada. CQDM funds innovative life science projects and as of today has invested $31.8 million in 34 research projects. These projects have involved more than 450 researchers, including close to 85 graduate students, from 28 public and 22 private research institutions in Quebec and around the world. As part of its program, CQDM also provides mentorship to all funding recipients. The Centre for Drug Research and Development (CDRD) is a fully integrated national drug development and commercialization centre located in Vancouver. Part of the federal government’s Centres of Excellence for Commercialization and Research program, the CDRD provides business expertise, infrastructure and financial sup- port for researchers working in publicly funded health research agencies to advance promising early-stage drug candidates. Through its programs, CDRD sup- ports more than 10,000 scientists at over 30 Canadian and select international academic institutes by providing, among other things, professional management support. CDRD also works with large organizations such as Pfizer Canada, GlaxoSmithKline Canada and Janssen Inc. Canada to develop funding partnerships aimed at advancing and commercializing

“The support also takes many different forms including networking and business development opportunities, mentorship and training, legal support, and financing” 45


CHAPTER 2: HOW CANADA’S BIOTECH ECOSYSTEM WORKS

selected promising discoveries. MaRS Innovation commercializes the most promising research breakthroughs from 15 of Toronto’s top universities, hospitals and research institutes. Their portfolio, built through over 1,000 intellectual property disclosures from their member institutions, turns discoveries into businesses through industry partnerships, licensing arrangements and start-up companies. Bioindustrial Innovation Canada (BIC) is an industrial biotech accelerator located in Sarnia, Ontario. It plays a key role in translating Southwestern Ontario’s strengths in agriculture, chemical and automotive production into new, sustainable bioproducts and renewable energy. It is creating North America’s first bio-industrial laboratories and shared pilot plant facilities for gasification, pyrolysis, fermentation and bio-conversion. BIC was set up with $15 million in seed funding from the Centres of Excellence for Commercialization and Research program. Bio-Enterprise Corporation, a business accelerator and commercialization agent headquartered in Guelph, Ontario, was established to promote the creation, growth and expansion of businesses engaged in agri-technologies. Bio-enterprise works with companies at all stages of development providing business plan advice/assistance, financial and marketing strategy development, investment preparation, as well as sourcing of a variety of capital funding options.

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GROWTH CAPITAL As biotech companies grow, they require additional funding to support later stages of work including clinical trials for medical biotech applications, field trials for agricultural crops and demonstration sites for industrial biotech products and processes. Growth capital requirements could be as much as $25 million or more. At this stage, biotech companies are still too small to raise money in the public markets through Initial Public Offerings (IPOs). Growing biotech companies turn to Venture Capital funds — investors who provide money in exchange for a share in the company — for support. North America’s major biotech venture capital firms are largely concentrated in Boston and San Francisco - cities that were early leaders in biotech innovation. While Canada’s biotech venture capital industry was also strong during the 1990’s — a period of expansion in Canada — many important venture capital firms were lost during the global biotech industry’s contraction in the early 2000’s and during the 2008 economic recession. Today, Canada has only a small number of institutional Venture Capital firms that specialize in biotechnology - firms that mainly focus on life sciences and medical biotechnology. The availability of Canadian Venture Capital funding does appear to be improving but even today few Canadian firms would be large enough to finance a major biotech fund on their own. As such, most biotech venture capital funds are syndicated and often include investments from private investment funds, federal and provincial governments, agencies like the Business Development Bank and large pharmaceutical companies - organizations that have an interest in furthering Canada’s biotech sector. 48

A Sample of Biotech Venture Capital Funds Investing In Canada  : - A  morChem Fund (Merck, FIER Partenaires, Investissement Quebec, FTQ Solidarity Fund) : $41M - Bloom Burton Canadian Healthcare Fund LP - B  loom Burton Healthcare Structured Lending Fund LP - CITI Life Sciences fund $134 million - G  SK Canada Life Sciences Innovation Fund: $50M - GlaxoSmithKline SR One: $600M - J ohnson & Johnson Development Corporation - L  umira Capital II Fund (Merck, Lumira Capital, Teralys Capital): $110M Merck Lumira Biosciences Fund (Merck, Teralys Capital) : $42M OrbiMed Venture Capital Fund: $40M - Pfizer Venture Investments - T  VM Life Sciences Ventures VII (Eli Lilly, BDC, Fonds d’action CSN, Advantus Capital Management, Teralys and TVMCapital) : $170M - Teralys Capital Fund: Teralys’s first fund raised $700M, raising a second fund of $2S0-300M - Versant Ventures Health Care Fund $305 million


MATURE CANADIAN BIOTECH COMPANIES As it matures, a biotech company may begin to require financing in amounts of fifty million dollars or more in order to enter later stage clinical and demonstration trials and to ultimately enter the commercialization phase. To raise this funding, biotech companies may consider “going public” through an IPO or may look for an opportunity to be acquired by a larger firm that has the necessary infrastructure to continue the development, manufacturing and marketing of the product on a global basis. In 2011, Alexion Pharmaceuticals, Inc., a global biopharmaceutical company that is focused on developing therapies for severe and life-threatening rare diseases, acquired Enobia Pharma Corp. for $1.08 billion. Enobia, based in Montreal, develops therapies for patients with genetic metabolic bone disorders — including hypophosphatasia, a life threatening disease that can cause skeletal deformity, severe muscle weakness and progressive damage to vital organs. Aquinox Pharmaceuticals, Inc. started in 2006 as a spin-off from the University of British Columbia, the BC Cancer Agency and the Vancouver Coastal Health Research Institute. Between 2007 and 2013 Aquinox raised $57.5M in successive rounds of private funders and financing from Venture Capital funds and from investors including Johnson & Johnson Development Corporation, Pfizer Venture Investments and Pharmstandard International. In 2014 Aquinox was listed on NASDAQ through an IPO that raised $53 million — money that will be used to fund Phase 2 clinical trials on its two candidate drugs.

Xenon Pharmaceuticals Inc., a clinical-stage biopharmaceutical company in Vancouver, uses its platform Extreme Genetics® technology to study rare human diseases with extreme traits. Using its technology, Xenon develops therapeutics for orphan indications that it intends to commercialize on its own, but partners with global pharmaceutical companies like Merck or Roche’s affiliate Genentech to develop therapeutics for larger market indications. Xenon announced its IPO in 2014 — an offering that raised $38 Million. Alternatively, the company may remain private but seek out licensing agreements that permit large companies to utilize the technology while providing the Innovator with a revenue stream from royalties or licensing agreements. Zymeworks Inc., a privately held biotherapeutics company in Vancouver, develops protein therapeutics for the treatment of cancer, autoimmune and inflammatory diseases. Zymeworks — which has developed molecular modeling software for optimizing protein structure — enters drug development agreements with pharmaceutical companies giving them access to Zymeworks’ tech- nologies. Throughout the drug development process Zymeworks benefits from up-front payments, nearterm milestone revenue, and long-term royalty streams. Zymeworks also works on its own internal pipeline of antibody and protein-based drug candidates. January 2015 saw a new collaboration and licensing agreement announced with Celgene Corp. for the research, development, and commercialization of bi-specific antibody therapeutics enabled using Zymeworks’ proprietary Azymetric™ platform.

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KEY COMPONENTS FOR A GLOBALLY COMPETITIVE ECOSYSTEM Leaders in some of the most successful small and mid-sized life science companies in the country, venture capital firms, investment banks, biotech incubators and accelerators, intellectual property law firms, pharmaceutical, agricultural, bio-chemical and bio-fuels companies and industry associations all agree Canada has one of the most robust ecosystems for biotechnology discovery and early development in the world. They are unwavering in their support for Canada’s biotech activities and see the potential for Canada to become one of the leading biotech jurisdictions in the world. They believe biotechnology can strengthen the Canadian economy through biotech research, development and clinical activities, through investment opportunities and through the manufacture and export of biotech products.

Leaders spoke of Canada’s excellence in research and recognized that this and Canada’s many other strengths could be a calling card to attract investors and business leaders from Canada and around the globe to Canada’s biotech community. They believe through biotechnology, Canada has an opportunity to leverage the investments it is making in its post-secondary institutions and public research facilities to ensure the benefits of that research stay in Canada, Canada’s university system continues to prosper and its people benefit from the economic and scientific advances made here at home. Industry leaders identified four key themes for competitive bio-economy development.

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CHAPTER 3: KEY COMPONENTS FOR A GLOBALLY COMPETITIVE ECOSYSTEM

PEOPLE AND PARTNERSHIPS Industry leaders identified people and partnerships as being critical to the development of a world-class bio-economy in Canada. Those interviewed spoke extensively about the strength of Canada’s scientific and research community. However, they also stressed the importance of attracting and developing more entrepreneurs and mangers to support the development of biotech companies and of providing mentorship and entrepreneurial training for Innovators themselves. The interviewees also stressed the need for Canada’s biotech ecosystem to foster the right balance between curiosity and demand driven science. Demand driven research- research focused on specific targets - can be critical to the discovery of transformational and life-saving technologies. Curiosity driven research — research that is exploratory and undirected — often leads to or provides the building blocks for transformational discoveries down the line. A balance between the two is needed to ensure the long-term sustainability of Canada’s bioeconomy. Collaboration was also highlighted as being a critical factor in the success of Canada’s bioeconomy. Biotechnology is complex. It involves many different actors - academic researchers, clinicians, entrepreneurs and managers, angel investors, venture capitalists, and governments— all with various skill sets. It is, in many ways, a virtual economy. The nature of biotechnology and the structure of the sector make collaboration essential. Canada’s small population, geographic spread and federal-provincial joint governance structure make collaboration

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even more important. The United States, with 10 times the population of Canada, hosts a number of biotech regions, many of which - like Boston and San Francisco are, in and of themselves, considered world-class. With Canada’s smaller population and geographical spread, it cannot afford to develop competing biotech hubs. Canada needs all elements of the biotech sector to work together so the country can position itself as one biotech region ready to compete with the world. We are seeing the beginning of this collaboration, and these activities need to be made a priority. The Québec-Ontario Life Sciences Corridor was created in 2011 to better connect the medical biotech communities in those two provinces. With 66,000 people working in over 1,100 life science companies, as well as 490 undergraduate and graduate programs in biological and biomedicine sciences, the Corridor is now the second largest life sciences cluster in North America. Accel-Rx Health Sciences Accelerator (Accel-Rx) is a new initiative bringing together five of Canada’s leading health sciences Centres of Excellence for Commercialization and Research: The Vancouver Prostate Centre’s Translational Research Initiative for Accelerated Discovery and De- velopment (PCTRIADD), The Centre for Commercialization of Regenerative Medicine (CCRM), The Centre for Probe Development and Commercialization (CPDC), MaRS Innovation, and the Centre for Drug Research and Development (CDRD). Accel-Rx will help build relationships between technology developers, experts in drug development, clinical/regulatory


affairs, deal making and finance and entrepreneurs, mentors and research and development resources. CQDM, the pre-competitive research consortium based in Quebec encourages collaboration between Quebec and Massachusetts companies through

their partnership with Massachusetts Life Sciences Center. CQDM and its Massachusetts partner collaboratively fund investments in cross-border partnerships. Through this partnership, CQDM and its funding recipients also gain advice and mentorship from one of the world’s leading biotech regions.

ecosystem

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CHAPTER 3: KEY COMPONENTS FOR A GLOBALLY COMPETITIVE ECOSYSTEM

FINANCING Funding is an ongoing challenge for companies in the biotech industry. Before a biotech idea becomes commercially viable, years of research and development costing tens, if not hundreds of millions of dollars must take place. Even after a promising scientific discovery is made, most small biotech companies will operate for years without any revenue stream as they continue to develop and test their technologies and as they work through lengthy regulatory processes. External funding is critical to ensure these ideas have a chance to survive and to develop into viable products and applications. Biotechnology company leaders cite how Canada is beginning to emerge from the biotech capital drought that started in the early 2000’s. More venture capital and institutional funds are becoming available but Canada remains behind other jurisdictions, particularly the U.S., in this regard. But both IRAP and SR&ED are seen as cornerstones of Canada’s innovation system and are regarded as being among the best in the world. Beyond IRAP and SR&ED, however, federal research and development spending is spread across dozens of programs in a

number of departments. In 2011, the Jenkins-led Innovation Canada: A Call to Action report identified at least sixty federal funding programs that have been put in place to support innovation in Canada. Industry leaders noted small and midsized biotech companies often don’t have the resources to research or apply for these programs. They welcomed the National Research Council’s new Concierge Service, which has been put in place to help biotech companies navigate the collection of programs that may be available to them but also suggested program consolidation may be beneficial to ensure more material dollar amounts are available to applicants. Many of those interviewed noted that while the availability of early stage biotech funding had decreased during the 2008 global economic downturn the situation is starting to improve. While many believe “good science will attract capital”, they also caution many Innovators are not adept at marketing themselves or putting themselves in the path of potential funders. Many need support and counselling in understanding how to find and attract potential investors.

“Before a biotech idea becomes commercially viable, years of research and development costing tens, if not hundreds of millions of dollars must take place.” 58


SUPPORTIVE REGULATORY ENVIRONMENT Many industry leaders note the importance of Canada having a rigorous and responsive regulatory system to support biotech research, development and commercialization. They believe a nimble regulatory system — one with fast, reliable, predictable regulatory approvals could provide Canada with a competitive edge over other countries in developing this country’s bioeconomy. Canada’s regulatory system already ranks among the best in the world and Canada’s collection of regulatory standards and approvals is one of the country’s greatest assets as it develops a biotech ecosystem. They did stress however the importance of Canada maintaining this standard and, in particular, of ensuring those working within the regulatory system maintain an up-to-date understanding of biotechnology and its developments — an on-going challenge in a field of discovery inherently complex and is continually evolving in many different directions. Industry recognizes the critical importance of intellectual property protections to biotech research. Regardless of the partnership model, size of the business or nature of the research organization, the value chain is in lock-step agreement that a predictable and consistent intellectual property regime is critical to the long-term success of the biotech industry in Canada. Small Innovators in particular noted the fundamental nature of patent predictability to their ability to raise capital and garner attention from potential partner organizations, especially at the initial clinical trial stage. They underscored the high risk, high reward nature of the biotech industry means inconsistent rules bringing into question whether one’s patent might be successfully challenged in the future becomes an immediate and conclusive

suppressant in the pursuit of biotechnology innovation and investment. A surprising number of industry leaders comment on Canada’s potential strength as a global leader in clinical trials. While not an area limited exclusively to biotech products, clinical trials are a critical and costly stage in the development of medical biologics. Leaders commented on the many strong foundational elements present here in Canada - a modern health care system, a rigorous regulatory process, well- trained doctors and clinicians, a heterogeneous population base - could support the country becoming a global clinical trial leader. They noted, in large measure, clinical trials can be conducted anywhere and many other countries, particularly developing countries like China and India, are actively improving their infrastructure to permit more expeditious clinical trials.

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CHAPTER 3: KEY COMPONENTS FOR A GLOBALLY COMPETITIVE ECOSYSTEM

LEADERSHIP Industry leaders believe that to achieve excellence in biotechnology Canada must have a coordinated vision and a common set of objectives for its biotech economy. Many firmly believe leadership must rest with industry, not with government. While federal and provincial governments play a critical role in supporting the bioeconomy — by making it an economic priority, by putting in place strong and transparent policy programs and by championing the industry in international circles and at home - ultimately, leadership must come from within. They acknowledged the challenges inherent in this. Biotechnology is complex and the branches of study are diverse. It crosses many different sectors and embraces many layers in the development process. However it is this complexity that makes it imperative for there to be strong leadership and common objectives that can draw all elements of the economy together. Leaders noted the importance of having “everyone on the same page”, working together to develop Canada’s leadership in this field. There is also strong agreement from industry leaders that Canada’s biotech sector needs to do a better job communicating its strengths and telling its story. Without that, the biotech economy will go largely unnoticed by Canadians and will not receive the attention it needs and warrants from policy makers. Industry leaders also believe the sector needs to focus on developing collaborative partnerships with governments — partnerships based on the scientific and

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economic opportunity that biotechnology can offer, creating a biotechnology brand and communicating the value and story of biotechnology to decision makers and the public. While leadership must, first and foremost, come from industry, many of those interviewed acknowledged the important role government can play in supporting the biotech economy in Canada. Many of those interviewed observed there is no one federal government department or minister responsible for biotechnology in Canada — a situation that exists in many provinces as well. They believe the biotech economy needs champions at the federal level and in each province : political leaders who can signal to other countries and to investors that Canada is committed to excellence in this field, political leaders who can ensure there is a domestic policy environment that supports research and development and that draws the necessary talent and money to support Canada’s biotech industry, and political leaders who can work together to make Canada’s bioeconomy thrive.


“Industry leaders believe that to achieve excellence in biotechnology Canada must have a coordinated vision and a common set of objectives for its biotech economy�

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CHAPTER 4: A VISION FOR CANADA’S BIOTECH SECTOR

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CHAPTER 4 :

A VISION FOR CANADA’S BIOTECH SECTOR

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CHAPTER 4: A VISION FOR CANADA’S BIOTECH SECTOR

A VISION FOR CANADA’S BIOTECH SECTOR

BIOTECanada believes Canada’s biotech community has what it takes to become one of the Top 3 biotech economies in the world by 2025. This view was supported by many of the industry leaders interviewed for this paper. They too believe that Canada

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can build on its existing strengths and evolve from being a country with a strong biotech research base to being an undisputed global leader in biotech research, development and commercialization.


Reaching the top 3 by 2025 It is clear from our research that becoming one of the Top 3 biotech jurisdictions by 2025 will require a focused, coordinated and sustained effort on the part of Canada’s biotech industry. Canada’s biotech sector is broad — it is geographically spread out, it encompasses many different types of organizations each of which plays a critical role along the biotech development chain, and it addresses almost all facets of biotech research. All partners in the biotech community will need to work together to ensure Canada has a strong ecosystem to realize global leadership by 2025. As a first step, Canada’s biotech community must adopt a common vision for the biotech economy. To reach the Top 3 by 2025, BIOTECanada’s Board of Directors and leaders from across Canada’s biotech community must confirm, embrace and aggressively pursue this common goal. The community must evaluate what steps will lead Canada to the Top 3 by 2025 and must implement a program to pursue this objective. As the industry organization representing Innovators from across Canada’s biotech economy, BIOTECanada is uniquely positioned to design, launch and lead this initiative. BIOTECanada cannot do it alone. Reaching the Top 3 by 2025 will require broad support and participation from Canada’s biotech leaders. BIOTECanada is well recognized and well respected as the organization representing all facets of biotech innovation in Canada. BIOTECanada should work to actively recruit leading Canadian biotech organizations (universities, government agencies, industry associations, incuba-

“Canada’s biotech community must adopt a common vision for the biotech economy.” tors and accelerators and companies) to join them and to commit to working together to reach the Top 3 by 2025. Reaching the Top 3 by 2025 will also require that Canada put in place the necessary programs and initiatives to support Canada’s biotech community as it works towards the Top 3 by 2025 goal. Industry leaders have identified the need for support in four key areas: People and Partnerships, Financing, Supportive Regulatory Environment, and Leadership.

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CHAPTER 4: A VISION FOR CANADA’S BIOTECH SECTOR

LEADERSHIP BIOTECanada has identified a number of priorities to support Canada reaching the Top 3 by 2025 and will begin work on these immediately. They include : Goals and Metrics Canada’s biotech community must establish specific goals and metrics to measure its success in reaching the Top 3 by 2025. The biotech economy is diverse and can be difficult to capture in a single window, but industry must agree on key indicators that will allow it to meaningfully measure its global competitive position in biotechnology today, in 2025 and at critical points in between. Today, there are few current statistics examining the activity and performance of Canada’s biotech economy. Having this information would allow industry to measure its progress, verify its competitive position and better understand the impact of various domestic policies, programs and initiatives. Industry is best positioned to identify these information requirements whether it be academic royalties from the licensing of biotech innovations, investment in biotech research and development or employment levels- and industry should define its information needs and the options for collecting and analysing that data. BIOTECanada - representing health, agriculture and industrial biotechnology — should work with its members and with industry associations and government partners to identify the key metrics needed to measure the state and development of Canada’s overall biotech economy, as well as its key segments, and to develop recommendations on how data that is meaningful to the industry’s performance and progress should be collected, with a

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goal of starting the collection of data for the 2015 calendar year. Government Champions While leadership must, first and foremost, come from industry, governments also have a critical role to play. Industry needs champions. Today, there is no one federal government department or minister responsible for biotechnology in Canada. Depending on the process or the product, biotechnology may fall under the mandates of no fewer than six federal cabinet ministers including Industry, Health, Finance, Agriculture, Environment, and Natural Resources. Without a vocal champion coordinating the government’s efforts, the biotech economy will appear fragmented and domestic policies and programs will be developed at too granular a level, potentially overlooking the broad initiatives needed to bolster the entire community. The Canadian government also has an important role to play in promoting Canada’s bioeconomy — signaling to other countries and investors that Canada is committed to excellence in this field, ensuring there is a domestic policy environment that supports and protects research and development of ideas, and that draws the necessary talent and money to support Canada’s biotech industry. To ensure biotechnology has a strong coordinated voice in domestic and international policy circles, the federal government should appoint a lead Cabinet Minister for the bioeconomy. This minister should be a partner in and key champion to the drive to reach the Top 3 by 2025. Provincial governments are equally important. Across Canada, biotechnology is a critical contributor to provincial economies.


Provincial governments have an important role to play in inspiring their academics and public research scientists, in developing programs and policies that support and attract biotech Innovators and in working together to ensure Canada’s biotech economy ranks as one of the best in the world. To ensure biotechnology remains a central point of provincial economies, each province should appoint a senior minister to be responsible for biotechnology and these ministers should include biotechnology as a key discussion item in their annual policy meetings. Securing Canada as a preferred destination for investment While Canada is certainly well-positioned, other nations are also acutely aware of the global opportunity and are quickly moving to develop technology sectors by implementing policy frameworks supportive of both innovation and investment. If Canada is to compete globally and reap the benefits robust innovative industries can deliver, then it must keep pace with other jurisdictions and attract investment- the catalyst of research and development

place in the world as a leading economy where investment seeks to come and be deployed. It is suggested a Parliamentary Committee study be initiated within a year to analysis the Canadian envirnoment for investment into start-up, SME technology driven enterprises. The purpose of this study will be to ensure Canada is maximizing its advantages to attract the volume of investment needed for SME companies to grow to bring new products and technologies into the global marketplace. Does Canada have an equitable system of investment incentives to attract investment across all sectors with high risk profiles? The strength of knowledge-driven research and development has never been more valuable. Given the recently achieved balanced budget established by the federal government, the time is right for the analysis of competitiveness of Canada as a destination for investment for risk intensive technology platforms like biotechnology.

Given the diversity of expertise required to create and maintain an economy attracting international capital investment, able to withstand global competition, it is an opportune time for Canada to review its

“It is an opportune time for Canada to review its place in the world as a leading economy� 71


Profile for LaCamaraderie

BIOTECANADA Ecosystem Report 2015  

BECOMING A WORLD LEADING BIOECONOMY BY 2025 Canada’s biotechnology ecosystem has what it takes to become one of the Top 3 bioeconomies in t...

BIOTECANADA Ecosystem Report 2015  

BECOMING A WORLD LEADING BIOECONOMY BY 2025 Canada’s biotechnology ecosystem has what it takes to become one of the Top 3 bioeconomies in t...

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