BioPortal | Report on Biotechnology

An explosion of extraordinary advances in molecular biology, genetics and biochemistry - the life sciences - has spawned a broad array of biotechnology products and services which are transforming everything from the foods people eat, to the integrity of the physical environment, to the quality of health care Canadians receive. A key contributor to the knowledge-based economy, biotechnology generates new jobs and business opportunities, and supports the competitiveness of some of Canada's most important industries. Industry Canada (IC) enables biotechnology's development by ensuring that Canadians can conduct research, commercialize, adopt technology and, as a result, grow stronger, more productive businesses. The department provides access to information technology so Canadians can acquire the necessary knowledge to develop their skills, stay abreast of new technological developments, conduct business transactions and gain access to new ideas that lead to innovative technological advancements.

Equally important, IC fosters the stability and efficiency needed in the Canadian marketplace to conduct business and maintain consumer trust in business transactions as well as the goods and services produced. It works to increase investor awareness and confidence in Canada as an investment location of choice and to encourage domestic and foreign direct investment, which benefits Canadians in business development and job creation. Among its many services, the department introduces Canadian businesses to new technologies, helps them upgrade their management and marketing skills, and provides wider access to markets. It also works with Canadians to increase the number of exporting firms, which are typically more profitable and generate more jobs, providing higher salaries to employees of these firms.

Contributions to the CBS

Investing in discovery

Most Canadian biotechnology discoveries have been built on research originating in Canadian universities, research hospitals and government laboratories. To fuel this innovation, basic research funding is critical. Industry Canada contributes to scientific breakthroughs by funding the Canada Foundation for Innovation, the Canada Research Chairs Program, Networks of Centres of Excellence and Genome Canada.

Genome Canada, for example, was set up by IC to enable Canada to become a world leader in genomics and proteomics research in key areas such as agriculture, environment, fisheries, forestry and health. New drug therapies, improved diagnostics, personalized medicines, more nutritious foods, more bountiful crop yields and a cleaner environment are just some of the benefits deriving from genomics research. More details about the work of Genome Canada can be found on page 62 of this chapter.

Given the breakneck pace of such developments, much of Canada's biotechnology research has become increasingly complex. It often involves teams that operate globally, huge repositories of research and observational data, and high performance computers to perform simulations and visualize results. Innovation, therefore, requires access to information technology infrastructure. Industry Canada supports world-class biotechnology research by investing in organizations like CANARIE Inc., a not-for-profit corporation working to expand Canada's national research network to allow Canadian researchers to create high-capacity connections and computing resources.

To fully capture the social and economic benefits of federal investments in basic research and information technology, there must be opportunities to translate new discoveries into biotechnology products and services through commercialization. To facilitate and accelerate these developments, Industry Canada has created the Life Sciences e-Technology Transfer, a searchable database of domestic and international licensing opportunities, as well as the Commercialization Portal, a comprehensive source of information on business development.

In addition, government programs such as Technology Partnerships Canada provide repayable investments to spur the evolution of innovative technologies. Investment Partnerships Canada (IPC) raises awareness of Canada internationally as a location of choice for foreign investment. When foreign firms are looking to invest in Canada, IPC offers assistance in providing site selection data, advice on programs, regulations, transportation and taxation, as well as introductions to key government and private sector contacts. And the Business Development Bank of Canada, a financial institution wholly owned by the Government of Canada, announced in 2002 that it would target $200 million in venture capital investments to the biotechnology sector over the following five years.

Industry-government partnerships also bolster the development of biotechnology products and services. These partnerships allow timely information flow among all stakeholders to accelerate the pace of technology transfer and to improve the odds of commercializing discoveries. For instance, Industry Canada supports Bio-Products Canada, an industry-led, not-for-profit organization. Given that bioproduct technologies embrace many sectors - from wood-based products to chemicals and fuels - Bio-Products Canada plays a critical coordinating role in identifying opportunities and providing advice to drive research and development agendas.

Finally, technology foresight is essential to plan effective research strategies that will eventually lead to the commercialization of bio-based products and services. Industry Canada has worked over the last few years to link research, capital, training and commercialization organizations, encouraging them to look 10 to 20 years into the future in order to determine what the market will require.

Having determined those needs, industry then identifies the technologies that must be developed to meet future market demand and strategizes the best way to attain these targets. Industry Canada representatives act as facilitators and catalysts in developing these "technology roadmaps" for high-growth sectors such as biopharmaceuticals.

Creating a better business climate

The growth of the biotechnology industry requires world-class business and regulatory regimes that nurture innovation and build public trust and confidence. Industry Canada supports such a competitive business climate by monitoring key marketplace frameworks such as intellectual property and regulations. The department then participates in initiatives to promote the creation of optimal conditions to attract and retain biotechnology companies while also protecting the public interest.

Given the complex nature of biotechnology, the examination and processing of biotechnology patent applications generally takes longer compared with other technologies. The Canadian Intellectual Property Office (CIPO) provides an online Manual of Patent Office Practice that describes the scope of patentable subject matter, including in the field of biotechnology, as well as the manner of application of the patentability criteria. The recruitment and hiring of new examiners has been stepped up appreciably to cope with the increasing volume of applications and to reduce the time required to grant patents. CIPO's current performance standard is a 24-month turn-around. The Office is committed to reducing the time to process applications to 18 months by 2004.

With its advanced level of electronic filing and e-commerce, CIPO remains one of the leading mid-sized intellectual property offices in the world, employing innovation in its business practices to enhance its services and performance. Given the importance of intellectual property and regulatory systems in strengthening Canada's biotechnology community, Industry Canada has worked with partners to provide online information products for industry and others interested in knowing more about the Canadian federal and provincial acts and regulations.

As crucial as marketplace frameworks are highly qualified people who can capitalize on a competitive business climate. The biotechnology community has stated there is a critical need for experienced senior management in Canadian biotechnology companies. Often, biotechnology failures are attributed to a lack of experienced managers who can take a firm beyond the initial development stages to successful licensing and commercialization. For biotechnology to flourish in Canada, the current skills gap faced by the sector must be addressed.

Industry Canada is working with industry to develop, attract and retain talent, and upgrade the skills of the population to fuel Canada's innovation performance. Efforts have been undertaken to improve processes to recognize foreign credentials, encourage multidisciplinary skills development and provide incentives to increase in-house training and apprenticeships.

A feasibility study published in 2001 recommended a one-year national training program to support the sector. In 2002, the department, in collaboration with the Biotechnology Human Resource Council (BHRC), developed the design and cost estimates for the graduate level program which will focus on regulatory requirements and processes, business development, technology transfer, intellectual property and management skills.

Consumer concerns surrounding biotechnology are addressed within Industry Canada by the Office of Consumers Affairs (OCA), whose mandate is to protect and promote the consumer interest. In order to understand consumers' reactions to and perceptions of biotechnology, the OCA has funded a number of research projects. The research results contribute to the formulation of government policies to ensure they reflect and respond to public consumer policy priorities, such as the issues surrounding genetic privacy and the labelling of genetically engineered foods. The OCA has worked on the Canadian General Standards Board Committee to develop a Standard for the Labelling of Foods that are and are not products of genetic engineering, and participates in a working group on Genetic Information and Privacy, established under the Canadian Biotechnology Strategy.

The Life Sciences Branch of Industry Canada also participates in the same working group on Genetic Information and Privacy. During the 2002-2003 fiscal year, it commissioned a Statistics Canada survey of Canadian biotechnology companies to gain a better understanding of how much material is being held by companies, how they are obtaining and storing this material, and what steps are being taken to protect the privacy of Canadians.

Supporting investment and trade

Attracting and retaining investment is vital to the Canadian economy and the biotechnology industry in particular. A long, costly and risky development process requires significant investment and venture capital from domestic government financing as well as multinational corporations.

Securing new investments and building greater international awareness of Canadian excellence in biotechnology requires sophisticated communications tools used in conjunction with targeted conferences, expositions and sector-based marketing. Industry Canada, Investment Partnerships Canada and the Canadian Institutes of Health Research established the Life Sciences Investment Roundtable to link Canadian R&D with industry interests. It has helped Canada attract numerous investments, primarily from multinational pharmaceutical and biotechnology companies.

With a small domestic market, Canadian biotechnology companies rely on international trade for growth. Recognizing the increasing number of products in the pipeline, the Government of Canada and industry have been marketing Canada's biotechnology capability more aggressively abroad.

Over the past five years, partnering events have taken place in New York, Boston, Tokyo, Singapore and Taiwan. With its sector expertise, Industry Canada coordinates efforts among other federal departments at international biotechnology trade shows, incoming and outgoing business missions, seminars and match-making events. Biotechnology firms also benefit from IC's programs and services for new exporters, which are delivered through International Trade Centres located in every province across Canada.

The department worked with the federal community to launch the Canadian presence at Biotechnology Industry Organization (BIO), held in June 2002 in Toronto. BIO is the world's largest and most important biotechnology conference and trade show. The 198 firms that completed a detailed questionnaire during BIO 2002 reported that 97 percent of the Canadian companies exhibiting identified sales leads and 73 percent made on-site sales.

Early successes

Industry Canada strives to foster a growing, competitive, knowledge-based Canadian economy. Many of the department's policies, programs and services specifically focus on accelerating sustainable economic benefits from biotechnology to improve Canadians' quality of life. The department funds the work of the following organizations and agencies which are at the forefront of biotechnology innovation:

The innovative research of the Networks of Centres of Excellence has spun off 15 biotech companies in the past three years. Among them is GLYCODesign Incorporated, which became publicly traded in 2000 and now employs almost 100 people. The company's lead anti-cancer compound, GD0039, blocks the production of specific carbohydrates that coat the outside of cancer cells and restores some degree of growth control. In animal models, tumour growth has been slowed by the compound and the spread has been blocked. The anti-cancer product is in Phase II clinical trials and is targeted at treating metastatic renal cancer, which is resistant to chemotherapy. The compound may be used in conjunction with chemotherapy for other cancers, which could allow smaller toxic doses than usual. The company expects to have this treatment on the market in 2005.

Networks of Centres of Excellence

Networks of Centres of Excellence (NCE) are unique partnerships among universities, industry, government and non-governmental organizations aimed at turning Canadian research and entrepreneurial talent into economic and social benefits for all Canadians. An integral part of the federal government's Innovation Strategy, these nation-wide, multidisciplinary and multisectoral research partnerships connect excellent research with industrial know-how and strategic investment.

The Government of Canada, through NCE, has invested close to $30 million annually since 1998 in seven networks undertaking work with biotech dimensions, including: the Canadian Bacterial Diseases Network, the Canadian Genetic Diseases Network, the Protein Engineering Network of Centres of Excellence, the Canadian Network for Vaccines and Immunotherapeutics, the Canadian Arthritis Network, the Canadian Stroke Network and the Canadian Stem Cell Network. In addition to their own research studies, more than 770 researchers at these centres are training over 1,600 students and other highly qualified personnel for the biotechnology sector.

The leading-edge research carried out at these networks is resulting in improved treatments of the most common human diseases and developmental deficits as well as new vaccines. Examples of NCE innovations include the development of a cattle vaccine against the deadly E. coli bacteria. Canadians are familiar with E. coli because of the Walkerton tragedy in which seven people lost their lives and more than 2,000 became ill. The vaccine reduces the number of organisms in cattle and cattle manure which, in turn, reduces the risk of contaminating food and water.

Canada's Innovation Strategy

More than 10,000 Canadians, including members of the biotechnology community, voiced their views about how to create a culture of innovation and learning across Canada during public consultations held in 2002. This input helped to shape the Government of Canada's Innovation Strategy, which aims to move Canada to the front ranks of the world's most innovative countries.

Biotechnology has the potential to be a major contributor to many of the Innovation Strategy's targets and objectives, including the government's goal to double R&D, better commercialize Canadian research, and modernize our business and regulatory policies. More important, there is a clear potential for the biotechnology sector to provide health and environmental benefits for Canadians. The recommendations and commitments received from the biotechnology community will help to shape the government's national action plan for innovation.

Canada Foundation for Innovation

The Canada Foundation for Innovation (CFI), established in 1997 as an independent organization operating at arm's length from government, is helping universities and research institutes to build up Canada's research infrastructure. The CFI fosters innovative, multidisciplinary research by providing state-of-the-art research facilities and equipment in Canadian universities, colleges and hospitals. A significant and growing portion of the CFI's federally funded budget is dedicated to enabling fundamental biological research, the foundation of biotechnological advances.

To date, the CFI has helped finance 650 research projects in biotechnology valued at $350 million. This funding provides the essential research equipment needed to support research teams. It also enables institutions to recruit outstanding new researchers and to retain Canada's current research leaders.

The CFI's funding supports research in a broad and diverse range of areas, including: genomics and stem cells; vaccines; improving the quality and sustainability of the Canadian natural environment and its forest industry; and in the treatment of waste water. This research is making significant contributions to the Canadian economy, the environment and to the health and well-being of Canadians, and is helping to keep Canada among the leading countries in biotechnology research.

Canada Research Chairs

In 2000, the Government of Canada provided $900 million to support the establishment of 2,000 Canada Research Chairs to enable Canadian universities, together with their affiliated research institutes and hospitals, to achieve the highest levels of research excellence to become world-class research centres in the global, knowledge-based economy. As of June 2003, the Government of Canada had invested $220.5 million to create 201 Canada Research Chairs focused on biotechnology.

This represents an investment of $192 million from the Canada Research Chairs Program and $28.5 million in infrastructure funding from the CFI. These biotech researchers are making advances in areas as diverse as identifying genes that cause food and waterborne illnesses, developing artificial limbs, researching effective treatments for blood vessel abnormalities and examining the implications of genetic engineering.

Technology Partnerships Canada

The Technology Partnerships Canada (TPC) investment program is a key instrument of Canada's Innovation Strategy that is helping innovative Canadian biotech companies advance great ideas to get them to market. TPC's biotech investments enable companies to develop pioneering technologies, pursue significant medical breakthroughs, strengthen their R&D capacity through a wide variety of alliances, and provide new career opportunities within businesses across the country.

TPC-funded initiatives include promising Canadian biotechnology applications ranging from health care to agriculture, energy and aquaculture. Biotech investments in health, particularly, are helping position Canada as a location of choice for medical biotech R&D and strengthening Canada's position as a world leader in cancer vaccine research.

TPC investments have enabled successful medical breakthroughs such as the revolutionary cancer treatment Theralux™, developed by Celmed BioSciences of Montréal. The company believes it has discovered the answer to the challenge of helping the 70 percent of cancer patients who need a bone marrow transplant but are unable to find a compatible donor.

After determining this leading-edge technology was worthy of taxpayers' backing, in November 1999, TPC invested $4.6 million to advance clinical trials on Theralux™. The company's photodynamic therapy (PDT) technology is designed to destroy cancer cells in a patient's own bone marrow or blood outside the body. Theralux™ works by using a proprietary drug, TH9402, to selectively kill cancer cells when exposed to light.

More than 100,000 heart patients worldwide who annually require heart transplants could soon benefit from TPC investments in Ottawabased World Heart Corporation, developers of the HeartSaverVAD™ ventricular assist device that helps a patient's weakened heart circulate blood. Only about 4,000 transplantable hearts are available each year, leaving roughly 95 percent of heart patients in need of treatment. This technology is projected to fill that gap; it is believed that HeartSaverVAD™ may, one day, become as common as a pacemaker.

In 1996, World Heart acquired the worldwide rights to ventricular assist device (VAD) technology, the basis for the HeartSaverVAD™, from its developers at the University of Ottawa Heart Institute and, with a $9.98 million repayable investment in November 2001, from TPC, undertook clinical trials in partnership with the university. With continued investment from TPC, the improved device should be available on the market by 2007.

Online information products and services

Online information products available at the Biotechnology Gateway (strategis.gc.ca/bio) strengthen Industry Canada's capacity to promote public awareness of biotechnology, increase the transparency of the regulatory system and merge scientific innovation with business knowledge, thereby fostering growth in the Canadian life sciences industry.

Additional sites with valuable information about biotechnology can be accessed through the department's Life Sciences Web site (strategis.gc.ca/lsb), including:

Genomics is a discipline that aims to decipher and understand the entire genetic information content of an organism; it is fundamental to all biological and biotech research. It differs from classical biological research in its large scale, broad scope and intense reliance on data collection, analysis and information technology (bioinformatics). It is widely recognized as the key to the future of the biotechnology industry, providing the essential science base for a wide range of biotech applications.

Proteomics is the study of the full set of proteins encoded by a genome.

Genomics is rapidly changing the way we understand nature, including the nature of humans. This fast-evolving field, aimed at "cracking the code of life," holds the promise of unprecedented scientific breakthroughs that may lead to new treatments and even cures for diseases, plentiful, healthier foods and a cleaner environment.

Genome Canada is an arm's length, not-for-profit corporation that serves as the primary funding and information resource for genomics and proteomics in Canada. Its mission is to develop and implement a national strategy in genomics and proteomics research for the benefit of all Canadians.

The corporation has received $375 million from the Government of Canada to date to establish five Genome Centres across the country (Atlantic, Quebec, Ontario, Prairies and British Columbia) and to ensure that Canada becomes a world leader in genomics and proteomics research. Together with its five Centres and other partners, Genome Canada invests and manages large-scale research projects in selected areas such as agriculture, environment, fisheries, forestry, health and new technology development. Genome Canada also supports research projects studying and analyzing the ethical, environmental, economic, legal and social issues related to genomics research.

Genome Canada has leveraged its federal contribution by securing approximately $300 million more from provincial governments, industry, not-for-profit organizations, international agencies and other partners. When these contributions are added, this amounts to almost $680 million available for the 57 innovative science and technology platforms and genomics and proteomics research projects undertaken thus far.

Some of these projects will help develop tools that will bridge the gap between basic discovery research and practical application in hospitals and community clinics. A recent example was the sequencing of the SARS virus through the use of Genome Canada's funded platform in Vancouver. The investments made by Genome Canada and Genome BC in that platform allowed Canada to be first in the world to sequence the virus.

Other research projects focus on finding solutions to agriculture pollution and environmental challenges. One such Genome Canada project is looking at alternatives to high-cost fertilizers like Sinorhizobium meliloti, a soil bacterium that shares a natural symbiotic relationship with plants. By sequencing these bacteria, researchers will be able to use them as replacements for harmful nitrogen fertilizers.

Genome Canada is conducting some of the most interesting, innovative and significant genomics and proteomics research in the world, positioning Canada at the leading edge for years to come. Genome Canada is also connecting Canada's best researchers with the world's best. Genome Canada's International Consortium Initiative program led to the approval, in March 2003, of the largest international health research project ever funded in Canada: the Structural Genomics Consortium. The $95 million project, aimed at unravelling the structure of hundreds of proteins, is believed to be significant to human health. Partners include four other Canadian organizations, the United Kingdom's Wellcome Trust and the pharmaceutical company GlaxoSmithKline.

Genome Canada has a number of international agreements and collaborates with many countries including Denmark, the Netherlands, Spain, Sweden, the UK and the USA in multinational projects. One such initiative is the International HapMap Project, a $150 million international consortium aimed at speeding the discovery of genes related to common illnesses such as asthma, cancer, diabetes and heart disease.

Because the potential of genomics is so profound, it is essential that Canadians have a firm grasp of its implications in order to make informed decisions about its many applications. In 2003, Genome Canada launched a major public outreach and education project - the GEEE! in Genome - an interactive multidimensional exhibit, officially opened by the Prime Minister at the Canadian Museum of Nature in April, that is travelling to nine cities across Canada. Through this exhibition, Canadians will learn about the structure of DNA, the role of genes and proteins, and catch a glimpse of the substantial role Canada is playing in the genomics revolution.

For a complete list and comprehensive description of all 57 projects and information about Genome Canada programs, policies and initiatives, please visit: www.genomecanada.ca/projects

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Harnessing the benefits of biotechnology