Presentation to World Health Organization

BIOTECanada

Ottawa, October 7, 2004

About BIOTECanada

• Member funded association• Advocacy to federal government• Public Dialogue• Business solutions• 2001 created Statement of Ethical

Principles

BIOTECanadaCanada’s Voice for Biotechnology

hRepresents over 85% of Canadian health care, agriculture, food, research and other organizations that work towards improving the lives of Canadians through biotechnology.

hBIOTECanada is the voice of the biotechnology community, where research and development leads to new cures, treatments and innovations.

Our Members

• Discovery platforms• Therapeutics• Agricultural innovations• Diagnostics• Stem Cells• Biopharmaceuticals• Vaccines• Genetic and cell based therapies• Service suppliers

Distribution of firms by sector

Advanced Materials

3%

Environment4%

Agriculture12%

Genomics, Proteomics & bioinformation

12%

Diagnostics10%

Therapeutics59%

Source: Ernst & Young, 2004

Distribution of Biotech Firms by Province

Source: Ernst & Young, 2004 and Regional Associations

0 50 100 150 200

Atlantic Canada

QC

ON

MB

SK

AB

BC

Biotechnology Products & Processesin the Pipeline

• 327 firms developing products requiring biotechnology

• 228 firms developing processes requiring biotechnology

Source: Statistics Canada

A typical BIOTECanada member is . . .

• Private• Works in human therapeutics with an R&D focus • Employs less than 50 people• Does not have a commercialized product • Has less than 12 to 18 months of funding• Faces barriers to commercialization (regulatory

approval etc.) and lacks skilled human resources• Priorities are alliances and partnerships, within

Canada and the US• Outsources some activities in the product

development cycle

Canada 3,2,1!

• Canada ranks third, behind the U.S. and United Kingdom, in generating revenues

• Second, behind the U.S in the number of biotech companies

• And first in R&D expenditure per employee

Federal Government Commitment

• 5% of R&D investment to a knowledge-based approach to develop assistance for less fortunate companies

• Appointment of a National Science Advisor, Dr. Arthur Carty

• Canada as a world leader

Top 10 biotechnologies for improving the health in developing nations

1.Molecular diagnostics

2. Recombinant vaccines

3. Vaccine and drug delivery

4. Bioremediation

5. Sequencing pathogen genomes

Source: University of Toronto Joint Centre for Bioethics

6. Female-controlled protection against sexually transmitted infections

7. Bioinformatics

8. Enriched GM crops

9. Recombinant drugs

10. Combinatorial chemistry

Top 10 biotechnologies for improving the health in developing nations

Source: University of Toronto Joint Centre for Bioethics

Competitive Canada

• KPMG's 2004 international business cost study demonstrated that Canada is the least costly place in which to do business among the G7 countries.

• The cost of biomedical R&D in Canada is 16.6% lower than in the United States.

Research Excellence

• $13 billion federal government investment in Canadian knowledge infrastructure

• Genome Canada created in 2000• CIHR established in 2000• 2000 Canada Research Chairs

Research Excellence• Canada has also developed about 10 percent of the

world's new medicines and helped discover more than 25 percent of known disease-causing genes.

• As of 2004, more than 500 therapeutic products are being developed in Canadian biopharma research labs.

• In 2003, more than $1 billion was invested in life-sciences research and development (R&D), with the pharmaceutical industry spending more than another $1 billion on R&D.

The potential of biotech• New vaccines – Cancer, SARS• Plant made pharmaceuticals• Regenerating tissue• Non-allergenic and healthier foods• Bio industrial development• Plants that change colour in the presence of

land mines• Trees that detoxify mercury • Nanoparticle-based drug delivery

Research leadership

• Polio• E. Coli vaccine• AIDS • Cancer vaccine development• Wellcome Trust partnership• Stem Cell research

Canadian biotech excellence

• Specialty Pharma/Drug Delivery• Biotechnology/New Chemical Entity• Genomics/Proteomics• Medical Discoveries/Diagnostic• Healthcare Services/IT

Orphan drugs

• Ability to meet unique medical needs• Small-sized patient groups, high cost of

development, however…– Stimulate drug development– Lower mortality rates– Unmet medical needs at a global level provide

Canada an opportunity for leadership

Value of IP

• Volume of global innovation unheralded• Health and science revolution underway• Nature of health care is changing

– Early diagnosis– Prevention playing larger role in healthcare– More targeted care for greater numbers of

people

Political will to achieve potential

• “We want to see greater collaboration among nations to ensure that economic policies go hand in hand with stronger social programs to alleviate hunger, poverty, and disease, and to help to raise the standards of living in developing countries.”

• “Canada’s obligation does not stop there. We are a knowledge-rich country. We must apply more of our research and science to help address the most pressing problems of developing countries.”

- Speech from the Throne, Feb. 2004

• “The Government of Canada has made substantial investments—more than $13 billion since 1997—that have built a strong foundation in basic science and technology, including the Canada Foundation for Innovation, health research and other initiatives to create leading-edge capabilities. It will continue to build on this strength.”

• “The Government will develop policies to foster Canadian capabilities in key enabling technologies—such as biotechnology, information and communications, and advanced materials—which will be drivers of innovation and productivity in the 21st century economy.”

- Speech from the Throne, Oct. 2004

Political will to achieve potential

Patent World is Changing

• Largest growth in past 20 years-IT and biotech• Empirical evidence shows patents do

encourage innovation • Patents allow small companies to compete

against larger, international counterparts• New innovative nations: Korea, Chinese Taipei,

China, India and Israel

Source: (OECD report 2003)

Canadian IP situation

• No patent term restoration• No Harvard Mouse recognition• Difficulty in all levels of government

recognizing patents

Sustaining Canadian biotech

• Research to commercialization is expensive

• 7-10 years development for treatments• Regulations are slowing the process down• Increased need for skilled workers• Public acceptance of technology key to

success