edison liu, m.d. [email protected] +65-68478-8007 wipo conference on dispute resolution in...
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Edison Liu, [email protected]
+65-68478-8007
WIPO Conference on Dispute Resolution in International Science and Technology Collaboration
25-26 April, 2005 Geneva
Who am I?
• Physician: Oncologist
• Academic: Professor Medicine, Biochemistry, Genetics, Epidemiology
• Government: Scientific Director, NCI and Genome Institute of Singapore
• Businessman or Lawyer
Therefore this talk will be centered on Biomedicine
Fundamental Realities: 2005
• The state of the science is remarkable
• Phase shifts in conceptualization and action are taking place
• Disruptive changes in the industry are happening at a pace that outstrips legal and social/cultural responses
• Conflicts will inevitably arise
• Solutions will come easier if there is an understanding of scientific culture and its social history
Phase shifts in how governments view biology:
• Before 1900 (Europe): Biology as an academic exercise - privileged activity for gentleman scholars (or monks)
• 1900-2000 (USA): Biology with clinical impact – biological research for public health (NIH model): social service cost center
• 2001-future (Asia?): Biology with commercial impact – biology for public wealth:
revenue generator
Conflicts brought on by these phase shifts:
Europe vs. US:
“Making money from scientific research is immoral”
“I am not going to patent anything”
West vs. Asia:
“Companies are moving to Asia to avoid ethical requirements”
Conflicts brought on by these phase shifts:
Europe vs. US:
Europe – until recently patents were the personal responsibility of the professor
US – Bayh-Dole and institutional ownership and exploitation of university IP
Asia – government ownership and direct IP from universities and research institutes
Phase Shift in Biology:
Before After
Observational Creating
Single investigator Complex teams
Reductionist Data mining
Phase Shift in Pharmaceutical Industry:
Many key biomedical discoveries will come from well organized and coordinated national/international efforts.
Fundamental Realities: 2005
• Speed of discovery in biology and medicine is profound
Biomarkers:HER-2 and prognosis: one marker in 12 years (1989-2001)Array prognostics: 100-400 markers in 1 year (2004)
Drug developmentTarget discovery and validation: 1985 – one molecule and a thousand compound2005 – 40,000 cDNAs and 1 million compounds
Fundamental Realities: 2005
• The scope of knowledge necessary to be successful in biomedical research is remarkable
What you need to know to be a good biologist:
1965: Biology
2005: Developmental biologyMolecular biology
Biochemistry Structural biology
Model systems (mammalian, yeast, drosophila, C. elegans) Computational literacy
Fundamental Realities: 2005
• The scope of knowledge necessary to be successful in biology and medicine is remarkable
• Speed of discovery in biology and medicine is profound
No single entity can corner innovation and domain knowledge
Collaborations and alliances are essential
Collaborations are now highly complex
11
Biotech/Pharma Alliances
0
100
200
300
400
500
600
1993 1994 1995 1996 1997 1998 1999 2000
Source: Goldman Sachs Global Equity
Research
Collaborations are essential in today’s research labs
Active collaborations in my laboratory:
Karolinska Institute
University of Illinois, Champaign Urbana
NCI, USA
Johns Hopkins University
Eli Lilly
Cloning and sequencing group: GIS
Functional genomics: GIS
Bioinformatics group: GIS
Institute for Infocomm Research
RIKEN: Japan
Conflicts that arise:
Ownership of IPR
Control issues
Conflicts in key performance indicators:
Academic vs. Commercial entity
Open source vs. trade secrets
Academic emotion vs. business realities
Area of future conflict
• Governments play a pivotal role in the life sciences unlike other industries
• Models for governmental involvement differ between Americas, Europe, and Asia
• These differences are due to different social culture assumptions in addition to differential development
• These differences will be a source of future conflict
Points of strategic conflict: Biomedicine
– The differing concept of conflict of interest and the role of government in direct investment
Ministerial CommitteeDPM Dr Tony Tan (Chairman)Minister (Education)Minister (Health)Minister (Trade and Industry)
Executive CommitteePhilip Yeo, EDB/NSTB (Chairman)and Representatives from 12 Agencies
Intellectual Capital
• Public R&D
• IPR/Legal Framework
• Industry R&D
Industrial Capital
• Investment Promotion
• Infrastructure Development
• Equity Investments
International Advisory CouncilChairman -
Sir Richard Sykes,Rector, Imperial College &
Chmn, GSKCo-Chairman -
Sydney Brenner, Professor Salk Institute for Biological Studies
Human Capital
• BMS Education
• Undergrad Trg
• Grad/Post-Doc Trg
Ethical Framework
• Bioethics Advisory Committee
INTEGRATED BIOMEDICAL SCIENCES STRATEGY
Singapore Approach: High Level Integration
The Singapore Strategy: Government planning and large scale integration
Development of local manpower:
scholarships
Recruitmentoverseas
talent
Economic development: investments
Legal, ethical Framework: BAC
Change in education systemClinical Centers ofExcellence
Research Institutes
Extramuralfunding for PI
basedresearch
Add physical infra
structure:
Biopolis
•Airbus vs. Boeing•Cotton subsidies in the
US vs. the developing world
• Japan’s MITI in post war reconstruction
Conflicts from political philosophy:The role of government
Fundamental Realities: 2005
• Governments play a pivotal role in the life sciences unlike other industries
Auto manufacturing:
Local requirements - roads, logistics, power, blue collar workforce
Impact:
Jobs, air pollution
Fundamental Realities: 2005
• Governments play a pivotal role in the life sciences unlike other industries
Biotechnology:
Local requirements – schools, hospitals, universities, PhD workforce, enforcement of safety laws, legal framework (IP and human subjects protection), R&D infrastructure, highly varied reagents acquired in small quantities,
Impact: Life and death, reproduction
• Stem cell research• Xenotransplantation (pig vs cow)• Birth control research• GMO crops and animals• Creationism vs. Evolution
Moral issues in biotechnology strike at core national and religious values
Points of strategic conflict: Biomedicine
– Differences in the national histories relating to human experimentation in times of war, or commercial exploitation during times of colonial imperialism.
Safety, confidentiality, and research on human subjects laws are among the most restrictive in Germany and Japan.
Japanese pharmaceuticals and
organizations will have difficulty conducting clinical trials in China and Korea
Any breach of “ethics” by these countries
will lead to international incidents
World war II and the conduct of biomedicine today
Edison Liu, [email protected]
+65-68478-8007
WIPO Conference on Dispute Resolution in International Science and Technology Collaboration
25-26 April, 2005 Geneva