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WIPO Conference on Dispute Resolution in International Science and Technology Collaboration 25-26 April, 2005 Geneva. Edison Liu, M.D. liue@gis.a-star.edu.sg +65-68478-8007. Who am I?. Physician: Oncologist Academic: Professor Medicine, Biochemistry, Genetics,
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WIPO Conference on Dispute Resolution in International Science and Technology Collaboration 25-26 April, 2005 Geneva Edison Liu, M.D. liue@gis.a-star.edu.sg +65-68478-8007
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 development Target discovery and validation: 1985 – one molecule and a thousand compound 2005 – 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 biology Molecular 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
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
Singapore Approach: High Level Integration Ministerial Committee DPM Dr Tony Tan (Chairman) Minister (Education) Minister (Health) Minister (Trade and Industry) International Advisory Council Chairman - Sir Richard Sykes, Rector, Imperial College & Chmn, GSK Co-Chairman - Sydney Brenner, Professor Salk Institute for Biological Studies Executive Committee Philip Yeo, EDB/NSTB (Chairman) and Representatives from 12 Agencies INTEGRATED BIOMEDICAL SCIENCES STRATEGY • Intellectual Capital • Public R&D • IPR/Legal Framework • Industry R&D • Human Capital • BMS Education • Undergrad Trg • Grad/Post-Doc Trg • Industrial Capital • Investment Promotion • Infrastructure Development • Equity Investments • Ethical Framework • Bioethics Advisory Committee
Recruitment overseas talent Legal, ethical Framework: BAC Change in education system Extramural funding for PI based research Clinical Centers of Excellence Development of local manpower: scholarships Research Institutes The Singapore Strategy: Government planning and large scale integration Economic development: investments Add physical infrastructure: Biopolis
Conflicts from political philosophy: The role of government • Airbus vs. Boeing • Cotton subsidies in the US vs. the developing world • Japan’s MITI in post war reconstruction
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
Moral issues in biotechnology strike at core national and religious values • Stem cell research • Xenotransplantation (pig vs cow) • Birth control research • GMO crops and animals • Creationism vs. Evolution
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.
World war II and the conduct of biomedicine today 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
WIPO Conference on Dispute Resolution in International Science and Technology Collaboration 25-26 April, 2005 Geneva Edison Liu, M.D. liue@gis.a-star.edu.sg +65-68478-8007