Keynote Speakers:
FDA's Critical Path Initiative: 2008 Update
ShaAvhrée Buckman, M.D., Ph.D., F.A.A.P.
Acting Director
Office of Translational Sciences
Center for Drug Evaluation and Research
US Food and Drug Administration
Medical Science, Regulation and Statistics
Prof. Hans-Georg Eichler, M.D., MSc
Senior Medical Officer
European Medicines Agency (EMEA)
Current Status of Drug Safety Evaluation in China
Shaohong Jin
Director, Center for Drug Evaluation,
The State Food and Drug Administration of
China
Invited Industry Plenary Discussion Session:
Topics: Statistics in Global Biopharmaceutical Research and Development: Current States and Future Directions
- Statistical technical issues & influence in shaping drug development
- Innovation
- Core competencies; significant influence
- Non-traditional areas; clinical operations
- Industry-academia-government collaborations
- New business models / approaches
- Transparency, public trust, benefit/risk
Discussants:
- Raymond P. Bain (Vice President, Merck)
- Cassie Burton (Vice President Novartis)
- Christy J Chuang-Stein (Senior Director, Pfizer)
- Cyrus Hoseyni (Vice President, Wyeth)
- Frank W. Rockhold (Vice President, GlaxoSmithKline)
- Stephen J. Ruberg (Vice President, Eli Lilly)
- Ji Zhang (Vice President, Sanofi-Aventis)
Closing Keynote Speech
The Role of Statistics in the Early Development of Pharmaceutical Products
Joseph F. Heyse, Editor of Statistics in Biopharmaceutical Research and Vice President of Merck & Co.,
Inc.
The JAMA Policy on Statistical Analysis
Peter A. Lachenbruch, President of the American Statistical Association & Professor of Oregon State
University
Opportunities and Challenges in the Globalization of Drug Development: The Critical Role of
Pharmaceutical statistics
Mark Chang, Scientific Fellow of Millennium Pharmaceuticals