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Science Board to the FDA
Agenda

Agency Date Time Location
FDA April 22, 2004 8 a.m. - 5 p.m.

Food and Drug Administration
5630 Fishers Lane
Rm. 1066
Rockville, MD

       
8:00 a.m. Call to Order
Kenneth I. Shine, M.D., Chair, FDA Science Board
8:15 a.m. Welcome and opening remarks
Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA
8:30 a.m. Overview of the FDA Initiative on Obesity
Robert E. Brackett, Ph.D., Director, Center for Food Safety & Applied Nutrition, FDA
8:40 a.m. Obesity - Therapeutics
David G. Orloff, M.D., Director, Division of Metabolic and Endocrine Drugs, ODE II, Office of New Drugs, Center for Drug Evaluation & Research, FDA
9:00 a.m. Obesity - Research
David W.K. Acheson, M.D., Director, Food Safety and Security Staff, Center for Food Safety & Applied Nutrition, FDA
9:20 a.m. Break
9:45 a.m. Highlights of the Obesity Working Group Report
Alan M. Rulis, Ph.D., Director, Office of Food Additive Safety, Center for Food Safety & Applied Nutrition, FDA
10:15 a.m. Questions and Discussion with the Board/Presenters
10:45 a.m. Update on ORA Peer Review
John R. Marzilli, Deputy Associate Commissioner for Regulatory Affairs, FDA
11:00 a.m. Open Public Hearing
12:15 p.m. Lunch
1:15 p.m. Introduction to Critical Path
Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA
2:00 p.m. Perspective on Anti-infectives and Vaccines
Gail H. Cassell, Ph.D., Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company
2:20 p.m. Perspective on Chronic Disease Therapies
Robert M. Califf, M.D., Associate Vice Chancellor for Clinical Research and Director, Duke Clinical Research Institute, Duke University Medical Center
2:40 p.m. Drug Formulation and Development, and Tissue Engineering Issues
Robert S. Langer, Sc.D., Kenneth J. Germeshausen Professor of Chemical and Biomedical Engineering, MIT
3:00 p.m. Break
3:20 p.m. Overview of Opportunities- Drugs
Robert Temple, M.D., Director, Office of Medical Policy, Center for Drug Evaluation & Research, FDA
3:40 p.m. Overview of Opportunities- Devices
Larry G. Kessler, Sc.D., Director, Office of Science and Engineering Laboratories,
Center for Devices & Radiological Health, FDA
4:10 p.m. Overview of Opportunities- Biologics
Jesse Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation & Research, FDA
4:30 p.m. Questions and Discussion with Board – Recommendations
5:00 p.m. Adjourn

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