FDA Science Board Advisory Committee Meeting

April 22, 2004

5630 Fishers Lane, Room 1066




8:00 a.m. Call to Order

Kenneth I. Shine, M.D., Chair, FDA Science Board

8:15 a.m. Welcome and opening remarks

Lester M. Crawford, D.V.M., Ph.D., Acting Commissioner of Food and Drugs

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., Senior Advisor for Special Projects, 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