FDA Science Board Advisory Committee Meeting

April 9, 2003

5630 Fishers Lane, Room 1066


8:00 a.m. Call To Order

Michael P. Doyle, Ph.D., Chair, FDA Science Board

Waiver Statements

Susan Bond, Office of the Commissioner

Introductory Remarks

Norris E. Alderson, Ph.D., Associate Commissioner for Science, FDA


8:15 a.m. Welcome & Overview of FDA's Initiative to Improve the Development and Availability of Innovative Medical Products

Mark B. McClellan, M.D., Ph.D., Commissioner of Food & Drugs


8:45 a.m. Quality Systems Approach to Medical Product Review

Janet L. Woodcock, M.D., Director, Center for Drug Evaluation & Research (CDER)


9:00 a.m. Quality Teams to Improve Regulatory Processes

David W. Feigal Jr., M.D., M.P.H., Director, Center for Devices & Radiological Health (CDRH)


9:15 a.m. Break


9:30 a.m. Quality Systems for Clinical Pharmacology & Biopharmacology Review

Larry Lesko, Ph.D., Office of Clinical Pharmacology and Biopharmaceutics, CDER

Quality Systems for CMC Review

Yuan-yuan Chiu, Ph.D., Director, Office of New Drug Chemistry, CDER


10:00 a.m. Questions & Discussion with Board/Presenters


10:30 a.m. Update on Pharmaceutical Manufacturing Initiative

Ajaz Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Science, CDER


10:45 a.m. Update on Patient Safety Initiative

Kelly Cronin, Senior Advisor, Office of Policy & Planning, FDA


11:00 a.m. Fostering Technology Development Pharmacogenomics

Janet Woodcock, M.D., CDER


11:30 a.m. Questions & Discussion with Board/Presenters


12:00 p.m. Lunch


1:00 p.m. Open Public Comment


2:00 p.m. Industry Use of Pharmacogenomics and Regulatory Issues

Brian Spear, Ph.D., Director Pharmacogenomics, Global Pharmaceutical Research and Development, Abbott Laboratories


2:30 p.m. Pharmacogenomics Preclinical Studies

Frank Sistare, Ph.D., Acting Director, Office of Testing & Research, CDER

3:00 p.m. Pharmacogenomics Drug Metabolism/Dosage

Larry Lesko, Ph.D., CDER


3:30 p.m. Ethical Issues with Regulatory Review of Pharmacogenomic Data

Benjamin Wilfond, M.D., Medical Genetics Branch, National Human Genome Research Institute, National Institutes of Health


3:45 p.m. Questions & Discussion with the Board/Presenters

Janet Woodcock to present questions


4:30 p.m. Closing Remarks/Future Direction

Michael P. Doyle, Ph.D.