FDA Logo links to FDA home page
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

FDA Home | Search FDA Site | A-Z Index | Contact FDA

horizonal rule

Science Board to the Food and Drug Administration

Center Date Time Location
FDA Office of the Commissioner April 9, 2003 8:00 a.m. - 4:30 p.m.

Food and Drug Administration
Room 1066
5630 Fishers Lane
Rockville, MD

Detailed Agenda:
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.

horizonal rule