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