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.