Food and Drug Administration

Center for Biologics Evaluation and Research

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #37, March 18-19, 2004

Hilton Hotel, Silver Spring, Maryland

AGENDA

Friday, March 19, 2004

8:30 a.m. Call to Order

Mahendra Rao, M.D., Ph.D., Chair

8:40 FDA Opening Remarks

Philip Noguchi, M.D.

Office of Cellular, Tissue and Gene Therapies, CBER

Open Committee Discussion – Cellular Therapies for Cardiac Disease

8:45 Open Public Hearing

9:15 FDA Charge to Committee – Introduction of Questions

Stephen Grant, M.D., Medical Officer

Clinical Evaluation Branch

Office of Cellular, Tissue and Gene Therapies, CBER

9:30 Committee Discussion of Questions

10:30 Break

10:45 Committee Discussion of Questions (Cont’d)

12:00 noon Lunch

1:00 p.m. Committee Discussion of Questions (Cont’d)

3:00 p.m. Closing Remarks/Adjourn