Food and Drug Administration
Center for Biologics Evaluation and Research
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
AGENDA
Meeting #31, Holiday Inn, Gaithersburg, MD
October 24-26, 2001
Wednesday, October 24
9:00 a.m. Opening Remarks
Dr. Daniel Salomon, Chair
9:10 Conflict of Interest Statement
Gail Dapolito, Executive Secretary
9:15 Introduction of Committee
OPEN COMMITTEE DISCUSSION
TOPIC: LONG-TERM FOLLOW-UP: GENE TRANSFER CLINICAL TRIAL PARTICIPANTS
9:20 FDA Perspective
Dr. Philippe Bishop
Office of Therapeutics Research and Review, CBER
Dr. Steve Rosenthal
Office of Vaccines Research and Review, CBER
9:50 Q&A
10:05 Open Public Hearing
10:35 Break
11:00 Committee Discussion of Questions
12:00 noon Lunch
1:00 p.m. Committee Discussion of Questions (Cont’d)
3:00 Adjourn