DRAFT DRAFT DRAFT DRAFT
Food and Drug Administration
Center for Biologics Evaluation and Research
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
AGENDA
Meeting #31, Holiday Inn, Gaithersburg, MD
October 25-26, 2001
Thursday, October 25
8:00 a.m. Opening Remarks
Dr. Daniel Salomon, Chair
8:15 Conflict of Interest Statement
Gail Dapolito, Executive Secretary
8:20 Introduction of Committee
Topic 1 – Lentivirus Vectors in Gene Transfer Clinical Trials
Introduction
8:30 Dr. Inder Verma, Salk Institute
9:00 Q&A
FDA Perspective
9:15 Dr. Daniel Takefman
9:45 Q&A
10:00 Break
Guest Presentations
10:15 Dr. Dale Ando, Cell Genesys, Inc.
Dr. Gabor Veres, Cell Genesys, Inc.
11:00 Q&A
11:15 Dr. Jeffrey Kordower, Rush Presbyterian Medical Center
12:00 Q&A
12:15 p.m. Lunch
1:15 Dr. Susan Kingsman, Oxford BioMedica (UK) Ltd.
2:00 Q&A
BRMAC Meeting #31
Agenda – Page 2
Thursday, October 25 (cont’d)
2:15 p.m. Dr. John Kappes, University of Alabama at Birmingham
2:45 Q&A
3:00 Open Public Hearing
3:15 Break
3:30 Committee Discussion of Questions
5:30 – 6:00 Adjourn
Friday, October 26
8:00 a.m. Opening Remarks
Dr. Daniel Salomon, Chair
Topic 2 – Lentivirus Vector Gene Transfer Product for Treatment of People with HIV
Guest Presentation
8:15 Dr. Boro Dropulic, VIRxSYS Corp.
9:45 Q&A
10:00 Break
10:15 Open Public Hearing
10:30 Committee Discussion of Questions
12:00 noon Lunch
12:30 p.m. Committee Discussion (cont’d)
2:00 Adjourn