DRAFT DRAFT DRAFT
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
Meeting #30
Holiday Inn, Bethesda, MD
July 13, 2001
8:30 a.m. Welcome and Introductions, Dr. Daniel Salomon, Chair
8:40 Conflict of Interest Statement, Ms. Gail Dapolito, Executive Secretary
OPEN COMMITTEE DISCUSSION
8:45 FDA Introduction
Responses to March 6, FDA Gene Therapy Letter: Adenovirus Vector Titer Measurements and RCA Levels, Dr. Steve Bauer, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research
9:15 Guest Presentations
Dr. Estuardo Aguilar-Cordova, Harvard Gene Therapy Initiative, Harvard University Medical School
9:30 Questions from the Committee
9:35 Dr. Beth Hutchins, Process Scientist, Canji
9:50 Questions from the Committee
9:55 Dr. Richard Sublett, Director, Quality Systems, Introgen Therapeutics, Inc.
10:10 Questions from the Committee
10:15 Break
Guest Presentations (Cont'd)
10:30 a.m. Dr. Phyllis Flomenberg, Thomas Jefferson University Medical School
10:50 Questions from the Committee
11:00 Open Public Hearing
12:00 noon Lunch
1:00 p.m. Committee Discussion of Questions
2:55 Committee Update
NIH Final Action on Serious Adverse Event Reporting
Dr. Amy Patterson, Office of Biotechnology Activities, National Institutes of Health
3:15 Questions from the Committee
3:30 Adjourn