FOOD AND DRUG
ADMINISTRATION
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
CELLULAR,
TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
April 10, 2008
Hilton Hotel,
DRAFT AGENDA
OPEN
COMMITTEE DISCUSSION
Topic
1: Cellular Therapies Derived from Human Embryonic Stem
Cells
Scientific
Considerations for Pre-Clinical Safety Testing
9:00 a.m. Welcome and Introduction of Members
Walter
Urba, M.D., Ph.D., Chair
9:10 Conflict
of Interest Statement
Gail
Dapolito, Executive Secretary
9:15 FDA
Introduction: Scope and Limitations
Steven
Bauer, Ph.D.
Chief,
Cell and Tissue Therapy Branch
Division
of Cellular, Tissue and Gene Therapies
Center
for Biologics Evaluation and Research, FDA
Guest
Presentations
9:30 Melissa K.
Carpenter, Ph.D.
Vice President of Research and Development
Novocell, Inc.
9:50 Q&A
10:00 Jonathan
Dinsmore, Ph.D.
Senior
Vice President, Clinical and Regulatory
Advanced
Cell Technology
10:20 Q&A
10:30 Jane S.
Lebkowksi, Ph.D.
Senior Vice President of Regenerative Medicine
Geron Corporation
10:50 Q&A
11:00 Break
11:15 Guest
Presentations (Cont’d)
Ole
Isacson, M.D.
Professor
of Neurology
11:45 Q&A
11:55 Jeffrey Bulte, Ph.D.
Professor
of Radiology
12:25 p.m. Q&A
12:35 OPEN
PUBLIC HEARING
1:05
Lunch
2:05 Committee
Discussion of Questions
4:00 Break
6:00 p.m. Adjourn