FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
April 10, 2008
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
9:30 Melissa K. Carpenter, Ph.D.
Vice President of Research and Development
10:00 Jonathan Dinsmore, Ph.D.
Senior Vice President, Clinical and Regulatory
Advanced Cell Technology
10:30 Jane S. Lebkowksi, Ph.D.
Senior Vice President of Regenerative Medicine
11:15 Guest Presentations (Cont’d)
Ole Isacson, M.D.
Professor of Neurology
11:55 Jeffrey Bulte, Ph.D.
Professor of Radiology
12:25 p.m. Q&A
12:35 OPEN PUBLIC HEARING
2:05 Committee Discussion of Questions
6:00 p.m. Adjourn