FOOD AND DRUG
ADMINISTRATION
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
CELLULAR,
TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
April 10-11,
2008
Hilton Hotel,
DRAFT AGENDA
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 and Gene
Therapies
Center for Biologics Evaluation and
Research, FDA
9:30-12:35 p.m. Guest Presentations
12:35 OPEN PUBLIC HEARING
1:05
Lunch
2:05 Committee Discussion of Questions
6:00 p.m. Adjourn
FOOD AND DRUG
ADMINISTRATION
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE
AND GENE THERAPIES ADVISORY COMMITTEE
April 10-11, 2008
Hilton Hotel,
DRAFT AGENDA
April 11, 2008
OPEN
COMMITTEE DISCUSSION
Topic 2: Research
and Regulatory Updates
8:00 a.m. Welcome and Introduction of Members
Walter Urba, M.D.,
Ph.D., Chair
8:05 Conflict of Interest Statement
Gail Dapolito,
Executive Secretary
8:10 Recognition of Committee Service for Retiring Members
Jesse Goodman, M.D.,
M.P.H.
8:20 Update – Research Program, Office of Cellular,
Tissue and Gene Therapies (OCTGT)
Response
to September 2005 Review of OCTGT Research Program
Carolyn Wilson, Ph.D.
Acting Associate
Director for Research, Center for
Biologics Evaluation
and Research (CBER)
Suzanne Epstein,
Ph.D.
Associate Director
for Research, OCTGT, CBER
9 :20 Q&A
9:30 Break
9:45 OPEN PUBLIC HEARING
10:15 Update – FDA Somatic Cell Therapy Letter
Kimberly Benton,
Ph.D.
Deputy Director,
Division of Cellular and Gene Therapies, OCTGT, CBER
10:45 Q&A
10:50 Update – OCTGT
Guidance Development Program
Richard
McFarland, Ph.D., M.D.
Associate Director for Policy, OCTGT, CBER
11:20 Q&A
11:25 a.m. Adjourn