Food and Drug Administration
Center for Biologics Evaluation and Research
Cellular, Tissue and Gene Therapies Advisory Committee
Meeting # 43
March 29, 2007
Hilton Hotel,
DRAFT AGENDA
OPEN SESSION
Topic I: Open Committee Discussion: Sipuleucel-T, Dendreon (BLA-STN
125197) indicated for the treatment of men with asymptomatic
metastatic hormone refractory prostate cancer
8:00 a.m. Welcoming Remarks
James Mulé, Ph.D., Chair
Conflict of Interest Statement
Gail Dapolito, Executive Secretary
Introduction of Members
James Mulé, Ph.D.
Recognition of Committee Service
Jesse L. Goodman, M.D., M.P.H., Director
Center for Biologics Evaluation and Research
8:30 Sponsor Presentation
9:30 Q&A
9:50 Break
10:10 FDA Perspective
11:10 Q&A
11:30 Open Public Hearing
12:30 p.m. Lunch
1:30 Questions
for Committee Discussion
3:20 Break
3:30 Committee
Vote
5:30 p.m. Break
Topic
II: Overview Research Programs,
Division of Cellular and Gene Therapies
(DCGT), CBER
5:45 p.m. Raj
Puri, M.D., Ph.D., Director, DCGT and
Chief,
Tumor Vaccines and Biotechnology Branch
6:05 Steven Bauer, Ph.D.
Chief,
Cellular and Tissue Therapy Branch
6:25 Adjourn
Open Session
6:30 Closed
Session
7:20 p.m. Adjourn
Closed Session