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Advisory Committees

November 19, 2010: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Draft Agenda

Meeting #49, November 19, 2010
Hilton Hotel, Gaithersburg, MD

DRAFT AGENDA

Open Session

8:30 a.m.

Call to Order and Opening Remarks
Matthew Allen, M.B. Vet Med, Ph.D., Acting Chair

Conflict of Interest Statement
Gail Dapolito, Designated Federal Official

8:40

Recognition of Committee Service

Topic: Testing of Replication Competent Retrovirus (RCR)/Lentivirus
(RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products

9:00FDA Presentations
Introduction and Overview of RCR/RCL Testing
9:30Q&A
9:45Break
10:00Guest Presentations
RCR/RCL Lot Release Testing for Retroviral and Lentiviral Vector Transduced Cells
11:30Lunch
12:30 p.m.Guest Presentations (Cont’d)
Accumulative RCR/RCL Lot Release Data of Final Transduced Cell Products from Clinical Studies: Challenges and Alternative Proposals
1:45Open Public Hearing
2:45Break
3:00Committee Discussion of Questions
5:00 p.m.Adjourn

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