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
9:00	FDA Presentations Introduction and Overview of RCR/RCL Testing
9:30	Q&A
9:45	Break
10:00	Guest Presentations RCR/RCL Lot Release Testing for Retroviral and Lentiviral Vector Transduced Cells
11:30	Lunch
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
1:45	Open Public Hearing
2:45	Break
3:00	Committee Discussion of Questions
5:00 p.m.	Adjourn