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Advisory Committees

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

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


Open Session (Grand Ballroom)

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


Recognition of Committee Service


FDA Presentation
Testing for Replication Competent Retrovirus (RCR)/Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products – Revisiting Current

FDA Recommendations
Xiaobin Victor Lu, Ph.D.
Center for Biologics Evaluation and Research, FDA

10:00Guest Presentations
Replication Competent Retrovirus Testing at the Indiana University Vector Production Facility
Kenneth Cornetta, M.D.
Indiana University
10:45RCL Lot Release Testing for Lentiviral Vector
Transduced Cells
Laurent Humeau, Ph.D.
VIRxSYS Corporation
12:30 p.m.Findings and Challenges in Product Testing and Patient Monitoring for RCR/L in Gene Therapy Clinical Trials
Gwendolyn K. Binder-Scholl, Ph.D.
University of Pennsylvania School of Medicine
12:55NCI Experience Using Engineered T cells for the Treatment of Cancer (Implication for RCR Testing)
Richard A. Morgan, Ph.D.
National Cancer Institute
1:20Clinical Experience at Baylor College of Medicine with
T Lymphocytes Genetically Modified Using Retroviral Vectors
Gianpietro G. Dotti, M.D.
Baylor College of Medicine
1:45Open Public Hearing
3:00Committee Discussion of Questions
5:00 p.m.Adjourn

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