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U.S. Department of Health and Human Services

Advisory Committees

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

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

AGENDA

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

8:40

Recognition of Committee Service

9:00

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

9:30Q&A
9:45Break
10:00Guest Presentations
Replication Competent Retrovirus Testing at the Indiana University Vector Production Facility
Kenneth Cornetta, M.D.
Indiana University
10:30Q&A
10:45RCL Lot Release Testing for Lentiviral Vector
Transduced Cells
Laurent Humeau, Ph.D.
VIRxSYS Corporation
11:15Q&A
11:30Lunch
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
12:45Q&A
12:55NCI Experience Using Engineered T cells for the Treatment of Cancer (Implication for RCR Testing)
Richard A. Morgan, Ph.D.
National Cancer Institute
1:10Q&A
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
1:35Q&A
1:45Open Public Hearing
2:45Break
3:00Committee Discussion of Questions
5:00 p.m.Adjourn