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Advisory Committees

September 22, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Final Agenda

Food and Drug Administration
Center for Biologics Evaluation and Research
Cellular, Tissue and Gene Therapies Advisory Committee
Meeting # 53, September 22, 2011
Hilton Hotel, Gaithersburg, MD

Agenda

8:00 a.m.Call to Order and Introduction of Committee
Evan Snyder, M.D., Ph.D., Acting Chair
Conflict of Interest Statement
Gail Dapolito, Designated Federal Officer

Open Committee Discussion: BLA 125397, Umbilical Cord Blood, New York Blood Center, indicated for hematologic malignancies, bone marrow failure, primary immunodeficiency diseases, beta thalassemia, Hurler syndrome, Krabbe disease, and X-linked adrenoleukodystrophy

8:10FDA Introductory Remarks
Celia Witten, Ph.D., M.D., Director
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research (CBER), FDA
8:15National Cord Blood Program at the
Howard P. Milstein Cord Blood Center Presentation
BLA 125397, Hematopoietic Progenitor Cells, Cord (HPC-C)
Andromachi Scaradavou, M.D., Medical Director
National Cord Blood Program, New York Blood Center

 

Pablo Rubinstein, M.D., Program Director
National Cord Blood Program, New York Blood Center
 

9:15Q&A
9:30Break
9:45FDA Presentation
Introduction and Efficacy Review
John Hyde, Ph.D., M.D., Medical Officer
Office of Cellular, Tissue and Gene Therapies, CBER, FDA

Safety Review
Donna Przepiorka, M.D., Ph.D., Medical Officer
Office of Cellular, Tissue and Gene Therapies, CBER, FDA

10:45Q&A
11:00Open Public Hearing
12 noonLunch
1:00 p.m.Committee Discussion of Questions
5:00 p.m.Adjourn

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