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

8:10	FDA Introductory Remarks Celia Witten, Ph.D., M.D., Director Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and Research (CBER), FDA
8:15	National 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
9:15	Q&A
9:30	Break
9:45	FDA 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
10:45	Q&A
11:00	Open Public Hearing
12 noon	Lunch
1:00 p.m.	Committee Discussion of Questions
5:00 p.m.	Adjourn