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U.S. Department of Health and Human Services

Advisory Committees

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May 31, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Draft Agenda

FOOD AND DRUG ADMINISTRATION
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
Meeting #51, May 31, 2011
Teleconference
National Institutes of Health
Building 29B, Conference Rooms A-B

DRAFT AGENDA
Open Session

2:30 p.m.

Welcome and Roll Call
Steven Dubinett, M.D., Chair
Conflict of Interest Statement
Gail Dapolito, Designated Federal Officer

2:40

Overview – Office of Biotechnology (OBP), Center for Drug Evaluation and Research (CDER)
Dr. Steven Kozlowski, Director, OBP, CDER
Dr. Edward Max, Associate Director for Research, OBP, CDER

2:50

Overview – Research Program, Division of Therapeutic Proteins (DTP) and Laboratory of Biochemistry
Dr. Amy Rosenberg, Director, DTP

3:15Q&A
3:25

Overview – Research Program, Division of Monoclonal Antibodies (DMA) and Individual Research Programs – Laboratory of Cell Biology, Laboratory of Molecular and Developmental Immunology, Laboratory of Molecular Oncology
Dr. Patrick Swann, Ph.D., Deputy Director, DMA

4:00Q&A
4:15Open Public Hearing
5:20Closed Session
6:15 p.m.

Adjourn Closed Session

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