FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE

Meeting, February 5, 2008

National Institutes of Health, Building 29B, Conference Room C

Bethesda, MD

 

 

DRAFT AGENDA

 

OPEN SESSION

 

12 noon Eastern Time

Welcome

Walter Urba, M.D., Ph.D., Chair

Roll-Call and Conflict of Interest Statement

Gail Dapolito, Executive Secretary

 

12:10 p.m.Introduction Site Visit Process

Keith Webber, Ph.D., Deputy Director, Office of Pharmaceutical Science,
Center for Drug Evaluation and Research

12:30Overview Research Office of Biotechnology Products (OBP) Steven Kozlowski, M.D., Director, OBP

 

12:40 Overview Research Division of Therapeutic Proteins (DTP)

and Laboratory of Immunology

Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, DTP

 

1:00 p.m.Q&A

1:05Overview Research Division of Monoclonal Antibodies (DMA)

and Laboratory of Molecular and Developmental Immunology

Kathleen Clouse, Ph.D., Director, DMA

 

1:30Q&A

 

1:35 Open Public Hearing

2:35 CLOSED SESSION

 

3:15 p.m. Adjourn