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

 12:30             Overview 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

                                   

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

                      and Laboratory of Molecular and Developmental Immunology

                      Kathleen Clouse, Ph.D., Director, DMA

 

1:30                Q&A

 

1:35                Open Public Hearing

                                   

2:35     CLOSED SESSION     

 

3:15 p.m.        Adjourn