FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
Meeting #44, Teleconference
July 26, 2007
National Institutes of Health, Building 29B,
Conference Rooms A/B
AGENDA
OPEN SESSION
11:00 a.m. Eastern Time
Opening Remarks
Walter
Urba, M.D., Ph.D., Chair
Roll-Call and Conflict of
Interest Statement
Gail Dapolito,
Executive Secretary
11:10 Introduction – Site Visit Process
Kathryn Carbone,
M.D., Associate Director for Research
Center for Biologics
Evaluation and Research
11:30 Overview Research – Office of Cellular,
Tissue and Gene Therapies (OCTGT)
Celia Witten, M.D.,
Ph.D., Director, OCTGT
11:40 Overview
Research – Gene Transfer and Immunogenicity Branch (GTIB)
Eda Bloom, Ph.D.,
Chief, GTIB
12:10 p.m. Q&A
12:15 Overview Research - Office of
Biotechnology Products (OBP)
12:20 Overview Research – Division of Monoclonal
Antibodies (DMA), OBP
Kathleen Clouse,
Ph.D., Director, DMA
12:35 Q&A
12:40 Overview
Research – Division of Therapeutic Proteins (DTP), OBP
Amy Rosenberg, M.D.,
Director, DTP
1:10 Q&A
1:15 Open
Public Hearing
2:15 CLOSED SESSION
3:30 p.m. Adjourn