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

Bethesda, Maryland

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)

Elizabeth Shores, Ph.D., Deputy Director, (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