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June 29, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Final Meeting Agenda

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
Meeting #52, June 29, 2011
Crowne Plaza Hotel, Silver Spring, MD

AGENDA

Open Session (Lincoln Ballroom)

8:00 a.m.Call to Order and Introduction of Members
Stanton Gerson, M.D., Chair (Acting)
 Conflict of Interest Statement
Gail Dapolito, Designated Federal Officer
8:10Recognition of Committee Service
Celia Witten, Ph.D., M.D.
Director, Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research, FDA

Cellular and Gene Therapy Products for Retinal Disorders

8:25FDA Introduction and Overview of Cellular and Gene Therapy Products for
Retinal Disorders
Samuel B. Barone, M.D.
Medical Officer, Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research, FDA
8:55

Q&A

Clinical Issues Related to Evaluation of Efficacy Endpoints and Safety

9:05

Albert Maguire, M.D.
Associate Professor of Ophthalmology
Scheie Eye Institute, University of Pennsylvania

Jean Bennett, M.D., Ph.D.
F.M. Kirby Professor of Ophthalmology
Perelman School of Medicine at the University of Pennsylvania

Curtis Scribner, M.D.
Senior Vice President, Clinical and Regulatory Affairs
RRD International, LLC

9:35Q&A
9:45Tim Stout, M.D., Ph.D., M.B.A.
Professor of Ophthalmology
Casey Eye Institute
Oregon Health and Science University
10:15Q&A
10:25 a.m.Break
10:40

Clinical Issues Related to Evaluation of Efficacy Endpoints and Safety
Peter A. Campochiaro, M.D.
Professor of Ophthalmology
The Wilmer Eye Institute
The Johns Hopkins University School of Medicine

11:10Q&A
11:20Preclinical Issues
Peter Coffey, B.Sc., D.Phil.
Professor of Visual Psychophysics
University College London
11:50Q&A
12 noonOpen Public Hearing
1:00 p.m.Lunch
2:00Committee Discussion of Questions
5:00 p.m.Adjourn