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U.S. Department of Health and Human Services

Advisory Committees

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

Open Session (Ballroom)

8:00 a.m.

Call to Order and Introduction of Members
Stanton Gerson, M.D., Acting Chair

Conflict of Interest Statement
Gail Dapolito, Designated Federal Officer

8:10

Recognition of Committee Service
Celia Witten, Director, Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), FDA

Topic: Gene and Cell Therapy Products for Retinal Disorders

8:25

FDAIntroduction and Overview of Gene and Cell Therapy Products for Retinal Disorders
Samuel B. Barone, M.D.
Medical Officer, OCTGT, CBER, 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
University of Pennsylvania Perelman School of Medicine

9:35Q&A
9:45

Peter Francis, M.D., Ph.D., Associate Professor of Ophthalmology
Oregon University of Health Sciences

10:15Q&A
10:25Break
10:40

Peter Campochiaro, M.D., Professor of Ophthalmology
Johns Hopkins University

11:10Q&A
11:20

Preclinical Issues
Peter Coffey, BSc., DPhil, Professor of Visual Psychophysics
University College London

11:50Q&A
12 noonOpen Public Hearing
1:00 p.m.Lunch
2:00 p.m.

Committee Discussion of Questions

5:00 p.m.Adjourn
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