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October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Final Agenda

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
Meeting #48, October 9, 2009
Pooks Hill Marriott, Bethesda, MD

AGENDA

Open Session - ISOLAGEN THERAPY (BLA # 125348), Fibrocell Technologies, Inc. (formerly Isolagen Technologies, Inc.), for Moderate to Severe Nasolabial Fold Wrinkles

8:30 a.m.

Welcome and Introduction of Members
Stanton Gerson, M.D., Chair

Conflict of Interest Statement
Gail Dapolito, Designated Federal Officer

8:40

Presentations

Fibrocell Technologies, Inc
Girish Munavalli, M.D.
Dermatologist
Laser and Vein Specialists of the Carolinas

Lillian B. Nanney, Ph.D.
Professor of Plastic Surgery and Cell and Developmental Biology
Vanderbilt University School of Medicine

Jeanne M. Novak, Ph.D.
President and CEO
CBR International Corp.

Stacy R. Smith, M.D.
Dermatologist
Therapeutics Clinical Research

Robert A. Weiss, M.D.
Dermatologist
Maryland Laser, Skin and Vein Institute, LLC

10:10Q&A
10:30 a.m.Break
10:45 a.m.

FDA

Product Review
Terrig Thomas, Ph.D.
Division of Cellular and Gene Therapies
Office of Cellular, Tissue and Gene Therapies (OCTGT)
Center for Biologics Evaluation and Research (CBER)

Clinical Efficacy Review
Agnes Lim, M.D.
Division of Clinical Evaluation, Pharmacology and
Toxicology, OCTGT, CBER

Clinical Safety Review
Yao-Yao Zhu, M.D.
Division of Clinical Evaluation, Pharmacology and
Toxicology, OCTGT, CBER

Statistical Review
Shiowjen Lee, Ph.D.
Division of Biostatistics
Office of Biostatistics and Epidemiology, CBER

11:45Q&A
12:00Open Public Hearing
1:00Lunch
2:00

Committee Discussion of Questions

5:00 p.m.Adjourn