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Food and Drug Administration

Center for Biologics Evaluation and Research

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #37, March 18-19, 2004

Hilton Hotel, Silver Spring, Maryland

AGENDA

Thursday, March 18, 2004

8:30 a.m. Call to Order/Introduction of Committee

Mahendra Rao, M.D., Ph.D., Chair

8:40 Conflict of Interest Statement

Gail Dapolito, Executive Secretary

8:45 FDA Opening Remarks

Presentation of Certificates of Appreciation to Retiring Members

Philip Noguchi, M.D., Director

Office of Cellular, Tissue and Gene Therapies

Center for Biologics Evaluation and Research, FDA

Jesse Goodman, M.D., M.P.H., Director

Center for Biologics Evaluation and Research (CBER), FDA

Open Committee Discussion – Cellular Therapies for Cardiac Disease

9:00 FDA Perspective – Clinical Experience

Dwaine Rieves, M.D., Chief

Clinical Evaluation Branch

Office of Cellular, Tissue and Gene Therapies, CBER

Guest Presentations

9:25 Emerson Perin, M.D., F.A.C.C., Director

New Cardiovascular Interventional Technology

Texas Heart Institute

9:55 Q&A

10:05 Break

10:20 a.m. Clinical Experience of Autologous Myoblast Transplantation Philippe Menasché, M.D., Professor Thoracic and Cardiovascular Surgery

University of Paris

10:50 a.m. Q&A

Food and Drug Administration

Center for Biologics Evaluation and Research

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #37, March 18-19, 2004

AGENDA

Thursday, March 18, 2004

Open Committee Discussion – Cellular Therapies for Cardiac Disease

11:00 a.m. Steven Epstein, M.D., Executive Director

Cardiovascular Research Institute

Washington Hospital Center

11:30 Q&A

11:40 Lunch

12:40 p.m. FDA Perspective – Preclinical Experience

Richard McFarland, Ph.D., M.D., Medical Officer

Pharmacology/Toxicology Branch

Office of Cellular, Tissue and Gene Therapies, CBER

Guest Presentations

1:00 Myoblasts: The First Generation Cells for Cardiac Repair -

What Have We Learned?

Doris Taylor, Ph.D., Professor

Department of Physiology

University of Minnesota

1:30 Q&A

1:40 Silviu Itescu, M.B.B.S., Assistant Professor

Division of Surgical Science

Columbia University Medical Center

2:10 Q&A

2:20 From Mouse to Man: Is it a Logical Step for Cardiac Repair?

Doris Taylor, Ph.D.

University of Minnesota

2:50 Q&A

3:00 Break

3:15 Overview - Cardiac Catheters

Donald Nick Jensen, D.V.M., MSEE

Electrical Engineer

Office of Device Evaluation

Center for Devices and Radiological Health, FDA

3:35 p.m. Q&A

Food and Drug Administration

Center for Biologics Evaluation and Research

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

Meeting #37, March 18-19, 2004

AGENDA

Thursday, March 18, 2004

Open Committee Discussion – Cellular Therapies for Cardiac Disease

3:45 p.m. Preclinical Cardiac Catheter Models

Robert Lederman, M.D., Investigator

Cardiovascular Branch

National Heart, Lung and Blood Institute, NIH

4:05 Q&A

4:15 Open Public Hearing

4:45 p.m. Adjourn