FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE

 

April 10-11, 2008

Hilton Hotel, Gaithersburg, Maryland

 

DRAFT AGENDA

April 10, 2008

 

OPEN COMMITTEE DISCUSSION

Topic 1: Cellular Therapies Derived from Human Embryonic Stem Cells Scientific Considerations for Pre-Clinical Safety Testing

 

9:00 a.m. Welcome and Introduction of Members

Walter Urba, M.D., Ph.D., Chair

 

9:10 Conflict of Interest Statement

Gail Dapolito, Executive Secretary

 

9:15 FDA Introduction: Scope and Limitations

Steven Bauer, Ph.D.

Chief, Cell and Tissue Therapy Branch

Division of Cellular and Gene Therapies

Center for Biologics Evaluation and Research, FDA

 

9:30-12:35 p.m. Guest Presentations

12:35 OPEN PUBLIC HEARING

 

1:05 Lunch

 

2:05 Committee Discussion of Questions

 

6:00 p.m. Adjourn


FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE

 

April 10-11, 2008

Hilton Hotel, Gaithersburg, Maryland

 

DRAFT AGENDA

April 11, 2008

 

OPEN COMMITTEE DISCUSSION

Topic 2: Research and Regulatory Updates

 

8:00 a.m. Welcome and Introduction of Members

Walter Urba, M.D., Ph.D., Chair

8:05 Conflict of Interest Statement

Gail Dapolito, Executive Secretary

 

8:10 Recognition of Committee Service for Retiring Members

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

 

8:20 Update Research Program, Office of Cellular, Tissue and Gene Therapies (OCTGT)

Response to September 2005 Review of OCTGT Research Program

Carolyn Wilson, Ph.D.

Acting Associate Director for Research, Center for

Biologics Evaluation and Research (CBER)

Suzanne Epstein, Ph.D.

Associate Director for Research, OCTGT, CBER

9 :20 Q&A

 

9:30 Break

 

9:45 OPEN PUBLIC HEARING

10:15 Update FDA Somatic Cell Therapy Letter

Kimberly Benton, Ph.D.

Deputy Director, Division of Cellular and Gene Therapies, OCTGT, CBER

 

10:45 Q&A

 

10:50 Update OCTGT Guidance Development Program

Richard McFarland, Ph.D., M.D.

Associate Director for Policy, OCTGT, CBER

11:20 Q&A

 

11:25 a.m. Adjourn