December 14, 2010: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Minutes

SUMMARY MINUTES
Teleconference, Meeting #50, December 14, 2010
National Institutes of Health
Building 29B, Conference Room C
Bethesda , MD

COMMITTEE MEMBERS FDA PARTICIPANTS
Stanton Gerson, M.D., Chair
Tabassum Ahsan, Ph.D.
Larry A. Couture, Ph.D.
Linda Dahlgren, D.V.M., Ph.D. DACVS
Steven M. Dubinett, M.D. +
Evanthia Galanis, M.D. ++
Steven Goldman, M.D., Ph.D.
J. Francis Hornicek, Ph.D., M.D. +
Mary Horowitz, M.D., M.S.
Larry Kwak, M.D., Ph.D. ++
Mei-Ling Ting Lee, Ph.D. +
Mahendra S. Rao, M.D., Ph.D. *
Peter Saltonstall **+
Evan Synder, M.D., Ph.D.

FDA Participants
Carolyn Wilson, Ph.D.
Celia Witten, Ph.D., M.D.
Suzanne Epstein, Ph.D.
Raj Puri, M.D., Ph.D.
Syed Rafat Husain, Ph.D.
Bharat Joshi, Ph.D.
Shyh-Ching Lo, Ph.D., M.D.
Michail Alterman, Ph.D.

Designated Federal Official
Gail Dapolito

Committee Management Specialist
Sheryl Clark, M.B.A.

The summary minutes for the December 14, 2010 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee were approved on _______________.

I certify that I attended the December 14, 2010 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and that this report accurately reflects what transpired.

______//s//___________________ Gail Dapolito, Designated Federal Official

___________//s//___________________ Stanton Gerson, M.D., Chair Cellular, Tissue and Gene Therapies Advisory Committee

+ Not Attending
++ Non-Voting
*Industry Representative
**Consumer Representative

FDA Cellular, Tissue and Gene Therapies Advisory Committee
Summary Minutes
Meeting #50, December 14, 2010

The Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) met by teleconference on December 14, 2010. Dr. Stanton Gerson, Chair, opened the meeting. The Designated Federal Official called the roll and read a statement into the public record that it was determined that the Committee discussion on December 14 presented no potential for a conflict of interest. FDA participants were introduced and time was allotted during the meeting for public comment. No individuals from the public requested time at the meeting to address the Committee on the issue at hand.

Open Session

In open session, the Committee heard presentations on the following:

• Overview of the Center for Biologics Evaluation and Research (CBER), FDA, research review program
• Overview of research and regulatory activities in the Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER
• Overview of individual research programs in the Tumor Vaccines and Biotechnology Branch, OCTGT, CBER

Following the presentations and the open public hearing the open session was adjourned.

For more detailed information concerning the open session presentations and committee discussions summarized above, please refer to the meeting transcripts available on the FDA website. Please submit all external requests to the FDA Freedom of Information Office.