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January 15, 2013: Cellular, Tissue and Gene Therapies Advisory Committee Summary Minutes

SUMMARY MINUTES
Meeting # 57, January 15, 2013
National Institutes of Health, Building 29B, Conference Room C
Bethesda, MD

COMMITTEE MEMBERS FDA PARTICIPANTS
Evan Y. Snyder, M.D., Ph.D.. Chair
Tabassum Ahsan, Ph.D.
Michael R. Bishop, M.D., FACP
Scott Bruder, M.D., Ph.D.*
Larry A. Couture, Ph.D.
Timothy P. Cripe, M.D., Ph.D.
Linda A. Dahlgren, D.V.M., Ph.D., DACVS
Leisha A. Emens, M.D., Ph.D.
John D. Gearhart, Ph.D.+
Steven A. Goldman, M.D., Ph.D.
Francis Hornicek, Ph.D., M.D.
Patrick Hwu, M.D.
Mei-Ling Ting Lee, Ph.D.
Stephen M. Rose, Ph.D.**
Arulvathani Arudchandran, Ph.D.
Harold Dickensheets, Ph.D.
Raymond Donnelly, M.S., Ph.D.
Steven Kozlowski, M.D.
Edward Max, M.D., Ph.D.
Michael Norcross, M.D.
Montserrat Puig, Ph.D.        
Jack Ragheb, M.D.
Amy Rosenberg, M.D.
Daniela Verthelyi, M.D., Ph.D.
* - Industry Representative
** - Consumer Representative
+ - Not Attending

The summary minutes for the January 15, 2013 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee were approved on  February 15, 2013.

I certify that I attended the January 15, 2013 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and that this report accurately reflects what transpired.

//s//

Evan Snyder, M.D., Ph.D., Chair
Cellular, Tissue and Gene Therapies
Advisory Committee, FDA

//s//

Gail Dapolito, Designated Federal Officer
Cellular, Tissue and Gene Therapies
Advisory Committee, FDA

The Cellular, Tissue and Gene Therapies Advisory Committee met by teleconference on January 15, 2013.  Dr. Evan Snyder, Chair, opened the meeting.  The Designated Federal Officer called the roll and read a statement into the public record that it was determined that the Committee discussion on January 15 presented no potential for a conflict of interest. The Committee Members and FDA participants were introduced.   Time was allotted during the meeting for public comment. No individuals from the public requested time at the meeting to address the Committee.

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

  • Overview of research and regulatory activities in the Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), FDA
  • Overview of research and regulatory activities in the Division of Therapeutic Proteins (DTP),  OBP, CDER FDA
  • Summary of individual research programs in the Laboratory of Immunology, DTP, CDER, FDA.

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 at the Cellular, Tissue and Gene Therapies Advisory Committee 2013 meetings page.  Please submit all external requests to the FDA Freedom of Information Office.