Food and Drug Administration

Food and Drug Administration

Center for Biologics Evaluation and Research

Cellular, Tissue and Gene Therapies Advisory Committee

SUMMARY MINUTES

Teleconference

Meeting #42, November 20, 2006

National Institutes of Health

Building 29, Room 115

Bethesda, MD

COMMITTEE MEMBERS                           TEMPORARY VOTING MEMBER

James J. Mulé, Ph.D., Chair                             David M. Harlan, M.D., Site Visit Chair

Matthew J. Allen, Vet. M.B., Ph.D.

Michéle P. Calos, Ph.D.

Jeffrey S. Chamberlain, Ph.D.

Richard J. Chappell, Ph.D.

Stanton L. Gerson, M.D.                                  FDA PARTICIPANTS

Kurt C. Gunter, M.D.   *                                  Kathryn Carbone, M.D.

Farshid Guilak, Ph.D.                                     Kathleen Clouse, Ph.D.

Larry W. Kwak, M.D., Ph.D.                           Steven Kozlowski, M.D.

Doris A. Taylor, Ph.D.                                     Barbara Rellahan, Ph.D.

Sharon F. Terry, M.S.**⁺                                 Amy Rosenberg, M.D.

William W. Tomford, M.D.*                           Daniela Verthelyi, M.D., Ph.D.

Walter Urba, M.D., Ph.D.                                Keith Webber, Ph.D.

Savio L.C. Woo, Ph.D.                                                Wendy Weinberg, Ph.D.

Executive Secretary                                       Committee Management Specialist

Gail Dapolito                                                   Rosanna Harvey

The summary minutes for the November 20, 2006 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee were approved on May 7, 2007.

I certify that I attended the November 20, 2006 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and that this report accurately reflects what transpired.

                        //s//                                                                   //s//

___________________________                  ______________________________

Gail Dapolito, Executive Secretary                  James J. Mulé Ph.D., Chair

⁺Not Attending

*Industry Representative

**Consumer Representative

FDA Cellular, Tissue and Gene Therapies Advisory Committee

Summary Minutes

Meeting #42, November 20, 2006

The Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) met by teleconference on November 20, 2006. Dr. James Mulé, Chair opened the meeting and called the roll. The Executive Secretary read a statement into the public record that it was determined that the Committee discussions on November 20, 2006 presented no potential for a conflict of interest. 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 received 1) an overview of the research and regulatory activities in the Divisions of Therapeutic Proteins and Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research and, 2) an overview of individual research programs in the Laboratory of Immunology, Division of Therapeutic Proteins and the Laboratory of Immunobiology, Division of Monoclonal Antibodies. Following the research overviews and the open public hearing, the open session was adjourned.

For more detailed information concerning the open session presentations and committee discussion summarized above, please refer to the meeting transcripts available on the FDA website at http://www.fda.gov/ohrms/dockets. Please submit all external requests to the FDA Freedom of Information Office.