Food and Drug Administration

Center for Biologics Evaluation and Research

Cellular, Tissue and Gene Therapies Advisory Committee

Meeting # 43


March 29, 2007

Hilton Hotel, Gaithersburg, Maryland




            OPEN SESSION

            Topic I:           Open Committee Discussion: Sipuleucel-T,  Dendreon (BLA-STN 125197) indicated for the treatment of men with                                                    asymptomatic metastatic hormone refractory prostate cancer


8:00 a.m.                                 Welcoming Remarks

                                                            James Mulé, Ph.D., Chair


                                                Conflict of Interest Statement

                                                            Gail Dapolito, Executive Secretary


            Introduction of Members

                        James Mulé, Ph.D.


                                                Recognition of Committee Service

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

                                                            Center for Biologics Evaluation and Research


8:30                                         Sponsor Presentation

9:30                                         Q&A


9:50                                         Break


10:10                                       FDA Perspective

11:10                                       Q&A


11:30                                       Open Public Hearing


12:30 p.m.                               Lunch


1:30                                         Questions for Committee Discussion


3:20                                         Break


3:30                                         Committee Vote


5:30 p.m.                                 Break




            Topic II:         Overview Research Programs, Division of Cellular and Gene                             Therapies (DCGT), CBER


5:45 p.m.                                 Raj Puri, M.D., Ph.D., Director, DCGT and

                                                Chief, Tumor Vaccines and Biotechnology Branch


6:05                                         Steven Bauer, Ph.D.

                                                Chief, Cellular and Tissue Therapy Branch


6:25                             Adjourn Open Session


6:30     Closed Session


7:20 p.m.                     Adjourn Closed Session