FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

RESEARCH REVIEW SUBCOMMITTEE OF THE

CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE

 

Research Review Subcommittee of the

Cellular, Tissue and Gene Therapies Advisory Committee

 

SITE VISIT

OFFICE OF CELLULAR, TISSUE AND GENE THERAPIES

 

September 29, 2005ite Visit

Office of Cellular, Tissue and Gene Therapies

Holiday Inn Select, Bethesda, MD

September 29, 2005

 

DRAFT AGENDA

 

Open Committee Discussion

 

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

Mahendra Rao, M.D., Ph.D., Chair

 

8:10                 Conflict of Interest Statement

                                    Gail Dapolito, Executive SecretaryFDA Ethics and Integrity Staff

 

8:15                 Introduction/Charge to Committee

             Jesse L. GoodmanKaren Midthun, M.D., M.P.H.

Deputy             Director, Center for Biologics Evaluation and Research

                        CBER Mission

                        CBER Program Structure

 

8:40                 Overview of CBER Research Programs

                                    Kathryn Carbone, M.D.

                                    Associate Director for Research

 

9:10                 Overview of the Office of Cellular, , Tissue and Gene Therapies (OCTGT)s (OCTGT)

Celia Witten, M.D., Director (and others?)

                        Office Mission and Structure

                        Regulatory Activities and Priorities

                                    Research Program Introduction

 

 

9:35                 Q & A (to Drs. Midthun, Carbone, Witten)

 

910:50 a.m.                        Break

Research Review Subcommittee of the

Cellular, Tissue and Gene Therapies Advisory Committee

Site Visit Review

Office of Cellular, Tissue and Gene Therapies

September 29, 2005

 

 

DRAFT AGENDA (Cont’d)

 

            Open Committee Discussion

 

10:05 a.m.            Overview of the Division of Cellular, Tissue and Gene Therapies (DCGT)

                                    R        Raj Puri, M.D., Ph.D., Director DCGT

Mission/Philosophy/Regulatory Activities and 

    Public Health Impact

                                                Regulatory and Research Expertise

Research Program Structure and  & Research

                                                Activities and Priorities

                                               

                                               

10:40               Office of Cellular, Tissue and Gene Therapies Research Program

Suzanne Epstein, Ph.D., Associate Director of Research, OCTGT

                                                            Overview of the Office of Cellular, Tissue and Gene Therapies Research Management, Aaccomplishments and Future PlansFive-year Objectives

     Suzanne Epstein, Ph.D., Associate Director of Research

 

 

11:05               Q&A

 

11:20               Open Public Hearing

 

12:20 p.m.            Adjourn Open SessionLunch

 

 

1:20     Closed Committee Discussion

 

1:20 p.m.  Administrative Remarks and Instructions

        Mahendra Rao, M.D., Ph.D., Chair

 

1:30    Discussion of  Research Management Issues

Introduction of CBER Panel and Questions to Panel by committee

  Panel : Drs. Witten, Epstein, Division Directors (DCGT, DCEPT, DHT), Lab and Branch Chiefs

 

2:30    Closed Executive Session of Committee

 

3:30  Oral Summary (Deputy Director, Assoc. Dir. Research, CBER, Office Director, Office Associate Director of Research, and Division Directors (DCGT, DHT and DCEPT)

             

4:00 p.m.                         Adjourn Closed Session            

 

Presentation of finalized Sub-Committee Report at next full meeting of the Cellular, Tissue and Gene Therapies Advisory Committee for discussion/vote by CTGTAC.