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National Institutes of Health
Recombinant DNA Advisory Committee (RAC)

92nd Meeting of the NIH RAC

Bethesda Marriott Hotel
Bethesda, Maryland

September 17-18, 2003
Meeting Agenda

Wednesday, September 17, 2003
Morning Webcast

Afternoon Webcast

 

10:30 AM

    Morning Webcast
    Call to Order and Opening Remarks
    Theodore Friedmann, M.D., Chair, NIH RAC

        Tab 2305 For Your Information
        - Notice of Meeting
        - Conflict of Interest Guidance

10:40

    Minutes of the June 18-19, 2003 RAC Meeting
    Tab 2306

      RAC Reviewers: Theodore Friedmann, M.D.
      David DeMets, Ph.D.

10:50

    Discussion of Human Gene Transfer Protocol #0307-594 entitled:
    A Phase I Study to Determine the Safety and Biological Activity of Cell-Mediated Gene Therapy Using Tissue Gene-C in Patients with Degenerative Joint Disease of the Knee Prior to Total Knee Arthroplasty

    Powerpoint file of presentation

      PI: Michael A. Mont, M.D., Sinai Hospital, Baltimore, MD

      RAC Reviewers: Terry Kwan, M.S.Ed.
                                 Diane Wara, M.D.
                                 Neal DeLuca, Ph.D.

      Ad Hoc Reviewers: Robert H. Carter, M.D., University of Alabama, Birmingham

      Powerpoint file of presentation

        Tab 2307 Protocol

        Tab 2308 OBA Summary
                         OBA Letter to PI on in-depth RAC Review and Public
                         Discussion
                         Outcome of Initial Review by RAC Members
                         Reviews from Ms. Kwan, and Drs. Wara, DeLuca, and Carter
                         PI's/Sponsor's Response

12:40            Public Comment

12:50           Lunch

1:50

      Afternoon Webcast

      Discussion of Human Gene Transfer Protocol #0307-588 entitled:

      A Phase I Dose- Escalation Study of Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector containing the TNFR: Fc Fusion Gene in Rheumatoid Arthritis

      Powerpoint Presentation

      PI: Philip J. Mease, M.D., Swedish Hospital, Seattle, WA

      RAC Reviewers: Robert Simari, M.D.
                               Baruch Brody, Ph.D.
                               Thomas Gelehrter, M.D.

      Ad Hoc Reviewers: Robert H. Carter, M.D., University of Alabama, Birmingham
                                   Christopher H. Evans, D.Sc., Ph.D., Harvard Medical School
      Powerpoint file of Dr. Carter review
       

      Powerpoint file of Dr. Evans Review

      Tab 2309 Protocol

      Tab 2310 OBA Summary
                       OBA Letter to PI on in-depth RAC Review and Public Discussion
                       Outcome of Initial Review by RAC Members
                       Reviews from Drs. Simari, Brody, Gelehrter, Carter, and Evans

                     Dr. Evans Powerpoint file
                    
      PI's/Sponsor's Response
       

3:40 PM          Public Comment

3:50 PM         Break

Webcast of session after the break.

         Data Management Report
         Tab 2311 Protocol List
                         Protocols Not Selected for RAC Public Revi

         RAC Reviewers: Baruch Brody, Ph.D
                                     Linda Gooding, Ph.D.
                                     Larry Johnson, M.D.
                                     Robert Simari, M.D.
                                     Diane Wara, M.D.

4:20 PM          Informed Consent Working Group Update

4:45 PM          ADJOURNMENT

             

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