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National Institutes of Health
Recombinant DNA Advisory Committee (RAC)

94th Meeting

Bethesda Marriott Hotel
Bethesda, Maryland

December 3-4, 2003

Meeting Agenda*

Wednesday, December 3, 2003

Morning before break
Morning after break
Afternoon before break
Afternoon after break

9:00 AM Call to Order and Opening Remarks  WEBCAST

    Theodore Friedmann, M.D., Chair, NIH RAC
    Tab 2316 For Your Information
      Notice of Meeting
      Conflict of Interest Guidance

9:10 AM Minutes of the September 17, 200

    Tab 2317
    RAC Reviewers: Philip Johnson, M.D.
     Thomas Gelehrter, M.D.

9:20 AM Update on the RAC Gene Transfer Clinical Trial Design Working Group

      Presenters: David DeMets, Ph.D., NIH RAC
       Cheryl McDonald, M.D., NIH Office of Biotechnology Activities
      (OBA) Staff

9:40 AM Data Management Report   WEBCAST

    Tab 2318 Protocol List
       Protocols Not Selected for RAC Public Review
      RAC Reviewers: Larry Johnson, M.D.
         Robert Simari, M.D.
         Diane Wara, M.D.

10:10 AM Update on the Development of a Mechanism to Apprise the RAC of Investigator and Institutional Responses to RAC Reviews  WEBCAST

10:40 AM BREAK

11:00 AM Amendments and Updates to Human Gene Transfer Protocol #0010-419:     WEBCAST

    Intratumoral Injections of a Replication-Incompetent Adenoviral Vector Encoding a Factor VII Immunoconjugate to Induce a Cytolytic Immune Response Against Melanoma Tumors: A Pilot Trial (Indepth review and public discussion at the December 2000 RAC meeting)

    Powerpoint Presentation

    PI: Albert B. Deisseroth, M.D., Ph.D.
     Sidney Kimmel Cancer Center, San Diego, CA
    Tab 2319 Protocol, amendments, December 2000 RAC recommendation letter, and Dr. Deisseroth's slides


1:00 PM Discussion of Human Gene Transfer Protocol #0310-610: WEBCAST

    A Phase I/II Study of the Treatment of Recurrent or Progressive Malignant Glioma Using Autologous Bone Marrow-Derived Stromal Cells (BMSC) Nonvirally Transduced to Express IL-12

    Powerpoint Presentation

      PI Tom Mikklesen, M.D.
    Henry Ford Cancer Center, Detroit, MI
    RAC Reviewers: Martha Bohn, Ph.D.
       David Sidransky, M.D.
       James Childress, Ph.D.
       Diane Wara, M.D.
    Ad Hoc Reviewer: Evan Y. Snyder, M.D., Ph.D. (via teleconference)
    The Burnham Institute, La Jolla, CA 

      Tab 2320 Protocol

     Tab 2321  OBA Summary
    OBA Letter to PI on Indepth RAC Review and

       Public Discussion

    Outcome of Initial Review by RAC Members
    Reviews from Drs. Bohn, Sidransky, Childress, Wara, and
    PI's/Sponsor's Response

3:00 PM Public Comment

3:10 PM Educational Seminar Series on Retroviruses: "Global Site Preferences for MLV and HIV-1 Proviral Integration in the Human Genome"



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