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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*

Thursday 4 December 2003

Webcast
Morning before break
Morning after break
Afternoon

8:30 AM Call to Order and Opening Remarks

    Theodore Friedmann, M.D., Chair, NIH RAC

8:35 AM Discussion of Human Gene Transfer Protocol #0307-589:

    Powerpoint Presentation

    A Phase 1 Study in Glaucoma Subjects Receiving SCH 412499 (rAd-p21) Administered as a Single Injection into the Subconjunctival Space Prior to Primary Trabeculectomy

    PIs: Paul L. Kaufman, M.D.
    University of Wisconsin Medical School, Madison
    Robert N. Weinreb, M.D.
    University of California, San Diego

    RAC Reviewers: Neal DeLuca, Ph.D.
    Robert Simari, M.D.
    Terry Kwan, M.S.Ed.

    Ad Hoc Reviewer: Donald L. Budenz, M.D.
       Bascom Palmer Eye Institute, Miami, FL

      Tab 2322 Protocol

    Tab 2323 OBA Summary
    OBA Letter to PI on Indepth RAC Review and
      Public Discussion
         Outcome of Initial Review by RAC Members
    Reviews from Drs. DeLuca and Simari and Ms. Kwan

     PIs'/Sponsor's Response

10:35 AM Public Comment

10:45AM BREAK

11:00 AM "NIH Guidance on Informed Consent for Gene Transfer Research"A Web-Based Resource

    Powerpoint Presentation

    Presenter: Nancy M.P. King, J.D., University of North Carolina, Chapel Hill
    Sue L. Levi-Pearl, Tourette's Syndrome Association, Inc.,  Bayside, NY

12:00 NOON LUNCH

 

1:00 PM Discussion of Human Gene Transfer Protocol #0307-592:

     

     A Phase 1 Study to Determine the Safety and Immunogenicity of Vaccination With Listeria Monocytogenes Expressing Human Papillomavirus Type 16 E7 for the Treatment of Progressive, Recurrent, and Advanced Squamous Cell Cancer of the Cervix

    Powerpoint Presentation

      PI: John Marshall, M.D.
    Georgetown University Medical Center, Washington, DC

      RAC Reviewers: Emmett Barkley, Ph.D.
    Larry Johnson, M.D.
    Bernard Lo, M.D.

      Tab 2324 Protocol

     Tab 2325  OBA Summary
    OBA Letter to PI on Indepth RAC Review and Public Discussion
         Outcome of Initial Review by RAC Members
    Reviews from Drs. Barkley, L. Johnson, and Lo
    PI's/Sponsor's Response

3:00 PM Public Comment

3:10 PM ADJOURNMENT

             

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