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 FRIDAY 17th OCTOBER 2003

National Institutes of Health
Recombinant DNA Advisory Committee (RAC)

93rd Meeting of the NIH RAC

Bethesda Marriott Hotel
Bethesda, Maryland

October 17, 2003

Meeting Agenda

                 WEBCAST Recording

8:30 AM    Call to Order and Opening Remarks
                 Theodore Friedmann, M.D., Chair, NIH RAC

8:35 AM    Powerpoint Slides

      Discussion of Human Gene Transfer Protocol #0307-593 entitled:
      A Phase I Open-label Safety Study of Intrastriatal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-amino acid Decarboxylase (AAV-hAADC-2) in Subjects With Advanced Parkinson's Disease [AAV-hAADC-2-003]

             PI: Michael Aminoff, M.D., D.Sc., University of California, San Francisco

             RAC Reviewers: Philip Johnson, M.D.
                                         Martha Bohn, Ph.D.
                                         Madison Powers, J.D., D. Phil.

               Ad Hoc Reviewer: D. Eugene Redmond, Jr.,M.D., Yale University,
                                             (via teleconference)

        Tab 2314 Protocol
        Tab 2315 OBA Summary
                         OBA Letter to PI on In-depth RAC Review and Public
                         Discussion
                         Outcome of Initial Review by RAC Members
                         Reviews from Drs. P. Johnson, Bohn, Powers, and Redmond,
                         PI's/Sponsor's Response

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