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NATIONAL INSTITUTES OF HEALTH
RECOMBINANT DNA ADVISORY COMMITTEE (RAC)
Thursday, December 16, 2004
98th Meeting
Bethesda Marriott Hotel
Bethesda, Maryland
Morning Session before break (Real Video)
Morning Session after break (Real Video)
Afternoon Session before Break (Real Video)
Afternoon Session after Break (Real Video)
CAPTION TEXT
Meeting Agenda
8:30 AM - Call to Order and Opening Remarks (Real Video)
Diane Wara, M.D., Chair, NIH RAC
Tab 2357 For Your Information
Notice of Meeting
Conflict of Interest Guidance
National Gene Vector Laboratories Notice of New Services
8:40 AM - Minutes of the September 23, 2004, RAC Meeting (Real Video)
RAC Reviewers:
Martha Bohn, Ph.D.
Stephen Dewhurst, Ph.D.
Tab 2358 Minutes of the September 23, 2004, Meeting
8:50 AM Discussion of Human Gene Transfer Protocol #0410-679: (Real Video)
Phase I Clinical Trial of rAAV2.5-CMV-Minidystrophin
Gene Vector in Duchenne Muscular Dystrophy
PI: Jerry Mendell, M.D.
Columbus Children's Research Institute, Columbus, OH
679 - Samulski
RAC Reviewers:
Thomas Gelehrter, M.D.
Bernard Lo, M.D.
Glen Nemerow, Ph.D.
Ad Hoc Reviewer: Jeffrey Chamberlain, Ph.D.
University of Washington, Seattle, WA
Tab 2359 Protocol
Tab 2360 OBA Summary
OBA Letter to PI on In-Depth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Gelehrter, Lo, Nemerow, and Chamberlain
PI's/Sponsor's Response
10:30 AM BREAK
DVD Video on Duchenne Muscular Dystrophy (Real Video)
10:45 AM - Data Management Report (Real Video)
Tab 2361 Protocol List
Protocols Not Selected for RAC Public Review
RAC Reviewers: Steven Albelda, M.D.
Helen Heslop, M.D.
Robert Simari, M.D.
Diane Wara, M.D.
11:45 AM - LUNCH
1:30 PM - Followup on Safety Symposium: Safety Considerations in Recombinant DNA Research with Pathogenic Viruses—Development of a Web-Based
Resource (Real Video)
Marina O'Reilly, Ph.D., Office of Biotechnology Activities
Neal DeLuca, Ph.D., RAC
Kathryn Holmes, Ph.D., University of Colorado, Denver, CO (via teleconference)
2:00 PM - The Immune Response to Lymphopenia (Real Video)
Speaker: Crystal MacKall, M.D., National Cancer Institute, Bethesda, MD
2:30 PM - Discussion of Human Gene Transfer Protocol #0410-675: (Real Video)
Development of Effective Immunotherapy for Prostate Cancer Patients:
Phase I/II Study of Human GM-CSF Gene-Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®) in Advanced Prostate Cancer Patients Made Lymphopenic by Chemotherapy and Infused with Autologous Peripheral Blood Mononuclear Cells
PIs: Walter Urba, M.D., Ph.D.
Earle A. Chiles Research Institute, Portland, OR
Bernard Fox, Ph.D.
Earle A. Chiles Research Institute, Portland, OR
RAC Reviewers:
Helen Heslop, M.D.
Nicholas Muzyczka, Ph.D.
Madison Powers, J.D., D.Phil.
Ad Hoc Reviewer: Jonathan Simons, M.D.
Emory University, Atlanta, GA (written response)
Tab 2362 Protocol
Tab 2363 OBA Summary
OBA Letter to PIs on In-Depth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Heslop, Muzyczka, Powers, and Simons
PIs'/Sponsor's Response
4:00 PM Public Comment
4:15 PM ADJOURNMENT
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