National Institutes of Health
Recombinant DNA Advisory Committee (RAC)
Bethesda Marriott Hotel
Bethesda , Maryland
Wednesday, March 16, 2005
Morning Session before break (Real Video)
Morning Session after break (Real Video)
Afternoon Session after lunch (Real Video)
Afternoon Session after break (Real Video)
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NOTE: The caption text is a record of the close captioning offered to support the video. It is not a totally accurate, verbatim transcript of the meeting. It is offered here for interest and support of the video. A correct transcript will be available on the NIH web site in due course.
Meeting Agenda
8:00 AM - Call to Order and Opening Remarks
(Real Video)
Diane Wara, M.D., Chair, NIH RAC
Tab 2364 For Your Information
Notice of Meeting
Conflict of Interest Guidance
8:10 AM - Minutes of the December 16, 2004, RAC Meeting
(Real Video)
RAC Reviewers:
Thomas Gelehrter, M.D.
Emmett Barkley, Ph.D.
Tab 2365 Minutes of the December 16, 2004, RAC Meeting
8:20 AM - Update onHuman Gene Transfer Protocol#9906-322: A Phase I Study of NGF Ex Vivo Gene Therapy for Alzheimer’s Disease
Presenter: Mark H. Tuszynski, M.D., Ph.D., University of California, San Diego
Presentation (PDF)
(Real Video)
8:40 AM - Update onHuman Gene Transfer Protocol # 0401-623: A Phase I/II, Dose-Escalating, Randomized and Controlled Study to Assess the Safety, Tolerability, and Efficacy of CERE-110 (Adeno-Associated Virus [AAV]-Based, Vector-Mediated Delivery of Beta-Nerve Growth Factor [NGF]) in Subjects with Mild to Moderate Alzheimer’s Disease
Presenter: Raymond T. Bartus, Ph.D., Ceregene, Inc.
(Real Video)
Presentation (PDF)
8:45 AM - Discussion of Human Gene Transfer Protocol #0501-689 : A Phase I, Open-Label Study of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) to Assess the Safety and Tolerability of Intrastriatal Delivery to Subjects with Ideopathic Parkinson’s Disease
(Real Video)
Presentation (PDF)
Presentation (PDF)
PI: William J. Marks, Jr., M.D., University of California, San Francisco
RAC Reviewers:
Martha Bohn, Ph.D.
Philip Johnson, M.D.
Terry Kwan, M.S.Ed.
Ad Hoc Reviewer : Ho ward J. Federoff, M.D., Ph.D., University of Rochester, Rochester, NY
Tab 2366 Protocol
Tab 2367 OBA Summary
OBA Letter to PI on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Bohn, Johnson, and Federoff and Ms. Kwan
PI’s/Sponsor’s Response
10:10 AM - Public Comment
10:20 AM - BREAK
10:35 AM - Discussion of Human Gene Transfer Protocol #0501-691 :Phase I Trial of Systemic Administration of Edmonston Strain of Measle Virus, Genetically Engineered to Express NIS, with or without Cyclophosphamide, in Patients with Recurrent or Refractory Multiple Myeloma
Presentation (PDF)
(Real Video)
PIs: Morie A. Gertz, M.D., Mayo Clinic, Rochester, MN
Angela Dispenzieri, M.D., Mayo Clinic, Rochester, MN
Presenter: Stephen J. Russell, M.D., Ph.D., Mayo Clinic, Rochester, MN
RAC Reviewers: Steven Albelda, M.D.
Stephen Dewhurst, Ph.D.
Bernard Lo, M.D.
Ad Hoc Reviewer : Diane E. Griffin, M.D., Ph.D., Johns Hopkins University, Baltimore, MD ( via teleconference )
Tab 2368 Protocol
Tab 2369 OBA Summary
OBA Letter to PIs on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Albelda, Dewhurst, Lo, and Griffin
PIs’/Sponsor’s Response
12:05 PM - Public Comment
12:15 PM - Presentation of American Association for the Advancement of
Science Award to RAC Members
Elias A. Zerhouni, M.D., Director, National Institutes of Health
(Real Video)
12:30 PM - LUNCH
1:30 PM - General Clinical Research Center Resources for Long-Term Followup
Presenter: TBD
Presentation (PDF)
(Real Video)
1:45 PM - Data Management Report
Tab 2370 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.
2:05 PM - Discussion of Human Gene Transfer Protocol #0411-681: Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer after Nonmyeloablative Conditioning
Presentation (PDF)
(Real Video)
PI: Richard Paul Junghans, M.D., Ph.D., School of Medicine, Boston University
RAC Reviewers:
Madison Powers, J.D., D.Phil.
Naomi Rosenberg, Ph.D.
Diane Wara, M.D.
Ad Hoc Reviewer: Theodore Friedmann, M.D., University of California,
San Diego
Tab 2371 Protocol
Tab 2372 OBA Summary
OBA Letter to PI on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Friedmann, Powers, Rosenberg, and Wara
PI’s/Sponsor’s Response
3:35 PM - Public Comment
3:45 PM - BREAK
4:00 PM - Update and Discussion of Human Gene Transfer Protocol #0312-619: Administration of a Replication-Deficient Adeno-Associated Virus Gene Transfer Vector Expressing the Human CLN2 cDNA to the Brain of Children with Late Infantile Neuronal Ceroid Lipofuscinosis
Presenter: Ronald G. Crystal, M.D., Weill Medical College, Cornell University,
New York, NY
Presentation (PDF)
(Real Video)
5:30 PM - Public Comment
5:45 PM - ADJOURNMENT
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