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NATIONAL INSTITUTES OF HEALTH Recombinant DNA Advisory Committee (RAC) 91st Meeting of the NIH RAC
Bethesda Marriot Hotel Bethesda, Maryland June 18-19 2003
Corrected Agenda (9/26/03) in PDF file
Wednesday, June 18, 2003
8.30 AM Call to Order and Opening Remarks
Theodore Friedmann, M.D., Chair, NIH RAC
8:45 AM Minutes of the February 10, 2003 RAC Meeting
Tab 2296
RAC Reviewers: Theodore Friedmann, M.D.
Madison Powers, J.D., D.Phil.
9:00 AM Presentation of NIH Award of Merit to Dr. Theodore Friedmann
and Dr. Linda Gooding
9:30 AM Discussion of Human Gene Transfer Protocol #0301-575 entitled:
A Phase I Study of NT-501, An Implant of Encapsulated Human
NTC-201 Cells Releasing Ciliary Neurotropic Factor (CNTF), in Patients with Retinitis Pigmentosa
Powerpoint Slides for Protocol
PI: Paul A. Sieving, M.D., Ph.D., National Institutes of Health
RAC Reviewers: Neal DeLuca, Ph.D.
Larry Johnson, M.D.
Maxine Linial, Ph.D.
Bernard Lo, M.D.
Ad Hoc Reviewer: Jean Bennett, M.D., Ph.D.
Tab 2298 Protocol
Tab 2299 OBA Summary
OBA Letter to PI on in-depth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Review from Drs. DeLuca, L. Johnson, Linial,
Lo, and Bennett
PI's/Sponsor's Response
11:15 AM Public Comment
The Foundation Fighting Blindness
11:40 AM BREAK
11:55 Data Management Report
Tab 2300 Protocol List
Protocols Not Selected for RAC Public Review
Discussion of Amendments to Protocol 304
RAC Reviewers: Baruch Brody, Ph.D.
Linda Gooding, Ph.D.
Larry Johnson, M.D.
Robert Simari, M.D.
Diane Wara, M.D.
1:00 PM LUNCH
2:00 PM Review of Selected American Society of Gene Therapy (ASGT)
Annual Meeting Sessions Related to Retroviral Vectors
Theodore Friedmann, M.D., Chair, NIH RAC
POWERPOINT SLIDES
Tab 2301 "Ethical and Policy Dilemmas in Clinical Gene Therapy Studies: Balancing Real Benefits and Real Risks"
"Report from the ASGT Ad Hoc Committee on
Retroviral-mediated GeneTransfer to Hematopoietic Stem Cells"
"SCID-X1 Clinical Trial: Current State"
Recommendations of the United Kingdom Gene Therapy
Advisory Committee (GTAC) and Committee on Safety of Medicines (CSM) Working Party on Retroviruses (April 2003)
Marina O'Reilly, Ph.D., Biotechnology Program Advisor, OBA
Tab 2302
POWERPOINT FILES
3:00 PM Public Comment
3:10 PM BREAK
3:25 PM Retroviral Vectors: Topics for Future Presentations and
Discussions at RAC Meetings
Marina O'Reilly, Ph.D., Alexander Rakowsky, M.D., and Madison Powers, J.D., D.Phil.
Retrovirus Working Group Members: Martha Bohn, Ph.D.
Neal DeLuca, Ph.D.
Theodore Friedmann, M.D.
Larry Johnson, M.D.
Maxine Linial, Ph.D.
Robert Simari, M.D.
Diane Wara, M.D.
POWERPOINT FILES
3:45 Public Comment
3:55 Presentation of in-depth Assessment Regarding
Containment-Level Requirements for Modified Vaccinia (MVA) Pox Viral Vector
RAC Presenter: Emmett Barkley, Ph.D.
Tab 2303
POWERPOINT FILES
Assessment Team: Mark Feinberg, M.D., Ph.D, Emory University
Bernard Moss, M.D., Ph.D., National Institute of
Allergy and Infectious Diseases, NIH
Paul Spearman, M.D., Vanderbilt University
4:45 Public Comment
5:00 ADJOURNMENT
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