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NATIONAL INSTITUTES OF HEALTH
RECOMBINANT DNA ADVISORY COMMITTEE (RAC)
DoubleTree Hotel & Executive Meeting Center
Rockville, Maryland
June 20-21, 2002
MEETING AGENDA with Links to PowerPoint slides and Video files*
Thursday, June 20, 2002
8:00 AM Call to Order and Opening Remarks
Theodore Friedmann, M.D., RAC Chair
Tab 2251 For Your Information
- Notice of Meeting
- Conflict of Interest Statement
8:10 AM Minutes of the March 7-8, 2002, RAC Meeting
RAC Reviewers: Sue Levi-Pearl, RAC Member
Linda Gooding, Ph.D., RAC Member
Tab 2252 Minutes of the March 7-8, 2002, Meeting
8:15 AM Discussion of Human Gene Transfer Protocol #0201-523 entitled:
Phase I Trial of Intraperitoneal Administration of an Attenuated Strain (Edmonston strain) of Measles Virus, Genetically Engineered to Produce Carcinoembryonic Antigen, in Patients With Recurrent Ovarian Cancer
PIs: Evanthia Galanis, M.D., Mayo Clinic
Jeff Sloan, Ph.D., Mayo Clinic (via teleconference)
Powerpoint Files
Video files (powerpoint and audio in Real Media format)
(there were some audio-visual difficulties during this discussion)
RAC Reviewers: Philip Johnson, M.D.
Linda Gooding, Ph.D.
Baruch Brody, Ph.D. (written review)
Neal DeLuca, Ph.D.
Ad Hoc Reviewer: Diane Griffin, Ph.D., M.D., Johns Hopkins University
Tab 2253 Protocol
Tab 2254 OBA Summary
OBA Letter to PIs on Indepth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews From P. Johnson, Gooding, Brody, DeLuca, and Griffin Sponsor s Response
Thursday June 20, 2002 (continued)
10:15 AM BREAK
10:30 AM Discussion of Human Gene Transfer Protocol #0201-521 entitled: Inducible
Nitric Oxide Synthase Gene Therapy for the Prevention of Intimal Hyperplasia in Arteriovenous Grafts Used for Hemodialysis Access
PI: Edith Tzeng, M.D., University of Pittsburgh Medical Center
PowerPoint Files
Video Tape Part One
Video Tape Part Two
RAC Reviewers: Robert Simari, M.D.
Nancy King, J.D.
Theodore Friedmann, M.D.
Ad Hoc Reviewer: Michael Mann, M.D., University of California,
San Francisco
Tab 2255 Protocol
Tab 2256 OBA Summary
OBA Letter to PI on Indepth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews From Simari, King, Friedmann, and Mann
Sponsor s Response
12:00 NOON LUNCH
1:15 PM Discussion of Human Gene Transfer Protocol #0201-528 entitled:
Pilot Study of the Use of the Human hSlo/maxi-K Gene to Treat Erectile
Dysfunction
PI: Arnold Melman, M.D., Albert Einstein College of Medicine
PowerPoint files
Video Tape Part One
Video Tape Part Two
RAC Reviewers: Kwaku Ohene-Frempong, M.D.
James Childress, Ph.D
. Thomas Gelehrter, M.D.
Ad Hoc Reviewers: Ira Fox, M.D., University of Nebraska Medical Center
John Mulcahy, M.D., Indiana University School of
Medicine(via teleconference)
Powerpoint files
Mark Nelson, Ph.D., University of Vermont(via
teleconference)
Powerpoint files
Tab 2257 Protoco
Tab 2258 OBA Summary
OBA Letter to PI on Indepth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews From Ohene-Frempong, Childress, Gelehrter, Fox,
Mulcahy, and Nelson
Sponsor s Response
3:15 PM BREAK
3:30 PM Discussion of Human Gene Transfer Protocol #0201-529 entitled: Gene
Transfer for Intractable Pain: A Phase I Clinical Trial to Determine the Maximum Tolerable Dose of a Replication-Defective HSV Vector Expressing Human Proenkephalin
PIs: David Fink, M.D., University of Pittsburgh School of Medicine
Joseph Glorioso, Ph.D., University of Pittsburgh School of Medicine
PowerPoint Slides
Video Tape Part One
Video Tape Part Two
RAC Reviewers: Xandra Breakefield, Ph.D.
Sue Levi-Pearl
Diane Wara, M.D.
Ad Hoc Reviewers: Bernard Lo, M.D., University of California, San Francisco
(via teleconference)
Howard Federoff, M.D., Ph.D., University of Rochester
(written reponse)
Tab 2259 Protocol
Tab 2260 OBA Summary
OBA Letter to PIs on Indepth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews From Breakefield, Levi-Pearl, Wara, Lo, and Federoff
Sponsor s Response
5:00 PM ADJOURNMENT
Friday, June 21, 2002
8:15 AM Call to Order
Theodore Friedmann, M.D., RAC Chair
Video files
8:20 AM Informed Consent Working Group Report
Nancy King, J.D.
9:00 AM Presentation of RAC Member Certificates and Induction of New RAC
Members
Ruth L. Kirschstein, M.D., Deputy Director, NIH
Amy Patterson, M.D., OBA Director
Video files
9:25 AM Discussion of Human Gene Transfer Protocol #0112-533 entitled: Phase I Trial of in situ Gene Therapy for Locally Recurrent Prostate Cancer Following Radiation Therapy
Failure Using Sodium/Iodide Symporter and Radioiodine
PowerPoint slides
Video files
PI: John Morris, M.D., Mayo Clinic
RAC Reviewers: Larry Johnson, M.D.
James Childress, Ph.D.
Theodore Friedmann, M.D.
PowerPoint slides
Ad Hoc Reviewers: Terry Kwan
Paul Ladenson, M.D., Johns Hopkins Medical Institute
(via teleconference)
Nancy Carrasco, M.D., Albert Einstein College of
Medicine
Tab 2261 Protocol
Tab 2262 OBA Summary
OBA Letter to PI on Indepth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews From L. Johnson, Childress, Friedmann,
Kwan, Ladenson, and Carrasco
Sponsor s Response
11:10 AM BREAK
Friday, June 21, 2002 (continued)
11:30 AM Data Management Report
Tab 2263 Protocol List
Protocols Not Selected for RAC Public Review
Serious Adverse Event Summary Report
Amendments and Update Summary Table
Video file
12:30 PM LUNCH
1:30 PM Discussion of Human Gene Transfer Protocol #0201-534 entitled: Phase I Study of AD4-"E3-HIVenv and AD4-"E3-HIVgag/pro Recombinant Vaccines in HIV-Negative
Volunteers
PI: Mark Connors, M.D., National Institute of Allergy and Infectious Diseases
PowerPoint slides
Video files
RAC Reviewers: Xandra Breakefield, Ph.D.
Maxine Linial, Ph.D.
Diane Wara, M.D.
Nancy King, J.D.
Ad Hoc Reviewers: Ira Fox, M.D., University of Nebraska
Stephen Dewhurst, Ph.D., University of Rochester
Tab 2264 Protocol
Tab 2265 OBA Summary
OBA Letter to PI on Indepth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews From Breakefield, Linial, Wara, King, Fox, and Dewhurst
Sponsor s Response
3:30 PM Closing Remarks
4:10 PM ADJOURNMENT
* Final agenda as of 06/17/02.
Please Note: If you wish to make public comments at the meeting, please contact Laurie Harris at (301) 496-9838 or e-mail at harrisla@od.nih.gov.
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