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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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