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Recombinant DNA Advisory Committee (RAC)

 100 th Meeting

 Bethesda Marriott Hotel
Bethesda , Maryland

 June 15, 2005

Morning Session   (Real Video)

Afternoon Session  (Real Video)

CAPTION TEXT (HTML)
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

(To view the Agenda in PDF format, click here.)

Wednesday, June 15, 2005

8:30 AM Call to Order and Opening Remarks  (Real Video)

Diane Wara, M.D., Chair, NIH RAC

Tab 2373 For Your Information
Notice of Meeting
Conflict of Interest Guidance  (Real Video)

8:40 AM Minutes of the March 16, 2005, RAC Meeting  (Real Video)

RAC Reviewers:
Nicholas Muzyczka, Ph.D.
Emmett Barkley, Ph.D.

Tab 2374 Minutes of the March 16, 2005, RAC Meeting

8:45 AM Certificates of Appreciation  (Real Video)

Presenter: Raynard S. Kington, M.D., Ph.D., Deputy Director,
National Institutes of Health

8:55 AM Followup from March 15, 2005, Gene Transfer Safety Symposium:
Current Perspectives on Gene Transfer for X-SCID  (Real Video)

Presenters: Diane Wara, M.D.
Marina O’Reilly, Ph.D., Office of Biotechnology Activities

9:20 AM Discussion of Human Gene Transfer Protocol #0311-613: A Phase I Dose-Escalation Study of Intratumoral Herpes Simplex Virus-1 Mutant rRp450 in Patients with Refractory Sarcoma or Neuroblastoma  (Real Video)

Presentation (PDF)

PI: Timothy P. Cripe, M.D., Ph.D., Cincinnati Children’s Hospital Medical Center, Cincinnati, OH

RAC Reviewers:
Neal DeLuca, Ph.D.
Terry Kwan, M.S.Ed.
Thomas Gelehrter, M.D.

Tab 2375 Protocol

Tab 2376 OBA Summary

  • OBA Letter to PI on In-Depth RAC Review and Public Discussion
  • Outcome of Initial Review by RAC Members
  • Reviews from Drs. DeLuca and Gelehrter and Ms. Kwan
  • PI’s/Sponsor’s Response

10:50 AM Public Comment

11:00 AM BREAK

11:15 AM Discussion of Human Gene Transfer Protocol #0502-699 :A Pilot Study of Temozolomide and O 6-Benzylguanine for Treatment of High-Grade Glioma Using Autologous Peripheral Blood Stem Cells Genetically Modified for Chemoprotection  (Real Video)

Presentation (PDF)

PI: Lars Martin Wagner, M.D., Cincinnati Children’s Hospital Medical Center/University of Cincinnati College of Medicine, Cincinnati, OH

Submitter: Christopher von Kalle, M.D., Cincinnati Children’s Hospital Medical Center/University of Cincinnati College of Medicine, Cincinnati, OH

RAC Reviewers:
Bernard Lo, M.D.
Glen Nemerow, Ph.D.
Naomi Rosenberg, Ph.D.

Tab 2377 Protocol

Tab 2378 OBA Summary

  • OBA Letter to PI on In-Depth RAC Review and Public Discussion
  • Outcome of Initial Review by RAC Members
  • Reviews from Drs. Lo, Nemerow, and Rosenberg
  • PI’s/Sponsor’s Response

12:45 PM Public Comment

12:55 PM LUNCH

1:55 PM Data Management Report   (Real Video)

Tab 2379 Response M-1-C-1

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.

2:15 PM Discussion of Human Gene Transfer Protocol #0504-703:A Phase I Safety, Dose-Escalating Study of MultiGeneAngio in Patients with Peripheral Arterial Disease  (Real Video)

 PI: P. Michael Grossman, M.D., University of Michigan/

VA Ann Arbor Health Systems, Ann Arbor, MI

Presentation (PDF)

Sponsor: Moshe Flugelman, M.D., Multigene Vascular Systems, Ltd., Haifa, Israel

RAC Reviewers:
Stephen Dewhurst, Ph.D.
Madison Powers, J.D., D.Phil.
Robert Simari, M.D.

Ad Hoc Reviewer: Stephen Epstein, M.D., Washington Hospital Center, Washington, DC

Tab 2380 Protocol

Tab 2381 OBA Summary

  • OBA Letter to PI on In-Depth RAC Review and Public Discussion
  • Outcome of Initial Review by RAC Members
  • Reviews from Drs. Dewhurst, Powers, Simari, and Epstein
  • PI’s/Sponsor’s Response

3:45 PM   Public Comment

4:00 PM ADJOURNMENT


 

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