National Institutes of Health

[Entry Page]
[23 Sep 2004]
[22 Sep 2004]
[21 Sep 2004]
[9 June 2004]
[8 June 2004]
[11 Mar 2004]
[10 Mar 2004]
[9 Mar 2004]
[4 Dec 2003]
[3 Dec 2003]
[17 Oct 2003]
[17 Sept 2003]
[19 June 2003]
[18 June 2003]
[6-7 Mar 2003]
[4-6 Dec 2002]
[20-21 June 2002]
[7-8 Mar 2002]
[7-8 Dec 2001]
[06 Dec 2001]

 

 

NATIONAL INSTITUTES OF HEALTH
RECOMBINANT DNA ADVISORY COMMITTEE (RAC)

September 23, 2004

97th Meeting

Bethesda Marriott Hotel
Bethesda, Maryland

Morning Session (Real Video)

Caption Text

AGENDA

8:30 AM Call to Order and Opening Remarks
Diane Wara, M.D., Chair, NIH RAC

Call to Order and Opening Remarks ( Real Video)

Tab 2352 For Your Information
  - Notice of Meeting
  - Conflict of Interest Guidance

8:35 AM - Introduction of New RAC Members

8:50 AM - Minutes of the June 8-9, 2004, RAC Meeting

RAC Reviewers:
Helen Heslop, M.D.
Robert Simari, M.D.

Tab 2353 Minutes of the June 8-9, 2004, Meeting

9:00 AM - Update on the RAC Gene Transfer Clinical Trial Design Working Group

Presenters: David DeMets, Ph.D.
NIH RAC

David DeMets, Ph.D. (Real Video)

David DeMets, Ph.D. - Presentation (PDF)

Terry Kwan, M.S.Ed.
NIH RAC

Tiffany Scharschmidt
University of California, San Francisco

Tiffany Scharschmidt (Real Video)

Tiffany Scharschmidt - Presentation (PDF)

10:00 AM Data Management Report

Data Management Report (Real Video)

Tab 2354 - Protocol List
Protocols Not Selected for RAC Public Review

RAC Reviewers:
Helen Heslop, M.D.
Robert Simari, M.D.
Diane Wara, M.D.

10:15 AM - Discussion of Human Gene Transfer Protocol #0407-669:
Hippocampal NPY Gene Transfer in Subjects with Intractable Mesial Temporal Lobe Epilepsy

Matthew During, M.D., D.Sc. (Real Video)

Matthew During, M.D., D.Sc.- Presentation (PDF)

PIs: Matthew During, M.D., D.Sc.
Cornell University, New York, NY

Itzhak Fried, M.D., Ph.D.
University of California, Los Angeles (UCLA)

John Stern, M.D.
UCLA

RAC Reviewers:
Martha Bohn, Ph.D.
Stephen Dewhurst, Ph.D.
Philip Johnson, M.D.
Madison Powers, J.D., D.Phil.

Ad Hoc Reviewer: Marc A. Dichter, M.D., Ph.D.
University of Pennsylvania, Philadelphia, PA (via teleconference)

Ad Hoc Reviewer: Marc A. Dichter, M.D., Ph.D. (Real Video)

Tab 2355 Protocol

Tab 2356OBA Summary
OBA Letter to PI on In-Depth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Bohn, Dewhurst, Johnson, Powers, and Dichter
PIs'/Sponsor's Response

12:00 NOON - Public Comment

12:15 PM - Synopsis of RAC Discussion and RAC Recommendations

12:45 PM ADJOURNMENT

 

This webcast produced by