National Institutes of Health
Recombinant DNA Advisory Committee (RAC)
Bethesda Marriott Hotel
December 3-4, 2003
Wednesday, December 3, 2003
Morning before break
Morning after break
Afternoon before break
Afternoon after break
Call to Order and Opening Remarks WEBCAST
Theodore Friedmann, M.D., Chair, NIH RAC
Tab 2316 For Your Information
Notice of Meeting
Conflict of Interest Guidance
9:10 AM Minutes of the September 17, 200
RAC Reviewers: Philip Johnson, M.D.
Thomas Gelehrter, M.D.
9:20 AM Update on the RAC Gene Transfer Clinical Trial Design Working Group
Presenters: David DeMets, Ph.D., NIH RAC
Cheryl McDonald, M.D., NIH Office of Biotechnology Activities
9:40 AM Data Management Report WEBCAST
Tab 2318 Protocol List
Protocols Not Selected for RAC Public Review
RAC Reviewers: Larry Johnson, M.D.
Robert Simari, M.D.
Diane Wara, M.D.
10:10 AM Update on the Development of a Mechanism to Apprise the RAC of Investigator and Institutional Responses to RAC Reviews WEBCAST
10:40 AM BREAK
11:00 AM Amendments and Updates to Human Gene Transfer Protocol #0010-419: WEBCAST
Intratumoral Injections of a Replication-Incompetent Adenoviral Vector Encoding a Factor VII Immunoconjugate to Induce a Cytolytic Immune Response Against Melanoma Tumors: A Pilot Trial (Indepth review and
public discussion at the December 2000 RAC meeting)
PI: Albert B. Deisseroth, M.D., Ph.D.
Sidney Kimmel Cancer Center, San Diego, CA
Tab 2319 Protocol, amendments, December 2000 RAC recommendation letter, and Dr.
12:00 NOON LUNCH
1:00 PM Discussion of Human Gene Transfer Protocol #0310-610: WEBCAST
A Phase I/II Study of the Treatment of Recurrent or Progressive Malignant Glioma Using Autologous Bone Marrow-Derived Stromal Cells (BMSC) Nonvirally Transduced to Express IL-12
PI Tom Mikklesen, M.D.
Henry Ford Cancer Center, Detroit, MI
RAC Reviewers: Martha Bohn, Ph.D.
David Sidransky, M.D.
James Childress, Ph.D.
Diane Wara, M.D.
Ad Hoc Reviewer: Evan Y. Snyder, M.D., Ph.D. (via teleconference)
The Burnham Institute, La Jolla, CA
Tab 2320 Protocol
Tab 2321 OBA Summary
OBA Letter to PI on Indepth RAC Review and
Outcome of Initial Review by RAC Members
Reviews from Drs. Bohn, Sidransky, Childress, Wara, and
3:00 PM Public Comment
3:10 PM Educational Seminar Series on Retroviruses: "Global Site Preferences for MLV and HIV-1 Proviral Integration in the Human Genome"
4:10 PM ADJOURNMENT