National Institutes of Health
Recombinant DNA Advisory Committee (RAC)
94th Meeting
December 3-4, 2003
9:00 AM Call to Order and Opening Remarks
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, 2003
Tab 2317
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
(OBA) Staff
9:40 AM Data Management Report
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
Presenters: Cheryl McDonald, M.D., NIH OBA Staff
Thomas Shih, M.D., Ph.D., NIH OBA Staff
10:40 AM BREAK
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. Deisseroth’s slides
12:00 NOON LUNCH
1:00 PM Discussion of Human Gene Transfer Protocol #0310-610:
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
Public Discussion
Outcome
of Initial Review by RAC Members
Reviews from Drs. Bohn, Sidransky, Childress, Wara, and
Snyder
PI’s/Sponsor’s Response
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”
Speaker: Shawn M. Burgess, Ph.D.
National Human Genome Research Institute, NIH
4:10 PM ADJOURNMENT
Thursday, December 4, 2003
8:30 AM Call to Order and Opening Remarks
Theodore Friedmann, M.D., Chair, NIH RAC
8:35 AM Discussion of Human Gene Transfer Protocol #0307-589:
A Phase 1 Study in Glaucoma Subjects Receiving SCH 412499 (rAd-p21) Administered as a Single Injection into the Subconjunctival Space Prior to Primary Trabeculectomy
PIs: Paul L. Kaufman, M.D.
University of Wisconsin Medical School, Madison
Robert N. Weinreb, M.D.
University of California, San Diego
RAC Reviewers: Neal DeLuca, Ph.D.
Robert Simari, M.D.
Terry Kwan, M.S.Ed.
Ad Hoc Reviewer: Donald L. Budenz, M.D.
Bascom Palmer Eye Institute, Miami, FL
Tab 2322 Protocol
Tab 2323 OBA Summary
OBA Letter to PI on Indepth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. DeLuca and Simari and Ms. Kwan
PIs’/Sponsor’s Response
10:35 AM Public Comment
10:45AM BREAK
11:00 AM “NIH Guidance on Informed Consent for Gene Transfer Research”—A Web-Based Resource
Presenter: Nancy M.P. King, J.D., University of North Carolina, Chapel Hill
Sue L.
Levi-Pearl, Tourette’s Syndrome Association, Inc.,
Bayside, NY
12:00 NOON LUNCH
1:00 PM Discussion of Human Gene Transfer Protocol #0307-592:
A Phase 1 Study to Determine the Safety and Immunogenicity of Vaccination With Listeria Monocytogenes Expressing Human Papillomavirus Type 16 E7 for the Treatment of Progressive, Recurrent, and Advanced Squamous Cell Cancer of the Cervix
PI: John Marshall, M.D.
Georgetown University Medical Center, Washington, DC
RAC Reviewers: Emmett Barkley, Ph.D.
Larry Johnson, M.D.
Bernard Lo, M.D.
Tab 2324 Protocol
Tab 2325 OBA Summary
OBA Letter to PI on Indepth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Barkley, L. Johnson, and Lo
PI’s/Sponsor’s Response
3:00 PM Public Comment
3:10 PM ADJOURNMENT
*Draft agenda as of 11/21/03