National
Institutes of Health
Recombinant DNA Advisory Committee (RAC)
92nd
Meeting of the NIH RAC
10:30 AM Call to Order and Opening Remarks
Theodore Friedmann, M.D., Chair, NIH RAC
Tab 2304 For Your Information
- Notice of Meeting
- Conflict of Interest Guidance
Tab 2305
RAC
Reviewers: Theodore
Friedmann,
M.D.
David DeMets, Ph.D.
10:50 AM Discussion of Human Gene Transfer Protocol #0307-594 entitled:
A Phase Study to Determine the Safety and Biological Activity of Cell-Mediated
Gene Therapy Using Tissue Gene-C in Patients with Degenerative Joint Disease of
the Knee Prior to Total Knee Arthroplasty
PI: Michael A. Mont, M.D.,
RAC
Reviewers: Terry Kwan
Diane Wara,
M.D.
Neal DeLuca, Ph.D.
Ad Hoc Reviewers: Robert H. Carter, M.D.,
Tab
2306 Protocol
Tab
2307 OBA Summary
OBA Letter to PI on in-depth RAC Review and Public
Discussion
Outcome
of Initial Review by RAC Members
Reviews
from Ms. Kwan, and Drs. Wara, DeLuca, Carter
PI’s/Sponsor’s
Response
12:40 PM Public Comment
12:50 PM LUNCH
A
Phase I Dose Escalation Study of Intra-Articular Administration of tgAAC94, a
Recombinant Adeno-Associated Vector containing the TNFR: Fc Fusion Gene in
Rheumatoid Arthritis
PI: Philip J. Mease, M.D.,
RAC
Reviewers: Robert Simari, M.D.
Baruch Brody,
Ph.D.
Thomas Gelehrter, M.D.
Ad Hoc Reviewers: Robert H. Carter, M.D., University of
Alabama
Christopher H. Evans, D.Sc., Ph.D., Harvard Medical School
Tab 2308 Protocol
Tab
2309 OBA Summary
OBA Letter to PI on in-depth RAC Review and Public
Discussion
Outcome
of Initial Review by RAC Members
Reviews from Drs. Simari, Brody, Gelehrter, Carter, and Evans
PI’s/Sponsor’s Response
3:40 PM Public Comment
3:50 PM BREAK
4:05
PM Data Management Report
Tab
2310 Protocol List
Protocols
Not Selected for RAC Public Review
RAC
Reviewers: Baruch Brody, Ph.D.
Linda
Gooding, Ph.D.
Larry
Johnson, M.D.
Robert
Simari, M.D.
Diane
Wara, M.D.
4:20 PM Informed Consent Working Group Update
4:45 PM ADJOURNMENT
8:00 AM Call to Order and Opening Remarks
Theodore Friedmann, M.D., Chair,
NIH RAC
| 8:10 AM | Amendments and Updates to Protocol 0010-419: Intratumoral Injections of a Replication-Incompetent Adenoviral Vector Encoding a Factor VII Immunoconjugate to Induce a Cytolytic Immune Reponse Against Melanoma Tumors: A Pilot Trial | |
| Speaker: | Albert B. Deisseroth, M.D., Ph.D., |
|
9:10 AM Discussion
of Human Gene Transfer Protocol #0307-592 entitled:
A Phase 1 Study to Determine the Safety and Immunogenicity of
Vaccination with Listeria Monocytogenes Expressing Human Papilloma Virus type
16 E7 for the Treatment of Progressive, Recurrent and Advanced Squamous Cell
Cancer of the Cervix
PI: John
Marshall, M.D.,
RAC
Reviewers: Emmett Barkley, Ph.D.
Larry
Johnson, M.D.
Bernard Lo, M.D.
Tab
2311 Protocol
Tab
2312 OBA Summary
OBA Letter to PI on In-depth RAC Review and Public
Discussion
Outcome
of Initial Review by RAC Members
Reviews
from Drs. Barkley, L. Johnson, Lo and PI’s/Sponsor’s Response
11:00 AM Public Comment
11:10 AM BREAK
11:25 AM Global Site Preferences for MLV and HIV-1 Proviral
Integration in the Human Genome
Speaker: Shawn M. Burgess, Ph.D., NIH
12:10 PM LUNCH
1:10
PM Discussion of Human
Gene Transfer Protocol #0307-593 entitled:
A Phase I Open-label Safety Study of Intrastriatal infusion of
Adeno-associated virus encoding human aromatic L-amino acid decarboxylase
(AAV-hAADC-2) in subjects with advanced Parkinson’s Disease [AAV-hAADC-2-003]
PI: Michael Aminoff,
M.D., D.Sc.,
RAC
Reviewers: Philip Johnson, M.D.
Martha Bohn,
Ph.D.
Madison Powers, Ph.D.
Ad
Hoc Reviewer: Eugene
Redmond, M.D.,
Tab 2313 Protocol
Tab 2314 OBA Summary
OBA Letter to PI on In-depth RAC Review and Public
Discussion
Outcome
of Initial Review by RAC Members
Reviews
from Drs. P. Johnson, Bohn, Powers, and Redmond,
PI’s/Sponsor’s
Response
2:45 PM Public Comment
3:00 PM ADJOURNMENT