9:15 AM Gene Transfer Safety Assessment Board Report (Real Video)
Tab 2396 Response to M-I-C-1
Protocol List
Protocols Not Selected for RAC Public Review
RAC Reviewers: Steven Albelda, M.D.
Helen Heslop, M.D.
Howard Federoff, M.D., Ph.D.
Diane Wara, M.D.
9:30 AM Risk-Benefit Assessment in Early-Phase Pediatric Research (Real Video)
Presenter: Gilman Grave, M.D., National Institute of Child Health and
Human Development, National Institutes of Health, Bethesda, MD
Presentation (PDF)
10:00 AM BREAK
10:15 AM Discussion of Human Gene Transfer Protocol #0510-740: (Real Video)
A Phase I Safety Study in Subjects with Leber Congenital Amaurosis (LCA) Using Adeno-Associated Viral Vector to Deliver the Gene for Human RPE65 into the Retinal Pigment Epithelium (RPE)
Presentation (PDF)
PI: Albert M. Maguire, M.D., Scheie Eye Institute, University of Pennsylvania Health System, Philadelphia, PA
Sponsor: Katherine A. High, M.D., University of Pennsylvania
Health System, Philadelphia, PA
RAC Reviewers: Madison Powers, J.D., D.Phil.
Robyn Shapiro, J.D.
Richard Vile, Ph.D.
Diane Wara, M.D.
Tab 2394 Protocol
Tab 2395 OBA Summary
OBA Letter to PI on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Powers, Vile, and Wara and Ms. Shapiro
PI’s/Sponsor’s Response
12:05 PM Public Comment
12:15 PM LUNCH
1:15 PM Discussion of Human Gene Transfer Protocol #0510-732: (Real Video)
A Phase I/IIA Dose-Escalation Trial of Intratumoral Injection with Oncolytic Adenovirus Vector INGN 007 (VRX-007) in Patients with Advanced Solid Tumors
Presentation (PDF)
PI: John Nemunaitis, M.D., Mary Crowley Medical Research Center,
Dallas, TX
Sponsor: Introgen Therapeutics, Inc., Houston, TX
RAC Reviewers: Steven Albelda, M.D.
Stephen Dewhurst, Ph.D.
Madison Powers, J.D., D.Phil.
Tab 2397 Protocol
Tab 2398 OBA Summary
OBA Letter to PI on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Albelda, Dewhurst, and Powers
PI’s/Sponsor’s Response
2:45 PM Public Comment
3:00 PM BREAK
3:15 PM Discussion of Human Gene Transfer Protocol #0510-734: (Real Video)
An Open-Label, Phase I, Dose-Escalation Study of AD-EGFR-CD533 and Surgery for Patients with Resectable Recurrent High-Grade Glioma
Presentation (PDF)
PIs: William C. Broaddus, M.D., Ph.D., Virginia Commonwealth University Medical Center, Richmond, VA
Theodore D. Chung, M.D., Ph.D., Virginia Commonwealth University Medical Center, Richmond, VA
RAC Reviewers: Howard Federoff, M.D., Ph.D.
Terry Kwan, M.S.Ed.
Glen Nemerow, Ph.D.
Tab 2399 Protocol
Tab 2400 OBA Summary
OBA Letter to PIs on In-Depth RAC Review and
Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Federoff and Nemerow and Ms. Kwan
PIs’/Sponsor’s Response
4:45 PM Public Comment
5:00 PM ADJOURNMENT |
