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Recombinant DNA Advisory Committee (RAC) 

102nd Meeting

Bethesda Marriott Hotel
Bethesda, Maryland

Tuesday, December 13, 2005

Morning Session before break (Real Video)

Morning Session after break  (Real Video)

Afternoon Session after lunch  (Real Video)

Afternoon Session after break  (Real Video)

CAPTION TEXT (HTML)
NOTE: The caption text is a record of the close captioning offered to support the video. It is not a totally accurate, verbatim transcript of the meeting. It is offered here for interest and support of the video. A transcript will be available on the NIH web site in due course.

Meeting Agenda


Tuesday, December 13, 2005

9:00 AM          Call to Order and Opening Remarks  (Real Video)

Diane Wara, M.D., Chair, NIH RAC

 

Tab 2392           For Your Information

  Notice of Meeting

  Conflict of Interest Guidance

 

9:10 AM          Minutes of the September 21, 2005, RAC Meeting (Real Video)

 

RAC Reviewers:           Naomi Rosenberg, Ph.D.

Nikunj Somia, Ph.D.

 

Tab 2393         Minutes of the September 21, 2005, RAC Meeting

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


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