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RAC December 13, 2005 - Presentation Materials
102nd Meeting - Day One
Bethesda, Maryland

Call to Order and Opening Remarks  
  Diane Wara, M.D., Chair, NIH RAC  
  Webcast   
 

Minutes of the September 21, 2005, RAC Meeting  
  RAC Reviewers: Naomi Rosenberg, Ph.D. and Nikunj Somia, Ph.D.  
  Webcast   
 

Gene Transfer Safety Assessment Board Report  
  RAC Reviewers: Steven Albelda, M.D., Helen Heslop, M.D., Howard Federoff, M.D., Ph.D., and Diane Wara, M.D.  
  Webcast   
 

Risk-Benefit Assessment in Early-Phase Pediatric Research  
  Gilman Grave, M.D., National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD  
  Slides  Webcast   
 

Discussion of Human Gene Transfer Protocol #0510-740  
  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)  
  Albert M. Maguire, M.D., Scheie Eye Institute, University of Pennsylvania Health System, Philadelphia, PA  
  Slides  Webcast   
 

Discussion of Human Gene Transfer Protocol #0510-732  
  A Phase I/IIA Dose-Escalation Trial of Intratumoral Injection with Oncolytic Adenovirus Vector INGN 007 (VRX-007) in Patients with Advanced Solid Tumors  
  John Nemunaitis, M.D., Mary Crowley Medical Research Center, Dallas, TX  
  Slides  Webcast   
 

Discussion of Human Gene Transfer Protocol #0510-734  
  An Open-Label, Phase I, Dose-Escalation Study of AD-EGFR-CD533 and Surgery for Patients with Resectable Recurrent High-Grade Glioma  
  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  
  Slides  Webcast   
 

ADJOURN  
 

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