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NATIONAL INSTITUTES OF HEALTH
RECOMBINANT DNA ADVISORY COMMITTEE (RAC)
Bethesda Marriott Hotel
Bethesda, Maryland

March 6-7, 2003

MEETING AGENDA*

Thursday, March 6, 2003

Real Video

• 1:00 PM Call to Order and Opening Remarks
• Theodore Friedmann, M.D., RAC Chair
• Tab 2286 For Your Information
•   - Notice of Meeting
     - Conflict of Interest Guidance
• 1:15 PM Minutes of the December 4-6, 2002, RAC Meeting
• RAC Reviewers: Thomas Gelehrter, M.D
  James Childress, Ph.D.
• Tab 2287 Minutes of the December 4-6, 2002 Meeting
• 1:25 PM Data Management Report
• Tab 2288 Protocol List
•   Protocols Not Selected for RAC Public Review
   
•   RAC Reviewers: Robert Simari, M.D.
•     Diane Wara, M.D.
•     Linda Gooding, Ph.D.
•     Larry Johnson, M.D.
•     Baruch Brody, Ph.D.

 

• 1:40 PM Discussion of Human Gene Transfer Protocol #0301-570 entitled: 
• Use of in vivo Expression Technology To Identify Virulence Factors and Protective Antigens of Vibrio cholerae 01

           570 Dr Tacket Powerpoint Slides

• PI: Carol O. Tacket, M.D., University of Maryland
• RAC Reviewers: Martha Bohn, Ph.D.
•     Diane Wara, M.D.

     Philip Johnson, M.D.

     Terry Kwan, M.S.Ed.

• Ad Hoc Reviewer: Mitchell Cohen, M.D., Cincinnati Children's Hospital Medical Center
  
  570 Dr. Cohen Powerpoint Slides
  
   
•  Tab 2289 Protocol
• Tab 2290 OBA Summary
•   OBA Letter to PI on in-depth RAC Review and Public Discussion

   Outcome of Initial Review by RAC members

• Reviews From Drs. Bohn, Wara, P. Johnson, and Cohen and Ms. Kwan
•   PI's/Sponsor's Response
  
   
• Public Comments
  Real Video File
  
   
• 4:00 PM ADJOURNMENT

Friday, March 7, 2003

Real Video File

• 8:30 AM Call to Order and Opening Remarks
• Theodore Friedmann, M.D., RAC Chair
• 8:35 AM Discussion of Human Gene Transfer Protocol #0301-564 entitled:
• Phase Ia/Ib Trial of Second-Generation Designer T Cells in Adenocarcinom
• PI: Richard Junghans, Ph.D., M.D., Harvard Medical School
• RAC Reviewers: Larry Johnson, M.D.
•     Theodore Friedmann, M.D.
•     Madison Powers, J.D., D.Phil.
• Tab 2291 Protocol
• Tab 2292 OBA Summary
•   OBA Letter to PI on in-depth RAC Review and Public Discussion

   Outcome of Initial Review by RAC members

• Reviews From Drs. L. Johnson, Friedmann, and Powers
•   PI's/Sponsor's Response
  
   
• 10:35 AM BREAK
  
  Real Video File
   
• Dr. Rose - Questions
  
  Powerpoint Slides
   
• 10:50 AM Discussion of Human Gene Transfer Protocol #0212-563 entitled: Administration of Peripheral Blood T Cells and Epstein-Barr Virus-Specific Cytotoxic T Lymphocytes Transduced To Express GD-2-Specific Chimeric T-Cell Receptors to Patients With Neuroblastoma
   
• 563 Powerpoint slides
   
•   PI: Heidi Russell, M.D., Texas Children's Cancer Center, Baylor College of Medicine
• RAC Reviewers: Bernard Lo, M.D.
•     Neal DeLuca, Ph.D.

     Maxine Linial, Ph.D.

 

•   Tab 2293 Protocol
• Tab 2294 OBA Summary
•   OBA Letter to PI on in-depth RAC Review and Public Discussion

   Outcome of Initial Review by RAC members

•   Reviews From Drs. Lo, DeLuca, and Linial
•   PI's/Sponsor's Response

 

• 12:50 PM ADJOURNMENT

* Draft agenda as of 3/3/03