2003

Toxicogenomics in Risk Assessment

Assessing the utility, challenges, and next steps

June 5 – 6, 2003
Hyatt Fair Lakes
Fairfax, Virginia

Download Workshop Program (PDF - 269kb)
Download Final Meeting Minutes (PDF - 267kb)
Download Committee Report on Status, Findings, and Next Steps – March 2003. (pdf - 238kb)

Download Meeting Presentations and Related Materials below:

• Program and Committee Overview - S. Pettit (PPT - 6mb)
  
  
• Nephrotoxicity Working Group Presentation – C. Afshari (pdf - 460kb)
• Hepatotoxicity Working Group Presentation – R. Ulrich
• Genotoxicity Working Group Presentation – R. Newton (PPT - 1.8mb)
• Common Findings Across Work Groups – W. Pennie
  
  
• Database Working Group Presentations and Materials
  • Introduction – W. Mattes (PPT - 403kb)
  • ILSI HESI-EBI Collaboration – S. Sansone (PPT - 6.4mb)
  • Download draft MIAME-Tox standards document (comments encouraged - Word -  175kb)
    
    
• Sample Acute Risk Assessment with Toxicogenomic Data – F. Goodsaid (PPT - 635kb)
  • Download complete draft risk assessment document (ZIP - 5.2mb)
    
    
• Panel Discussion on Risk Assessment and Genomics

1. FDA-Dr. John Leighton, Supervisory Pharmacologist, CDER (PPT - 31kb)
2. FDA – Dr. Joe Hackett, CDRH (PPT - 227kb)
3. NIEHS –Dr. Ray Tennant, Director, National Center for Toxicogenomics (PPT - 1mb)
4. EPA- Dr. Paul Gilman, Scientific Advisor to the Agency, and Assistant Administrator for Office of Research and Development (NO SLIDES PRESENTED)
5. Japan NIHS- Dr. Inoue, Center for Biological Safety and Research, National Institute of Health Sciences  (in absentia - PPT - 1.1mb)
6. European Medicines Evaluation Agency, UK - Dr. Jean-Marc Vidal - "Scientific Administrator, Safety & Efficacy, Pre-Authorization Unit" (PPT - 191kb)
7. Discussion Questions (Word - 25kb)