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Promise of “toxicogenomics”

Advisory Committee for Pharmaceutical Science Pharmacology/Toxicology Subcommittee Meeting June 10, 2003. Promise of “toxicogenomics”. toxic responses identified: based mechanism of action earlier in development using fewer animals permitting: optimization of lead compounds

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Promise of “toxicogenomics”

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  1. Advisory Committee for Pharmaceutical Science Pharmacology/Toxicology Subcommittee MeetingJune 10, 2003

  2. Promise of “toxicogenomics” • toxic responses identified: • based mechanism of action • earlier in development • using fewer animals • permitting: • optimization of lead compounds • better extrapolation to humans • faster development of safer drugs

  3. Challenge of “toxicogenomics” • varied platforms and technologies • correlations of expression changes and health effects still evolving • data “overlomics”

  4. Questions for the Committee • Should CDER be proactive in enabling the incorporation of toxicogenomics data into routine pharmacological and toxicological studies and in clarifying how the results should be submitted to the agency?

  5. Questions for the Committee • What should the present and future goals be for use of the data by CDER and what major obstacles are expected for incorporating these data into nonclinical regulatory studies?

  6. Questions for the Committee • Is it (a) feasible, (b) reasonable, and (c) necessary for CDER to set a goal of developing an internal database to capture gene expression and associated phenotypic outcome data from nonclinical studies in order to enhance institutional knowledge and realize the data’s full value?

  7. Questions for the Committee • Is it advisable for CDER to recommend that sponsors follow one common and transparent data processing protocol and statistical analysis method for each platform of gene expression data but not preclude sponsors from applying and sharing results from additional, individually favored methods?

  8. Questions for the Committee • What specific advice do you have for clarifying recommendations on data processing and analysis as well as data submission content and format?

  9. Overview of Toxicogenomics at the Drug Development and Regulatory Interface • Janet Woodcock, M.D. • Roger Ulrich, Ph.D. • William Pennie, Ph.D.

  10. Toxicogenomic Data Quality and Database Issues • Kurt Jarnigan, Ph.D. • John Quackenbush, Ph.D. • Krishna Ghosh, Ph.D.

  11. Product Review and Linking Toxicogenomics Data with Toxicology Outcome • John Leighton, Ph.D. • Randy Levin, M.D. • William Mattes, Ph.D. • Lilliam Rosario, Ph.D.

  12. Questions to Subcommittee • Frank Sistare, Ph.D.

  13. Conclusions and Summary Remarks • Meryl Karol, Ph.D.

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