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Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines: a commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop

The Pharmacogenomics Journal volume 6, pages 78–81 (2006)Cite this article

The origin of these FDA-industry co-sponsored workshops on pharmacogenetics (PGt) and pharmacogenomics (PGx) dates back to 2002 with the report of the 1st workshop that can be summarized by three broad conclusions:1

  1. 1

    PGt and PGx should be considered in all phases of drug development to improve our understanding of the safety and efficacy of new drugs and to optimize dosing regimens.

  2. 2

    Greater clarity on the most appropriate applications of PGt and PGx biomarkers in drug development is needed to advance the field.

  3. 3

    Continued dialog between academic researchers, industry scientists and regulatory agencies is needed to help guide strategies for exploiting PGt and PGx information to optimize the benefit/risk ratio of drugs.

PGt and PGx should be considered in all phases of drug development to improve our understanding of the safety and efficacy of new drugs and to optimize dosing regimens.

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References

  1. Lesko LJ, Salerno RA, Spear B, Anderson DC, Anderson T, Brazell C et al. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop. J Clin Pharmacol 2003; 43: 342–358.

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  3. Guidance for Industry. Pharmacogenomics Data Submission 2005; Website: http://www.fda.gov/cder/genomics/regulatory.htm.

  4. Wang S, Cohen N, Katz D, Ruano G, Shaw P, Spear B . Retrospective validation of genomic boomarkers – what are the questions, challenges and strategies for developing useful relationships to clinical outcomes. Pharmacogenomics 2005, in press.

  5. Trepicchio WL, Essayan D, Hall ST, Schechter G, Tezak Z, Wang SJ et al. Designing prospective clinical pharmacogenomic (PG) trials: meeting report on drug development strategies to enhance therapeutic decision making. Pharmacogenomics 2005, in press.

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Authors and Affiliations

  1. Worldwide Regulatory Affairs, Pharma & Translational Medicine, Wyeth Research, Collegeville, PA, USA

    R A Salerno

  2. Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    L J Lesko

Authors
  1. R A Salerno
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  2. L J Lesko
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Correspondence to R A Salerno or L J Lesko.

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Salerno, R., Lesko, L. Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines: a commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop. Pharmacogenomics J 6, 78–81 (2006). https://doi.org/10.1038/sj.tpj.6500345

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  • DOI: https://doi.org/10.1038/sj.tpj.6500345

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