This report summarizes the case studies presented and ensuing discussions held during Track 6 of the DIA-FDA-PWG-PhRMA-BIO Pharmacogenomic Workshop on ‘Retrospective Validation of Genomic Biomarkers – What are the Questions, Challenges and Strategies for Developing Useful Relationships to Clinical Outcomes’ held in Washington, DC in April 2005. Because pharmacogenomics depends largely on the patients’ genetic background, it seems likely that there will be variations across populations in patterns and markers that predict a particular drug's side-effect risk and efficacy. In addition, the genetic basis or contribution to disease may vary across populations and make prediction of response and efficacy non-uniform, so that what is true for one group will be either not true, or only partially true, for another group. The regulatory landscape upon which pharmacogenomics is being developed is also non-uniform and has the potential to confound drug development for a global market. The goal of this session was to explore international regulatory issues related to the development of drugs and, when warranted, their accompanying diagnostics and to identify some areas where harmonization may be possible. Along with the authors of this paper, these individuals comprised the panel: Eric Abadie (EMEA), Lawrence J. Lesko, (CDER, FDA), Marisa Papaluca (EMEA), Yoshiaki Uyama (PMDA, Japan), Sanae Yasuda (Eisai Co., Ltd), and Christopher Webster (Millennium Pharmaceuticals, Inc.).
This example served to elicit discussion around two central points: (1) efficacy versus safety biomarkers and (2) international viewpoints on combined drug/diagnostic products.
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