US developments in pharmacogenomics

29 April 2008

In the last month there have been several new moves form the US intended to accelerate the pace of change in pharmacogenomics, the study of genetic influences on drug responses. The National Institutes of Health (NIH) has sought input from scientists, the pharmaceutical sector and other on challenges and barriers to pharmacogenomics research, on behalf of the Trans-NIH Pharmacogenomics Working Group, with a view “to highlight opportunities, reveal gaps, and aid in identifying specific, achievable goals that will advance the field” (see Request for Information).

Scientists from the NIH Pharmacogenetics Research Network have joined with Japanese scientists from the Centre for Genomic Medicine (part of the RIKEN Yokohama Institute) to sign a letter of intent for the creation of a new Global Alliance for Pharmacogenomics. The aim is to co-ordinate ongoing research efforts to identify genetic factors that influence responses to drugs, with initial projects including investigation of warfarin and selected drugs for breast and pancreatic cancers, as well as exploring genetic factors that affect drug-induced long QT syndrome.Yusuke Nakamura, director of the Center for Genomic Medicine said: "By bringing together our resources, we will advance the understanding of how changes in DNA affect our responses to medicines. Thus we can begin to realize the promise of personalized medicine" (see press release).

Meanwhile, in a move intended to harmonize pharmacogenomic definitions and guidance with Japan and the EU, the US Food and Drug Agency (FDA) has issued a new industry guideline for comment. E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories defines a genomic biomarker as a measurable DNA or RNA characteristic that is an indicator of normal biologic or pathogenic processes or a response to therapeutic or other interventions, and also notes that certain principles in the document may also be applicable to proteomics and metabalomics (see FDA news).

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