Archive for April, 2014

A Strategy for PGx Discovery – Millions of Variants: Where to Start?

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To appreciate the need for advancement in pharmacogenomics (PGx), let’s start by taking an inventory of the success in this space since the approval of Herceptin (the first drug with PGx / biomarker information in its label). A review of the FDA’s Pharmacogenomic Biomarkers in Drug Labeling Table revealed only 12% of drugs since Herceptin had PGx / biomarker information in their label and only 14 of these labels direct clinicians to utilize testing prior to prescription. Clearly, there is need for improvement in PGx-driven patient selection for therapeutic intervention; however, the current paradigm and PGx analytics are failing to…

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Who to treat: a multi-assay signature approach for subgroup identification

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The promise of personalized medicine is becoming a reality in the space of oncology with a noticeable shift in the past decade from targeting the largest possible population to targeting cancer subtypes with smaller patient populations or biomarker-defined subgroups of a patient population with enhanced response. Approximately 60% of US drug sales related to anti-cancer drugs are targeted therapies and it is estimated that a similar percentage of drugs in development have a biomarker component. As the emphasis on biomarker strategies in anti-cancer therapies is widespread and on the rise, it is critical that consideration is given to advancing analytics…

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