Regulatory Issues in Pharmacogenomics

Presented by

Grail Sipes of Covington & Burling LLP

About this talk

Pharmacogenomics and personalized medicine are priorities for the new administration, but many regulatory hurdles remain. This presentation will address a number of issues faced by industry in the clinical development phase, including issues related to regulatory approval pathways, the collection and testing of tissue samples, and the co-development of therapeutics and diagnostics. The presentation will also explore a number of larger debates that may have a direct impact on the progress of pharmacogenomic research in the coming years, including the current interest in comparative effectiveness and evidence-based care; differing viewpoints on reimbursement; and the debate over how genetic tests should be regulated.

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