Abstract

Predicting an individual patient’s response to drug therapy has long been a goal of personalized medicine in every therapeutic area. The mapping of the human genome and subsequent advancements in genetic technology raised the public expectation that personalized drug therapy would come sooner than later. However, most stakeholders involved in drug development and clinical decision making would agree that achieving this goal remains years, if not decades, away. The application of genomic findings and technologies in clinical practice and drug development requires addressing the logistics and challenges at multiple levels that go beyond discovery of gene variants and/or completion of prospective controlled clinical trials. The goal of personalized medicine can be achieved only with all stakeholders in the field working together and occasionally accepting a paradigm change in their current approach.

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