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Personalized Medicine Needs Enlightened Regulation To Realize Its Potential

Henry I. Miller

Abstract

Precision, or personalized, medicine, reflects that treatments -- especially those using biopharmaceuticals -- are gradually shifting from a relatively imprecise "one size fits all" approach to a more personalized one, so that patients can be matched to the best therapy based on their genetic makeup and other predictive factors. However, for the pharmaceutical industry, it could be a double-edged sword.  On the one hand, it could diminish the number of patients required to demonstrate efficacy in clinical trials, but on the other, it might narrow the approved labeling indications (uses), once the FDA allows the drug to be marketed.  Moreover, if regulators require huge safety studies, that could offset the advantage of being able to show efficacy with smaller numbers of patients. 

Keywords

biopharmaceuticals; personalized medicine; precision medicine; FDA; regulation; pharmaceuticals; drugs;

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