¹Deputy Commissioner for Operations, Food and Drug Administration, Rockville, Maryland, USA

Correspondence: J Woodcock, (janet.woodcock@fda.hhs.gov)

Abstract

There has been much recent discussion about the advent of "personalized medicine," but controversy exists over its exact definition; how, when, and whether it will be brought about, and what means could be used to measure its attainment. In fact, the concept of "personalized medicine" is a sort of shorthand used to represent the logical next steps in progression of medical science toward greater mechanistic understanding of health, disease, and treatment. This shorthand is attractive to the public because of its intuitive appeal, and irritating to the biomedical community because it glosses over the very real scientific and implementation challenges. This paper evaluates the trajectory and promise of these next steps for the currently problematic states of both drug development and therapy.