FDA's Woodcock: personalized medicine a reality

Personalized medicine has "come of age," but a number of scientific and policy challenges must be overcome before it can mature, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said Tuesday at a meeting of the Personalized Medicine Coalition.

Woodcock, who noted that one-third of NME submissions in 2012 contained genome biomarker data, predicted drug labels will increasingly contain genomic data and said drug developers, pathologists and regulators will have to work hard to make labels useful to clinicians. "When I talk to the medical community about targeted therapies, they are very clear on what they want. They want directions; they don't want education. They want to know 'What do I do?'" ...