The Efficacy Challenge

Drug companies have always had three customers-physicians, patients and regulators. But they've focused on the doc, a customer who's allowed them to align customer requirements with research capabilities. But drug companies are now ever more conscious of the other two customers--consumers and regulators. They're courting the former; and the latter are forcing themselves upon their notice. In consequence, and for a variety of reasons--not the least of which is the regulators' recognition of the facts of consumer-driven prescribing--drug development will need more than a tune-up. Companies will have to figure out how to dramatically improve the efficacy data on which their drugs are approved and marketed. One essential tool: new diagnostics for identifying which patients will benefit from specific therapies.