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.

Drug companies have always had three customers—physicians, patients and regulators. But the message of their clinical endpoints and their marketing has been targeted to the doc, a customer who's allowed them to align customer requirements with research capabilities.

It's always been easier to come up with products that provide incremental benefits in treating disease, and drug companies have...

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