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Summary
There is widespread belief that current models of drug discovery and development need revamping and reinvention in order to make pharmaceutical research and development (R&D) more predictable, reliable, and less costly. We suggest a novel approach to this challenge that involves profound changes in the way postmarketing surveillance data are gathered and used. This approach capitalizes on recent advances in molecular medicine, human genomics, and information technology, as well as an increasingly sophisticated public eager for solutions to their unmet medical needs. Novel business models and imaginative legal and regulatory reforms will be critical to fulfill this promise and to maximize its impact.
