Use public impatience to open drug R&D efforts

Image removed.A wave of impatience is crashing on the drug discovery and development business. From the U.S. Chief Executive down to individual patients, the drug public wants results: new treatments, better than today's.

Frustrated researchers and bureaucrats alike, hearing this message, are taking action. Welcome to biopharma's unilateral action stage, which is marked by some big thinking among those tired of the status quo. NIH chief Francis Collins, for example, is planning a translational medicine center for discovery research, the results of which the agency would pass on to drug developers. The plan would gather $700 million in R&D work at the center in hopes of attracting further funding to push drug candidates past the early-mortality stage.

In another recent example, the Critical Path Institute and the Clinical Data Interchange Standards Consortium will build a storehouse of brain-disease-treatment development data contributed by industry from clinical trial archives. Their goal is precompetitive collaboration to speed drug development. The database will be accessible to researchers as a standardized platform for trial design, and the partners say they will extend the concept to other diseases.

Then there's the idea proposed by David Shaywitz and Mathai Mammen of Theravance [but writing on their own behalf], as relayed in the Boston Globe, suggest social media as a drug development stimulator. Facebook and Google could be gateways to systematic harnessing of R&D community wisdom that can be put to use for discovery and development.

The idea is open innovation, the cousin of precompetitive collaboration. "A thoughtfully constructed open innovation platform built around existing medications could offer enormous value in the development of new therapeutics," they write. The quantity of information from such a platform "will emphasize the need not to overweigh any individual data point, while the transparency of data will ensure statistically suspect analyses are appropriately challenged."

As the crashing wave of impatience shatters existing drug development models, let's promote precompetitive collaboration via open platform as the starting point for the rebuilding effort. - George Miller