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Crossing the valley of death: bridging the drug-development divide

Newsweek science columnists Sharon Begley and Mary Carmichael have written a cogent and provocative article about the impediments to moving promising early drug research out of the lab and into the clinic. Recent years, the authors state, have seen a slowdown in the transit of drugs through the clinical pipeline.

Among the culprits the authors finger for drug-development delays (which industry insiders refer to as the "valley of death"): a lack of incentives from the National Institutes of Health to encourage its grantees to bring drugs to market; disincentives to academics who are rewarded for publications rather than for tedious screening exercises; and intellectual-property rules that create a tension between publications and patents.

It's not that there aren't any entrepreneurs ready to translate early-stage lab results into actual drugs. There are plenty of them. A key constraint, however, is a dropoff in early funding of biotech start-ups, enabling the key toxicology and pharmacokinetic studies that, if successful, could draw interest from deep-pocketed drugmakers. The authors write:

It is at this step-turning a discovery into something that can be manufactured and that is safe and effective-that the valley of death has gotten dramatically more fatal over the last few years.

Such funding is the bailiwick of venture capitalists and so-called angel investors: wealthy individuals - family, friends, someone with a loved one suffering from an incurable disease - willing to step in and bet big at an early and dicey stage of a biotech's development.

Yet the finance-reform bill wending its way through Congress threatens, however inadvertently, to diminish biotech start-ups' ability to get such funding. Some authors have raised concerns about the bill's new restrictions on "accredited investors" (i.e., angel investors), which could effectively shrink the pool of enabling biotech investors further from its currently attenuated level.

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