Drug safety data sharing
In a move the US Food and Drug Administration (FDA) hailed as “unprecedented,” several large drug companies have agreed to share information about how they predict drug safety. Members of the Predictive Safety Testing Consortium will submit data about internally developed biomarkers and tests to the Critical Path Institute (C-Path) of Tucson, Arizona, an independent nonprofit founded by the FDA, SRI International of Menlo Park, California, and the University of Arizona. C-Path will compile information for the FDA, which hopes to use it to recommend how best to screen drugs for side effects. This could reduce the time and cost of preclinical screening. The consortium members announced on 16 March include Bristol-Myers Squibb and Pfizer of New York, GlaxoSmithKline of Brentford, UK, Johnson & Johnson of New Brunswick, NJ, Merck and Co. of Whitehouse Station, NJ, Novartis of Basel, Switzerland, Roche of Palo Alto, CA, Schering Plough Research Institute of Kenilworth, NJ, and SRI International. Three biotech companies are also in negotiations to join. The agreement stems from the FDA's Critical Path Initiative to speed drug development. Industry watchers have applauded the initiative but question whether it can garner enough momentum or funding to make a difference. However, Greg Simon, head of think tank FasterCures, says the cultural shift from sharing, rather than hoarding, data is “a terrific first step. You get the information moving first, and then the money will come.” MB
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