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12:00 AM
Oct 01, 2007
 |  BioCentury  |  Product Development

Unraveling the idiosyncratic

A key current safety concern is how to identify patients who might be at risk of rare but serious adverse events from drugs. Because these events are so rare, no single company can collect enough data to perform a meaningful statistical analysis based on the SAEs that occur with an individual drug. But many of these SAEs are triggered by different drugs. Last week, seven pharmaceutical companies teamed up with academic institutions and FDA to identify genetic markers that could predict which patients are at risk of drug-related adverse events.

If the consortium is successful, patients would get access to drugs that otherwise might not be on the market, drug companies would get more drugs to market and shut down fewer late-stage programs, and the healthcare system would save money because fewer patients would suffer adverse events.

The non-profit international Serious Adverse Events Consortium (SAEC) is the result of conversations that Chairman and CEO Arthur Holden had with R&D heads of pharma companies and FDA starting in 2005. Holden was CEO of the SNP Consortium from 1999 to 2002 and also was involved with other genomic consortia such as the HapMap Project.

Abbott Laboratories (ABT, Abbott Park, Ill.); GlaxoSmithKline plc (LSE:GSK; GSK, London, U.K.); Johnson & Johnson (JNJ, New Brunswick, N.J.); Pfizer Inc. (PFE, New York, N.Y.); Roche (SWX:ROG, Basel, Switzerland); sanofi-aventis Group (Euronext:SAN; SNY, Paris, France); and Wyeth (WYE, Madison, N.J.) are members of the consortium.

SAEC will be funded by dues from participating companies. So far, the consortium has funding in the millions of...

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