FDA teams with pharma to find markers for adverse drug events

A lineup of the world's biggest pharma companies are joining hands with some influential regulatory groups to support open-access research into genetic markers for serious adverse events spurred by therapeutics. In what's being billed as a unique public-private venture, the non-profit International Serious Adverse Events Consortium will seek gene variants that can predict an individual's risk of developing immunologic-related adverse reactions to specific drugs or classes of drugs.

"Understanding the genetic underpinnings of major drug-related adverse events such as drug-induced liver injury remains one of our top priorities at FDA," says Janet Woodcock, M.D., director for FDA's Center for Drug Evaluation and Research.  "We are encouraged by iSAEC's progress and applaud their leadership in this area. They are providing invaluable information to the medical and scientific community to predict and prevent serious drug risks in patients."

Once the research is completed, it will be made available to interested researchers through a controlled-access database. The iSAEC has support from the Wellcome Trust in the UK as well as Abbott, Amgen, AstraZeneca, Daiichi Sankyo, GlaxoSmithKline, Merck, Novartis, Pfizer and Takeda.

- here's the iSAEC press release for more info