Pharma majors, FDA et al join forces for safer drugs using genetic data

Some of the world's leading pharmaceutical companies have joined forces with drug regulators - including strategic input from the US Food and Drug Administration - and university researchers to seek the genetic links that are associated with the safety of drugs.

They have set up the non-profit corporation, the International Serious Adverse Events Consortium (SAEC), and plan to launch two initial research programs designed to identify genetic markers that may help predict which individuals are at risk for serious drug-related adverse events. The two studies will address drug-related liver toxicity and a rare, but serious, drug-related skin condition called Stevens-Johnson Syndrome (SJS).

Founding drug industry partners in the SAEC are: Abbott Laboratories, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche, Sanofi-Aventis and Wyeth, which will provide ongoing consultation on the structure of the consortium's scientific model, contribute cohort data and underwrite the costs of SAEC studies.