A coalition of seven top pharma companies is collaborating with the FDA on a hunt for genetic markers that may predict patients' vulnerability to serious drug-related adverse events.
The Serious Adverse Events Consortium (SAEC) includes Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical R&D, Pfizer, Roche, Sanofi-Aventis and Wyeth. The companies and their academic partners will receive scientific and strategic guidance from FDA, as well as its European counterpart and other national regulatory bodies.
The companies will pool serious adverse events data for two initial studies aimed at identifying those markers associated with drug-related liver toxicity and Stevens-Johnson Syndrome. Because incidents of those ailments are rare, data from individual companies would be insufficient to make predictions about risk, SAEC said, but combined, the reports may point to common factors.
“Developing new scientific approaches to detect, understand, predict and prevent serious drug-related adverse events is at the heart of FDA's ambitious plans to strengthen our drug safety system,” said FDA deputy commissioner and chief medical officer Dr. Janet Woodcock. “Given the considerable time, size and cost of conducting safety studies, a coordinated, strategic partnership between industry, academia and government can more rapidly advance this critical science.”