FDA, pharma companies launch research collaboration linked to drug safety
The international serious adverse events consortium (SAEC) has been formed and has planned to launch two initial research programs designed to identify genetic markers that may predict which individuals are at risk for serious drug-related adverse events (SAEs).

The studies will address drug-related liver toxicity and a rare but serious drug-related skin condition, called Stevens-Johnson Syndrome.

The SAEC, a Chicago-based nonprofit consortium of pharmaceutical companies and academic institutions, will have scientific and strategic input from the FDA.

The SAEC research study results will be made available to the research community. The studies will eventually equip drug developers, biomedical researchers and pharmaceutical companies with genetic markers that help them address safety issues of new drugs in development, according to the consortium.

The SAEC also plans to collect available SAE data from participating pharmaceutical companies and academic institutions in the streamlined databases.