The International Serious Adverse Events Consortium (SAEC) announced that its formation and plans 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 (SAEs).
The two studies will address drug-related liver toxicity and a rare but serious drug-related skin condition called Stevens-Johnson Syndrome (SJS). The SAEC is a nonprofit corporation comprised of leading pharmaceutical companies, and academic institutions with scientific and strategic input from the U.S. Food and Drug Administration (FDA).
Patients respond differently to medicines and all medicines can have side effects in some people. The SAEC’s work is based on the hypothesis that these differences have a genetic basis, and its research studies will examine the impact genes can have on how individuals respond to medicines.
The results from SAEC research studies will be made available to the research community for further study. These studies will eventually arm drug developers, biomedical researchers and pharmaceutical companies with genetic markers that help them address safety issues of new drugs in development.
SAEC research results may also provide physicians with more information on the balance between the benefits and risks of medicines if an individual has a specific genetic variation that is linked with an increased risk of adverse events.
“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. We are encouraged that this new consortium will play an important role in enhancing drug safety by accelerating and advancing our understanding of genetic variants associated with these adverse events,” said Janet Woodcock, M.D., FDA’s deputy commissioner and chief medical officer. “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.”