The International Serious Adverse Events Consortium (SAEC) will be launching a program that can determine if an individual is at risk for harmful drug-related occurrences, the corporation said on Thursday.
The nonprofit corporation will use gene technology to identify markers that may help foresee if a person responds to medication adversely, and to develop alternatives for medications that may be harmful to patients. SAEC said in a release that its “work is based on the hypothesis that these differences have a genetic basis.”
“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 Janet Woodcock, FDA deputy commissioner and chief medical officer. “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.”
SAEC also said that the two studies would address drug-related liver toxicity and a rare drug-related skin condition called Stevens-Johnson Syndrome.
“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,” Woodcock added.