FDA inked a five-year research collaboration with MolecularHealth to refine the firm’s Molecular Analysis of Side Effects (MASE) software intended to support mechanism-based drug safety assessment and prediction. FDA’s Center for Drug Evaluation and Research (CDER) will work with the company to incorporate nonproprietary molecular and clinical endpoints of regulatory interest into MASE along with nonproprietary data on patient populations, drug promiscuity, molecular modes of action, and mechanisms of disease.
“We are pleased to collaborate with the FDA to obtain their input into the evaluation of the analytical power of MASE for assessing drug safety in the U.S.,” says Jeffrey D. Marrazzo, chief business officer of MolecularHealth. “MASE has the potential to benefit pharmaceutical developers, regulators, and clinicians alike, helping them to develop and monitor drugs in a safer, more efficient manner.”
MASE uses information about drug modes of action and the molecular implications of interacting treatments, co-morbidities, and genetic profiles to enable a more precise assessment of drug safety. It enables the analysis of adverse event information from both statistical and molecular perspectives. It also provides analytical and visualization tools to support the detection and validation of drug-related safety issues.
“Drug safety monitoring and detection have become increasingly important and complex endeavors that depend heavily on a static, binary, observational system,” points out David Jackson, CSO of MolecularHealth. “We believe that MolecularHealth’s predictive approach to understanding the molecular basis of adverse events will complement the agency’s current mode of drug safety assessment to advance the promise of precision medicine.”