Last month, MolecularHealth, a leader in clinico-molecular informatics, formed a five-year collaboration with the U.S. Food and Drug Administration (FDA) to evaluate and refine the company’s Molecular Analysis of Side Effects (MASE) software system. With this tool, users are able to combine current statistical methods of pharmacovigilance with mechanism-based analytics for identifying and validating drug safety signals.
MolecularHealth’s system is intended to help predict adverse drug events before they occur. MASE uses specific molecular information, such as drug mechanism of action and metabolism data as well as genomic factors affecting the behavior of a drug within the body, to more precisely assess and predict safety events. This is also an advantageous tool for pharmaceutical companies, as safety problems can be identified early on.
Through this collaboration, the FDA’s Center for Drug Evaluation and Research (CDER) will work with MolecularHealth to incorporate relevant, non-proprietary molecular and clinical endpoints into the system, along with non-proprietary information about patient populations, molecular modes of action and mechanisms of disease.
Russo Partners looks forward to working with MolecularHealth to raise awareness of its solutions that translate medical data into safer and more effective drug choices for patients.
Below is a Pharmaceutical Executive blog entry about the collaboration: