Company News: Molecular Health and U.S. Food and Drug Administration (FDA) Extend Software Collaboration to Drug Safety Prediction

Molecular Health, Inc (MH), a company marketing computational biomedicine tools to support healthcare decisions with clinical and molecular data, and the FDA’s Center for Drug Evaluation and Research (CDER) have extended for an additional 5 years, their research collaboration to jointly address one of the biggest challenges in drug development: the prediction of drug safety.

In recent years, nearly 30% of new drugs failed in Phase II and III clinical studies[1] and 270 marketed drugs have been withdrawn worldwide for safety reasons[2]. To tackle this issue, MH has developed its Molecular Health Effect® (MH Effect) technology, a leading-edge software solution for the comprehensive clinical and molecular assessment of drug action and adverse events.

Under the initial research collaboration agreement (RCA) executed in January 2012, FDA used the MH Effect to molecularly analyze adverse events data. During the first five years of collaboration, MH Effect was used to evaluate the potential mechanisms of emerging safety issues. Under the new RCA, the FDA will continue to assess the ability of MH Effect to predict adverse events and safety label changes. The results of the collaboration will be incorporated into MH’s technology to jointly advance computational capabilities for drug development.

“After our successful research collaboration with the FDA for the past 5 years, we are excited about the decision to extend our collaboration,” said Dr. Friedrich von Bohlen, CEO of Molecular Health. ” This decision underlines the unique value proposition of MH Effect for predicting and characterizing drug adverse events that patients are or can be exposed to. With MH Effect and our other products and technologies creating novel insights from data we will continue to help improve the development of novel medicines, with benefits for patients and the entire healthcare industry.”