MolecularHealth and FDA to Collaborate on Analytical Tools for Mechanism-Based Drug Safety Assessment

NEW YORK, Feb. 14, 2012 /PRNewswire/ -- MolecularHealth, Inc., a leader in clinico-molecular informatics™, today announced the establishment of a five-year research collaboration agreement with the U.S. Food and Drug Administration (FDA) to evaluate and refine MolecularHealth's Molecular Analysis of Side Effects (MASE), a software system intended to support mechanism-based drug safety assessment and prediction.

The FDA's Center for Drug Evaluation and Research (CDER) will work with MolecularHealth to incorporate non-proprietary molecular and clinical endpoints of regulatory interest into MASE, along with non-proprietary information 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.," said 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. MASE enables the exploration and analysis of adverse event information from both statistical and molecular perspectives and 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," said David Jackson, chief scientific officer 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."

About MolecularHealth

MolecularHealth, Inc., a clinico-molecular informatics company, is advancing precision medicine by translating patient-specific molecular and genomic data, clinical history and published scientific and medical evidence into safer, more effective drug choices for patients. The company's solutions range from a next generation drug safety assessment and prediction tool that analyzes the molecular basis of adverse events to a treatment decision support system that transforms genome sequences into evidence-based treatment strategies for cancer patients. Backed by the co-founder and former chairman and chief executive officer of SAP, Dietmar Hopp, through dievini Hopp BioTech, MolecularHealth maintains offices in Basel, Switzerland; Heidelberg, Germany; Houston and New York. The company is led by a team of seasoned entrepreneurs, including the founding members of Generation Health, LION Bioscience, Model N Life Sciences and Xapien, and a group of scientists and technologists instrumental in the development of data analysis software for the Human Genome Project and clinical IT systems for leading U.S. health systems. MolecularHealth's collaborators include the University of Texas MD Anderson Cancer Center and the U.S. Food and Drug Administration (FDA).

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MolecularHealth and FDA to Collaborate on Analytical Tools for Mechanism-Based Drug Safety Assessment