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MolecularHealth and FDA to Collaborate on Analytical Tools for Mechanism-Based Drug Safety Assessment
Date:2/14/2012

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 dru
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