Molecular Based Safety Science: A New Paradigm
Evidence about drug modes of action and the molecular implications of interacting treatments, co-morbidities, and genetic profiles can enable more precise drug safety assessment. In 2011, the U.S. Food and Drug Administration outlined goals for its new mechanism-based drug safety assessment and prediction program, “…a hypothesis to be tested is that predictive power will be increased by including mapping of the potential drug toxicity to the molecular level.”1 Aligned with this recent shift in the drug regulatory and pharmaceutical manufacturing landscape, MolecularHealth’s next generation approach to drug safety assessment combines adverse event information with clinico-molecular knowledge about drug activity within a patient.
Next Generation Safety Assessment:
Molecular Analysis of Side Effects (MASE)
In 2012, MolecularHealth launched Molecular Analysis of Side Effects – a next generation approach to drug safety assessment. Also in 2012, the company announced a 5-year collaboration with the U.S. Food and Drug Administration pertaining to mechanism-based drug safety assessment and prediction. The company’s safety solution is built upon a series of extensive biomedical and molecular databases, analytical methods, and visualization tools. MASE provides a comprehensive and dynamic analytical approach to the detection and molecular analysis of drug-induced adverse events. By continuously integrating case reports from spontaneous reporting and proprietary data sets, including the FDA’s Adverse Event Reporting System (AERS), with molecular mechanism of action models from the company’s core platform, MASE enables safety analysis for all drugs currently on the market, along with the identification of potential adverse events for drugs in development.
- Safety signal detection and analysis
- Exploration and prediction of potentially causative molecular mechanisms
- Analysis of adverse event data for drugs, drug classes, targets or pathways
- Comparative effectiveness and comparative safety analyses
- Definition and analysis of virtual patient cohorts
- Molecular analysis of individual patients
- Extendible to include results from clinical trial and adverse drug event management programs
1 Abernathy, DR, Woodcock, J & Lesko LJ. Pharmacological Mechanism-Based Drug Safety Assessment and Prediction. State of the Art, Nature Publishing. 89, 793-797 2011