CAMBRIDGE, Mass., Oct. 5, 2015 (GLOBE NEWSWIRE) -- Molecular Health, a leader in cloud-based healthcare decision support technology to optimize the selection of therapies for improved patient outcomes, today announced that it will initiate an early access program (EAP) offering its SafetyMAPTM software to pharmaceutical companies and clinical professionals involved in drug safety starting in November 2015.
Molecular Health recently entered into a commercial license to provide the U.S. Food and Drug Administration (FDA) with use of its SafetyMAP software, which the FDA considers a "mission critical" capability for assessing the importance of possible safety issues of drugs pre- and post-approval.
SafetyMAP is a comprehensive and dynamic analytical solution for the detection and molecular analysis of drug-induced adverse events for all marketed drugs and for predicting safety issues of new drug candidates. It is designed to help users further understand and discover relationships between scientific findings and diverse events and confirm relationships between drugs, toxicity mechanisms, patient susceptibility, and clinical effects. SafetyMAP provides an integrated approach not available in any single other tool to identify the safety interactions and adverse events related to specific drugs, drug classes, disease, and molecular targets and pathways.
Lutz Voelker, President and CEO of Molecular Health, said, "Ideal patient treatment selection is based upon the optimal efficacy of the therapy balanced against its optimal safety. Understanding and effectively managing treatment selection and the inherent safety profile of those treatments can alleviate considerable cost to the healthcare system. We are excited to offer an early access program for SafetyMAP to help support this complex issue and address drug development challenges. SafetyMAP, first available through the soon-to-launch EAP, is an instrumental value-add for pharmaceutical developers or clinical professionals making decisions in researching, developing and managing therapeutic treatments."
Laura T. Housman, Global Head of Molecular Health's Therapeutics Business, added, "Drug safety and adverse drug events (ADEs) are a serious public health issue. Each year in the United States approximately 700,000 emergency department visits and 120,000 hospitalizations are due to ADEs and more than $3.5 billion is spent on extra medical costs as a result of ADEs1. Furthermore, at least 40% of the costs of ambulatory (non-hospital settings) ADEs are estimated to be preventable2. These numbers are staggering. We're eager to offer a solution to this growing problem and to provide EAP users with the opportunity to provide feedback for further customizing SafetyMAP during and following the early access period."
This EAP is a unique opportunity to engage with Molecular Health scientists in consultation on a specific program or drug safety research question while having early access to the comprehensive SafetyMAP database and computational modeling software.
Pharmaceutical companies, systems pharmacologists and clinical professionals interested in the SafetyMAP Early Access Program may contact Molecular Health at SafetyMapEAP@molecularhealth.com or the Cambridge, MA office at (617) 453-3938 for more information and to join the EAP, which is scheduled to launch in November 2015.
Leveraging Molecular Health's platform technology of biomedical and molecular databases, analytical methods and visualization tools, SafetyMAP was developed by integrating clinical information from more than five million reports from the FDA Adverse Event Reporting System (FAERS), with information about targets and drug mode action and disease pathways at the molecular level. This drug-centric data integration process enables the molecular transformation of clinical information, enabling human clinical information to now be analyzed from the perspective of molecular parameters (e.g., targets or pathways).
Molecular Health is marketing SafetyMAP to pharmaceutical regulatory agencies such as the U.S. FDA and to the pharmaceutical and health insurance industries worldwide.
References
- Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006;296:1858-66.
- Institute of Medicine. Committee on Identifying and Preventing Medication Errors. Preventing Medication Errors, Washington, DC: The National Academies Press 2006.
About Molecular Health
Molecular Health is a leading biomedical company that is transforming molecular data and medical knowledge into actionable clinical information for more efficient and safe targeted therapies for each individual patient. SafetyMAPTM is a content and analytics solution for drug de-risking and drug safety analysis and for analysis to be used for research by regulatory authorities and the pharmaceutical and health insurance industries. Molecular Health also generates individualized tumor analysis and clinical interpretation for evidence-based targeted therapy identification utilizing published medical knowledge in a clinical context. This analysis is offered in the U.S., utilizing an end-to-end CLIA laboratory test grounded in next-generation sequencing technology. In Europe, Molecular Health has the first registered medical device of its kind for personalized cancer medicine. Molecular Health Inc., headquartered in Cambridge, Massachusetts, with a laboratory and support center in Greater Houston, Texas, is a wholly owned subsidiary of Molecular Health GmbH, headquartered in Heidelberg, Germany. To learn more, please visit: www.molecularhealth.com.