Molecular Health to Offer Early Access Program for SafetyMAP(TM)
(Thomson Reuters ONE) -
Enrollment Now Open for Early Access Program (EAP) Set to Launch in November
2015
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 SafetyMAP(TM) 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 ADEs(1). Furthermore, at least
40% of the costs of ambulatory (non-hospital settings) ADEs are estimated to be
preventable(2). 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(at)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
1. 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.
2. 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. SafetyMAP(TM)
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.
CONTACT: Media Contacts
U.S.: Mark Rodgers 832-247-3068 mark.rodgers(at)molecularhealth.com
EU: Carla Mertens +49 6221 43851-2275
carla.mertens(at)molecularhealth.com
--------------------------------------------------------------------------------
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Source: Molecular Health via GlobeNewswire
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Datum: 05.10.2015 - 19:39 Uhr
Sprache: Deutsch
News-ID 424774
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