Molecular Health and U.S. Food and Drug Administration (FDA) Extend Software Collaboration to Drug Safety Prediction
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Molecular Health GmbH /
Molecular Health and U.S. Food and Drug Administration (FDA) Extend Software
Collaboration to Drug Safety Prediction
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The issuer is solely responsible for the content of this announcement.
Cambridge, MA, USA - November 16, 2017 - Molecular Health, Inc (MH), a company
marketing computational biomedicine tools to support healthcare decisions with
clinical and molecular data, and the FDA's Center for Drug Evaluation and
Research (CDER) have extended for an additional 5 years, their research
collaboration to jointly address one of the biggest challenges in drug
development: the prediction of drug safety. In recent years, nearly 30% of new
drugs failed in Phase II and III clinical studies[1] and 270 marketed drugs have
been withdrawn worldwide for safety reasons[2]. To tackle this issue, MH has
developed its Molecular Health Effect(®) (MH Effect) technology, a leading-edge
software solution for the comprehensive clinical and molecular assessment of
drug action and adverse events.
Under the initial research collaboration agreement (RCA) executed in January
2012, FDA used the MH Effect to molecularly analyze adverse events data. During
the first five years of collaboration, MH Effect was used to evaluate the
potential mechanisms of emerging safety issues. Under the new RCA, the FDA will
continue to assess the ability of MH Effect to predict adverse events and safety
label changes. The results of the collaboration will be incorporated into MH's
technology to jointly advance computational capabilities for drug development.
"After our successful research collaboration with the FDA for the past 5 years,
we are excited about the decision to extend our collaboration," said Dr.
Friedrich von Bohlen, CEO of Molecular Health. " This decision underlines the
unique value proposition of MH Effect for predicting and characterizing drug
adverse events that patients are or can be exposed to. With MH Effect and our
other products and technologies creating novel insights from data we will
continue to help improve the development of novel medicines, with benefits for
patients and the entire healthcare industry."
###
About Molecular Health
Molecular Health is a computational biomedicine company focused on big-data
curation, integration and analytics to enable precision medicine. The company
has developed Dataome®, a top quality-curated, interoperable technology system
comprising a large set of databases and analytics that allow the integration and
referencing of clinico-molecular drug and disease data to generate novel and
actionable insights on drug outcomes for stakeholders across the healthcare
ecosystem. These include physicians, hospitals, research networks, commercial
labs, regulators and pharma companies. The company is compliant to all relevant
regulatory certification and accreditation standards. Molecular Health's
scientific and commercial teams are based in Heidelberg, Germany, and Boston,
MA, USA.
To learn more, please visit: www.molecularhealth.com.
Contact Molecular Health
Scientific queries:
David Jackson
David.jackson(at)molecularhealth.com
Business queries to license the technology:
Blanca Baez
Blanca.baez(at)molecularhealth.com
Media Contact
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info(at)akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68
--------------------------------------------------------------------------------
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4847363/
[2] http://cheminfo.charite.de/withdrawn/
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Source: Molecular Health GmbH via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 16.11.2017 - 10:02 Uhr
Sprache: Deutsch
News-ID 568443
Anzahl Zeichen: 4526
contact information:
Town:
Heidelberg
Kategorie:
Business News
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