Navigation Links
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 drug safety assessment to advance the promise of precision medicine."

About MolecularHealthMolecularHealth, Inc., a clinico-molecular informatics company, is advancing precision medicine by translating patient-specific molecular and genomic data, clinical history and published scientific and medical evidence into safer, more effective drug choices for patients. The company's solutions range from a next generation drug safety assessment and prediction tool that analyzes the molecular basis of adverse events to a treatment decision support system that transforms genome sequences into evidence-based treatment strategies for cancer patients. Backed by the co-founder and former chairman and chief executive officer of SAP, Dietmar Hopp, through dievini Hopp BioTech, MolecularHealth maintains offices in Basel, Switzerland; Heidelberg, Germany; Houston and New York. The company is led by a team of seasoned entrepreneurs, including the founding members of Generation Health, LION Bioscience, Model N Life Sciences and Xapien, and a group of scientists and technologists instrumental in the development of data analysis software for the Human Genome Project and clinical IT systems for leading U.S. health systems. MolecularHealth's collaborators include the University of Texas MD Anderson Cancer Center and the U.S. Food and Drug Administration (FDA).Media Contacts

Corporate Contact 

 Tony Russo, Ph.D., or Matt Middleman, M.D.Eric M. StoneRusso Partners, LLC

Vice President, Sales and MarketingT: 212-845-4251

T: (713) 834-9990T: 212-845-4272

eric.stone@molecularhealth.com tony.russo@russopartnersllc.com

 matt.middleman@russopartnersllc.com

  


'/>"/>

SOURCE MolecularHealth
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. MolecularHealth to Introduce Knowledge-Driven Solutions that Enhance Drug Safety and Enable Molecularly-Guided Treatment Decision Support
2. BioNeutral and Barnabas Health to Collaborate for Surgical Instrument Sterilization
3. Mercy/ROi and BD Collaborate to Improve Quality of Care and Reduce Costs
4. Ventana Medical Systems, Inc. to Collaborate with Bayer on Companion Diagnostic Test for New Biological Cancer Therapy
5. UCSF, Sanofi Collaborate to Find New Diabetes Cures
6. Xenon to Collaborate with Genentech on Discovery of Novel Targeted Pain Therapeutics
7. DFH Pharma to Collaborate with CiVentiChem to Develop Second-Generation HIV Maturation Inhibitor Drugs
8. FDA, Austen BioInnovation Institute to Collaborate on the Safety and Performance of Materials used in Medical Devices
9. Lineagen and Fast Forward Collaborate to Develop Gene and Biomarker-Based Clinical Assays for Multiple Sclerosis
10. Biospace Lab Collaborates With ImaBio Group to Develop a Unique X-Ray Tomographic Module for its Preclinical Imaging System
11. Roche, ChanTest Collaborate for Preclinical Cardiac Safety Testing of Drug Compounds Using iCell Cardiomyocytes and xCELLigence RTCA Cardio Instrument
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/16/2017)... Jan. 16, 2017  Today, Analytics 4 Life (A4L), ... announced its expansion into JLABS @ Toronto ... science incubators. As a resident in the space, A4L ... device development and commercialization expertise. JLABS @ ... innovation center that provides a flexible environment for start-up ...
(Date:1/15/2017)... , January 16, 2017 Le conseil ... à base de collagène pour la régénération de tissus humains, ... poste de directeur général avec effet immédiat. ... Bill est un dirigeant ... occupé plusieurs postes de gestion générale et de direction au ...
(Date:1/13/2017)... Stock-Callers is currently reviewing the following Medical Appliances ... WMGI ), Varian Medical Systems Inc. (NYSE: VAR ... NuVasive Inc. (NASDAQ: NUVA ). These companies belong ... finish on Thursday, January 12 th , 2017, with the ... health care companies in the S&P 500 were down less ...
Breaking Medicine Technology:
(Date:1/16/2017)... ... January 16, 2017 , ... Houston dentist, Dr. Behzad ... offering complimentary consultations and financing for orthodontics for a limited time. Complimentary for ... learn about their orthodontic options. Walk-in, late-evening, Saturday, and same-day appointments are available. ...
(Date:1/16/2017)... ... ... well-aware of the following facts at present:, Flu and cold ... effect on keeping this particularly bad strain of the flu away , In ... , These facts are well-known among the team at Woodard! About halfway ...
(Date:1/16/2017)... ... January 16, 2017 , ... San Francisco dentist, Dr. Ben ... in 3-D scanning device which is capable of taking digital impressions of teeth and ... such as CAD CAM restorations , in terms of speed, efficiency and patient ...
(Date:1/15/2017)... ... ... is announcing the release of an updated version of their top selling clipper, the ... wide jaws that will accommodate nails up to 4mm in thickness . Nails like ... reinforced for extra strength when pressing down on dense nails which can be a hindrance ...
(Date:1/15/2017)... , ... January 15, 2017 , ... The Gravity Vault ... in Radnor, Pennsylvania. As construction wraps up on the 14,000+ square foot climbing gym, ... Vaults sixth location, including three in New Jersey and two in New York. With ...
Breaking Medicine News(10 mins):