The Hamner Releases DILIsym® v3A and MITOsym™ v2A

Non-profit research institute announces the release of the latest versions of its flagship DILI platform and its accompanying sister platform focused on mitochondrial function

RESEARCH TRIANGLE PARK, NC – The Hamner Institutes for Health Sciences (www.thehamner.org) announces the release of DILIsym® v3A and MITOsym™ v2A. DILIsym® and MITOsym™ software are developed and released as part of the DILI-sim Initiative (www.dilisym.com), an effort to develop a mathematical, mechanistic model of drug-induced liver injury chaired by Dr. Paul B. Watkins. DILIsym® v3A and MITOsym™ v2A were made available to all DILI-sim Initiative industry members as of March 6, 2014.

DILIsym® v3A includes several key additions and upgrades, such as a new mechanistic representation of bile acid effects on mitochondrial function, an enhanced innate immune model, and parameters relevant for several additional xenobiotics, among other features. An expanded set of SimPops™ population samples relevant to mitochondrial dysfunction and bile acid homeostasis is also included.

MITOsym™ is a mathematical model similar to DILIsym®, executed in MATLAB with code and graphical interface versions provided. Unlike DILIsym®, MITOsym™ is a model of mitochondrial function in the in vitro setting, designed to help with parameter identification and data interpretation from experiments conducted to infer mitochondrial function in hepatocytes using the Seahorse Bioscience XF Analyzer machines. Ideally, experiments are run on the XF Analyzer machine, data is interpreted and parameters identified with MITOsym™, and those parameters are then fed into DILIsym® for predictions of in vivo hepatotoxicity risk. MITOsym™ v2A includes new parameters specifically optimized for primary human hepatocyte experiments, in addition to the parameters related to HepG2 cells included in version 1A.

ABOUT THE DILI-SIM INITIATIVE

The DILI-sim Initiative is a pre-competitive partnership between The Hamner and a diverse set of stakeholders to develop a computational model that will predict whether new drug candidates will cause drug-induced liver injury (DILI) in patients. The goals of the Initiative are to improve patient safety, reduce the need for animal testing, and reduce the costs and time necessary to develop new drugs. It is the intent of the DILI-sim Initiative to make the model, in the form of DILIsym® software, broadly available so that it may be used by the pharmaceutical industry and other entities in academia, government, and industry. The Initiative is led by Dr. Paul B. Watkins, Director of the Hamner-University of North Carolina Institute for Drug Safety Sciences, located on the campus of The Hamner Institutes for Health Sciences in the heart of Research Triangle Park, North Carolina. For more information, please visit www.dilisym.com.

ABOUT THE HAMNER INSTITUTES FOR HEALTH SCIENCES

The Hamner Institutes for Health Sciences is a nonprofit translational biomedical research institute located on an open, multidisciplinary campus in North Carolina’s Research Triangle Park. Building upon 35 years of research excellence in toxicology, The Hamner works on drug and chemical safety in collaboration with academic, corporate and government partners. Novel technologies used at The Hamner include genomic and bioinformatic approaches for improving toxicity testing, in silico models for predictive toxicology, in vitro models that utilize human cells or cell lines to evaluate perturbations of cellular responses, and in vivo models to elucidate genes that play a role in susceptibility to drug-induced toxicities. For more information, please visit www.thehamner.org.

Otsuka Joins The DILI-sim Initiative

RESEARCH TRIANGLE PARK, N.C. – February 19, 2014 – The Hamner Institutes for Health Sciences (The Hamner) has announced that Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) has agreed to become the newest member of The DILI-sim Initiative. Established in 2007, OPDC is a part of the Japan-based Otsuka Group (Otsuka) responsible for the research and clinical development of healthcare products. Otsuka becomes the twelfth member of the DILI-sim consortium, joining current members Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Gilead, GlaxoSmithKline, Janssen Research & Development, LLC, Merck, Mitsubishi Tanabe Pharma, Pfizer and Sanofi.

ABOUT THE DILI-SIM INITATIVE

The DILI-sim Initiative, a pre-competitive partnership between The Hamner and a diverse set of stakeholders to develop a computational model that will predict whether new drug candidates will cause drug-induced liver injury (DILI) in patients. The goals of the Initiative are to improve patient safety, reduce the need for animal testing, and reduce the costs and time necessary to develop new drugs. The Initiative is led by Dr. Paul B. Watkins, Director of the Hamner-University of North Carolina Institute for Drug Safety Sciences, located on the campus of The Hamner Institutes for Health Sciences in the heart of Research Triangle Park, North Carolina. The goal for the DILI-sim Initiative is for DILIsym® software to be a routinely used component of the pharmaceutical industry’s preclinical safety toolbox by 2014.

Certara Signs Research Agreement with The Hamner Institutes for Health Sciences

Partners Will Explore Population-based Model Approach to Help Determine Drugs’ Likely Impact on Liver 

Resulting model would aim to help researchers to assess likelihood that drug exposure will result in liver toxicity among specific populations using early pre-clinical data   

ST. LOUIS, MO – Aug. 20, 2013– Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, today announced that it has signed a research agreement with The Hamner Institutes for Health Sciences. Under this research agreement, Certara and The Hamner will explore the scientific benefits of using Certara’s Simcyp™ Simulator to drive hepatic drug exposure within The Hamner’s population-based, drug-induced liver injury (DILI) model. The partners plan to integrate The Hamner’s DILIsym® modeling software into Certara’s Simcyp Population-based Simulator and test the integrated product’s simulation capabilities with respect to drug exposure and resultant liver toxicity. Both of these systems are used by several leading international pharmaceutical companies.

The Hamner Releases DILIsym® v2B and MITOsym™ v1A

Non-profit research institute announces mid-year improvements to flagship DILI platform and launches new model of mitochondrial function

RESEARCH TRIANGLE PARK, NC – The Hamner Institutes for Health Sciences (www.thehamner.org) announces the release of DILIsym® v2B and MITOsym™ v1A. DILIsym® and MITOsym™ software are developed and released as part of the DILI-sim Initiative (www.dilisym.com), an effort to develop a mathematical, mechanistic model of drug-induced liver injury chaired by Dr. Paul B. Watkins. DILIsym® v2B and MITOsym™ v1A were made available to all DILI-sim Initiative industry members as of July 24th, 2013.

The Hamner Releases DILIsym® v2A

RESEARCH TRIANGLE PARK, NC – The Hamner Institutes for Health Sciences (www.thehamner.org) announces the release of DILIsym® v2A. DILIsym® software is developed and released as part of the DILI-sim Initiative (www.dilisym.com), an effort to develop a mathematical, mechanistic model of drug-induced liver injury chaired by Dr. Paul B. Watkins. DILIsym® v2A was made available to all DILI-sim Initiative industry members as of April 10th, 2013.