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.

DILIsym^® v2B adds critical new capabilities and improvements to v2A, which was released in April 2013. DILIsym^® v2B enhances the model via the additions of a new functional model of bile acid homeostasis for rodents, as well as an expanded set of SimPops™ population samples relevant to mitochondrial dysfunction and bile acid homeostasis. The newly released version of the model also features faster, more efficient simulations and various improvements to the graphical user interface.

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 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.

“We are pleased to meet the needs of our industry partners with these two software releases,” said Dr. Paul Watkins, director of The Hamner-University of North Carolina Institute for Drug Safety Sciences, and the DILI-sim Initiative. “In particular, MITOsym™ represents an important development that will ultimately incorporate mitochondrial function data back into DILIsym^®, which will, in turn, strengthen its predictive capabilities with regard to adverse events in the liver.”  

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. The goal for the DILI-sim Initiative is for DILIsym^® to be a routinely used component of the pharmaceutical industry’s preclinical safety toolbox by 2014. 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.