Non-profit research institute announces the release of the latest version of its flagship DILI platform

RESEARCH TRIANGLE PARK, NC – The Hamner Institutes for Health Sciences (www.thehamner.org) announces the release of DILIsym^® v3B. 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^® v3B was made available to all DILI-sim Initiative industry members as of August 26, 2014.

DILIsym^® v3B features several added capabilities and improvements, such as including apoptosis as an active mode of cell death during hepatotoxicity, caspase-cleaved cytokeratin 18 as a biomarker indicative of apoptosis, and inhibition of glycolysis as a mechanism of hepatotoxicity.  The software’s representation of existing biomarkers has been expanded to include apoptosis, and its set of exemplar compounds has been expanded to include troglitazone, among others.  Additional SimPops™, capturing impact of variability in key pathways, have also been included.

DILIsym^® v3B is the final model version of the initial term of the DILI-sim Initiative, which focused on dose-related DILI and early stage clinical development.  Beginning in 2015, the development focus of the DILIsym^® software will shift to less frequent DILI that may only become evident in late stage clinical development or post-marketing.

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.

The topic for the July 9th, 2014 broadcast was the DILI-sim Initiative, a pre-competitive partnership with 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 video features Drs.  Paul Watkins, and Brett Howell. More information on the segment, including an accompanying blog post, can now be seen online at UNC-TV’s website at http://science.unctv.org/content/liver-takes-it-all.

More information on the "North Caroline Science Now" series can be found here: http://science.unctv.org/content/ncsciencenow.

RESEARCH TRIANGLE PARK, N.C. – April 2, 2014 – The Hamner Institutes for Health Sciences (The Hamner) has announced that Takeda Pharmaceuticals International, Inc. (Takeda) has agreed to become the newest member of The DILI-sim Initiative. Having sustained a long corporate history of more than 230 years, Takeda conducts activities according to the corporate mission to “strive towards better health for people worldwide through leading innovation in medicine.” Takeda becomes the fourteenth member of the DILI-sim consortium, joining current members AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Gilead, GlaxoSmithKline, Janssen Research & Development, LLC, Merck, Mitsubishi Tanabe Pharma, Otsuka, 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.

RESEARCH TRIANGLE PARK, N.C. – March 21, 2014 – The Hamner Institutes for Health Sciences (The Hamner) has announced that AbbVie Inc. has agreed to become the newest member of The DILI-sim Initiative. Founded in 2013, AbbVie is a research-based global biopharmaceutical company with the focus and capabilities to address some of the world's greatest health challenges. AbbVie becomes the thirteenth 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, Otsuka, 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.