Nonprofit Institute is Spearheading Multi-stakeholder Partnership to Use Computer Model to Make Drugs Safer

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Nonprofit Institute is Spearheading Multi-stakeholder Partnership to Use Computer Model to Make Drugs Safer

Published: September 14, 2012
This article has been reprinted with permission from The Hamner Insitutes for Health Sciences. The article was originally published here.

The Hamner Institutes for Health Sciences (The Hamner) has announced the formation of 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. It is the intent of the DILI-sim Initiative to make the model, in the form of DILIsymTM software, broadly available so that it may be used by the pharmaceutical industry, the U.S. Food and Drug Administration (FDA), and other entities in academia, government and industry.

Current members of the Initiative include Amgen, AstraZeneca, Eli Lilly and Company, GlaxoSmithKline, Janssen Research & Development, LLC, Merck, Novartis Pharmaceuticals, Pfizer and Sanofi. It is anticipated that additional members will join as the Initiative continues to grow and meet its objectives. The FDA is involved as well, providing support for one of the modelers on the project.

The Initiative will provide a forum for sharing knowledge and experiences related to DILI across the partner organizations. Top experts from the stakeholders will help to identify relevant data to be incorporated into the computational model, and to recommend reasonable standards for developing, using and accessing DILIsym™ software. In the process of producing DILIsym™ software, the Initiative will advance fundamental understanding of the mechanisms that cause DILI. This knowledge should aid in the development of safer new drugs in the future, and help identify improved tests to monitor patient safety in clinical trials and in clinical practice.


“Liver toxicity remains the major organ toxicity that limits development of new drugs and drives up their costs,” said Dr. Paul Watkins, director of The Hamner-University of North Carolina Institute for Drug Safety Sciences and chair of the DILI-sim Initiative. “The DILI-sim Initiative addresses this problem by bringing together the top experts in the world to share and analyze critical data that has not been previously accessible to the scientific community.”

“Innovative approaches to researching drug-induced liver injury, like those being used by The Hamner Institutes, are critical to understanding this serious adverse drug event,” said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the FDA. “The FDA looks forward to the results of The Hamner’s research in this area.”

“The need for a rigorous, physiologically driven framework, which can integrate quantitative data that describe the many contributory mechanisms responsible for DILI in preclinical test species and in humans, is clear,” said Dr. Gerry Kenna, AstraZeneca principal scientist and company representative for the DILI-sim Steering and Research Committees. “Without this framework, it is unrealistic to believe that strategies which enable pharmas to undertake effective prediction and management of DILI hazard and risk during design, selection and development of novel pharmaceuticals can be developed and implemented. DILI-sim offers a unique opportunity for leading scientists from industry, academia and regulatory agencies to work together to tackle this important challenge.”

“GSK is pleased to be one of the first companies to support this effort,” said Dr. Rich Miller, GlaxoSmithKline vice president of safety assessment and company representative for the DILI-sim Steering and Research Committees. “It is critical that pharma companies work together with outside experts to find solutions to the substantial drug development costs and delays currently caused by concerns for drug safety. We are impressed with The Hamner modeling team and the progress they have already made. We look forward to collaborating on this important initiative towards decreasing DILI-related attrition.”

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– The Hamner on Twitter:

  • Drug-induced liver injury (DILI) remains the single major adverse drug event that terminates drug development programs and results in regulatory actions leading to failed or stalled drug approvals, market withdrawals, usage restrictions and warnings to physicians.
  • Watkins will serve as chair of the DILI-sim Initiative and oversee all activities.
  • More information on the DILI-sim Initiative can be found here.
About The Hamner Istitutes for Health Sciences

The Hamner Institutes for Health Sciences is a nonprofit research organization located in the heart of Research Triangle Park (RTP), N.C. The two flagship institutes at The Hamner, the Institute for Chemical Safety Sciences and the Hamner-UNC Institute for Drug Safety Sciences, build upon 37 years of preeminent research in toxicology and human health research to develop and validate new cutting-edge tools for safety assessment. Novel technologies currently being developed include 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. The Hamner continues to grow its open, multidisciplinary campus through global partnerships with academia, industry, and government, and remains dedicated to positively impacting human health. For more information, please visit

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