Certara, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, 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.
“DILI results in more regulatory actions and more drug development programs being stopped than any other adverse event,” said Dr Brett Howell, lead scientist, and manager of the DILI-sim Initiative at The Hamner Institutes for Health Sciences. “Our aim is to develop a computer model that helps sponsors and regulators to predict which drugs will produce DILI symptoms, and which subsets of the population are most likely to be affected.”
“Certara is developing a systems- and population-based approach to help with early pre-clinical assessment of drug toxicity risk,” said Dr Amin Rostami, vice president of R&D at Certara. “Our Simcyp Simulator can already model the population variability in pharmacokinetic and pharmacodynamic responses and cardiotoxicity scenarios. We are looking forward to partnering with The Hamner scientists to extend our population safety assessment tools to liver toxicity.”
This Certara partnership marks the latest step taken under the DILI-sim Initiative toward developing and validating a mechanistic mathematical model of drug-induced liver injury in mice, rats, dogs, and humans. This initiative is being led by Dr Paul B Watkins, director of The Hamner-University of North Carolina Institute for Drug Safety Sciences, from The Hamner Institutes for Health Sciences campus in Research Triangle Park, NC. DILI-sim Initiative members include 12 major pharmaceutical and biotechnology companies – Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Gilead, Janssen Research and Development, LLC, Merck, Mitsubishi Tanabe Pharma, Novartis, Pfizer, and Sanofi. The Food and Drug Administration is also participating in the programme.
The Hamner Institutes for Health Sciences is a non-profit translational biomedical research institute, 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.