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Partnership to assess liver toxicity model

Certara, a provider of software and scientific consulting services, and The Hamner Institutes for Health Sciences in the US have signed a research agreement to 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. As part of the DILI-sim initiative, the partners plan to integrate The Hamner’s DILIsym modelling 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.

‘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.’

Dr Amin Rostami, vice president of R&D at Certara, added: ‘Certara is developing a systems- and population-based approach to help with early pre-clinical assessment of drug toxicity risk. 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.’

The DILI-sim initiative is being led by Dr Paul 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, with participation from the US Food and Drug Administration.


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