Certara, a provider of decision support technology and consulting services for optimising drug development, has announced that Mitsubishi Tanabe has joined its Simcyp Consortium and licensed its proprietary Simcyp Population-based Simulator.
Mitsubishi Tanabe is the 34th biopharmaceutical company and the 10th Japanese pharmaceutical company to join the consortium. In addition to its biopharmaceutical industry members, there are a number of academic institutions from around the globe, and key regulatory bodies, including the US Food and Drug Administration (FDA), European Medicines Agency, and Japanese Pharmaceuticals and Medical Devices Agency affiliated with the Simcyp Consortium.
‘We are thrilled to have Mitsubishi Tanabe as a member of the Simcyp Consortium,’ said Stephen Toon, BPharm, PhD, president and managing director of Certara’s Simcyp division. ‘Membership provides numerous benefits, including the opportunity to share knowledge and collaborate in the development of best practices and cutting-edge science for studying drug activity in virtual patients.
'In addition to creating annual updates to the Simcyp Simulator, Simcyp has also produced models for pediatric, pregnant, obese, hepatic- and renally-impaired populations. These advances have enabled member companies to evaluate new therapies in patient groups and clinical scenarios that might have historically been considered “untestable.”’
The Simcyp Consortium was formed in 2001 to serve as a collaborative research centre for physiologically-based pharmacokinetics (PBPK) and mechanistic modelling. Since that time, the Simcyp Simulator has evolved to become the most sophisticated platform for the prediction of pharmacokinetic outcomes in virtual patient populations. The software tool can provide valuable information, which informs key management decisions relating to clinical trial design, the need for specific clinical trials, formulation design, dosing in special populations, and drug-drug interactions (DDIs).
The Simulator is also used to identify key preclinical data requirements, which can prove extremely valuable for redefining and optimising early drug development processes and procedures.