Certara, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced that Mitsubishi Tanabe has joined its Simcyp Consortium and licensed its proprietary Simcyp Population-based Simulator.
Mitsubishi Tanabe is the 34th leading biopharmaceutical company and the tenth leading Japanese pharmaceutical company to join the consortium. In addition to its biopharmaceutical industry members, leading 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 are affiliates of 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 center for physiologically based pharmacokinetics (PBPK) and mechanistic modelling. Since that time, Simcyp has established itself as the vanguard of PBPK and mechanistic modelling and simulation sciences and the Simcyp Simulator has evolved to become the most sophisticated platform for the prediction of pharmacokinetic outcomes in virtual patient populations.
The Simulator provides 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 optimizing early drug development processes and procedures.
During the past few years, use of the Simcyp Simulator has been leveraged to inform more than 100 label claims for new drug and biologic approvals from FDA. These label additions include potential DDIs, formulation recommendations, dosing regimens, and data about new populations.