Certara, a provider of model-informed drug development and regulatory science, announced that Kyowa Hakko Kirin has joined the Simcyp Consortium and licensed the Simcyp Population-based Simulator. Kyowa Hakko Kirin is the 36th leading biopharmaceutical company and the 11th Japanese pharmaceutical company to join the Consortium. Member companies meet in a pre-competitive environment and work together to progress the evolution of modeling and simulation (M&S) and the Simcyp Simulator.

“We are thrilled to have Kyowa Hakko Kirin as a member of the Simcyp Consortium,” said Stephen Toon, BPharm, Ph.D., 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.’”

Underscoring that fact that M&S has progressed from a scientific nicety to a regulatory necessity, leading academic institutions and key regulatory bodies from around the world, including the FDA, EMA, and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) are affiliates of the Simcyp Consortium.

In the US, the Simcyp Simulator has informed more than 100 label claims for new drug and biologic approvals from FDA. Those label additions include potential drug-drug interactions (DDIs), formulation recommendations, dosing regimens, and data about new populations.

M&S is also increasingly being included in Japanese new drug applications (NDAs). PMDA announced in June that between 2014 and 2016, physiologically-based pharmacokinetic (PBPK) M&S reports were included in 17 NDAs.1 In those instances, M&S was used primarily to evaluate DDIs, predict drug exposure in pediatric patients and determine the impact of ethnic differences and disease states on drug PK.

The Simcyp Consortium was formed in 2001 to serve as a collaborative research center for PBPK and mechanistic modeling. Simcyp is now considered a global authority on PBPK and mechanistic M&S sciences, and the Simcyp Simulator has become the most sophisticated platform for predicting PK outcomes in virtual patient populations.

Simcyp Simulator data are used to inform a wide range of important management decisions, including formulation and clinical trial design, and the need for specific clinical trials, in addition to determining dosing in special populations and predicting the likelihood of DDIs. They can also identify preclinical data requirements, helping to refine early drug development processes and procedures.