Mitsubishi Tanabe licenses simulation tech
Certara has announced that Mitsubishi Tanabe has joined its Simcyp Consortium and licensed its proprietary Simcyp® Population-based Simulator – a platform for the prediction of pharmacokinetic outcomes in virtual patient populations.
Mitsubishi Tanabe is the 34th biopharmaceutical company and the tenth Japanese pharmaceutical company to join the Consortium.
Other members include various academic institutions and regulatory bodies, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japanese Pharmaceuticals and Medical Devices Agency.
“The consortium was created as a steering committee to ensure that new Simcyp products and services remain relevant to the current and future needs of its members,” Stephen Toon, BPharm, PhD, President and Managing Director of Certara’s Simcyp division, told us.
“Companies join the Simcyp Consortium to not only gain access to the unique Simcyp Simulator, but to extend their own R&D capabilities,” said Toon. “The consortium serves as a branch of their external R&D organization.”
Currently, 70% of the top-40 pharma companies (including all of the top ten) are members.
Modeling and simulation
Physiologically-based pharmacokinetic (PBPK) models describe and predict the way a body will handle drugs based on demography, physiology, biochemistry, and genetics.
“We integrate this information with in vitro drug absorption, metabolism, transportation and excretion data to simulate and predict pharmacokinetics in virtual patient populations,” explained Toon.
“Such ‘population-based’ PBPK modeling is increasingly being used in regulatory review to facilitate decisions about the necessity for specific clinical studies, to inform study design and guide appropriate labeling language,” he added.
The Simulator provides information which helps inform decisions relating to clinical trial design, “the need for specific clinical trials, formulation design, dosing in special populations, and drug-drug interactions (DDIs),” said Certara.
Additionally, it is used to identify preclinical data requirements for optimizing early drug development processes and procedures.
According to the company, it has recently been used to support more than 100 label claims for new drug and biologic approvals from FDA.
