Contributing to State-of-the-art Drug Development
The Simcyp Consortium was formed in 2001 to serve as a collaborative research center for physiologically-based pharmacokinetics (PBPK) and mechanistic modeling. Since that time, Simcyp has established itself as the vanguard of PBPK and mechanistic modeling 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.
Over 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.
PBPK and Mechanistic Modeling R&D Leadership
Today, 36 biopharmaceutical companies (including all of the top ten global pharma) are members of the Simcyp Consortium. In addition to its 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. Hundreds of peer reviewed papers are written citing the use of the Simcyp Simulator in drug development, toxicology and other key scientific areas.
Consortium Members not only gain access to the latest version of the Simcyp Population-based Simulator and guide its future development but also to Simcyp’s training and educational programs. The Consortium acts as a steering committee to ensure that new Simcyp products and services are relevant to the current and future needs of the members. Consortium Members also have access to the members’ area of the website, with downloads of the latest version of the Simulator and other resources for users.
To join our Consortium and share in its contributions to state-of-the-art drug development, please contact us directly or come to one of our workshops, where you will learn more about the Simcyp Simulator and the services we offer.