Drug discovery and development is associated with high attrition rates largely due to a lack of efficacy and unexpected safety concerns of new drugs. An important question is therefore how to improve the prediction of drug efficacy and safety.

The mechanism-based PK-PD modeling platform 2.0 aims at the development of novel mechanism-based PK-PD modeling concepts for stationary and non-stationary biological systems and builds on the mechanism-based PK-PD modeling platform 1.0. The research program is a systems pharmacology approach which focuses on the development and application of novel mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling concepts. The developed mechanism-based PK-PD models contain expressions to describe, in a quantitative manner, processes on the causal path between plasma concentration and effect. To this end mechanism-based PK-PD modeling utilizes concepts from physiologically-based pharmacokinetic modeling, receptor theory, dynamical systems analysis and disease systems analysis. This research program will yield a mechanism-based PK-PD model library and database which can be used for 1) drug candidate selection, 2) design and evaluation of early 'proof of concept' studies in man, 3) optimization of phase-3 clinical trials, and 4) prediction of long-term outcome of drug treatment. In addition to the generation of models the platform educates a new generation of PK-PD modelers.

Fast facts
Full project title: PK-PD platform 2.0
Start date: 1 November 2012
End date: 1 November 2017
Goal: Develop a mechanism-based PK-PD model library together with a knowledge-based management system to securely store preclinical, clinical and epidemiological data and to support future model-based research in drug discovery and development
Principal investigator: Meindert Danhof
Project size: 9 FTE Partners: Astellas, Erasmus MC, Janssen, Leiden University, Takeda, MSD Oss, University of Groningen

“TI Pharma's program managers are experts in the content, enabling them to keep parties focused on the goals that were agreed upon at the outset.”

Jan Raaijmakers
Past VP External Scientific Collaborations GSK Europe
Chair TI Pharma Board of Directors

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