GMP webinar : A Growing Network of Open Science: PBPK modelling of Drug–Drug Interactions with the Open Systems Pharmacology Suite

In this webinar we want to feature Physiologically based pharmacokinetics (PBPK) as important tool in drug development [1], which is usually performed when results from known clinicals scenarios are used to predict unknown scenarios [2]. PBPK modelling represents a subdiscipline of System Pharmacology striving to understand the fate of the drug in body including impact of drug-drug interactions (DDI) and drug-gene interactions (DGI) [3].

Despite its generic relevance for drug applications, only a few verified, freely accessible, modifiable, and comprehensive DDI PBPK models are available. The Open Systems Pharmacology (OSP) community aims to overcome this bottlenecks and to grow PBPK knowledge with an open science approach [4]. OSP offers professional open access and open-source software tools (PK-Sim/MoBi) including qualified CYP3A4 DDI networks. Recently this network has been expanded with a CYP1A2 and CYP2C19 network, which can be applied to investigate drug-drug-gene interactions (DDGI). In his presentation Tobias Kanacher will show you how you can leverage the OSP software platform and the community for your drug development project, with a special focus on DDI.

[1]  J. E. Sager, J. Yu, I. Ragueneau-Majlessi, and N. Isoherranen, “Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A Systematic Review of Published Models, Applications, and Model Verification,” Drug Metab. Dispos., vol. 43, no. 11, pp. 1823–1837, Nov. 2015, doi: 10.1124/dmd.115.065920.
[2] L. Kuepfer et al., “Applied Concepts in PBPK Modeling: How to Build a PBPK/PD Model,” CPT Pharmacomet. Syst Pharmacol, vol. 5, no. 10, pp. 516–531, Oct. 2016, doi: 10.1002/psp4.12134.
[3]  T. Kanacher et al., “A Physiologically-Based Pharmacokinetic (PBPK) Model Network for the Prediction of CYP1A2 and CYP2C19 Drug–Drug–Gene Interactions with Fluvoxamine, Omeprazole, S-mephenytoin, Moclobemide, Tizanidine, Mexiletine, Ethinylestradiol, and Caffeine,” Pharmaceutics, vol. 12, no. 12, Art. no. 12, Dec. 2020, doi: 10.3390/pharmaceutics12121191.
[4] J. Lippert et al., “Open Systems Pharmacology community – an open access, open source, open science approach to modeling and simulation in pharmaceutical sciences,” CPT Pharmacomet. Syst. Pharmacol., vol. n/a, no. n/a, doi: 10.1002/psp4.12473.

Dr. Tobias Kanacher is a senior consultant in pharmacometrics at Pharmetheus. He is a licensed pharmacist and received his PhD from the University of Tübingen in 2003, for biochemical analysis and characterization of enzymatic regulatory domains as potential drug targets. Before joining Pharmetheus (2019-present), he gathered extensive experience in drug discovery and translational clinical development at Altana Pharma AG (2003-2006), Nycomed (2006-2011), Takeda (2011-2012), Bayer (2012-2017) and for SGS-Exprimo (2017-2019). He has broad experience to advice clinical development teams when and how to apply PBPK modelling for influencing internal and regulatory decisions across different stages of clinical drug development.