Systems Pharmacology/PBPK Workshop with PK-Sim and MoBi at PAGE meeting

Physiologically based modeling of intrinsic and extrinsic factors influencing pharmacokinetics A Systems Pharmacology Workshop by Bayer using PK-Sim® and MoBi® Monday, June 6th, Lisbon, Portugal Modeling and simulation scientists in drug development are faced with ever growing challenges regarding flexibility, accuracy and applicability of models to support an increasing number of projects. Moreover, clinical programs can benefit from more detailed mechanistic models as knowledge-driven drug development is taken to the next level by dedicated software tools for Quantitative Systems Pharmacology (QSP) applications. Such tools can provide a valuable means for addressing these challenges in a flexible and versatile manner and are supported by regulatory guidance such as the FDA Guidance for industry - Drug-Drug Interaction studies. In this one-day workshop, Bayer Technology Services (BTS) will focus on teaching and demonstrating how to build fully integrated systems pharmacology models using BTS' Software Suite with PK-Sim® and MoBi®, a QSP modeling & simulation platform applicable for a wide number of use cases. These include classic physiologically based pharmacokinetic (PBPK) approaches such as species extrapolation, translating between (special) populations and drug-drug interaction (DDI) prediction as well as more complex QSP models for different indications. Attendees will learn how to easily deal with challenging mechanistic modeling tasks focusing on pharmacokinetics and pharmacodynamics, exemplified by several real-life use cases. These will be introduced with in-depth lectures followed by dedicated hands-on training sessions. Particular attention is given to questions communicated by attendees, we will ensure that sufficient room will be given for detailed and lively discussions. Hands-on sessions will, among others, cover the following topics: - how to develop and set-up PBPK models with PK-Sim®, - how to scale an existing model to different populations (e.g. young, elderly, renally impaired, or hepatically impaired populations) - how to extend and couple models to investigate drug-drug interactions, e.g. via a common transporter using MoBi® - how automatic tracking and documentation functionalities available in the software can be applied for better overview and transparency We are looking forward to meeting you at the workshop and are happy to answer questions regarding registration and organization: [email protected]<mailto:[email protected]> Additional information: The workshop will be free of charge, the registration form is available at the following link: http://www.systems-biology.com/index.php?id=2681 Best regards, Donato Teutonico Systems Pharmacology CV [cid:C15DEDD5-288E-4312-857A-B6E1A5E2692F] Bayer Technology Services GmbH BTS-TD-ET-SPC, Systems Pharmacology CV Building B106, 210 51368 Leverkusen, Germany Tel: +49 214 30 55352 Mobile: +49 173 78 06651 E-mail: [email protected] Web: http://www.bayer.com Geschäftsführung: Armin Knors, Geschäftsführer Vorsitzender des Aufsichtsrats: Hartmut Klusik Sitz der Gesellschaft: Leverkusen | Amtsgericht Köln, HRB 49896