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Workshop: PBPK and QSP Modeling on OSP V12.

Workshop: PBPK and QSP Modeling on OSP V12.

OSP-Suite/Event

PBPK Foundations for small & large molecules, pediatrics, and model management in OSP V12.

Summary:

Physiologically-based pharmacokinetic (PBPK) modeling is a relevant approach to streamline drug development, providing a mechanistic framework to predict drug behaviour across different populations. With the latest developments in OSP Suite V12, PBPK modeling has become even more intuitive, efficient, and scalable.  

Led by the CEO of ESQlabs, Dr Stephan Schaller, this hands-on workshop will guide participants through the basis of PBPK modeling using PK-Sim, with a special focus on paediatric applications. For the second part of the workshop, we will dive into the latest OSP Suite V12, which introduces a revolutionary modularization approach that significantly enhances the flexibility, scalability, and efficiency of quantitative systems pharmacology (QSP) modeling and integrations with physiologically-based PK (PBPK-QSP) This session will also tackle the modular approach in MoBi, teaching how to efficiently build and manage complex models in a structured way. 

🔹 Part 1: Introduction to PBPK Modeling 

  • Learn the principles of PBPK modeling and its role in drug development. 

  • Understand the core functionalities of PK-Sim for model creation and simulation. 

🔹 Part 2: Hands-on Simple PBPK Model Development  

  • Build a basic PBPK model from scratch for small molecular entities using PK-Sim. 

  • Define drug-specific properties, ADME processes, and physiological parameters. 

  • Run and analyse simulations to understand key PBPK outputs. 

🔹 Part 3: Age-Dependent Pharmacokinetics – Pediatrics & Geriatrics 

  • Explore age-related physiological changes impacting drug pharmacokinetics. 

  • Modify PBPK models to simulate pediatric and geriatric populations. 

  • Perform dose adjustments and analyse pharmacokinetics differences across age groups. 

🔹 Part 4: The modularization concept and MoBi Training.  

  • Develop a PBPK model for large molecular entities (an antibody) and small molecule payload (as an antibody-drug conjugate, ADC). 

  •  Modularization: adding a Target-Mediated Drug Disposition reaction network as a reaction extension module. 

  • Optional: Modularization 2: adding a tumor organ as a physiological extension module. 

  • Work with separate modules to demonstrate how modular workflows streamline model management, reuse, and extension. 

Agenda Highlights: 

  •  PBPK fundamentals and model-building in PK-Sim 

  • Developing a simple PBPK model from scratch 

  •  Simulating age-dependent PK (pediatrics & geriatrics) 

  • Exploring drug exposure differences across populations 

  • Understanding modularization in OSP Suite V12 

  • Adding new components to PBPK models seamlessly 

  • Extending models with independent modules (e.g. for effect modeling/PBPK-PD) 

  • Explore modular PBPK-QSP workflows 

By the end of the workshop, attendees will have a working understanding of PBPK modeling and be equipped with practical skills to develop, refine, and analyse PBPK models for special populations using PK-Sim. Participants will also understand the new modular approach in MoBi, learning how to efficiently build and manage complex models in a structured way 

While automated model qualification will be touched upon in a lecture, the focus will be on hands-on modeling and modularization techniques that enhance collaboration, transparency, and reusability in PBPK-QSP modeling. 

Who Should Attend? 

This workshop is ideal for beginners and seasoned PBPK/QSP modelers, pharmacologists, and regulatory scientists looking to learn about PBPK(-QSP) modeling in OSP Suite V12. Attendees will leave with practical, hands-on experience in PBPK model development and complex (PBPK_QSP) model management and modularization, essential for regulatory-compliant customized PBPK(-QSP) modeling. 

Instructor: Dr Stephan Schaller 

The workshop fee includes both catering and full access to our training materials. 

Please note that this is a 1.5-day workshop, consisting of two sessions: 

  • Session 1: Tuesday, July 23, from 1:00 PM to 5:00 PM 

  • Session 2: Wednesday, July 24, from 9:00 AM to 4:00 PM 

We look forward to having you with us! 

 

 

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