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Tutorial

QSP/ PBPK

T2 - Ascending New Heights with Open Systems Pharmacology Suite V12: Innovations in Model  Qualification, Model Handling, and Clinical Trial Simulation

Wednesday, October 22, 2025
8:00 AM - 12:00 PM MDT
Location: Red Rock 8/9

Disclosure(s):
Stephan Schaller, PhD: No financial relationships to disclose
Pavel Balazki, MSc: No financial relationships to disclose
Brian Cicali, Phd, MS: No financial relationships to disclose

Description of session (include background & scientific importance): Session Background and Scientific Importance: The evolution of modeling and simulation in quantitative pharmacology demands tools that balance complexity with usability, and regulatory requirements with scientific innovation. The Open Systems Pharmacology Suite (OSP Suite) is providing open-source, high-quality software tools for physiologically-based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP) modeling to support these needs. The recent release of OSP Suite V12 marks a milestone, introducing model modularization and the framework for automated QSP model qualification and their integration with R. This tutorial will demonstrate how these new features address contemporary challenges, including reproducibility, regulatory compliance, and customizability witzh an example of a custom-developed DDI Clinical Trial Simulator. The session will provide participants with both conceptual insights and hands-on guidance using the OSP Suite tools PK-Sim, MoBi, and R-Packages ospsuiteR, esqlabsR..

Session

Description:
This tutorial will provide a comprehensive overview of the new features introduced with OSP Suite V12, including automated model qualification workflows, enhanced modularity, and robust R-based extensions. Attendees will learn how these innovations streamline model development, qualification, and application, particularly in regulatory contexts. Through hands-on demonstrations and real-world case studies, participants will see how PBPK/QSP modeling can be more efficient, reproducible, and transparent. The session concludes with a presentation on a novel clinical trial simulator for hormonal contraceptive DDIs, developed to address regulatory challenges and optimize trial design.

Learning Objectives:

  • 1. Understand the new model qualification framework and modular architecture in OSP Suite V12. 2. Gain practical insights into using ospsuiteR and esqlabsR for model development, sensitivity analysis, and parameter identification. 3. Explore the development and application of a clinical trial simulator to improve the design and interpretation of contraceptive DDI studies.

Presentations:

  • 8:00 AM - 9:00 AM MDT
    OSP Suite V12: Model Modularization Enabling Automated QSP Model Qualification

    Instructor: Stephan Schaller, PhD (he/him/his) – ESQlabs, GmbH

  • 9:00 AM - 10:00 AM MDT
    Integrating R-Based Workflows for Regulatory-Compliant PBPK/QSP Modeling

    Instructor: Pavel Balazki, MSc (he/him/his) – ESQlabs GmbH

  • 10:00 AM - 11:00 AM MDT
    Clinical Trial Simulator for Hormonal Contraceptive Drug Interactions

    Instructor: Brian Cicali, Phd, MS – University of Florida