Community Conference

Welcome & Keynote

Welcome from the OSP CC 25

Session I & II - Clinical Applications and Development

Human Intestinal Organoids and Potential Application for PBPK Modeling
Growing a Community-built Qualified OSP-Model Library
PK-SIM AND R FOR PBBM AND VBE - INTRODUCTION TO VIRTUAL BIOEQUIVALENCE WORKFLOWS
Bridging In Vitro Dissolution and In Vivo Pharmacokinetics: Application of a Novel PBBM Workflow to Vericiguat

Session III: Research and Development

Accelerating Drug Discovery: systematic application of PBPK/PD modelling supporting candidate selection
Insights on Predicting PK from Chemical Structure by Combining Machine Learning with Mechanistic Modeling
Integrating In Vitro and In Silico Approaches Enables Accurate Prediction of Drug-Induced Liver Injury

Session IV: Integrated PBPK-PD/QSP modeling

Tools and workflows for automated reporting of PBPK modeling with OSP
PBPK Modelling in Regulatory Submissions to the MHRA
Software Verification, Validation, and (CoU) Qualification of Open Source M&S Software for Regulatory Use in Translational Model-Informed Drug Development

Session V: Emerging areas

Building a Qualifiable MIDD Ecosystem with modular PBPK and QSP Models in OSP V12
PBPK-PD for siRNAs - An OSP implementation for Drug Disposition and Efficacy analyses

Session VI: Roadmap

OSP Software Release Roadmap
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