Open Systems Pharmacology Community Conference (OSP-CC) Proceedings 2025

ConferenceDDIJournalMethodologyPBPK/PBBMRegulatory interactionsSpecial/specific populationsTrial design and analysis

About

This publication highlight key advancements from the second Open Systems Pharmacology (OSP) Community Conference, held in Paris. The article explores topics such as:

  • The introduction of reusable “Extension Modules” in OSP V12 to handle increasing model complexity in PBPK and QSP.
  • The application of physiologically based biopharmaceutics modeling (PBBM) to bridge in vitro dissolution and in vivo pharmacokinetics.
  • Hybrid approaches combining deep learning with mechanistic PBPK models to predict human PK directly from chemical structures.
  • Regulatory applications, including automated reporting workflows and PBPK modeling in submissions to regulatory agencies.
  • The publication also discusses software verification, qualification frameworks, and the integration of in vitro toxicity assays to predict drug-induced liver injury (DILI).

This publication is co-authored by our colleagues Paul Vrenken, Erik Sjögren, Tobias Kanacher, and Marylore Chenel, together with valued collaborators from Sanofi, Bayer, Boehringer Ingelheim, Novartis, and additional members of the wider OSP community.

 

 

Open Systems Pharmacology

Open Systems Pharmacology (OSP) is a community-driven initiative that provides transparent, open-source solutions for model-informed drug development (MIDD). This annual conference gathers over 100 attendees from more than 40 institutions to share practical applications of the OSP Suite (PK-Sim and MoBi) across research, safety, and regulatory science.

OSP website