Workshop: PBPK Modeling for First-in-Human & DDI with OSP Suite

Workshop in connection to PAGE 2025 – Thessaloniki, Greece

Join us for an interactive two-day workshop where you will gain hands-on experience with physiologically-based pharmacokinetic (PBPK) modeling using the well-established whole-body PBPK model in PK-Sim® and the open modeling capabilities of MoBi®. Learn how to apply PBPK modeling to First-in-Human (FIH) studies and Drug-Drug Interactions (DDI), with training aligned to ICH M12 and ICH M15 guidelines. This workshop provides practical, hands-on exercises to ensure you can effectively use PK-Sim® and MoBi® in real-world scenarios.

Audience

This workshop is designed for scientists with a modeling background and a basic understanding of the drug development process. Attendees should bring a laptop to participate in hands-on activities.

Learning objective

The goal is to give participants a solid foundation to use  PK-Sim® and MoBi® to inform First-in-Human and DDI study designs and derive recommendations towards DDI risk. This workshop will showcase how PK-Sim and MoBi handle complex DDIs, ie. the ones requiring flexibility in standard implementation to adapt to the case.

Sign up now to secure your spot

• Fundamentals of PK-Sim® and MoBi®
• Setting up PBPK models in different species (e.g., Rat, Dog, Monkey)
• Using WB-PBPK models to establish in vitro-in vivo relationships
• Running simulations to inform First-in-Human design
• Retrieving reference compound files (victims & perpetrators) and enzyme/transporter framework
• Handling non-standard DDI cases (e.g., multiple enzymes, transporters, endogenous DDI biomarkers) with MoBi®
• Model verification, qualification, and applicability
• Running simulations to inform DDI study design
• Assessing model risk and providing recommendations for DDI labeling

Workshop tutors

_{Additional tutors may be added depending on the number of participants}

Senior Consultant

Tobias Kanacher

See bio

Consultant

Johanna Eriksson

See bio

Chief Research Officer

Marylore Chenel

See bio

Free speed consulting sessions

In addition to the ordinary program, the Pharmetheus tutors would be happy to schedule shorter individual free speed-consulting sessions in association to this workshop to support the participants on related topics.

Date and time

• 1st day, Monday 2^nd June. 13.00-17.00
• 2nd day, Tuesday, 3^rd June 8.00-17.00

Fees

• Commercial/Industry: 1200 (900*) EUR excl. VAT.
• Academia/government/non for profit: 600 (450*) EUR excl. VAT.
• Students: 300 (250*) EUR excl. VAT.

_{Price includes lunch and coffee breaks}

* _{Early bird: The reduced early bird price applies to registrations made by April 1.}