Pharmetheus Training

PBPK Modelling

Open source PBPK modelling with the OSPSuite (PK-Sim® & MoBi®) for MIDD

Title of the workshop
Open source PBPK modelling with the OSPSuite (PK-Sim® & MoBi®) for MIDD 

Workshop sponsors
Sponsored by Pharmetheus and co-hosted by Pharmacometrics Africa, NPC

Workshop target audience
Scientists/ Pharmacometricians interested in physiologically based pharmacokinetic modeling (PBPK) modelling and interested in learning how to consider age dependency, predict drug-drug interactions (DDIs) and conduct population simulations in PK-Sim® & MoBi®. 

Workshop faculty
Erik Sjögren, Pharmetheus, Uppsala, Sweden (See bio)
Tobias Kanacher, Pharmetheus, Hagnau, Germany (See bio)

Workshop overview
The workshop will feature PBPK modelling with the Open Systems Pharmacology suite (OSPS) also known as PK-Sim® and MoBi®. The goals are:

• Getting an introduction to the open source PBPK software PK-Sim® & MoBi® and it’s use for small molecule for investigations in clinical drug development.

• Learn how to do age dependent extrapolation with PBPK models (very young or very old populations).

• Learn how to model complex DDIs.

The combination of use cases based on published examples and hands-on lectures will enable the participants to build their own PBPK projects and maximise their impact by integrating physiological and mechanistic knowledge with preclinical and clinical information. 

While the workshop is aimed for beginners with PK-Sim® & MoBi®, many topics will be of interest even for advanced users.

 

Workshop Learning Objectives 
During the workshop, the participants will have the opportunity to become familiar with the software in extensive hands-on sessions, which will follow after a brief introduction to the basic concepts of PBPK. The participants will have a chance to experience the stepwise PBPK model development and qualification. First, a base PBPK model is built and compared to observed data. Then the model is refined and through a question-based approach strategy further aspects for model extrapolation are explored. Next, the use of PBPK modelling for development of a DDI strategy is shown. We will teach you how to use and integrate pre-existing models and building blocks to create a whole-body PBPK model for complex DDIs (e.g. simultaneous induction and inhibition by a perpetrator) and optimise study protocols. Finally, a workflow is presented on how PBPK models can extrapolate beyond tested scenarios like scaling form adult populations to young, old and very old.

Workshop Timetable

08h30-09h00Welcome and introduction
09h00-09h45Concepts of PBPK and applications in drug development
- Introduction OSP suite and OSP community
09h45-10h15Coffee Break
10h15-12h00Setting up a PBPK model in PK-Sim
- demo
12h00-13h00Lunch
13h00-14h30Use of PBPK to support DDI strategy
- introduction
- hands-on
14h30-15h00Coffee Break
15h00-16h30Use of PBPK to support pediatric or geriatric indications
- introduction
- hands-on

Date and Duration
Monday, April 6th 2020: 8:30AM-5PM

Registration Fee
Students: 25 $ / R400
Academia / Government: 125 $ / R1850
Commercial / Industry: 250 $ / R3750

Links
For info about this workshop and latest updates click here.
For registration click here.
For general info about the WCOP2020 click here.
For more information on PBPK at Pharmetheus click here.

Maximum Number Participants
21

Requirements
Participants are expected to bring their laptops and have installed the OSPSuite packages
on their laptops (for instructions and software please click here).

For starters it is useful to check out the tutorial site (videos & hands-on) here