Workshop
PBPK modeling with the OSPSuite (PK-Sim®): leveraging in vitro data for MIDD
Interested in PBPK with a focus on both IVIVE for FIH prediction and IVIVC for virtual BE trials? Join this two day workshop led by Pharmetheus' PBPK experts on 27-28th June 2022, in connection to PAGE in Ljubljana, Slovenia
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 in depth understanding of PBPK informed drug development with a focus on informing first human PK prediction and Biopharmaceutics
- Learn how to leverage preclinical in vitro and in vivo data for IVIVE and First In Human (FIH) predictions
- Learn how to leverage in vitro dissolution data for virtual bioequivalence trials
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 intermediate levels with PK-Sim® & MoBi®, many topics will be of interest even for beginners or more advanced users.
Workshop target audience
Intermediate course for Scientists/ Pharmacometricians with basic understanding of PK-Sim looking for support on how to use PBPK modelling for strategic decision-making across the whole drug development.
Workshop learning objectives
During the workshop, the participants will have the opportunity to become familiar with the software in extensive hands-on sessions while having a good understanding on how the tool can be used to inform drug development.
For each topic, a lecture on PBPK informed drug development will be given.
Then, the participants will have a chance to gain experience in the stepwise PBPK model development and qualification.
For the first topic, in vitro data is used to build an animal base PBPK model. Performance of the base model will be evaluated and refined leveraging on observed in vivo data.
The learnings from these steps will be used for predicting first in human PK.
Secondly, a workflow is presented on how PBPK models can be used in Biopharmaceutics for establishing an in-vitro-in-vivo relationship and how to utilize this in a virtual bioequivalence (VBE) trial workflow.
Finally, you will have the chance to get instant help for your own project in a speed consulting session.
Workshop logistic details
The workshop will start 09:00 on Monday and end at 18:00 on Tuesday (possibility to leave at 15:00 if not taking advantage of time reserved for speed consulting on your project). It will take place in a hotel within walking distance from the venue. The fee includes two coffee breaks with snacks and a lunch, per day.
Requirements
Participants are expected to use their laptops and have installed the OSPSuite packages on their laptops (for instructions and software please visit https://github.com/Open-Systems-Pharmacology/Suite/releases/tag/v10.0).
For starters it is useful to check out the tutorial site (videos & hands-on) here:
Registration fee
Students: € 300 + VAT
Academia / Government: € 600 + VAT
Commercial / Industry: € 1200 + VAT
Workshop faculty
Marylore Chenel, Ph.D.
Principal Consultant & Team Leader at Pharmetheus
Erik Sjögren, Assoc. Prof, Ph.D.
Senior Consultant at Pharmetheus
Tobias Kanacher, Ph.D.
Senior Consultant at Pharmetheus
Registration form
Use the form below to book your attendance to the workshop.
Please note that available slots are limited.
We will get back to you with more information and payment details.
