PAGE 2020 OSP-Suite Webinar

The workshops cover the basics of PBPK, qualification of PBPK for regulatory purpose, PBPK for DDI and pediatrics and the extension of PBPK with customized organ physiology and pharmacodynamics. The two workshops will enable participants to use PK-Sim® & MoBi® for PBPK in a regulatory setting (Day 1) and to build their very own PBPK-QSP platforms for the quantitative prediction of clinical trial outcomes by leveraging physiological and mechanistic knowledge to translate early in-vitro and preclinical outcomes to the clinic (Day 2).

Within the two workshops, you will learn how to:

Workshop 1 / Day 1:

• Qualify PBPK models for intended use using the PK-Sim® qualification framework,
• Learn how to model drug-drug interactions in PK-Sim (DDI)
• Learn how to consider age-dependency in drug PK in PK-Sim (Pediatric Analyses)
• Assess variability within population simulations

Workshop 2 / Day 2:

• Integrate PBPK with mechanism-based pharmacodynamics in MoBi
• Extend the PBPK physiology with customized organs in MoBi
• Conduct parameter identifications in PK-Sim and MoBi
• Run, plot, and analyze your PBPK-QSP models in R

The two workshops will be held by the consultants and scientists from esqlabs GmbH with extensive experience in the use of PK-Sim® & MoBi® in all application areas.

While the workshop does not require any prior experience with PK-Sim® & MoBi®, many topics will be of interest even for advanced users.

LOCATION

While the PAGE meeting was cancelled due to the corona virus pandemic, we have decided to NOT cancel the workshop. We will host it as a WEBINAR.

To provide you with the same value you would expect from a face to face workshop, we are offering each registered participant a 1-on-1 follow-up coaching session as a 1-hour (30 min per webinar day) video conference at a mutually agreed upon date and time after the workshop.

For the workshop itself, we will slightly change the format to fit a WEBINAR and to accommodate for the time-difference between time-zones of our participants (see agenda).

REGISTRATION

You can register for each workshop separately or for both days at a reduced price.

Each workshop day is currently restricted to 15 participants.

Registration includes coffee- and lunch breaks.

AGENDA

The use-cases within the workshops will be based on published examples.

We will develop PBPK models for small molecules for DDI and pediatric populations and PBPK models for biologics (antibody-drug conjugates (ADCs)), which we develop into a PB-QSP model for treatment of tumor growth.

The two workshop days are scheduled as follows:

Day 1 (9th June, 2020)

Day 2 (10th June, 2020)

PREPARATION

• BRING YOUR OWN LAPTOPS, pre-installed with the software! We will be doing hands-on work!
• To download the software, please click here
• Download & install the R distribution (Ver 3.5+) from here
• Download & install FREE RStudio Desktop (a GUI for R with additional functionalities for e.g. debugging and code visualization) from here
• For starters, please check out the tutorial site (videos & hands-on) here

NOTES

• Please add this site to your watchlist (very top of page) to be informed of any changes.

Visit our News & Events Section for info on additional workshops in the future and news on our future developments in physiologically-based quantitative-systems-pharmacology.

Best Regards,

Stephan Schaller
(Managing Director, esqLABS GmbH)