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Workshop

Biologics (ADC) whole-body PBPK/QSP in PK-Sim and MoBi

Biologics (ADC) whole-body PBPK/QSP in PK-Sim and MoBi, ESQlabs GmbH

Sunday, November 10, 2024
8:00 AM – 5:00 PM MST
Location: Kaibab

    Speaker(s)

  • Wilhelmus E.A. De Witte, PhD

    Lead Large Molecule Platform - Principal Scientist
    ESQlabs, Belgium

    Disclosure(s): No financial relationships to disclose

  • Alexander Kulesza, PhD (he/him/his)

    Principal Scientist
    Systems Pharmacology Lead, Rhone-Alpes, France

    Disclosure(s): ABLATOM SAS: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing); CreativeQuantum GmbH: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing); ESQlabs GmbH: Employment (Ongoing)

Disclosure(s):
Wilhelmus E.A. De Witte, PhD: No financial relationships to disclose
Alexander Kulesza, PhD: ABLATOM SAS: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing); CreativeQuantum GmbH: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing); ESQlabs GmbH: Employment (Ongoing)
The development of large-molecule drugs has become increasingly complicated over the last decades due to the continuous addition of new modalities and mechanisms of action. The crucial role of biodistribution into multiple tissues for target binding, catabolism, and FcRn-mediated recycling throughout the body makes whole-body PBPK modeling an attractive option for model-informed drug development in this area. These models are especially useful if they can be extended to include target-mediated drug disposition (TMDD) in multiple organs where the target is expressed, and if pharmacodynamic elements can be added to obtain integrated PBPK-QSP models. ESQlabs will provide hands-on training on the development of these models using PK-Sim® and MoBi® (OSP-Suite). The workshop will cover general introductions to applying this freely available open-source software suite and will provide state-of-the-art example models and development workflows. In-depth exercises will cover PBPK and PD modeling for monoclonal antibodies, antibody-drug-conjugates (ADCs) for tumor growth inhibition, FcRn inhibitors, and bispecific immune cell engagers.

Level of experience in PBPK/QSP modeling: New / Beginner / Intermediate / Expert
Level of experience in OSP Suite: New / Beginner / Intermediate / Expert
Level of expertise on the topic of the workshop: New / Beginner / Intermediate / Expert
How do you plan to use the OSP Suite in your research? As a free text
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