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Symposium

QSP/ PBPK

C3A - Challenges and opportunities in integrating QSP with new modeling techniques and datatypes

Monday, October 20, 2025
2:00 PM - 3:30 PM MDT
Location: Colorado B-D

Disclosure(s):
Karyn Sutton, PhD: No financial relationships to disclose
Khem Raj Ghusinga, PhD: No financial relationships to disclose
Shivendra Tewari, PhD: No financial relationships to disclose
Kimiko McGirr, PhD: No financial relationships to disclose
Stephan Schaller, PhD: No financial relationships to disclose

Description of session (include background & scientific importance): Quantitative Systems Pharmacology (QSP) models provide a framework within which multiple data types can be integrated to inform the mechanisms underlying disease pathology and drug actions. These models can be constructed so that they have multiple clinically relevant outputs, making them a valuable tool to inform clinical decisions based on efficacy as well as toxicity. Many QSP models are informed by a range of data sources, including traditional in vitro experiments as well as preclinical animal models, clinical studies, real-world evidence, etc. To harness the full predictive capability of QSP models, novel data types such as omics data and advanced cell systems or microphysical systems need to be leveraged. Further, building models that include outputs that are indicators of efficacy and toxicity in one framework results in a tool that can inform decisions based on drug effects across multiple axes.
The goal of this session is to discuss recent innovations in integrating novel data types and integration of pathways leading to clinical efficacy and toxicity. Challenges will be highlighted that arise while extending QSP model development.

Learning Objectives:

  • • Informing QSP models with multi-omics data • Preclinical to clinical translation of QSP models of microphysical systems • Clinical predictions with a combined efficacy and safety model for ADCs

Presentations:

  • 2:00 PM - 2:20 PM MDT
    Integration of multi-omics analyses with QSP models using metabolic knowledge graph

    Speaker: Shivendra Tewari, PhD (he/him/his) – AstraZeneca

  • 2:20 PM - 2:40 PM MDT
    Projecting Clinical Outcomes of Antibody-Drug Conjugates by Combining QSP and Virtual Populations

    Speaker: Kimiko McGirr, PhD (she/her/hers) – Certara

  • 2:40 PM - 3:00 PM MDT
    MPS–Digital Twin Synergy for Next-Generation Pharmacokinetic Predictions

    Speaker: Stephan Schaller, PhD (he/him/his) – ESQlabs, GmbH

  • 3:00 PM - 3:30 PM MDT
    Panel - Challenges and opportunities in integrating QSP with new modeling techniques and datatypes

    Panelist: Shivendra Tewari, PhD (he/him/his) – AstraZeneca

    Panelist: Kimiko McGirr, PhD (she/her/hers) – Certara

    Panelist: Stephan Schaller, PhD (he/him/his) – ESQlabs, GmbH