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Workshop

Workshop

ISoP Education Committee: Unlocking the Value of Physiologically-based Modeling for Small and Large Molecule Therapeutics: Hands-on modeling and simulation with open-source tools, R and PK-sim

Wednesday, October 22, 2025
1:00 PM - 5:00 PM MDT
Location: Red Rock 8/9

Disclosure(s):
Patrick M. Glassman, PhD: No relevant disclosure to display

This hands-on session will focus on practical exercises using Physiologically-Based Pharmacokinetic (PBPK) models, offering a mechanistic approach compared to traditional models. PBPK models use physiological, anatomical, physicochemical, and metabolic parameters from in vitro, in vivo, and clinical data to predict drug behavior, making them valuable for clinical applications like trial design and drug-drug interaction analysis.

Attendees will use open-source software tools to complete exercises that strengthen their understanding of PBPK modeling for biologics and small molecules. Key exercises include:
Predicting the clinical pharmacokinetics (PK) of monoclonal antibodies (mAbs)
Modeling lipid nanoparticle (LNP)-mediated delivery of mRNA in the vascular system
Predicting mAb PK following subcutaneous administration
Developing a minimal-PBPK model for simulating lung exposure in humans after oral administration of Ivermectin for COVID-19 treatment
Additionally, if time allows, attendees will participate in a case study exercise, discussing how they would utilize PBPK modeling output in the industry setting. This session aims to provide hands-on experience with open-source tools, improve study design understanding, and demonstrate the value of integrating PBPK models with pharmacodynamic models.

Agenda:
1:00 - 1:40 PM Overview and Introduction to PBPK Modeling - Patrick Glassman
1:40 - 2:00 PM Small Molecule PBPK example in R - Patrick Glassman
2:00 - 2:40 PM PBPK Modeling Applications - Gauri Rao
2:40 - 3:00 PM Preclinical PBPK Example - Gauri Rao
3:00 - 3:15 PM BREAK
3:15 - 3:45 PM PBPK Modeling of Large Molecules - Patrick Glassman
3:45 - 4:00 PM Large Molecule PBPK Example - Patrick Glassman
4:00 - 4:35 PM PBPK for Neurological Applications - Sharif Soleman
4:35 - 4:55 PM Neurological PBPK Example in PK-Sim - Sharif Soleman
4:55 - 5:00 PM Concluding Remarks - Gauri Rao, Patrick Glassman

Learning Objectives:

  • Understand the fundamentals of PBPK and the how the modeling approach compares to traditional mammillary or “tissue lumping” modeling.
  • Apply full- and minimal- PBPK modeling approaches using open-source software, R and PK-sim, through hands-on exercises to predict drug exposure of small molecules and biologics, including monoclonal antibodies (via IV or SC administration) and mRNA.
  • Understand how PBPK models can be integrated with PD models to enhance drug development.
  • Practice communicating modeling analyses and results to a simulated industry team to guide drug development and inform decision-making processes.

Presentations:

  • 1:00 PM - 1:40 PM MDT
    Overview and Introduction to PBPK Modeling

    Instructor: Patrick M. Glassman, PhD (he/him/his) – Temple University

  • 1:40 PM - 2:00 PM MDT
    Small Molecule PBPK example in R

    Instructor: Patrick M. Glassman, PhD (he/him/his) – Temple University

  • 2:00 PM - 2:40 PM MDT
    PBPK Modeling Applications

    Instructor: Gauri Rao, PharmD, MS – University of Southern California

  • 2:40 PM - 3:00 PM MDT
    Preclinical PBPK Example

    Instructor: Gauri Rao, PharmD, MS – University of Southern California

  • 3:00 PM - 3:15 PM MDT
    ISoP Education Committee Workshop - Break
  • 3:15 PM - 3:45 PM MDT
    PBPK Modeling of Large Molecules

    Instructor: Patrick M. Glassman, PhD (he/him/his) – Temple University

  • 3:45 PM - 4:00 PM MDT
    Large Molecule PBPK Example

    Instructor: Patrick M. Glassman, PhD (he/him/his) – Temple University

  • 4:00 PM - 4:35 PM MDT
    PBPK for Neurological Applications

    Instructor: Sharif Soleman, PharmD, MS – AbbVie

  • 4:35 PM - 4:55 PM MDT
    Neurological PBPK Example in PK-Sim

    Instructor: Sharif Soleman, PharmD, MS – AbbVie

  • 4:55 PM - 5:00 PM MDT
    ISoP Education Committee Workshop - Concluding Remarks

    Instructor: Gauri Rao, PharmD, MS – University of Southern California

    Instructor: Patrick M. Glassman, PhD (he/him/his) – Temple University