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Pre-meeting Workshop

PMWS: Physiologically-based Pharmacokinetic Analyses: Practical Applications in Clinical Drug Development

Saturday, September 7, 2024
8:00 AM – 5:00 PM ET
Location:Grand Ballroom H
CE: 6.0

Target Audience:

This full-day Workshop will be valuable for beginner to intermediate level physiologically-based pharmacokinetic (PBPK) users and those seeking updated information on current topics in PBPK modeling. The Workshop is designed for doctorate-level students (MD, PharmD, PhD, etc.), postdoctoral fellows and professionals at any career stage. The audience should have a foundational understanding of how to leverage PBPK modeling in support of drug development decisions. The target audience may either work directly with clinical data on a daily basis or are interested in enhancing their skills and knowledge in applying state-of-the-art PBPK methods in drug development. This Workshop is applicable to participants across academia, industry and regulatory settings.



Description:

PBPK modeling and simulation is a computer modeling approach that is widely used throughout clinical drug development to describe the PK properties of a drug and to assess intrinsic and extrinsic factors that may impact the PK properties of a drug. This full-day Workshop will focus on current scientific thinking and practical considerations to apply PBPK modeling in clinical drug development. Various software platforms utilized in PBPK modeling will be presented. Attendees will learn how PBPK modeling can be used to facilitate decision making and inform more efficient clinical study design. Attendees will also have the opportunity to learn through real-world case examples of direct application of PBPK modeling in drug development. In addition, regulatory perspectives on the use of PBPK modeling to support new drug applications will be presented and discussed.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Apply PBPK modeling in drug development based on evolving standards and practices and establish PBPK models using various software platforms;
  • Analyze the impact of extrinsic factors (such as food-drug and drug-drug interactions) on the pharmacokinetic properties of drug candidates using PBPK models;
  • Apply PBPK models for dosing recommendations in special populations, such as pregnancy, organ impairment and disease.

Presentations:

  • An Introduction to PBPK & Its Utilization in Clinical Drug Development

    Co-Chair & Faculty: Kacey Anderson, PhD – Terns Pharmaceuticals Inc

  • Interspecies Scaling Approach Using PBPK Modeling

    Faculty: Hannah M. Jones, PhD – Certara UK Ltd

  • PBPK Modeling Applications in Special Populations

    Faculty: Robert Bies, PhD – Univ of Buffalo School of Pharmacy & Pharmaceutical Sciences

  • Prediction of Formulation Effects & Clinical Drug-Drug Interactions Using PBPK Modeling

    Faculty: Hannah M. Jones, PhD – Certara UK Ltd

  • Application of PBPK Modeling for Large Molecules

    Co-Chair & Faculty: Sumit Basu, PhD – Novartis

    Faculty: Jongbong Lee, PhD – Novartis

  • Regulatory Perspectives on the Use of PBPK Modeling

    Faculty: Yuching Yang, PhD – US Food & Drug Administration

  • Discussion, Questions & Answers, Learner Feedback & Evaluations