PSMO-12 - Computational modelling and simulation: Challenges and opportunities for FIP

Meeting room 2.40
Organised by The FIP Board of Pharmaceutical Sciences in combination with the FIP Foundation

Chair(s)

Prof. Don Mager, University of Buffalo, USA

Introduction

Computational modelling and simulation to understand exposure-response relationships of medicines has emerged as a firmly established discipline that has ushered in an era of model-informed drug development and precision dosing. Based on the type of modelling, most contemporary methods fall within either pharmacometrics (often population-based modelling of drug exposure linked to a small number of biomarkers or clinical outcomes) and quantitative systems pharmacology (larger, more holistic models of complex mechanisms of drug disposition and action). Both approaches have shown clear value across all phases of clinical development of medicines. In addition, they have provided platforms for identifying sources of inter-subject variability and tools to individualize patient pharmacotherapy. However, there remain clear challenges and opportunities to better implement modelling and simulation more strategically to fully realize the promise of accelerating the drug development process to get new safe and effective medicines to the patients who need them and to enable clinicians with the tools they need to personalize therapy and improve individual patient outcomes. The goals of this session are to introduce the primary concepts of pharmacometrics and quantitative systems pharmacology, showcase how they are being used to enhance drug development and utilization, and to provide a forum for discussing how FIP could play a role in addressing the challenges and opportunities faced by educators, research scientists, and clinical pharmacists in using modelling and simulation to its fullest potential.

Programme

14:30 – 14:35 Introduction and welcome
14:35– 14:45 Introduction to modelling & simulation
Prof. Stephan Schmidt, University of Florida, USA
14:45– 15:00

Modelling & simulation in drug development
Prof. Cornelia Landersdorfer, Monash University, Australia
15:00– 15:15 Clinical application of modelling & simulation
Prof. Paolo Denti, University of Cape Town, South Africa
15:15 – 16:00 Panel discussion
Moderated by Prof Ross Mckinnon, Chair FIP Board of Pharmaceutical Sciences, Australia

Learning objectives

  • Describe the basic elements of computational models of drug exposure-response relationships.
  • Recognize the value modeling and simulation brings to critical decision-making processes in drug development and utilization.
  • Help identify and prioritize the roles FIP can have in promoting best practices, training opportunities, scientific advancement, and the clinical application of modeling and simulation of drug exposure-response relationships.

Take home messages

  • Modelling and simulation can be used to better understand drug exposure-response relationships and provide a model-informed approach to critical decision-making processes in the development and regulation of medicines.
  • Individualized dosing can be best achieved by forecasting individual patient pharmacokinetic and pharmacodynamic parameters from sparse clinical data and previously established population-based exposure-response models.
  • There are unique opportunities available for FIP in workforce training, providing a forum for scientific advancement, and applications of modeling and simulation in clinical practice.