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Symposium 9: Recent applications of physiologically-based pharmacokinetics (PB-PK) in drug discovery and development.

Tracks
Track 1
Friday, December 12, 2025
11:00 AM - 1:00 PM

Details

The principles of physiologically-based pharmacokinetics (PB-PK) are well established, however the application of PB-PK modelling to support effective decision making within drug discovery and development are ever-increasing. Further to this, the recent widely-publicised FDA announcement of policies heralding an anticipated end to animal testing will undoubtedly result in significant growth of PB-PK modelling under the broad umbrella of “Non-Animal Models (NAMs)”. This symposium will present a number of very recent examples of the application of PB-PK modelling to advance the development of diverse therapeutic modalities, ranging from in vitro-informed ADME properties of small molecules, peptide and biologic delivery via the pulmonary and subcutaneous routes, through to in vivo disposition of mRNA-based therapeutics.


Speaker

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Prof Carl Kirkpatrick
Director, Centre for Medicine Use and Safety
Monash University

Presenter

Biography

Carl is Professor of Pharmacy Practice, Medicine Use and Safety. He has a significant portfolio of research in optimising pharmacotherapy via pharmacokinetic/pharmacodynamic modelling techniques to improve patient outcomes. His research interests include population pharmacokinetic and pharmacodynamic modelling, monitoring and bayesian optimisation of dosing of antibacterial agents (especially aminoglycosides), optimisation of dosing in renal dysfunction, pharmacokinetics and dosing in obesity, drugs in breast milk and quality use of medicines.
Dr Jessica Tait
Postdoctoral Research Fellow
Monash University

PB-PK modelling in support of optimising LNP-delivery of mRNA therapeutics

Biography

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Miss Jia Li
PhD Student
Centre for Medicine Use and Safety, Monash University

What lies beneath - PBPK modelling to support subcutaneous administration of Anakinra in preterm neonates

Abstract document

Biography

Jia Li is a PhD candidate at the Centre for Medicine Use and Safety, Monash University. Her research focuses on model-informed drug development of anakinra in preterm neonates, including population pharmacokinetic (PPK), physiologically based pharmacokinetic (PBPK), and pharmacokinetic/ pharmacodynamic (PPK/PD) modelling approaches. Her work integrates the unique physiological characteristics of premature neonates to optimize dosing strategies and support clinical development. Jia holds a Bachelor’s degree in Pharmacy and a Master’s degree in Medicinal Chemistry. She has diverse experience across academia and the pharmaceutical industry, including roles as a manager coordinating preclinical and clinical studies in autoimmunology and oncology, and a researcher investigating the pathogenesis of neurodegenerative diseases.
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Kenneth Brouwer, PhD, RPh
Global Research Liason
BioIVT

In Vitro Models Integrating Metabolism and Transport to Support Mechanistic PK Modeling in Early Drug Discovery

Abstract document

Biography

Kenneth Brouwer is Vice President, ADME Tox Research at BioIVT. A pharmacologist by training, Dr. Brouwer has led in vitro ADME programs at GSK and at PPD. He later led development of B-CLEAR technology, a method to quantitate hepato-biliary excretion. He was a founder of Qualyst Transporter Solutions, where he expanded applications of B-CLEAR technology and developed assays that integrate uptake, efflux, and regulatory function of cells. In 2017, BioIVT acquired Qualyst, and Dr. Brouwer now helps biopharmaceutical clients design and implement in vitro ADME research programs to achieve their drug R&D and regulatory submission objectives.

Chair

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Carl Kirkpatrick
Director, Centre for Medicine Use and Safety
Monash University

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Cornelia Landersdorfer
Associate Professor
Monash University

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Dave Shackleford
Research Director
Centre for Drug Candidate Optimisation, Monash University

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