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Symposium 16: Quo vadis? The future of paediatric drug development

Tracks
Track 8
Wednesday, July 15, 2026
11:15 AM - 1:15 PM

Details

ICH M15 will soon be released as guidance for regulators and drug developers. This guideline defines for the first time results from model-based approaches as evidence for regulatory approval of medicines. This symposium will provide an overview of the evolution of modelling and simulation from a conceptual framework to a powerful decision-making tool, supporting the optimisation of experimental protocols, translation and integration of data, prediction and extrapolation across conditions, and population (e.g., age, ethnic groups). The concepts are essential for overcoming the barriers for the development of medicines for children. In parallel, the development and advancement of AI, machine learning and other platforms promises to further enhance the opportunities that model-based approaches offer for more efficient evidence generation during clinical develoment of novel molecules for paediatric diseases.


Speaker

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Dr Rulan Griesel
ViiV Healthcare (VH)/GSK

Paediatric Clinical Trial Networks for Infectious Diseases

11:15 AM - 11:45 AM

Abstract

Biography

Rulan Griesel is currently the Paediatric Clinical Development Lead (CDL) at ViiV Healthcare (VH)/GSK, where he is focuses on facilitating access to cabotegravir and dolutegravir for paediatric patients with HIV. He joined VH/GSK in 2023 as Medical Director, contributing to early-stage drug development initiatives, including broadly neutralising antibodies and capsid inhibitors, before advancing to his current role. Prior to joining VH/GSK, he was a PhD candidate at the University of Cape Town, earning his doctorate in Clinical Pharmacology. His research concentrated on the adverse effect profile of dolutegravir in an African population, specifically examining pharmacogenetic predictors, as well as the presence of a concentration-response relationship for weight gain and neuropsychiatric adverse effects. Additionally, he was Lead Investigator on a Wellcome trust funded randomised controlled trial that evaluated clinical outcomes with dolutegravir single dosing in adults with HIV receiving rifampicin-based anti-tuberculosis therapy, and Co-Investigator on a randomised controlled clinical trial assessing dolutegravir-based antiretroviral treatment as second-line therapy in adults with HIV failing a first-line regimen. He holds an MBChB from the University of Pretoria and has specialised in Clinical Pharmacology, obtaining an MMed and FCCP from the University of Cape Town and the South African Colleges of Medicine, respectively.
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Salvatore D'Agate
National Research Council (CNR), Italy

Disease, organ function and ontogeny in paediatric extrapolation

12:15 PM - 12:45 PM

Abstract

Biography

Salvatore D’Agate is a research fellow in the Clinical Pharmacology and Therapeutics group at University College London (UCL) and at the Italian National Research Council (CNR). His current research focuses on the model-based characterisation of the impact of ontogeny, maturation and disease-related factors on drug disposition and dosing regimens. In particular, he is interested in the optimisation of dosing regimens for antibiotics and antivirals in neonates and young children. Concurrently, he works with ERA4TB, a European consortium aimed at accelerating the development of new treatment regimens for tuberculosis. His main task is to develop drug-disease models describing bacterial growth dynamics in vitro and in vivo to aid the quantification of the efficacy of antibiotics both as monotherapy and in combination taking into account the role of immune system. Previously, he worked as a consultant for GSK in a project aimed at characterising disease progression and risk of acute urinary retention in patients with benign prostate hyperplasia, and at assessing the impact of drugs with disease-modifying and symptomatic treatment effects on the progression of LUTS symptoms and on the risk of acute urinary retention.
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Dr Ronaldo Morales Junior
Hospital Sirio-libanes

From Dose to Exposure: Shifting the paradigm of paediatric clinical pharmacology

12:45 PM - 1:00 PM

Abstract

Biography

Ronaldo Morales Junior is a Clinical Pharmacist specializing in pediatric care and precision dosing. He holds a Ph.D. in Pharmaceutical Sciences from the University of São Paulo (Brazil) and currently works as a Postdoctoral Researcher in Clinical Pharmacology at Cincinnati Children's. His research focuses on the pharmacokinetics and pharmacodynamics of antimicrobial agents, with a particular emphasis on critically ill children, post-transplant patients, and neonates. He investigates key factors affecting drug disposition to optimize antibiotic dosing strategies.
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Dr Julia Netylko
Murdoch Children's Research Institution

Genotype informed ​Bayesian dosing of tacrolimus in paediatric solid organ transplant patients

1:00 PM - 1:15 PM

Abstract

Biography

Dr Julia Netylko completed her medical degree at Moscow State University, followed by residency in cardiology. She joined the Cancer Therapies group at the Murdoch Children’s Research Institute in October 2024. Her research focuses on pharmacogenomics in paediatric oncology, with current projects investigating genetic predisposition to anthracycline-induced cardiotoxicity and genotype-informed dosing of tacrolimus in solid organ transplant recipients. Julia is passionate about advancing personalised medicine approaches to improve treatment safety and outcomes for children.

Session chair

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Oscar Della Pasqua
Chair Clinical Pharmacology & Therapeutics
University College London

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Janna Duong
Scientific Leader
GlaxoSmithKline

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