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
Dr Rulan Griesel
ViiV Healthcare (VH)/GSK
Paediatric Clinical Trial Networks for Infectious Diseases
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.
Tjitske van der Zanden
PhD candidate
Dutch Paediatric Pharmacotherapy Expertise Network
From data to doses: closing the knowledge gap
Biography
Tjitske van der Zanden is the technical director of the Dutch Paediatric Pharmacotherapy Expertise Network, that publishes the Dutch Paediatric Formulary (www.kinderformularium.nl ). Originally trained as a nurse and a clinical research coordinator, she worked on several paediatric clinical studies at the ErasmusMC-Sophia Childrens Hospital in Rotterdam, before she joined the Dutch Paediatric Formulary as a projectmanager from the very start in 2005. As a projectmanager and later on the technical director Tjitske is responsible for the technical development and maintenance as well as the contents (dosing information) of the Dutch Paediatric Formulary. In 2025 she completed her PhD on ‘Risk mitigation strategies for off-label drug use in children” at the Radboud UMC in Nijmegen. This dissertation shows that in children, dependent on age group 30-70 % all medicines are still used off-label and that a proper assessment of risks and benefits in pediatrics is severely hampered by the lack of available high-quality evidence. Because off-label use in children is still a necessary evil, this dissertation describes a number of innovative strategies to improve the quality of decision-making on and the provision of information about off-label use in children and thus to reduce the risks of off-label use.
Salvatore D'Agate
National Research Council (CNR), Italy
Disease, organ function and ontogeny in paediatric extrapolation
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.
Dr Ronaldo Morales Junior
Hospital Sirio-libanes
From Dose to Exposure: Shifting the paradigm of paediatric clinical pharmacology
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.
Mr Alessandro Di Deo
Univerisity College London
Session chair
Oscar Della Pasqua
Chair Clinical Pharmacology & Therapeutics
University College London
Janna Duong
Scientific Leader
GlaxoSmithKline