33th PAGE Meeting

  • Thessaloniki - Greece
  • 4-6 June, 2025

Tuesday

14:00-19:00 Registration at the Conference Venue
19:30-21:00 Opening Ceremony, welcome reception

Wednesday

08:00-08:45 Registrations
08:45-08:55 Welcome & Introduction

Aris Dokoumetzidis & Oscar Della Pasqua

08:55-09:00 Introduction PAGE Scientific Program

Thomas Dorlo

09:00-10:30 MIDD in Regulatory Interaction

Thomas Dumortier & Oscar Della Pasqua

09:00-09:20 Kristin Karlsson KEYNOTE LECTURE - Regulatory presentation: overview of the ICH M15 (MIDD) guideline
09:20-09:40 Nicolas Frey KEYNOTE LECTURE - Industry presentation: practical application of the ICH M15 guideline approach for assessing MIDD Evidence
09:40-09:50 Q&A ICH M15
09:50-10:10 Flora Musuamba Tshnanu Credibility assessment of model informed drug development approaches in paediatric and rare diseases: a review of EMA submissions and assessment reports from 2014 to 2024
10:10-10:30 Karen Sinclair Implementation of an MIDD strategy for ruxolitinib dosing in pediatric GvHD populations, and varying opinions of regulators
10:30-12:00 Coffee Break, Poster and Software Session I
12:00-13:20 MIDD in Action

Marylore Chenel & Pascal Girard

12:00-12:20 Thomas Dumortier Registration of an intravenous secukinumab regimen not tested in clinical trial – Analyses used to support this Model-Informed Drug Development approach
12:20-12:40 Stein Schalkwijk Straight-to-Phase 3: MIDD accelerates depemokimab clinical development in Type 2 inflammatory conditions
12:40-13:00 Sylvie Retout Model based extrapolation of efficacy to support Baloxavir Marboxil for uncomplicated influenza in children aged <1 year
13:00-13:20 Anders Strathe Model-informed drug development provide pivotal evidence for approval of semaglutide 1.7 mg in adolescents living with obesity
13:20-14:50 Lunch
14:50-15:30 QSP

Coen van Hasselt & Gauri Rao

14:50-15:10 WenYao Mak AI-augmented QSP simulation of hormonal and endometrial dynamics of IVF/FET cycles to inform external clinical prediction models for miscarriage risk assessment in women of advanced maternal age
15:10-15:30 Jane Knochel A Tutorial on Tackling High Dimensionality in QSP
15:30-17:00 Coffee break, Poster and Software session II
17:00-17:40 Viral transmission: from challenge studies to community

Zinnia Parra-Guillén & Thomas Dorlo

17:00-17:20 Maxime Beaulieu Modelling the efficacy of antiviral strategies of SARS-CoV-2 in a context of emerging variants: from hospitalized patients to general community
17:20-17:40 Clarisse Schumer Viral dynamics of the Respiratory Syncytial Virus during experimental challenge infections: insights for transmission and treatment

Thursday

8:30-9:50 Lewis Sheiner Student Session

Elin Svensson, Ron Keizer, Benjamin Ribba

8:30-8:55 Raphaël Saporta Model-based characterisation of antibiotic activity in the presence of immune response: towards improved preclinical-to-clinical translation
8:55-9:20 Linh Nguyen Phuong Mechanistic Modeling of Joint Circulating Cell-free DNA Concentration—Tumor Size Kinetics under Immune-Checkpoint Inhibitors in Advanced Cancer
09:20-09:45 Zrinka Duvnjak Dosing regimen optimisation of vedolizumab during pregnancy through physiologically-motivated sequential population modelling of albumin trends and vedolizumab pharmacokinetics
9:45-9:50 Presentation LBS awards
9:50-11:45 Coffee break, Poster and Software session III
11:45-12:45 Oncology

Ana Ruiz & Rob ter Heine

11:45-12:05 Han Liu Optimizing Sunitinib Dosing in mRCC: Addressing Confounding Bias and Immortal Time Bias in Exposure- and Toxicity-survival Analyses using a Multistate Survival Modeling Framework
12:05-12:25 Fenja Klima Development of efficient CAR-T cell clinical study designs: Towards understanding of novel anticancer therapies through optimal experimental design
12:25-12:45 Anna Fochesato A dynamic and machine learning-powered clinical decision support system to enhance patient management: an example from atezolizumab in non-small cell lung cancer patients
12:45-14:15 Lunch
14:15-14:55 New approaches for covariate modelling

France Mentré

14:15-14:35 Jan Rohleff Redefining Parameter Estimation and Covariate Selection via Variational Autoencoders: One run is all you need
14:35-14:55 Niklas Korsbo Free-form text as an NLME covariate and how Embedding models enable effective use of predictive factors from a wide range of complex data
14:55-15:00 Preview of PAGE 2026
15:00-16:45 Coffee break, Poster and Software session IV
16:45-17:45 Stuart Beal Methodology Session

Julie Bertrand & Gilbert Koch

16:45-17:05 Mats Karlsson A new PKPD modelling approach allowing a granular Exposure-Response analysis
17:05-17:25 Sebastian Tandar Computational Framework for Multi-Objective Optimization of Population Dosing Regimens
17:25-17:45 Manuela Zimmermann Performing causal inferences with pharmacometrics models – How to bridge the gap?
20:00 Social event

Friday

9:30-10:30 Modelling neurodegenerative progression

Camille Vong & Monica Simeoni

9:30-9:50 Tom Chebassier How disability progression is correlated with serum neurofilament light chain dynamics in relapsing remitting multiple sclerosis patients treated with Alemtuzumab: results from a mechanistic drug disease joint model
9:50-10:10 Niels Hendrickx Statistical methods to detect a disease-modifying treatment effect in clinical trials with few or very few patients for rare neurological diseases
10:10-10:30 Christos Kaikousidis A DeepNLME framework for modeling ordinal data to describe disease progression in patients with Alzheimer’s disease.
10:30-10:40 Announcement ISoP
10:40-11:25 Coffee break
11:25-12:25 Bispecific antibodies & antibody PBPK

Charlotte Kloft & Stefanie Hennig

11:25-11:45 Luca Marchetti Predicting aberrant pharmacokinetics of bispecific antibody-derived molecules from in vitro gradient chromatographic assays and physiologically based pharmacokinetic (PBPK) modeling
11:45-12:05 Salih Benamara Physiologically-Based Predictions of Monoclonal Antibody Pharmacokinetics: Insights from a Large-Scale Data Analysis
12:05-12:25 Donald Irby AN INCIDENCE-SEVERITY MODEL FOR CYTOKINE RELEASE SYNDROME FOLLOWING DOSE-PRIMING REGIMENS OF ELRANATAMAB
12:25-12:35 Closing remarks