Welcome to the Population Approach Group in Europe

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-Guill�n & 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	Rapha�l 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 Mentr�

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