Abstracts - PAGE Meeting (Population Approach Group Europe)

Abstracts (29)

B-05Kristin Karlsson

KEYNOTE LECTURE – Regulatory presentation: overview of the ICH M15 (MIDD) guideline

Wednesday 09:00-09:20

B-06Nicolas Frey

KEYNOTE LECTURE – Industry presentation: practical application of the ICH M15 guideline approach for assessing MIDD Evidence

Wednesday 09:20-09:40

B-08Flora 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

Wednesday 09:50-10:10

B-09Karen Sinclair

Implementation of an MIDD strategy for ruxolitinib dosing in pediatric GvHD populations, and varying opinions of regulators

Wednesday 10:10-10:30

B-12Thomas Dumortier

Registration of an intravenous secukinumab regimen not tested in clinical trial – Analyses used to support this Model-Informed Drug Development approach

Wednesday 12:00-12:20

B-13Stein Schalkwijk

Straight-to-Phase 3: MIDD accelerates depemokimab clinical development in Type 2 inflammatory conditions

Wednesday 12:20-12:40

B-14Sylvie Retout

Model based extrapolation of efficacy to support Baloxavir Marboxil for uncomplicated influenza in children aged <1 year

Wednesday 12:40-13:00

B-15Anders Strathe

Model-informed drug development provide pivotal evidence for approval of semaglutide 1.7 mg in adolescents living with obesity

Wednesday 13:00-13:20

B-18WenYao 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

Wednesday 14:50-15:10

B-19Jane Knochel

A Tutorial on Tackling High Dimensionality in QSP

Wednesday 15:10-15:30

B-22Maxime Beaulieu

Modelling the efficacy of antiviral strategies of SARS-CoV-2 in a context of emerging variants: from hospitalized patients to general community

Wednesday 17:00-17:20

B-23Clarisse Schumer

Viral dynamics of the Respiratory Syncytial Virus during experimental challenge infections: insights for transmission and treatment

Wednesday 17:20-17:40

C-02Raphaël Saporta

Model-based characterisation of antibiotic activity in the presence of immune response: towards improved preclinical-to-clinical translation

Thursday 8:30-8:55

C-03Linh Nguyen Phuong

Mechanistic Modeling of Joint Circulating Cell-free DNA Concentration—Tumor Size Kinetics under Immune-Checkpoint Inhibitors in Advanced Cancer

Thursday 8:55-9:20

C-04Zrinka Duvnjak

Dosing regimen optimisation of vedolizumab during pregnancy through physiologically-motivated sequential population modelling of albumin trends and vedolizumab pharmacokinetics

Thursday 09:20-09:45

C-08Han 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

Thursday 11:45-12:05

C-09Fenja Klima

Development of efficient CAR-T cell clinical study designs: Towards understanding of novel anticancer therapies through optimal experimental design

Thursday 12:05-12:25

C-10Anna 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

Thursday 12:25-12:45

C-13Jan Rohleff

Redefining Parameter Estimation and Covariate Selection via Variational Autoencoders: One run is all you need

Thursday 14:15-14:35

C-14Niklas 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

Thursday 14:35-14:55

C-18Mats Karlsson

A new PKPD modelling approach allowing a granular Exposure-Response analysis

Thursday 16:45-17:05

C-19Sebastian Tandar

Computational Framework for Multi-Objective Optimization of Population Dosing Regimens

Thursday 17:05-17:25

C-20Manuela Zimmermann

Performing causal inferences with pharmacometrics models – How to bridge the gap?

Thursday 17:25-17:45

D-02Tom 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

Friday 9:30-9:50

D-03Niels Hendrickx

Statistical methods to detect a disease-modifying treatment effect in clinical trials with few or very few patients for rare neurological diseases

Friday 9:50-10:10

D-04Christos Kaikousidis

A DeepNLME framework for modeling ordinal data to describe disease progression in patients with Alzheimer’s disease.

Friday 10:10-10:30

D-08Luca Marchetti

Predicting aberrant pharmacokinetics of bispecific antibody-derived molecules from in vitro gradient chromatographic assays and physiologically based pharmacokinetic (PBPK) modeling

Friday 11:25-11:45

D-09Salih Benamara

Physiologically-Based Predictions of Monoclonal Antibody Pharmacokinetics: Insights from a Large-Scale Data Analysis

Friday 11:45-12:05

D-10Donald Irby

AN INCIDENCE-SEVERITY MODEL FOR CYTOKINE RELEASE SYNDROME FOLLOWING DOSE-PRIMING REGIMENS OF ELRANATAMAB

Friday 12:05-12:25