23rd April

TimeItem
8:45Introducing the International PBPK Nexus
Chara Litou, Certara
Special Populations
Session Chair: Loeckie De Zwart, J&J and Pieter Annaert, KU Leuven
9:00Session Introduction
9:10PBPK Modeling to Support Dosing and Risk Assessment in Pregnancy and Lactation
Sophie Fischer, ESQLabs
9:25Lactation PBPK: Impact of CYP2D6 Phenotype on Fluoxetine
Amita Pansari, Certara
9:35Predicting Cefixime Exposure During Pregnancy using PBPK
Simon Koele, Radbound University
9:45PBPK Based Prediction of Liver Impairment – State of the Art
Agustos Ozbey, Idorsia
10:00PBPK Models of Elexacaftor, Tezacaftor, and Ivacaftor to Predict Drug-Drug Interactions and Apply to Moderate Hepatic Impairment
Jiangfan Wu, University Munich
10:10PBPK Modelling to Investigate the Impact of Hepatic Impairment on the Pharmacokinetics of Biologics
Felix Stader, Certara
10:20Q&A
10:40Refreshment Break & Poster Viewing
Biomarkers / Disease
Session Chairs: Maxime Le Merdy, Simulations Plus and Nada Abla Geiser, Medicines for Malaria Venture
11:00Session Introduction
11:10Development of a Physiologically Based Model of Bilirubin Metabolism in Health and Disease and its Comparison with Real-World Data
Ahenk Zeynep Sayin, University Hospital Aachen
11:30Insights into GI Tissue Exposure and Design of GI Restrictive Drugs Using PBPK Modelling
Simon Teague, Pharmaron
11:50Leveraging PBPK Modeling to Address Clinical Challenges of Long-Acting Injectable Drugs in Obese Populations
Mattia Berton, Roche
12:10Q&A
12:30Lunch Break & Poster Viewing
Rapid Fire Presentations
Session Chairs: Nico Holmstock, J&J and Justine Badee, Novartis
13:50Validation of optimized in vitro TDI assay conditions for CYP2C9 and CYP2D6 and clinical DDI risk assessment using mechanistic static and PBPK modeling.
Ines Herceg, Roche
 
PBPK modeling to support antimalarial drug development
Nada Abla Geiser, Medicines for Malaria Venture
 
PBPK Modelling of UGT1A4 Based Drug-Drug Interactions
Sara Peribañez-Dominguez, Astra Zeneca
 
Cracking the fed state code: A Python-based model and application for mechanistic exploration of irregular and variable plasma concentration profiles caused by stomach road and multiple water administrations
Dorota Danielak, Physiolution
 
Understanding Complex Food Effects Mechanisms and Quantitative Prediction Using PBPK Modelling 
Gaurangkumar Patel, Certara
 
Development and Validation of a Virtual Bioequivalence Workflow Using PBBM–PBPK Models: Application to Metoprolol Extended-Release Formulations 
Maximo Pettarin, Simulations Plus
14:50Refreshment Break & Poster Viewing
Biologics
Session Chairs: Neil Parrott, Roche and Pradeep Sharma, AstraZeneca
15:20Session Introduction
15:30Application of PBPK for Long-Acting Peptide Therapeutics
Howard Burt, Novo Nordisk
15:50PBPK of Tumor Targeting Bispecific mAbs
Armin Sepp, Certara
16:10PBPK of Subcutaneous Absorption for mAbs
Erik Sjögren, Pharmetheus
16:30Q&A
16:50Closing Remarks
Chara Litou, Certara

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