| Time | Item |
|---|---|
| 8:45 | Introducing the International PBPK Nexus Chara Litou, Certara |
| Special Populations Session Chair: Loeckie De Zwart, J&J and Pieter Annaert, KU Leuven | |
| 9:00 | Session Introduction |
| 9:10 | PBPK Modeling to Support Dosing and Risk Assessment in Pregnancy and Lactation Sophie Fischer, ESQLabs |
| 9:25 | Lactation PBPK: Impact of CYP2D6 Phenotype on Fluoxetine Amita Pansari, Certara |
| 9:35 | Predicting Cefixime Exposure During Pregnancy using PBPK Simon Koele, Radbound University |
| 9:45 | PBPK Based Prediction of Liver Impairment – State of the Art Agustos Ozbey, Idorsia |
| 10:00 | PBPK Models of Elexacaftor, Tezacaftor, and Ivacaftor to Predict Drug-Drug Interactions and Apply to Moderate Hepatic Impairment Jiangfan Wu, University Munich |
| 10:10 | PBPK Modelling to Investigate the Impact of Hepatic Impairment on the Pharmacokinetics of Biologics Felix Stader, Certara |
| 10:20 | Q&A |
| 10:40 | Refreshment Break & Poster Viewing |
| Biomarkers / Disease Session Chairs: Maxime Le Merdy, Simulations Plus and Nada Abla Geiser, Medicines for Malaria Venture | |
| 11:00 | Session Introduction |
| 11:10 | Development 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 |
| 11:30 | Insights into GI Tissue Exposure and Design of GI Restrictive Drugs Using PBPK Modelling Simon Teague, Pharmaron |
| 11:50 | Leveraging PBPK Modeling to Address Clinical Challenges of Long-Acting Injectable Drugs in Obese Populations Mattia Berton, Roche |
| 12:10 | Q&A |
| 12:30 | Lunch Break & Poster Viewing |
| Rapid Fire Presentations Session Chairs: Nico Holmstock, J&J and Justine Badee, Novartis | |
| 13:50 | Validation 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 |
| 14:50 | Refreshment Break & Poster Viewing |
| Biologics Session Chairs: Neil Parrott, Roche and Pradeep Sharma, AstraZeneca | |
| 15:20 | Session Introduction |
| 15:30 | Application of PBPK for Long-Acting Peptide Therapeutics Howard Burt, Novo Nordisk |
| 15:50 | PBPK of Tumor Targeting Bispecific mAbs Armin Sepp, Certara |
| 16:10 | PBPK of Subcutaneous Absorption for mAbs Erik Sjögren, Pharmetheus |
| 16:30 | Q&A |
| 16:50 | Closing Remarks Chara Litou, Certara |
Download the full program