| Time | Item |
|---|---|
| 8:45 | Welcome to the First International PBPK Conference Ioannis Loisios-Konstantinidis, Novartis |
| PBPK: Past, Present, and Future Session Chairs: Ioannis Loisios-Konstantinidis, Novartis and Stephan Schaller, ESQLabs | |
| 9:00 | Session Introduction |
| 9:10 | Aligning PBPK, Patients and R&D to Create a Common Future Thierry Lave, Independent Consultant |
| 9:30 | PBPK: Did a Knock Down in Round 1; What to Expect for Round 2? Amin Rostami, University of Manchester |
| 9:50 | Bridging PBPK and Biological Networks for Integrated QSP Models Lars Kuepfer, Aachen University |
| 10:10 | Q&A |
| 10:30 | Refreshment Break & Poster Viewing |
| Drug-Drug Interactions Session Chairs: Youssef Daali, Geneva University and Kenichi Umehara, Roche | |
| 11:00 | Session Introduction |
| 11:10 | Savolitinib PBPK Informed by Human ADME and in vitro Data Clarified its Major Elimination Pathway and Enabled DDIs Prediction Pradeep Sharma, AstraZeneca |
| 11:30 | Quantitative Prediction of DDI with Intestinal P-gp Inhibition and Induction Aki Heikkinen, Certara |
| 11:50 | Enhancing Mechanistic Accuracy in PBPK Modeling via Absolute Protein Abundances using Proteomics Chen Ning, KU Leuven |
| 12:10 | Q&A |
| 12:30 | Lunch Break & Poster Viewing |
| Rapid Fire Presentations Session Chairs: Angela Gummerlich, Boehringer-Ingelheim and Oguz Kaan, Simulations Plus | |
| 13:50 | Development of a Literature-Anchored PBPK Framework for Food Contaminant Mixtures; AFB1, BaP, and BPA Isaac Mensah, Federal Institute for Risk Assessment (BFR) PBPK Model of Enniatins B and B1 in Rat and Human: Applicability of Read-Across in these Mycotoxins Risk Assessment Mariam Mahdjoub, ANSES French Agency for Food, Environmental and Occupational Health and Safety Generalized MLR-PBPK Modelling for Nanoparticle Biodistribution Prediction from Physicochemical Properties Jimeng Wu, Empa, Swiss Federal Laboratories for Materials Science and Technology Preclinical PBPK Modeling of DOTA-TATE-based Radiopharmaceuticals: How Generalizable are the Models? Justine Henriot, Belgian Nuclear Research Centre (SCK CEN), Nuclear Medical Applications Institute Open Source Modular Framework for Pharmacokinetic, Pharmacodynamic, and Safety Simulations of Anti-Tuberculosis Drugs Marco Siccardi, ESQLabs |
| 14:50 | Refreshment Break & Poster Viewing |
| Regulatory Presentations and Open Discussion Session Chairs: Loeckie De Zwart, J&J and Kunal Taskar, GSK | |
| 15:20 | Session Introduction |
| 15:30 | PBPK Modelling for Special Populations in Regulatory Submissions to the MHRA Andrew Butler, MHRA |
| 15:45 | Lessons Learned from an EMA Workshop on Reporting and Qualification of Mechanistic Models for Regulatory Assessment Pieter Colin, EMA |
| 16:00 | PBPK Modeling: An Overview and Insights from Regulatory Submissions Yuching Yang, FDA |
| 16:20 | Open Discussion & Debate PBPK and PBBM – Should PBBM be Treated as a Separate Entity or as a Specialized Part in PBPK? Do we need Separate Guidances for Both? Panelists: Ioannis Loisios-Konstantinidis, Novartis; Marc McAllister, Biowaived; Tycho Heimbach, Merck Virtual Controls and Hepatic Impairment (HI) – Virtual Control Groups and Severe HI Predicted with Validated PBPK Models can Replace need for Clinical Control and/or Severe HI Groups Panelists: Islam Younis, Merck; Amitava Mitra, Kura Oncology; Maria Posada, Eli Lilly |
| 17:30 | Closing Remarks Ioannis Konstantinidis, Novartis |
Download the full program
PBPK Conference 2026 