24th April

TimeItem
Innovative Approaches
Session Chairs: Chara Litou, Certara and Bhagwat Prasad, Cincinnati Children’s Hospital
8:45Session Introduction
8:55New Approach Methodologies and PBPK Integration
Bhagwat Prasad, Cincinnati Children’s Hospital
9:10A Review of Virtual Twins in PBPK
Emily Mannix, Monash University
9:25State-of-the-Art Cluster Gauss-Newton Method Redefines what PBPK Models can Address in Early Clinical Development
Toshiaki Tsuchitani, Keio University
9:40Predicting First-in-Human Pharmacokinetics: Comparative Evaluation of Standard PBPK, High-Throughput PBPK and Machine Learning
Silvan Kaeser, Roche
9:55Liquid Biopsy–Informed Physiologically Based Pharmacokinetic Modeling of Systemic Exposure to Tyrosine Kinase Inhibitors in Leukemia
Amit Dahal, Rhode Island
10:10Q&A
10:30Refreshment Break & Poster Viewing
Oral Absorption
Session Chairs: André Dallmann, Bayer and Nikoletta Fotaki, University of Bath
11:00Session Introduction
11:10Establishing a physiologically based biopharmaceutics modelling and simulation framework to investigate the absorption process of poorly soluble drugs administered as amorphous solid dispersions (ASD)
Julia Macente, J&J
11:25Food effect prediction of a high permeability/low solubility drug formulated as an amorphous solid dispersion (ASD) using an Open Systems Pharmacology (OSP) PBBM approach
Paul Vrenken, Pharmetheus
11:40Physiologically Based Biopharmaceutics Modeling of Regional and Colon Absorption in Humans: A Systematic Evaluation
Harshad Jadhav, AstraZeneca
11:55From Dissolution to PBPK: A Probabilistic, Literature-Driven Framework for Risk-Informed Bioequivalence Evaluation
Jhennifer Rabelo, Universidade de São Paulo
12:10Q&A
12:30Closing Remarks

Download the full program