In this presentation, speaker will provide an innovative case-study for combining real-world data (RWD) and physiologically-based pharmacokinetic (PBPK) modeling to evaluate concomitant medication use in rare disease populations. This approach leverages RWD to identify common concomitant medications and their usage patterns in a specific rare disease population. This information is then incorporated into PBPK models to predict potential DDIs and their clinical significance. The presentation will discuss how this method can be used to prioritize DDI studies, optimize dosing strategies, and inform inclusion/exclusion criteria for clinical trials. Furthermore, speaker will also introduce a novel RWD dashboard that generalizes this approach, allowing for widespread adoption across various disease contexts. This user-friendly tool enables researchers and clinicians to easily access and interpret relevant RWD, facilitating more informed decision-making in drug development and patient care.
