Scemblix: Use of PBPK Models In Lieu of Clinical Trials

A nonlinear physiologically based PK model for asciminib was developed, validated and applied to support Scemblix NDA submission. The PBPK model was used in lieu of several clinical pharmacology studies at the submitted doses.

This will provide an example of how PBPK models and MIDD can be used to replace clinical pharmacology trials. This is a continuous learning area for development clinical scientists.

This talk will go over a real case study where industry scientists will be eager to learn how to avoid clinical trials, to streamline clinical drug development, and impact regulatory review. The audience can be engaged during Q&A or panel discussion at the end. The audience will be engaged during the talk with live feedback. The content will be more graphic and highly scientific to engage audience.

Clinical pharmacologists, PBPK/MIDD modeling scientists, Pharmacometricians, AAPS communities (PPDM, Clinical Pharmacology, Regulatory Sciences), Students who interested in modeling, Academia and modeling consultants