This webinar will focus on the PKPD models developed and used end-to-end to design and execute a Phase 1 study for a first brain-penetrant PROTAC ARV-102. Core PKPD models were developed using nonclinical data and included allometrically scaled PK parameters and animal-derived PD parameters for target engagement. Model simulations were used to select a dose range for the first in human study and the PKPD models were updated to refine the dose response. The iterative modeling-experimentation resulted in a successful Phase 1 study and illuminated important translational relationship of PROTAC PKPD between animals and humans.
The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.