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.

Quantitative Systems Pharmacology (QSP) is increasingly applied in MIDD frameworks and regulatory interactions, though challenges remain in ensuring transparency and credibility. This webinar will share insights from the group’s work, including considerations on virtual populations, regulatory submission examples, proposed minimum evaluation criteria, and ongoing challenges highlighting areas in need of further regulatory guidance.

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.

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.

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.

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.

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.

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.

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.

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.