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.

Clinical Utility Indexes (CUIs) provide a quantitative, integrated measure of efficacy and safety within a scalable platform. Traditionally, benefit and risk are assessed through exposure-response (ER) analyses and compared qualitatively to choose a dose. CUIs transform this by combining multiple ER geometries into a single, reproducible, and flexible dose/PK exposure-dependent metric, often represented as a bell-shaped curve, with the peak CUI mapped to a nominal dose or regimen.

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.

Building and nurturing your professional network is critical to success, especially in a field as small and collaborative as pharmacometrics. This webinar will help you develop meaningful connections, and schmooze with confidence!

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.

This webinar explores strategies for implementing risk-based quality control (QC), emphasizing the use of peer-review QC to optimize robust validation. By tailoring the QC level to project-specific risk factors such as analysis purpose and data complexity, the delivery process for high-quality pharmacometric analysis datasets can be streamlined. The session will discuss differentiating between QC levels, such as self-QC, peer review, and double programming. Participants will discover practical methods for fostering collaboration, establishing clear data derivation rules, and utilizing comprehensive QC checklists, particularly for peer-review processes. Additionally, the webinar will highlight tools to support peer-review QC, enhancing QC efficiency and effectiveness.

This webinar explores how Model-Informed Drug Development (MIDD) supports drug development and patient care by informing dosing strategies beyond clinical trial data. Through real-world case examples—such as guiding dosing after treatment interruptions and optimizing dosing for an ocular implant—we’ll highlight how MIDD aids decision-making, streamlines development, and reduces patient burden without additional trials.