A model-based dose selection and pharmacokinetic (PK) bridging approach was applied to support development of pembrolizumab SC (pembrolizumab with berahyaluronidase alfa for subcutaneous administration) from intravenous (IV) administration. Methodology, results and conclusions will be discussed in this presentation. 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.

Pediatric dose optimization is constrained by small cohorts and sampling limits. We applied Bayesian Forecasting to select the RP2D for pediatric patients with ALK-fusion tumors. An established PopPK model using adult data as prior in combination with real-time PK monitoring during Cycle 1 guided dose confirmation and/or adjustments. Doses were selected to match the adult steady-state therapeutic exposures. Model‑predicted doses achieved target exposure without adjustment in all 14 patients ≥20kg; 4/5 patients

The ISoP QSP SIG is hosting its annual fully-student-focused Virtual Student QSP Symposium on Sep 8th, 2026. This event allowed current students and trainees to learn about training and career paths and share their work with each other and professionals in the field. The Symposium featured a stellar line-up of speakers and panelists from industry and academia.