Learning Center

2026 MIDD Webinar Series | Efficient Pediatric Dose Optimization Leveraging Adult Population Pharmacokinetics and Bayesian Forecasting

2026 MIDD Webinar Series | Efficient Pediatric Dose Optimization Leveraging Adult Population Pharmacokinetics and Bayesian Forecasting

Includes a Live Web Event on 08/26/2026 at 12:00 PM (EDT)

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 <20kg required up-titration. Bayesian borrowing of adult knowledge enabled efficient pediatric dose optimization and rapid confirmation by improving the accuracy of exposure predictions across weight bands.

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.

Tu Mai

Tu Mai

Senior Principal Scientist, Clinical Pharmacology, Modeling & Simulation

Genentech

Tu Mai is a Senior Principal Scientist in Clinical Pharmacology, Modeling & Simulation at Genentech, where she leads clinical pharmacology and modeling and simulation strategies across multiple early and late-stage development programs. She has extensive experience in model-informed drug development (MIDD), including population PK/PD modeling, Bayesian forecasting, exposure-response analysis, and MIDD strategies to support regulatory submissions and dose optimization. Her work spans ophthalmology, oncology, immunology in small molecules and biologics. Tu received her Ph.D. in Pharmacology from Vanderbilt University.

Key:

Complete
Failed
Available
Locked
MIDD Series | Efficient Pediatric Dose Optimization Leveraging Adult Population Pharmacokinetics and Bayesian Forecasting
08/26/2026 at 12:00 PM (EDT)  |  60 minutes
08/26/2026 at 12:00 PM (EDT)  |  60 minutes 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 <20kg required up-titration. Bayesian borrowing of adult knowledge enabled efficient pediatric dose optimization and rapid confirmation by improving the accuracy of exposure predictions across weight bands.
You must register to access.