Publication: Clinical Pharmacology & Therapeutics
Abstract
This study showcases how quantitative systems pharmacology (QSP) and model-informed drug development (MIDD) can transform oncology drug development. Using a mechanistic model of PI3K and HRAS signaling in head and neck cancer, researchers identified optimal patient populations and dosing strategies for combination targeted therapy.
The results demonstrate how clinical trial optimization, biomarker-driven patient selection, and virtual patient simulations can improve therapeutic outcomes and guide precision medicine strategies. This approach highlights the growing role of pharmacometrics and systems modeling in accelerating safer, more effective cancer treatments.
Authors: Jaehee Shim, Douglas Chung, Alison Smith, Shivani Malik, Binaifer Balsara, Francis Burrows, Piet H. van der Graaf, Amitava Mitra
Published: March 18, 2026
Accelerate oncology drug development with Quantitative Systems Pharmacology (QSP). By integrating biological pathways, clinical data, and virtual patient simulations, Certara helps sponsors identify the right patients, optimize dosing strategies, and design smarter clinical trials.
From model-informed drug development to clinical trial optimization, our solutions enable confident, data-driven decisions that improve success rates and reduce development timelines in precision oncology.
