Optimizing dose, evidence, and lifecycle value from first-in-human studies to market access
Successful ADC development requires navigating complexity that traditional approaches weren’t built for. Antibody drug conjugates are transforming oncology, but narrow therapeutic windows, multiple analytes, complex pharmacology, evolving regulatory expectations, and the need to demonstrate long-term value are pushing ADC developers toward more integrated, evidence-driven strategies.
Building a model-informed drug development strategy for ADCs
This white paper brings together perspectives from Certara experts across clinical pharmacology, pharmacometrics, physiologically based pharmacokinetic modeling, quantitative systems pharmacology, translational science, regulatory strategy, and market access to explore how model-informed drug development (MIDD) in oncology can connect evidence and decision-making across the ADC lifecycle.
What you’ll learn in this white paper
- Strengthen first-in-human strategy and dose optimization
- Reduce uncertainty with integrated modeling and simulation
- Support regulatory expectations and evidence needs
- Inform patient selection, lifecycle planning, and market access
