How integrated modeling and evidence strategies can support better decisions from first in human studies through market access

Antibody drug conjugates are transforming oncology, but their complexity creates challenges that traditional development approaches were not designed to solve. 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.

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 can connect evidence and decision making across the ADC lifecycle.

Download the white paper to explore how model informed approaches can help teams:

• 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

These themes follow the lifecycle framework in the paper, which connects early translational development, clinical dose optimization, label expansion, and post approval and market access strategy.