Optimizing ADC value beyond approval through model-informed strategies
Originally aired: Thursday, April 2, 2026
As antibody–drug conjugates (ADCs) move from late-stage development into approval and commercialization, the role of modeling and simulation becomes increasingly strategic. Beyond supporting regulatory approval, model-informed approaches are essential for shaping labeling decisions, enabling global regulatory alignment, supporting expansion into new populations and indications, and strengthening market access strategies.
In the final webinar of the 3-part CHI ADC series, Certara experts Amy Cheung, Isabelle Deprez, Roman Casciano, and Ananth Kadambi explore how modeling can be applied beyond approval to maximize the long-term value of ADCs.
The session demonstrates how quantitative approaches—including physiologically based pharmacokinetic (PBPK) modeling, extrapolation strategies, and integrated evidence generation—can support labeling for special populations, inform drug–drug interaction (DDI) strategies, and enable pediatric and global regulatory decision-making. It also highlights how integrated evidence can strengthen value narratives to support reimbursement and access discussions.
Gain practical insight into how modeling can be leveraged as a continuous, decision-making framework across the ADC lifecycle—from regulatory approval through post-approval expansion and commercialization.
Key learning objectives:
- Use modeling to optimize labeling for special populations, DDI strategies, and global regulatory alignment
- Enable pediatric and post-approval strategies through extrapolation and model-informed evidence
- Support commercial expansion and market access with quantitative evidence that strengthens value and reimbursement discussions
- Apply integrated evidence approaches to bridge clinical development and real-world value
Who should watch?
- Clinical Pharmacology, Pharmacometrics, and Modeling & Simulation professionals working on ADC programs
- Regulatory Affairs, Regulatory Science, and Clinical Development leaders supporting labeling and global strategy
- Market Access, HEOR, and Evidence Generation teams focused on value and reimbursement
- Commercial, lifecycle, and portfolio strategy leaders driving post-approval expansion
- Senior cross-functional stakeholders (Director–VP level) involved in late-stage and commercial drug development
Presenters
Ananth Kadambi, PhD
VP, Real World Evidence & Modeling Solutions, Certara
Amy Cheung, PhD
Vice President, Europe/APAC Regional Lead of Quantitative Science, Global Lead of Certara’s Pediatric and Maternal Innovation Engine
Roman Casciano, MEng
SVP, Evidence & Access, Certara
Isabelle Deprez
Director, Consulting, Certara
