Amanda Ampey

Exploring the future of potency, where assays must mimic the tumor microenvironment and measure integrated functions beyond cytotoxicity. This panel will debate the practical limits of complexity, the role of surrogate assays, and how to validate a “systems biology” approach to potency.

Join a strategic discussion on building the agile ADC development organization of the future by:

• Debate how complex a potency assay should become to feasibly develop co-culture assays incorporating immune cells and stromal components to reflect the in vivo mechanism of action
• Explore the potential for non-cell-based binding assays, combined with AI models to serve as validated potency methods, reducing variability and resource strain while linking clinical efficacy
• Define the line between necessary scientific rigor and impractical method proliferation for dual-mechanism ADCs, to understand the minimum number of assays needed to ensure product quality

• Health Authority expectations include defining the primary, payload-mediated MoA and characterization of secondary MoAs (e.g., ADCC, ADCP, CDC) based on IgG subclass/engineering, target biology, and potential impact on efficacy and safety
• Fc effector functions as secondary MoA in ADC molecules can be demonstrated in vitro via ADCC, ADCP, and CDC assays. Fc determinants like glycosylation and Fc engineering should be monitored across Process lots and batches
• In vitro evidence of effector activity does not always translate to in vivo relevance; carefully designed in vivo studies with appropriate controls are often needed to confirm and finalize the MoA