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

• Deconstruct the ADC’s mechanism into discrete steps to identify biologically relevant activity to measure for potency assays, ensuring the method reflects the product’s therapeutic function
• Select or engineer a cell line that accurately expresses the target antigen to create a bioassay that is specific and responsive to the ADC’s activity, enabling reliable potency methods that detect changes in product quality
• Incorporating effector function assays when they are part of the intended MoA to fully capture the multifaceted activity of the ADC, providing a complete picture of potency for molecules designed to engage immune cells