Yiyuan Ding

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

• Develop antigen-binding assays to verify the structural integrity of bispecific molecules, ensuring both binding arms remain functionally intact, and the product retains its intended activity
• Apply a strategic cell line selection approach for cytotoxicity assays to develop a physiologically relevant bioassay that accurately models the MoA of ADCs
• Optimize and streamline bioassay method transfer from ARD to QC to accelerate implementation while ensuring robustness, reproducibility, and regulatory compliance