Kishore hotha

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

• Establishing an ADC-specific control strategy framework that addresses critical quality attributes to reduces clinical holds
• Implementing a dynamic, phase-appropriate method and specification roadmap to align analytical rigor with patient risk and accelerating progression through Phases 1 to 3
• Deploying a proactive post-submission readiness plan ensuring a streamlined review and securing timely market authorization for patient access