Karan Shah
Senior Director - Analytical Development & Quality Control Dyne Therapeutics
Seminars
Thursday 30th April 2026
Panel Discussion: Measuring Multi-Modal Function in a Complex Biological System to Create Potency Assay of the Future to Recapitulate the Tumor Microenvironment & Predict Clinical Efficacy In Vivo:
10:30 am
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
Tuesday 28th April 2026
Designing Robust, Mechanism-of-Action Driven Bioassays To Demonstrate Functional Integrity for Dual Payload & Bispecific ADCs & AOCs
Delve into translating biological complexity into robust, reproducible, and relevant bioassays that accurately reflect clinical function. Join this workshop to prove the functional integrity of next-generation ADCs & AOCs and meet regulatory expectations for critical quality attributes by:
- Deconstructing a complex ADC & AOC mechanism of action into testable functional units, ensuring the resulting potency assay is biologically relevant and measures the activity, leading to robust, meaningful potency methods
- Selecting and engineering of reproducible cell lines, focusing on promoter strength and banking strategies, to create a stable foundation that minimizes bioassay variability and ensures consistent, reliable potency data
- Designing bioassays for bispecific and dual-payload ADCs & AOCs to address the critical challenge of proving dual-target engagement, controlling complex modalities, and demonstrating functional integrity
