John Valliere-Douglass

Looking beyond current techniques to debate the next frontier in characterization, from continuous manufacturing control to analyzing single molecules. This panel discussion will challenge the status quo on what is “good enough” and explore the technologies that will redefine our understanding of ADC structure by:

• Speculate on the potential of single-molecule sequencing and mass spectrometry to fully resolve ADC populations, and whether this ultimate level of characterization is a necessary future standard or an analytical fantasy
• Debate the hurdles and rewards of implementing real-time PAT and in-line analytics for continuous ADC manufacturing, moving from batch release to a state of perpetual verification
• Explore the role of computational models and AI in predicting ADC biophysical behavior and long-term stability from early structural data, potentially rendering months of stability studies obsolete

• Navigate the increasing complexity of novel ADC modalities and chemotypes to accelerate development timelines and reduce costs across a growing portfolio of assets
• Establish a suite of robust, chemotype-agnostic platform methods for critical quality attributes, to minimize the number of methods requiring development, validation, and transfer, achieving greater efficiency, speed, and consistency across ADC development
• Implement a holistic, platform-based analytical strategy to de-risk project timelines, simplify tech transfer to QC, and create a more scalable, cost-effective framework for the future of ADC development