Are We There Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence in Biologics Manufacturing.

Digital transformation promises to revolutionize biopharmaceutical manufacturing, yet most organizations leverage only a fraction of their process data — and the challenges are paradoxically increasing with digitization and globalization. Digitization does not automatically deliver analytics-ready data. New AI capabilities, from multivariate methods through foundation models and agentic systems, demand data infrastructure that most sites have never been asked to provide.

This webinar introduces BioMetre, a practical maturity framework serving as a GPS for process monitoring readiness, developed and deployed across a global biologics manufacturing network. The model scores data readiness along two axes: what process data exists across six categories, and how well it flows across six delivery dimensions — freshness, frictionlessness, accessibility, authenticity, structure, and availability. Assessments across 25+ products revealed scores ranging from 30–80%, with organizations excelling at collecting critical data but struggling to make it analytically accessible.

Drawing on nearly four decades applying AI to biologics manufacturing, Jack Prior will share practical lessons for identifying the specific data gaps standing between current operations and effective AI adoption — and why getting the data foundation right is the highest-leverage investment a manufacturing organization can make.

Presented by Jack Prior, Head of Process Monitoring & Data/AI Strategy at Sanofi

Jack Prior leads process monitoring and data science/AI strategy within Sanofi’s Global Manufacturing Science and Technology organization, where he has spent nearly 30 years focused on biologics manufacturing. His career has consistently sat at the intersection of manufacturing science and data analytics, and at the interface of process development and cGMP manufacturing. He has led organizations of up to 50, supported global technology transfers, and delivered yield improvements with 8-figure annual impact.

Jack’s MIT doctorate applied artificial intelligence to biologics process troubleshooting and monitoring nearly four decades ago. He has been building on that foundation ever since, from early multivariate methods through modern data science to current efforts advancing agentic AI readiness across global operations. He earned his B.S. in Chemical Engineering from the University of Connecticut, where he was inducted into the Academy of Distinguished Engineers in 2013.

He serves on the PDA Science Advisory Board and the MIT Leaders for Global Operations Governing Board, and is a frequent speaker on practical AI readiness in regulated biomanufacturing. An eight-time marathoner and Boston Marathon qualifier, he has raised over $45,000 for Dana-Farber Cancer Institute and the National Organization for Rare Disorders.