BTEC Brings Industry Leaders Together to Address AI Implementation in Biomanufacturing
From left to right: Heather Lorenz, Chief Product Officer, ViQi; Lucas Vann, Ph.D., Global Head of Innovation at Applied Materials; Saly Romero-Torres, Ph.D., Founder of Hyperplane, LLC; Sebastian Scheler, Co-Founder & Managing Director, Innerspace; Chris Dayton, CEO, QualityAssured.ai; Daniel Delubac, CEO, IORGANBIO; Michael Fields, Lead Automation Engineer, Eli Lilly and Company; and Kathleen T. Kelsey, IT Senior Director, Eli Lilly and Company.
As in many industries, biomanufacturing is rapidly expanding its use of artificial intelligence(AI) and advanced automation. However, in the FDA regulated biopharmaceutical sector, companies must balance innovation with rigorous validation, compliance, and patient safety factors that make adoption significantly more complex. Through a major symposium in March followed by a technical short course that concluded May 13, the Biomanufacturing Training and Education Center (BTEC) has established itself as a hub for industry, academia, and regulators to navigate these challenges together through collaboration, technical training and open discussion.
The Symposium on Applied AI in Biomanufacturing that BTEC hosted March 12, 2026 at the Duke Energy Hall in NC State University’s Hunt Library, brought together academic researchers, industry leaders, and government policymakers both in-person and virtually. Sessions were organized into four main tracks: process improvement, analytical enhancement, quality oversight, and regulatory integration.
One of the highlights of the symposium was a panel discussion on AI implementation challenges. Panelists addressed technology readiness, regulatory expectations, and the importance of human oversight. The discussion reflected the broader industry view that successful AI adoption in the biopharma industry depends as much on validation and governance as on algorithm performance.
Building on the momentum of the symposium, BTEC hosted an intensive AI short course, Artificial Intelligence in FDA Regulated Manufacturing: From Foundations to Implementation, on May 12 and 13. The course was designed for professionals in quality, validation, regulatory and technical operations responsible for advancing AI initiatives in GxP compliant environments.
Led by Chris Dayton, CEO of QualityAssured.ai and featured symposium speaker, the two-day course moved from theory to the practical realities of deployment. The curriculum focused on the following topics:
- System Architecture – Designing control points and data strategies appropriate for GxP environments.
- Validation Strategies – Applying risk-based frameworks such as GAMP5 and FDA Case for Safety, or CSA, to specific use cases.
- Regulation & Compliance – Maintaining ALCOA+ data integrity standards and understanding FDA, EMA, and EU regulatory expectations.
Those attending the course returned to their organizations with an AI implementation plan, validation strategies, vendor evaluation tools, and regulatory reference guide.
Together, the symposium and training course reflect BTEC’s emphasis on Pharma 4.0 workforce development for safe and effective integration of AI into biomanufacturing operations.
