AI success in R&D depends less on ambition and more on focus. This session explores how leaders can prioritise fit-for-purpose AI applications by grounding decisions in AI-ready data foundations, clear scientific and operational value, and organisational readiness. Drawing on real R&D experience, it outlines practical criteria for selecting fit-for-purpose AI applications that scale into workflows, improve scientific and operational decisions, and ultimately accelerate development and improve outcomes for patients.

This presentation outlines Bayer’s journey toward AI governance and operational readiness, from early automation to enterprise level GenAI adoption. It highlights key lessons in organizational enablement, balancing internal and external capabilities, and an example of a holistic approach to transforming regulatory submissions. Attendees will gain practical patterns and pitfalls to help move from isolated experiments to scalable, well-governed AI ecosystems.

Industry dialogue has shifted from AI experimentation to operational readiness. Drawing from enterprise deployment experience, this session examines strategic approaches for scaling agentic AI in clinical trials—autonomous systems supporting risk identification and decision-making. Key topics: establishing robust data foundations, implementing governance frameworks, navigating regulatory requirements (EU AI Act, FDA guidance), managing organisational change, and measuring business impact beyond proof-of-concept.

Roundtable bullet points:

• ?Why do most AI pilots fail to scale beyond proof-of-concept?
• Can you build agentic AI on fragmented legacy data—or is infrastructure investment non-negotiable?
  
• Is regulatory compliance (EU AI Act, FDA guidance) a barrier to innovation or a competitive moat?
• How do you measure AI ROI when most value claims are declarative, not demonstrated?
  
• What's harder: deploying the technology or changing organisational behavior to trust it?
  

Join us for an interesting session jointly delivered by three roles across Clinical Development: Global Regulatory, Clinical Operations, and AI Governance for a story about how we in Novo Nordisk are enabling AI to assist with critical decisions in pivotal studies which only can succeed when people, processes, and systems are aligned through integrated workflows, training, and robust controls. When successfully implemented, AI not only strengthens governance and decision quality, but also unlocks meaningful operational efficiencies— accelerating trial execution throughout the study life cycle.