From AI Hype to TMF Reality: Early Lessons from Implementing AI Agents

About this session

Part of Session 4, Track D: AI in TMF Management (Chair: Marion Mays, Jerion Consulting).

While the potential of AI in TMF management is well understood, few organisations have shared concrete lessons from implementation. This presentation addresses that gap. BeOne Medicines, working with an implementation partner, is deploying not a single AI tool but a coordinated set of AI agents across the full TMF lifecycle - classification, document-level quality verification against ALCOA++ principles, and ongoing TMF oversight. Rather than presenting a theoretical framework, this session shares practical experience from the first six months of implementation. We describe our methodology for designing AI agents within GCP-compliant workflows, including risk-based human oversight, confidence-based routing, and inspection-ready audit trails. We discuss project governance, AI decisions and guardrails, what worked, what proved harder than expected, and what we would approach differently. Whether evaluating AI or preparing for implementation, attendees will gain practical insight into the decisions, governance, and trade-offs involved.

Speakers

• PR

  Pawel Rucki

  BASE Life Science

  Speaker

• JT

  Jamie Toth

  BeOne Medicines

  Speaker

• NN

  Nisi Nazim

  BeOne Medicines

  Speaker