Keynote: The Regulatory Imperative - R&D, Regulatory & AI
Chris
As AI becomes embedded across the life sciences value chain, regulatory teams have an opportunity to move from operational support functions to strategic enablers of innovation. This keynote explores how regulatory, R&D, and digital functions can work together to accelerate development, improve decision-making, and deliver better business outcomes.
Freyr ONE USA 2026 · 9:15 – 9:45 AM · Main stage
The 'cosmic collision' of BPOs, CROs, AI platforms, and hyperscalers is driving unprecedented digital transformation.
This convergence brings non-traditional players into regulatory spaces, accelerating change beyond incremental gains.
We must shift from managing regulatory information to managing regulatory context for true transformation.
This means integrating data, processes, and strategic dependencies into a connected ecosystem instead of isolated systems.
Grounded AI based on validated internal data is essential to avoid unreliable external information in decision-making.
Chris highlights risks of generic AI tools accessing unverified external sources.
An ecosystem of context requires semantic retrieval, knowledge graphs, predictive signals, and continuous learning loops.
These technology elements work together to generate actionable intelligence across regulatory operations.
Operational execution of digital visions must focus on measurable business value and patient outcomes.
Strategy alone isn’t enough; cross-functional governance and metrics drive real impact.
Legacy monolithic platforms inhibit progress; agnostic, integrated digital ecosystems enable scalable transformation.
Breaking free from old-school systems is needed to avoid incremental, frustrating improvements.