Panel Discussion: Reimagining the Regulatory Operating Model
Abhishek, Sathya, Jack, Andrew
The future of regulatory organizations will not simply be defined by technology, but by how people, processes, data, and AI work together. Industry leaders discuss how operating models must evolve to support greater speed, scalability, intelligence, and business alignment. Topics include organizational design, talent transformation, governance, data strategy, and the role of AI in shaping the regulatory function of the future.
Freyr ONE USA 2026 · 3:30 – 4:15 PM · Main stage
AI adoption is inevitable but 70% of regulatory functions remain in pilot or non-use stages.
Most organizations have visibility only to limited pilots rather than full enterprise AI integration, signaling early maturity stages.
Standardizing processes and data quality are prerequisites before scaling AI and automation in regulatory operations.
Takeda’s approach focused on clear workflows and clean data to enable effective AI deployment and governance.
Smaller or newer companies can build agile regulatory models unburdened by legacy systems, enabling faster innovation.
Denali exemplifies how startups can design regulatory operations to be AI-native and flexible from the outset.
ROI and scalability demand thoughtful, phased AI pilots over rushed, pinpoint solutions to ensure lasting impact.
Panelists caution that narrowly scoped pilots often fail without strategic planning and broader enterprise adoption.
Effective AI partnerships require shared investment, trust, governance, and partners proactively proposing use cases.
Leading companies seek collaborative relationships beyond vendor transactions to co-create and adapt solutions.
People are key: upskilling, AI champions, and change management enable teams to integrate AI as a functional teammate.
Education reduces anxiety and fosters a growth mindset necessary for AI adoption within regulatory teams.