Event concluded October 22, 2026 Hyatt Regency, Princeton, NJ

Thank you for joining us.
The conversations don't end here.Accelerating Regulatory Excellence

Freyr ONE brought together leaders from Regulatory, R&D, and Technology to explore how AI, regulatory intelligence, connected data, and new operating models are reshaping the future of regulatory excellence. If you couldn't join us, you'll soon be able to access session recordings, key takeaways, speaker insights, and event highlights. If you attended, this is where you'll be able to revisit the discussions, ideas, and conversations that mattered most.

Join the waitlist See what happened

AI and intelligent agents in regulatory operations
Regulatory intelligence and connected data
RIM innovation and adoption
Evolving operating models
Hands-on demonstrations in the Innovation Zones
AI and intelligent agents in regulatory operations
Regulatory intelligence and connected data
RIM innovation and adoption
Evolving operating models
Hands-on demonstrations in the Innovation Zones

What you missed

Some conversations don't fit in a recording.

The value of the day was in the room - the questions, the side conversations and the live demos.

AI is moving into regulatory and the next challenge is making it work across the enterprise. Freyr ONE USA 2026 brought an invite-only group of senior leaders together to explore where AI creates measurable value, what enterprise regulatory intelligence looks like, where intelligent agents fit and what needs to change across data, technology, governance and operating models.

Attendees compared notes with peers, saw AI and agentic workflows in action, and took back practical ideas for their own transformation priorities.

What we explored

Five conversations that defined the day.

01
AI and intelligent agents in regulatory operations
Where AI creates measurable value today, and which workflows agents can carry end to end.
02
Regulatory intelligence and connected data
Turning fragmented regulatory data into intelligence that drives proactive decisions at scale.
03
RIM innovation and adoption
How organizations are rethinking the role of RIM for agility and cross-functional collaboration.
04
Evolving operating models
Organizational design, talent, governance and data strategy for the regulatory function ahead.
05
Hands-on demonstrations in the Innovation Zones
Live, end-to-end scenarios attendees could explore with Freyr experts between sessions.

Session by session · October 22, 2026

A single-track program where each discussion is built on the one before it. Open a session to see what was covered.

9:00 AM
Setting the stage for regulatory excellence
Welcome note
Sudhir Kandarth, Freyr Solutions
The opening address on why regulatory transformation has become a strategic business priority.
- Why regulatory transformation is now a business priority
- How the single-track day was built
9:15 AM
The regulatory imperative across R&D, regulatory and AI
Keynote
Chris Lee, Gilead Sciences
How regulatory, R&D and digital teams can work together as enablers of innovation rather than as separate functions.
- Regulatory and R&D as enablers of innovation
- Where AI changes the work
- Working across regulatory, R&D and digital
9:45 AM
The future of regulatory excellence
Presentation · use cases & demos
Suren Dheenadayalan, Freyr Solutions
A vision for a unified operating model that links domain expertise, digital tools and enterprise data – brought to life with use cases and demos.
- A unified regulatory operating model
- Expertise, digital tools and enterprise data
- Use cases and live demos
11:00 AM
Delivering enterprise regulatory intelligence at scale
Demo
Wajeed Abdul, Freyr Solutions
An end-to-end scenario showing how platforms and AI agents turn fragmented regulatory data into proactive decisions.
- From fragmented data to proactive decisions
- Platforms and AI agents working together
- An end-to-end scenario
12:00 PM
Driving regulatory excellence
Panel discussion
Boris Reznichenko (Otsuka), Ryan McNeely (Gilead Sciences), Lauren Orme (West Pharmaceutical Services), Andres Del Rio (LIPTON Teas and Infusions) · moderated by Sudhir Kandarth
Industry leaders on workforce, operating models, technology adoption, readiness and leadership priorities.
- Workforce and capability
- Technology adoption and readiness
- Leadership priorities
2:00 PM
Rethinking regulatory information management
Entretien informel
Bruno Della Vecchia (Kenvue) · moderated by Sameer Siddiqui
How organizations are changing the role of RIM to drive agility and cross-functional collaboration.
- The changing role of RIM
- Agility across functions
- Collaboration interfonctionnelle
2:30 PM
Agentifying post-approval change management
Demo
Wajeed Abdul, Freyr Solutions
Agentic AI automating planning, impact assessment, orchestration and execution across the post-approval change lifecycle.
- Planning and impact assessment
- Orchestration and execution
- The full post-approval change lifecycle
3:30 PM
Reimagining the regulatory operating model
Panel discussion
Jack Cohen (Takeda), Andrew Robertson (Denali Therapeutics), Sathya K (Freyr Solutions) · moderated by Abhishek Rajan Desai
How the operating model is evolving across organizational design, talent, governance, data strategy and AI.
- Organizational design and talent
- Governance and data strategy
- The role of AI
4:15 PM
Wrap-up & closing remarks
Closing
Sudhir Kandarth, Freyr Solutions
A reflection on the key themes of the day and the calls to action leaders took back to their organizations.
- Key themes of the day
- Calls to action