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Thank you for joining us at FreyrONE USA 2026
Accelerating Regulatory Excellence
On 22 October, senior leaders from across Regulatory, R&D and Technology came together in Princeton for a day of practical conversations on the future of regulatory. Speakers from companies including Gilead Sciences, Kenvue, Takeda and Otsuka shared how regulatory intelligence, connected data, AI and intelligent agents are changing regulatory operations.
Thank you to everyone who joined us, to our speakers for their openness, and to our team for making the day happen.
Speakers
The people shaping the conversation
Chris Lee
VP, Regulatory Affairs Innovation and Strategic Operations
Gilead Sciences
Jack Cohen
Executive Director, Global Head, Regulatory Affairs Business Operations
Takeda
Lauren Orme
Senior Director, Regulatory Affairs
West Pharmaceutical Services
Boris Reznichenko
Senior Director, Head of Global Regulatory Operations and Clinical Transparency
Otsuka Pharmaceutical
Andres Del Rio
Global Director of Regulatory Affairs & Health Science
LIPTON Teas and Infusions
Ryan McNeely
Senior Director - Regulatory Affairs Human Capital
Gilead Sciences
Andrew Robertson
SVP and Head of Regulatory Affairs and Quality
Denali Therapeutics
Bruno Della Vecchia
Global Regulatory Operations and Decision Intelligence Head
Kenvue
Suren Dheenadayalan
Chief Executive Officer
Freyr Solutions
Sudhir Kandarth
Chief Revenue Officer
Freyr Solutions
Sathya K
Chief Domain Officer
Freyr Solutions
Wajeed Abdul
Vice President, Strategy & Growth
Freyr Solutions
Abhishek Rajan Desai
VP, Strategy & Partnerships
Freyr Solutions
Mohammad Sameer Siddiqui
Assistant Vice President
Freyr Solutions
What we explored
- 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
By the numbers
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[XX] speakers and panelists
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[XX] sessions
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[XX] Innovation Zone demos
What to Expect
A day designed to be worth your time
Join an invite-only group of approximately 100 senior leaders across Regulatory, R&D, Technology, Data and AI to explore what the next phase of Regulatory could look like.
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Compare regulatory transformation approaches with your peers
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See AI, Regulatory Intelligence and agentic workflows in action
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Connect RIM, Regulatory Intelligence, data and AI end to end
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Explore your priorities with Regulatory and Technology experts
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Exchange perspectives with leaders facing similar challenges
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Take back practical ideas for your own transformation
A single-track program designed so each discussion builds on the one before it
Welcome note – Setting the stage for the future of regulatory excellence Regulatory organizations are facing unprecedented pressure to accelerate innovation, navigate increasing complexity, and extract greater value from data. This opening address will explore why incremental improvements are no longer enough and why regulatory transformation has become a strategic business imperative.
Keynote - The regulatory imperative: R&D, Regulatory & AI 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 will explore how regulatory, R&D, and digital functions can work together to accelerate development, improve decision-making, and deliver better business outcomes.
Presentation - The future of regulatory excellence What does the next-generation regulatory enterprise look like? This session will present a vision for connecting domain expertise, digital capabilities, and enterprise data into a unified operating model. Through real-world use cases, platform demonstrations, and customer perspectives, attendees will see how AI, intelligence, and connected workflows can help organizations improve productivity, compliance, and business agility.
Demo: Delivering enterprise regulatory intelligence at scale Regulatory organizations generate enormous amounts of data, but turning that data into actionable intelligence remains a significant challenge. This session will showcase how modern intelligence platforms, analytics, and AI agents can transform fragmented information into meaningful business insights. Through an end-to-end scenario, attendees will see how organizations can move from reporting historical activity to driving proactive decisions and strategic actions.
Panel Discussion: Driving regulatory excellence Regulatory leaders from across industries will discuss the challenges shaping today's operating environments and the lessons they are carrying into the future. Topics will include workforce evolution, operating models, technology adoption, organizational readiness, and leadership priorities. The session will provide insights into what is working today, what organizations continue to struggle with, and how leading companies are preparing for the future.
Fireside Chat - Rethinking Regulatory Information Management This session will examine how leading organizations are rethinking the role of RIM to support greater agility, intelligence, and cross-functional collaboration. The discussion will cover emerging business needs, adoption challenges, and the capabilities required to unlock greater value from regulatory information investments.
Demo - Agentifying post-approval change management Post-Approval Change Management remains one of the most complex and resource-intensive regulatory processes. This session will demonstrate how agentic AI can automate planning, impact assessments, workflow orchestration, and execution across the PACS lifecycle. Attendees will experience an end-to-end demonstration that illustrates how intelligent agents can augment regulatory teams, reduce manual effort, and accelerate decision-making.
Panel Discussion - Reimagining the regulatory operating model The future of regulatory organizations will not simply be defined by technology, but by how people, processes, data, and AI work together. Industry leaders will discuss how operating models must evolve to support greater speed, scalability, intelligence, and business alignment. Topics will include organizational design, talent transformation, governance, data strategy, and the role of AI in shaping the regulatory function of the future.
Wrap-up & closing remarks The next chapter begins here. The day concludes with a reflection on the themes, insights, and calls to action that emerged throughout the summit. Attendees will leave with a clearer understanding of where regulatory transformation is headed and how they can begin applying these ideas within their own organizations. The session will reinforce the key takeaways from FreyrOne and outline the journey ahead.
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