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Accelerating Regulatory Excellence
Where domain expertise, digital innovation and data intelligence converge
AI is moving into Regulatory and the next challenge is making it work across the enterprise.
Join senior leaders across Regulatory, R&D and Technology for one focused day exploring how Regulatory Intelligence, connected data, AI and intelligent agents are changing regulatory operations.
Reserve your spot
Your information will only be used to manage your registration and event-related communications.
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 Pharma
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
Suren Dheenadayalan
Chief Executive Officer
Freyr
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
Event overview
A day away from the office
must be worth it
Regulatory teams are moving from AI pilots and disconnected technology initiatives toward enterprise-scale execution.
That raises bigger questions.
Accelerating Regulatory Excellence brings a select group of senior leaders together to explore those questions through executive conversations, customer perspectives and practical demonstrations.
Walk away with new perspectives, practical examples, and ideas to take back to your organization.
01
How should AI be applied?
Where AI creates measurable regulatory value today, and where it is still a pilot looking for a problem.
02
What does enterprise Regulatory Intelligence look like?
Moving from monitoring and reports to intelligence that reaches requirements, submissions and decisions at scale.
03
Where do intelligent agents fit?
Which regulatory workflows agents can carry end-to-end, and what oversight the work still requires.
04
What needs to change across data, technology, governance and operating models?
The structural work behind the technology: connected data, clear governance and a model the teams can actually run.
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.
01
Compare regulatory transformation approaches with your peers
02
See AI, Regulatory Intelligence and agentic workflows in action
03
Connect RIM, Regulatory Intelligence, data and AI end to end
04
Explore your priorities with Regulatory and Technology experts
05
Exchange perspectives with leaders facing similar challenges
06
Take back practical ideas for your own transformation
Agenda · 09:00 AM → 05:30 PM EST
A single-track program designed so each discussion builds on the one before it
09:00 – 09:15 AM
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.
Sudhir Kandarth Chief Revenue Officer
Freyr Solutions
Freyr Solutions
09:15 – 09:45 AM
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.
Chris Lee VP, Regulatory Affairs Innovation and Strategic Operations
Gilead Sciences
Gilead Sciences
09:45 – 10:45 AM
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.
Suren Dheenadayalan Chief Executive Officer
Freyr Solutions
Freyr Solutions
10:45 – 11:00 AM
Conversations over coffee Networking and innovation zone
11:00 AM – 12:00 PM
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.
Wajeed Abdul Vice President, Strategy & Growth
Freyr Solutions
Freyr Solutions
12:00 – 01:00 PM
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.
- Boris Reznichenko Senior Director, Head of Global Regulatory Operations and Clinical Transparency
Otsuka Pharmaceutical - Ryan McNeely Senior Director - Regulatory Affairs Human Capital
Gilead Sciences - Lauren Orme Senior Director, Regulatory Affairs
West Pharma - Andres Del Rio Global Director of Regulatory Affairs & Health Science
LIPTON Teas and Infusions - Moderator: Sudhir Kandarth Chief Revenue Officer
Freyr Solutions
01:00 – 02:00 PM
Lunch & networking Interactive experience zones showcasing Freyr offerings and capabilities
02:00 – 02:30 PM
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.
- Coming Soon Expert from leading biopharma organization
- Moderator: Sameer Siddiqui AVP, FDL FreyaFusion
Freyr Solutions
02:30 – 03:00 PM
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.
Harshith Subramanian Senior Manager
Freyr Solutions
Freyr Solutions
03:00 – 03:30 PM
Conversations over coffee Networking and innovation zone
03:30 – 04:15 PM
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.
- Jack Cohen Executive Director and Global Head of Regulatory Business Operations
Takeda - Andrew Robertson SVP and Head of Regulatory Affairs and Quality
Denali Therapeutics - Sathya K Chief Domain Officer
Freyr Solutions - Moderator: Abhishek Rajan Desai VP, Strategy & Partnerships
Freyr Solutions
04:15 – 04:30 PM
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.
Suren Dheenadayalan Chief Executive Officer
Freyr Solutions
Freyr Solutions
FAQs
Who should attend?
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Senior leaders across Regulatory Affairs, Regulatory Operations, Regulatory Intelligence, R&D, RIM, Technology, Data & AI and regulatory transformation.
Is there a fee to attend?
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No. attendance is complimentary. The event is invite-only, and places are limited.
How long is the event?
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The core program runs from 09:00 AM – 04:30 PM ET, followed by networking and cocktails from 04:30 PM – 05:30 PM ET.
What is the format?
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A single-track executive program combining industry perspectives, customer conversations, practical demonstrations, innovation zones and networking.
Where is the event being held?
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The event will take place at Hyatt Regency Princeton, Princeton, New Jersey. Full arrival details will be shared with confirmed attendees. Get directions →
Can I refer someone else?
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Yes. Use Refer a Peer to nominate someone whose perspective would add value to the conversation. Attendance will be subject to confirmation.
Resources
Take the next step
Who else should be in the room?
Know a regulatory, r&d, or technology leader whose perspective would add to the conversation? Refer them to us.
All referrals are subject to attendance confirmation.
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Your next Regulatory advantage starts with one conversation.
Invite-only and complimentary to attend. To keep the discussions focused and peer-led, attendance is limited.
Submit your details and we'll confirm your place by email.
Reserve your spot
Your information will only be used to manage your registration and event-related communications.