## [FreyrONE USA 2026 - Princeton NJ](/index%2Ephp/freyr-events/freyrone-usa-2026-princeton-nj)     Event concluded   October 22, 2026   [Hyatt Regency, Princeton, NJ](https://maps.app.goo.gl/ugHFhcXE6XoXM9zM7) # 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 →](#notify) [See what happened ↓](#missed) - 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 Fireside chat 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 - Cross-functional collaboration - 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 Moments from Princeton ## Inside the room ‹ › - ![Before the opening session]() Before the opening session Before the opening session - ![The main stage]() The main stage The main stage - ![Opening the day]() Opening the day Opening the day - ![Keynote – Regulatory context ecosystem]() Keynote – Regulatory context ecosystem Keynote – Regulatory context ecosystem - ![A full room in Princeton]() A full room in Princeton A full room in Princeton - ![Shaping what comes next]() Shaping what comes next Shaping what comes next - ![Building an AI-native operating model]() Building an AI-native operating model Building an AI-native operating model - ![On stage at Freyr ONE]() On stage at Freyr ONE On stage at Freyr ONE - ![freya.intelligence – global regulatory intelligence]() freya.intelligence – global regulatory intelligence freya.intelligence – global regulatory intelligence - ![From coordinated response to competitive advantage]() From coordinated response to competitive advantage From coordinated response to competitive advantage - ![Live demo – freya.GRR]() Live demo – freya.GRR Live demo – freya.GRR - ![Engaging the room]() Engaging the room Engaging the room - ![Delivering enterprise regulatory intelligence at scale]() Delivering enterprise regulatory intelligence at scale Delivering enterprise regulatory intelligence at scale - ![Wajeed Abdul, Freyr Solutions]() Wajeed Abdul, Freyr Solutions Wajeed Abdul, Freyr Solutions - ![Panel – Driving regulatory excellence]() Panel – Driving regulatory excellence Panel – Driving regulatory excellence - ![A question from the floor]() A question from the floor A question from the floor - ![Panelists in conversation]() Panelists in conversation Panelists in conversation - ![Speakers and panelists]() Speakers and panelists Speakers and panelists - ![Conversations that carried on]() Conversations that carried on Conversations that carried on - ![Delegates between sessions]() Delegates between sessions Delegates between sessions - ![Fireside chat – Rethinking regulatory information management]() Fireside chat – Rethinking regulatory information management Fireside chat – Rethinking regulatory information management - ![Deep in the discussion]() Deep in the discussion Deep in the discussion - ![Panel – Where is your function on its AI adoption journey?]() Panel – Where is your function on its AI adoption journey? Panel – Where is your function on its AI adoption journey? - ![The Freyr ONE community]() The Freyr ONE community The Freyr ONE community - ![The Freyr ONE team]() The Freyr ONE team The Freyr ONE team Speakers ## Thank you to the leaders who helped shape what comes next in regulatory ![Chris Lee]()   Chris Lee VP, Regulatory Affairs Innovation and Strategic Operations Gilead Sciences ![Jack Cohen]()   Jack Cohen Executive Director, Global Head, Regulatory Affairs Business Operations Takeda ![Lauren Orme]()   Lauren Orme Senior Director, Regulatory Affairs West Pharmaceutical Services ![Boris Reznichenko]()   Boris Reznichenko Senior Director, Head of Global Regulatory Operations and Clinical Transparency Otsuka Pharmaceutical ![Andres Del Rio]()   Andres Del Rio Global Director of Regulatory Affairs & Health Science LIPTON Teas and Infusions ![Ryan McNeely]()   Ryan McNeely Senior Director - Regulatory Affairs Human Capital Gilead Sciences ![Andrew Robertson]()   Andrew Robertson SVP and Head of Regulatory Affairs and Quality Denali Therapeutics ![Bruno Della Vecchia]()   Bruno Della Vecchia Global Regulatory Operations and Decision Intelligence Head Kenvue ![Suren Dheenadayalan]()   Suren Dheenadayalan Chief Executive Officer Freyr Solutions ![Sudhir Kandarth]()   Sudhir Kandarth Chief Revenue Officer Freyr Solutions ![Sathya K]()   Sathya K Chief Domain Officer Freyr Solutions ![Wajeed Abdul]()   Wajeed Abdul Vice President, Strategy & Growth Freyr Solutions ![Abhishek Desai]()   Abhishek Rajan Desai VP, Strategy & Partnerships Freyr Solutions ![Sameer Siddiqui]()   Mohammad Sameer Siddiqui Assistant Vice President Freyr Solutions ## Missed it? Start here - [Get the session highlights Key takeaways from all nine sessions → ](#notify) - [ Book a private briefing See the demos from the day with a Freyr expert → ](mailto:freyr-one@freyrsolutions.com?subject=FreyrONE%20follow-up%20briefing) - Nominate a colleague Put a peer on the list for the next edition → - [ Follow Freyr ONE updates Photos, recaps and next-edition news on LinkedIn ↗ ](https://www.linkedin.com/company/freyrsolutions)   Don't miss the next one ## Be the first to hear what's next. Join the Freyr ONE waitlist and we'll let you know as soon as the next event is announced. × Who should be in the room next time? Know a regulatory, R&D or technology leader who'd add to the conversation? We'll make sure they hear about the next edition first. Their full name Their business email Nominate Thank you – they're on the list for the next edition. 1 / 1 × ‹ ![]()   ›