I can’t believe another year has already gone by! It feels like only yesterday that we were preparing for PHUSE EU Connect 2025, and now, in just a couple weeks, the PHUSE community will come together again, this time in Glasgow, for PHUSE EU Connect 2026.

Last year was particularly special for me, as I had the great honor of supporting Jennie McGuirk and Jinesh Patel as Conference Co-Chair. This year, the journey continues: Jinesh will take the lead as the Conference Chair, with Diana Stuart joining as the new Co-Chair, while I continue to support the conference team and look forward to taking on the Chair role next year.

Glasgow promises another packed program: approximately 190 presentations, 32 posters, 8 hands-on workshops, 1 panel discussion, 4 interactive discussions, and 2 keynote speakers. Across 8 parallel streams, there is plenty to explore, from the practical application of AI to the evolving expectations for clinical data and regulatory submissions.

Once again, Cytel will make a significant contribution, with 1 workshop, 3 presentations, and 1 poster. We will also help co-chair the “Machine Learning, AI & Large Language Models” (Sebastià Barceló) and “People Leadership & Management” (Kath Wright) streams.

“Accelerating Regulatory Responses Through a Harmonized Clinical Data Warehouse”

The Cytel week kicks off on Monday with my colleagues Magalie Gallet and Silvia Faini, who will present “Accelerating Regulatory Responses Through a Harmonized Clinical Data Warehouse” in the “Data Handling & Data Engineering” stream at 3:00 pm. Their session explores how to bring together data from interventional and non-interventional studies in a flexible, CDISC-aligned warehouse. They will share practical lessons on harmonizing SDTM content, preserving traceability, and generating ADaM datasets to support pooled analyses, safety questions, and regulatory responses, even as new, heterogeneous studies are added.

“Token-Efficient Clinical Programming Through Hybrid Agentic AI and Rule-Based Systems”

“Token-Efficient Clinical Programming Through Hybrid Agentic AI and Rule-Based Systems” is the title of the Hands-on Workshop that Nicolas Rouillé and Manuel Cossio will conduct on Tuesday at 1:30 pm. Their interactive session will examine where AI is already creating value, with particular attention to agentic statistical programming, practical implementation and the economics of AI “inference.” As organizations scale their use of AI, token efficiency is becoming an important part of the conversation, not just what AI can do, but how to make it sustainable and cost-effective.

“Keeping ADaM Stable When the Registry Is Not: Programming Lessons from Long-Term European RWE”

Just after the end of Nicolas and Manuel workshop, there will be just enough time to change rooms for the 3:00 pm session, in the “Real-World Evidence” stream. My FSP colleague Rasal Abdulsalam will present “Keeping ADaM Stable When the Registry Is Not: Programming Lessons from Long-Term European RWE.” Drawing on two European registry studies with up to 15 years of follow-up, the presentation addresses a challenge familiar to many programmers: how to produce consistent, analysis-ready ADaM datasets when upstream registry data, identifiers, and mappings keep changing. Expect practical solutions for managing partially OMOP-mapped data and maintaining stability throughout a long study lifecycle.

“Unexpected Retrospective CBER Requests: Lessons Learned Across Three Years of Vaccine Submissions”

Later, in the traditional Tuesday evening poster session, please stop by for a discussion of “Unexpected Retrospective CBER Requests: Lessons Learned Across Three Years of Vaccine Submissions,” a poster I co-authored with my colleague Mark Malayas. We will share what retrospective requests from FDA CBER can mean in practice for vaccine submission teams, including the downstream effects on SDTM, ADaM, tables, figures, and listings, and the importance of anticipating additional analyses and possible resubmission activities. I would be especially interested to hear whether others have had similar experiences.

And there is more to Tuesday evening than posters! At 7:00pm, you are all invited to Cytel’s event at the Glasgow Science Centre Planetarium. The evening will include planetarium shows at 8:00 and 9:00 pm, access to the Science Centre, and food and drinks. It is just a short walk across the bridge from the main venue. The event is open to PHUSE EU Connect attendees, but pre-registration is required; the registration link will follow.

“Transition from a Culture of Compliance to One of Psychological Ownership”

On Wednesday at 12:00, another FSP colleague, Bidyot Sharma, will present “Transition from a Culture of Compliance to One of Psychological Ownership” in the “People Leadership & Management” stream. His talk considers how leaders can move beyond a mindset focused only on following SOPs and avoiding mistakes, while retaining the rigor that regulated work requires. He will discuss practical ways to encourage autonomy, transparency, psychological safety, and a stronger sense of personal accountability for outcomes.

Stop by the Cytel Booth!

Cytel will be at Booth #8! Please come and meet our Client Development colleagues, catch up with our presenters, or simply stop by for a conversation about the challenges and opportunities facing our industry.

And do stay until the end! I will have the pleasure of closing the conference and introducing PHUSE EU Connect 2027, including revealing its location (and the new conference co-chair). That remains a secret for now, so join us on Wednesday at 3:30 pm to find out.

I hope I have not missed anyone, or anything! Above all, I look forward to reconnecting with colleagues and friends from around the world, meeting new people and sharing ideas over another memorable PHUSE week.

See you all in Glasgow!

Share Via