Editor’s preview: GetReal Institute Annual Conference 2025

The GetReal Institute returns to Utrecht this October for its third Annual Conference. Under the theme “Real-World Evidence with Real-World Confidence: Shaping the Future of Healthcare,” the event will bring together global leaders from industry, academia, regulators, health technology assessment (HTA) bodies, and patient organizations. The program will tackle some of the most pressing questions around the use of real-world evidence (RWE) in regulatory and HTA decision-making – from data standards and methodological advances to pricing models and patient-centered approaches. Below, I preview the sessions across the two days.

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Day one – Building confidence in real-world evidence

Day one of the conference will open with a keynote, “EMA-led RWE generation – Value across the full lifecycle spectrum.” Speaking for the second year running, Patrice Verpillat (European Medicines Agency [EMA]) will set the stage by examining how RWE can generate value across the product lifecycle. Having heard him speak on several occasions, it will be interesting to gain the latest perspective on how the EMA views the potential for RWE to become a core element of regulatory science.

The first session, “Revolutionising RWD standards across the product lifecycle,” will explore how RWE can add value across the lifecycle, with perspectives from patients, HTA bodies and industry. Mariam Bibi (GetReal Institute) will moderate a panel including Carlos Martín Saborido (Instituto de Salud Carlos III), Iain Armstrong (Pulmonary Hypertension Association [PHA] UK), Neil Grubert (Independent Consultant) and Leo Russo (Pfizer), who holds the position of life sciences seat on the GetReal Institute board. Together, they will explore both the opportunities and barriers to embedding RWE in decision-making, and the drivers that may shape uptake in the years to come.

Attention will then turn to “Rethinking evidence generation in interventional studies – from trials to treatment decisions.” Co-moderated by Mira Zuidgeest (University Medical Center Utrecht [UMCU] and Executive Board Chair, GetReal Institute) and Iain Armstrong, the session will feature Sascha van Boemmel-Wegmann (Flatiron Health), Tim Williams (Clinical Practice Research Datalink [CPRD]) and Katrien Oude Rengerink (CBG-MEB). The panel will ask how RWD can enrich trial design and treatment decisions, while addressing challenges of methodology, data quality and regulatory acceptance.

This will be followed by “Designing stronger RWE studies to meet evidence thresholds,” where Anke van Engen (IQVIA), Martin Russek (BfArM) and newly appointed board member, Susan Oliveria (Thermo Fisher Scientific), will present methods-focused perspectives. By showcasing frameworks for external control studies and the growing role of target trial emulation, this session will highlight how methodological innovation can help RWE meet the evidence thresholds required by regulators and HTA bodies. These methods are increasingly visible in the RWE discussion, and it will be interesting to see how these approaches are positioned for broader regulatory and HTA use.

In the afternoon, “Submitting RWE to regulators, HTAs, and payers” will provide a simulated submission exercise. Carole Longson (Independent Adviser, HTA & Market Access), Sahar Barjesteh van Waalwijk van Doorn-Khosrovani (Leiden University Medical Center/CieBAG), Peter Mol (University Medical Center Groningen [UMCG]) and Leo Russo will demonstrate how regulators, HTA bodies and payers may apply differing expectations when evaluating the same RWE package. Moderated by Christine Leopold (Utrecht University), this is one of the sessions I’m most looking forward to, due to its interactive format and as it directly illustrates the real-world challenges of aligning evidence to meet varied decision-maker requirements.

Next, “The future of RWE-based HTA, pricing & reimbursement models” will see Steve Williamson (National Institute for Health and Care Excellence [NICE]) and Tarang Sharma (World Health Organization [WHO]) consider the role of RWE in managed entry agreements. Moderated by Christine Leopold, who holds the academic seat of the GetReal Institute board, the discussion will examine how frameworks can balance innovation with sustainability.

Day one will close with “Next-generation RWE strategies for regulatory decision-making,” where Catherine Cohet (EMA), Peter Mol (UMCG), Daniala Weir (Utrecht University), Lourens Bloem (Utrecht University) and Melinda Hanisch (Merck Sharp & Dohme) will look to the future. Drawing on experiences from DARWIN EU, Target-EU and EHDS, the speakers will consider how next-generation strategies could support regulatory decision-making and treatment optimization in Europe.

Day two – Innovation, patient focus and evidence quality

The second day of the conference will open with “AI & RWE – innovation meets evidence across the lifecycle,” as Melissa Estevez (Flatiron Health), Calum Yacoubian (IQVIA), Ashwin Kumar Rai (Thermo Fisher Scientific) and Jan-Willem Versteeg (Utrecht University), moderated by Stephen Duffield (NICE), explore how AI is transforming RWE. With practical demonstrations and expert insights, this session will highlight how advanced analytics can enhance evidence generation and inform healthcare decision-making.

Building on this, “Enhancing patient-centric RWE & digital health integration” will bring together Kevin Marsh (Thermo Fisher Scientific), Bettina Ryll (Melanoma Patient Network Europe), Ian Bonzani (IQVIA), Iain Armstrong and Mariam Bibi. The session will highlight how patient preferences, patient-reported outcomes (PROs) and digital health tools can be integrated into RWE generation.

The focus will then shift to “From RWD to decision-grade RWE,” where Catherine Cohet (EMA), Martin Russek, Susan Oliveria and Leo Russo will address what it takes for RWD to be considered decision-grade. Moderated by Russo, the session will examine EU and international guidance, transparency, reproducibility and methodological challenges – all topics we have covered extensively on The Evidence Base. It will be interesting to see learn how these issues are progressing as well as the latest thinking that may shape expectations for future RWE studies.

The conference will close with “Multi-stakeholder ‘hot seat’ debate – strengthening RWE acceptability.” Moderated by Charlie Nicholls (Sanofi), this final session will feature Pamela Dobay (Biogen), Finlay MacDougal (IQVIA), Frauke Naumann-Winter (BfArM) and Peter Mol. Together, they will debate the good, the bad and the ugly of RWE – covering data quality, transparency, submission thresholds and the role of RWE in joint clinical assessments. This is sure to spark a lively discussion amongst both the panellists and audience and should provide a fitting conclusion to the conference.

Meet The Evidence Base at the GetReal Institute 2025 Annual Conference

As media partner for the conference, The Evidence Base will provide comprehensive coverage of the two days, including session highlights as well as deep dives of the discussions. Follow The Evidence Base on LinkedIn for live updates throughout the meeting. For exclusive post-event insights, register on our site to receive regular updates.