DIA’s 2026 Real-World Evidence Conference: Editor’s picks of the sessions to attend

With DIA’s 2026 Real-World Evidence Conference approaching, The Evidence Base Editor Laura Dormer shares the sessions she’ll be following in North Bethesda and the discussions she’ll be listening out for as she reports from the meeting.

Next week, I’ll be in North Bethesda for DIA’s 2026 Real-World Evidence Conference, reporting from the meeting as part of The Evidence Base’s media partnership with DIA. This will be my fourth time attending the conference, and it has been interesting to see how both the meeting and the discussions around RWE have developed over that time.

DIA, together with Jaclyn Bosco (IQVIA), Chair of the DIA Real-World Evidence Conference Program Committee, has curated a comprehensive agenda spanning the regulatory, methodological and practical issues shaping RWE today.

I’ll be reporting from North Bethesda throughout the meeting, sharing daily roundups of the discussions and key takeaways from the sessions. Below are some of my picks from the program and what I’ll be looking out for during each session.

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How are regulatory expectations for RWE changing globally?

Session 1: RWE Regulatory Update: Perspectives from Around the Globe

This is high on my list for Day 1. Motiur Rahman and Namangolwa Jane Mutanga (FDA) will be joined by Masanao Sasaki (Pharmaceuticals and Medical Devices Agency [PMDA]), Patrice Verpillat (European Medicines Agency [EMA]) and Alison Cave (Medicines and Healthcare products Regulatory Agency [MHRA]), bringing together perspectives from four major regulatory agencies. The discussion will cover fit-for-purpose data, study design, bias, outcome ascertainment and data standards, as well as the role of RWE within the totality of evidence.

What I’m particularly interested to hear: This is one of my highlights across the whole conference. There’s a lot of interest in seeing RWE used more widely in regulatory decision-making, so having the FDA, EMA, MHRA and PMDA represented in one session is a real draw. We’ve been following how regulatory approaches to RWE are evolving on The Evidence Base, most recently with the launch of the MHRA’s dedicated RWE Knowledge and Guidance Hub. I haven’t attended a panel with all four agencies represented before, and I’ll be listening for where their expectations align, where differences remain and what that means for evidence generation in practice.

What does regulator-ready RWE look like in practice?

Session 2: Navigate Building Credible, Regulator-Ready RWE: Path from Protocol to Submission

Chaired by Hetal Pansuria (Pacira Biosciences), this session gets into the practicalities of delivering RWE that can withstand regulatory scrutiny. Yun Lu (CBER, FDA) will discuss negative controls for generating robust RWE, while Nicole Turner (Plinth Analytics) will explore simulation-enabled statistical analysis plans and Mayur Saxena (Droice Labs) will look at operationalizing modern trial designs using RWD/E for regulatory submissions. Motiur Rahman (CDER, FDA) will then provide the regulator’s perspective, including where these approaches align with FDA expectations and what adjustments sponsors should consider.

What I’m particularly interested to hear: We talk a lot about making RWE “regulator-ready,” including in our recent conversation on The Evidence Base about building RWE that survives regulatory scrutiny. This session gets into what that actually requires as a study moves from protocol to submission. I’ll be interested in where studies most commonly run into problems, what can be addressed through better design and pre-specification, and when engagement with regulators can make the biggest difference.

Where are external controls heading?

Session 4: Innovative Approaches and Considerations for Use of External Controls in Drug Development

Moderated by Gillis Carrigan (Amgen), this session will examine the evolving role of external controls in drug development and regulatory decision-making. Ulka Campbell (Datavant) will look at principles for the design and data selection of externally controlled trials using RWD, while Bernat Navarro (Friends of Cancer Research) will share lessons from a multi-stakeholder pilot exploring external control arms for regulatory use. Daniele Bertolini (Unlearn.AI) will take the discussion into newer territory with the use of digital twins as synthetic controls for single-arm trials.

What I’m particularly interested to hear: External controls are an area we’ve been following closely, particularly as regulators consider where and how they can provide credible comparative evidence. We recently spoke with Bernat Navarro about the Friends of Cancer Research multi-stakeholder pilot exploring the use of external control arms for regulatory decision-making, so I’m particularly interested to hear the latest findings from that work.

Can we demonstrate the return on investment from RWE?

Session 5: The Economics of RWD and RWE: How to Estimate and Maximize Return on Investment

Simon Dagenais (Pfizer) chairs this timely interactive session, which takes a different perspective on RWE: how can organizations assess whether growing investment in data and evidence generation is delivering value? Shelby Corman (Precision AQ) will examine the economics of RWD and RWE from a biopharma consulting perspective, with Dagenais also contributing to a broader discussion of the costs associated with acquiring and analyzing RWD, conducting noninterventional studies and generating evidence for different use cases. The session will consider approaches for estimating ROI across different decision-making scenarios.

What I’m particularly interested to hear: This session feels particularly timely given our recent panel discussion exploring whether HEOR can demonstrate its own return on investment, which drew on case examples from the ROI of HEOR Working Group and considered how HEOR can better demonstrate its value as a strategic business partner. I’m interested to see how that conversation translates specifically to RWE, particularly how we measure its value when the benefits can extend across clinical development, regulatory decision-making and market access, but may not always be straightforward to quantify.

What makes RWE decision-ready for HTA?

Session 8: Translate RWD into Decision-Ready for HTA and Market Access

Xiang Zhang (CSL) will lead a discussion exploring what makes RWE useful for HTA, reimbursement and market access. Mingyang Shan (Eli Lilly and Company) will examine the use of real-world trial emulation to support market access and reimbursement, while Renske MT Ten Ham (UMC Utrecht) will consider what drives the acceptance and use of RWE under uncertainty in HTA. Wei Hong Yuan (Hainan Boao Lecheng Real-World Data Research Institute) will bring experience from China’s RWE pilots and their use in regulatory decision-making.

What I’m particularly interested to hear: This feels particularly timely given the implementation of the EU HTA Regulation and the questions we’ve been exploring around the evidence needed for Joint Clinical Assessment. I’ll be interested in what makes RWE genuinely decision-ready for HTA, what drives acceptance or leads evidence to be discounted, and whether evidence can realistically be planned from the outset to meet the needs of both regulators and HTA bodies.

How is AI changing RWE, and what needs to stay human-led?

Session 9: Trust, but Verify: Governing AI-Enabled Real-World Evidence from Regulation to Rapid Deployment

Bringing together perspectives on governance, regulatory credibility and practical implementation, this session will be led by Lina Titievsky (GSK) and Matthew Curtis (AstraZeneca). John Diaz-Decaro (Black Swan Causal Labs) will compare approaches to AI governance across regulatory, HTA and specialty bodies, Wei Liu (Johnson & Johnson Innovative Medicine) will consider how credibility can be established for AI-enabled RWE in regulatory decision-making, and Sneha Kishnani (IQVIA) will share practical experience of using off-the-shelf generative AI in RWE, including where human oversight remains essential.

What I’m particularly interested to hear: AI is increasingly positioned as a way to generate RWE faster and at greater scale, but speed and efficiency only take us so far if the resulting evidence cannot be trusted. I’ll be interested in where speakers draw the boundaries between tasks that can increasingly be handed to AI and those that still require human judgment, and what regulators and HTA bodies will need to see to have confidence in AI-enabled RWE.

And finally, where does RWE go next?

Session 10: Navigating RWE: Practical Data, Evidence, and Innovative Considerations for the Future

The meeting will close with a fireside chat led by Jaclyn Bosco (IQVIA), who will be joined by Nancy Dreyer (Dreyer Strategies), Sebastian Schneeweiss (Harvard Medical School), Khaled Sarsour (Astellas) and Marie Bradley (FDA). Drawing on perspectives from academia, industry and the FDA, the discussion will consider how RWE is evolving in regulatory decision-making, including its use as substantial and confirmatory evidence and in safety, alongside practical issues around data provenance, transparency, data access, submission constraints and inspection readiness. AI and its potential to scale RWE generation and causal inference will also feature in the discussion.

What I’m particularly interested to hear: After two days of discussions spanning regulation, methods, data, HTA, AI and evidence generation, I’ll be interested to hear which challenges this group believes still need to be resolved and where they think RWE is now genuinely making progress. Most of all, I’ll be listening for what they see as the next priorities if RWE is to play a greater role in regulatory decision-making.