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Join DS2 at the DIA Real-World Evidence Conference 2026

DS2 will be in North Bethesda on October 19 and 20, in the sessions across both days and meeting customers and partners around them. Put a time in with us.

October 19–20, 2026Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852, USA
We'll be there

Let's Connect in North Bethesda

DIA convenes global regulators, industry leaders, data scientists and policy experts for this one, with the FDA, the EMA, the MHRA and the PMDA all on the programme alongside epidemiology and evidence generation leads from IQVIA, Astellas, AstraZeneca, Pfizer, Amgen, GSK and Harvard. Real-world evidence depends on data that can be traced back to how it was collected, and we provide industry-leading solutions across the entire connected sample supply chain. Where a study needs a specimen rather than a claim, the same standards apply. Collection kits that participants can use at home, mobile phlebotomy that keeps people enrolled, courier and cold chain with the record intact, and LIS, LIMS and EMR integration including HL7 and FHIR so the result arrives structured. We'd love to talk about how that sits alongside the data you already hold.

We often find during these events that the diary fills up quickly. Use the form and we'll block a time for you to meet our team while availability lasts.

Why Attend the DIA Real-World Evidence Conference?

October 19–20, 2026Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852, USA

DIA frames the conference under "Translating Insights into Real-World Value," opening with the observation that real-world evidence "is no longer confined to post-market safety. It is reshaping the entire product lifecycle, from early development through regulatory decision-making and reimbursement."

1

Ten sessions, two case studies: The programme runs as a single stream of ten numbered sessions plus two sponsor case studies, covering a global regulatory update, building regulator-ready RWE, scalable real-world data infrastructure and standards, external controls and digital twins, the economics and return on investment of RWD and RWE, a ten-year retrospective since the 21st Century Cures Act, open regulatory intelligence, HTA and market access, AI governance for RWE, and the future outlook.

2

Who's in the room: DIA publishes the audience as academia, advocacy and service providers, biopharma and medical device industry, clinical research, data analytics, epidemiology, health authorities, health economics and outcomes research, payers, pharmacovigilance, policy, real-world evidence and data, regulatory science and technology development.

3

One room, one conversation: A single stream means everyone is in the same room for the same conversation, which makes the breaks a straightforward place to pick up a thread from a session.

Why Meet with DS2?

Real-world evidence is only as good as its provenance, and that argument applies as much to a specimen as it does to a claims record. Where a study collects samples outside a traditional site, the collection method, the transport conditions and the route back into the data environment all become part of the evidence. DS2 builds and runs that layer, including at-home collection and the integration that puts a structured result where your analysts can use it. What we do:

  • Diagnostic and specimen collection kit design, assembly and fulfillment
  • Kit-to-patient and direct-to-patient distribution
  • Medical courier services, including STAT and next-flight-out specimen transport
  • Cold chain and temperature-controlled logistics, with the documentation to prove the range held
  • Biostorage and biorepository services
  • Mobile phlebotomy and specimen collection
  • LIS, LIMS and EMR integration, including HL7 and FHIR
  • Chain of custody and compliance documentation

Direct-to-patient kits, mobile phlebotomy, courier and cold chain, biostorage, and LIS, LIMS and EMR integration including HL7 and FHIR. We're excited to talk it through in North Bethesda.

Speaking Faculty

A selection from the 35 speakers published for 2026.

Alison Cave

MHRA, United Kingdom

Chief Safety Officer

Patrice Verpillat

European Medicines Agency

Head of Real World Evidence

Marie Bradley

Office of Medical Policy, CDER, FDA

Senior Advisor, Real-World Evidence

Motiur Rahman

OMP, CDER, FDA

Senior Epidemiologist and Policy Advisor, Real World Evidence Analytics

Masanao Sasaki

Pharmaceuticals and Medical Devices Agency, Japan

Biostatistics Reviewer

Jaclyn Bosco

IQVIA

Vice President and General Manager, Global Head of Epidemiology and Scientific Strategy

Khaled Sarsour

Astellas

Vice President and Global Head, Evidence Generation and Advanced Analytics

Donna Rivera

Canal Row Advisors

Executive Vice President, Clinical Evidence Modernization

Alicia Gilsenan

RTI Health Solutions

Vice President, Epidemiology

Sebastian Schneeweiss

Harvard Medical School and Brigham and Women's Hospital

Professor of Medicine and Epidemiology and Chief, Division of Pharmacoepidemiology

Nancy A Dreyer

Dreyer Strategies

Founder

Shirley Wang

Harvard Medical School

Associate Professor of Medicine

The full speaker list is on the official speakers page.

The Agenda, Day by Day

Times below are as published by DIA. A virtual pre-conference course was listed for October 13 and is still priced on the register page, although its detail page now carries a cancellation notice. Check with DIA before booking it. The full agenda is on the official agenda page.

Day One · Monday, October 19, 2026
07:30–08:30

Networking breakfast, with registration open from 07:30

08:30–08:45

Welcome and opening remarks

08:45–10:00

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

Chairs: Motiur Rahman and Namangolwa Jane Mutanga, FDA. Speakers: Masanao Sasaki, PMDA; Patrice Verpillat, EMA; Alison Cave, MHRA

10:10–10:40

Case study hosted by Truveta: From Two Trials to One

10:45–12:00

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

Chair: Hetal Pansuria, Pacira Biosciences. Speakers from AstraZeneca, Plinth Analytics, Droice Labs and CDER FDA

12:00–13:00

Networking luncheon

13:00–14:15

Session 3: Design Scalable RWD Infrastructure, Integrating Multimodal Data and Standards

Chair: Alicia Gilsenan, RTI Health Solutions. Speakers from IQVIA, Amgen and Datavant

14:20–15:35

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

Chair: Gillis Carrigan, Amgen. Speakers from Datavant, Friends of Cancer Research and Unlearn.AI

15:40–16:10

Case study hosted by Verily Health

16:10–17:25

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

Chair: Simon Dagenais, Pfizer. Speaker: Shelby Corman, Precision AQ

17:25–18:30

Networking reception

Day Two · Tuesday, October 20, 2026
07:45–08:30

Networking breakfast, with registration open from 07:45

08:30–09:15

Opening remarks and Session 6: A Ten-Year Retrospective on RWE Since the 21st Century Cures Act

Simon Dagenais, Asset Lead, Medical Evidence Development, Pfizer

09:15–10:30

Session 7: Open Regulatory Intelligence, Strategies, Data, Tools, Insights and Best Practices

Rachele Hendricks-Sturrup, Duke-Margolis Institute for Health Policy; Donna Rivera, Canal Row Advisors; John Diaz-Decaro, Black Swan Causal Labs; Shirley Wang, Harvard Medical School

10:30–11:15

Refreshment and networking break

11:15–12:30

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

Chair: Xiang Zhang, CSL Behring. Speakers from Eli Lilly, UMC Utrecht and the Hainan Boao Lecheng Real-World Data Research Institute

12:30–13:45

Networking luncheon

13:45–15:00

Session 9: Trust, but Verify, Governing AI-Enabled Real-World Evidence

Chairs: Lina Titievsky, GlaxoSmithKline; Matthew Curtis, AstraZeneca. Speakers from Black Swan Causal Labs, Johnson & Johnson Innovative Medicine and IQVIA

15:00–16:15

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

Chair: Jaclyn Bosco, IQVIA. Speakers: Nancy A Dreyer; Sebastian Schneeweiss, Harvard Medical School; Khaled Sarsour, Astellas; Marie Bradley, CDER, FDA

16:10–16:30

Closing remarks

16:30

Conference adjourns

DIA Real-World Evidence Conference FAQ

General

Fees & registration

Venue & travel

See You in North Bethesda

North Bethesda, October 19 and 20. Send a line on where your evidence comes from and we'll set aside time to talk about the collection side of it.