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.
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?
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."
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.
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.
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
Networking breakfast, with registration open from 07:30
Welcome and opening remarks
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
Case study hosted by Truveta: From Two Trials to One
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
Networking luncheon
Session 3: Design Scalable RWD Infrastructure, Integrating Multimodal Data and Standards
Chair: Alicia Gilsenan, RTI Health Solutions. Speakers from IQVIA, Amgen and Datavant
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
Case study hosted by Verily Health
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
Networking reception
Day Two · Tuesday, October 20, 2026
Networking breakfast, with registration open from 07:45
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
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
Refreshment and networking break
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
Networking luncheon
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
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
Closing remarks
Conference adjourns
Useful DIA Real-World Evidence Conference Resources
The official event page.
AgendaThe full two-day programme.
SpeakersThe published faculty.
RegisterRates, windows and group terms.
Hotel InformationThe Bethesda North Marriott block.
ExhibitsExhibit and marketing opportunities.
Terms and ConditionsCancellation and transfer policy.
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.

