Join DS2 at the DIA/FDA Oligonucleotide-Based Therapeutics Conference 2026
DS2 will be in Arlington from September 23 to 25, across the clinical, nonclinical and CMC tracks and meeting customers and partners around the sessions. Put a time in with us.
Let's Connect in Arlington
This conference is built jointly by DIA and the FDA, and the room reflects that. Reviewers and policy leads from CDER, CBER, the MHRA, the EMA, BfArM, the PMDA and the Dutch Medicines Evaluation Board sit alongside regulatory, CMC, nonclinical and clinical leaders from Alnylam, Ionis, Novartis, Eli Lilly, GSK, Sarepta, Stoke, Dyne, Denali and Avidity. Oligonucleotide programs depend on samples that are handled and documented well enough to survive that scrutiny, and we provide industry-leading solutions across the entire connected sample supply chain. Chain of custody that stands up in a filing, cold chain with the temperature record intact, kit design for PK and toxicology sampling, courier routes built around stability windows, biostorage and the integration that returns results into your systems. We're looking forward to talking through what your programme needs on the sample side as it moves toward submission.
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/FDA Oligonucleotide-Based Therapeutics Conference?
DIA describes the conference as convening "industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development," with a programme "developed collaboratively by regulators, industry professionals, and academics."
Coverage across the whole development arc: The published coverage runs across nonclinical, CMC and clinical areas, including emerging CMC guidances, learnings from recent regulatory filings, extra-hepatic and CNS delivery, toxicology testing, gene editing and safety assessments.
Three tracks, plus the general sessions: Three concurrent tracks run through the meeting, Clinical, Nonclinical and CMC, with general sessions for the keynote, the plausible mechanism pathway session, Hot Topics and a closing Grand Q&A panel that puts the audience directly in front of regulators and industry leaders.
The Oligonucleotide Safety Working Group: The DIA Oligonucleotide Safety Working Group also holds an open meeting on the afternoon of day two, which is a useful hour if safety assessment is your area.
Why Meet with DS2?
An oligonucleotide filing rests on data, and that data rests on samples that were collected, moved and stored in a way the agency can follow. Extra-hepatic and CNS programmes make that harder, with tighter stability windows and more complex sampling. DS2 builds and runs that layer, with the chain of custody and compliance documentation to show how every sample got where it went. 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
Kit design for PK and toxicology sampling, cold chain with the documentation to prove the range held, courier routes built around stability, biostorage and system integration. We're looking forward to talking it through in Arlington.
Speaking Faculty
A selection from the 85 speakers published for 2026.
Teresa Buracchio
FDA
Director, Office of Neuroscience
Emily Freilich
CDER, FDA
Director, Division of Neurology 1
Mahesh Ramanadham
OPQ, CDER, FDA
Deputy Director, Office of Policy for Pharmaceutical Quality
Robin Levis
OVRR, CBER, FDA
Deputy Director, Division of Viral Products
Julian Beach
MHRA, United Kingdom
Interim Executive Director, Healthcare Quality and Access
René Thürmer
BfArM, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology
Brian Dooley
European Medicines Agency
Pharmaceutical Quality Senior Specialist
Andrew Slugg
Alnylam Pharmaceuticals
Senior Vice President, Global Head of Regulatory Sciences
Lubomir Nechev
Alnylam Pharmaceuticals
Chief CMC Officer
Scott Henry
Ionis Pharmaceuticals
Senior Vice President, Nonclinical Development
Barry Ticho
Stoke Therapeutics
Chief Medical Officer
James Richardson
Sarepta Therapeutics
Chief Medical and Regulatory Officer
Klaus Romero
Critical Path Institute
Chief Executive Officer
Charles Thornton
University of Rochester Medical Center
Saunders Family Distinguished Professor in Neuromuscular Research
The full roster of 85 speakers is on the official speakers page.
The Agenda, Day by Day
Times below are as published by DIA. Three tracks run in parallel through much of the programme. The full session-by-session agenda, including every speaker, is on the official agenda page.
Day One · Wednesday, September 23, 2026
Networking breakfast
Welcome and opening remarks
Sorcha McCrohan, Senior Scientific Project Manager, DIA
Session 1: Keynote Address, on tissue and cell-type-specific RNA delivery
Chair: Jeffrey Foy, Nimbus Therapeutics. Speaker: Bryan Laffitte, Executive Director, Novartis
Case study sponsored by Agilent: Analytical Validation Approaches at Every Phase of Oligonucleotide Development
Mark Sanseverino, R&D Director, Agilent Advanced Therapeutics
Session 2, Track 1: The Brains Behind Delivery of Oligos to the CNS
Chairs: Barry Ticho, Stoke Therapeutics; Amy Kao, FDA. Speakers include Toby Ferguson, Alnylam Pharmaceuticals
Session 2, Track 2: Extrahepatic Delivery, Engineering LNPs and Ligand Conjugates for the Kidney and Lung Tumors
Chairs: Elena Braithwaite, FDA; Jeffrey Foy, Nimbus Therapeutics
Session 2, Track 3: Unlocking Faster, Sustainable Oligonucleotide Manufacturing Through Regulatory Innovation
Chairs: Benjamin Stevens, Alnylam Pharmaceuticals; Lawrence Blas Perez, CDER, FDA
Networking luncheon
Session 3, Track 3: Advancing the Analytical Toolbox for mRNA-Based Medicines
Chair: Brian Doyle, Senior Director, CMC Development, Moderna
Session 3, Tracks 1 and 2: Regulatory Considerations of Novel Conjugates
Chairs: Louis St. L. O'Dea, Biorchestra USA; Patrik Andersson, AstraZeneca R&D
Session 4, across all three tracks
Translational safety of genetically targeted oligonucleotides; PK/PD and tissue half-life in dose selection; enzymatic oligonucleotide manufacturing
Networking reception
Day Two · Thursday, September 24, 2026
Networking breakfast
Session 5: Implementing the Plausible Mechanism Pathway, From Concept to Clinic
Chairs: Hobart Rogers, CDER, FDA; Dan Swerdlow, GSK. Speakers: Teresa Buracchio, FDA; Klaus Romero, Critical Path Institute
Session 6, Track 1: Global Regulatory Perspectives on First-in-Human Trials for Oligonucleotide Therapies
Chair: Andrew Slugg, Alnylam Pharmaceuticals. Speakers from CDER, the MHRA and Peking University Third Hospital
Session 6, Track 2: Mind Over Matter, Cracking the Code of CNS Delivery
Chair: Aimee L. Jackson, Curie Bio. Speakers from Denali Therapeutics, Ionis Pharmaceuticals and KAIST
Session 6, Track 3: Navigating Change, Recent US CMC Policy Developments
Chair: Rumi Raquel Young, Novo Nordisk. Speakers from OPQ CDER, GSK and Friends of Cancer Research
Networking luncheon
Session 7, Track 3: Oligonucleotide Delivery, New Developments and Regulatory Strategies
Chairs: Ramin Darvari, Pfizer; Rohit Tiwari, Eli Lilly
Session 7, Tracks 1 and 2: Testing Strategy for ONTs Under the Updated ICH E14 and S7B Q&As
Chairs: Jennifer Sisler, Eli Lilly; Lars Johannesen, CDER, FDA
Session 8: Hot Topics
Draft ICH S13 guideline, regulatory roadmaps for New Approach Methodologies, and AI in project throughput. Chairs: Patrik Andersson, AstraZeneca; Susanne Brendler-Schwaab, BfArM
DIA Oligonucleotide Safety Working Group open meeting
Day Three · Friday, September 25, 2026
Networking breakfast
Session 9, Track 1: The Future of Oligonucleotide Therapy for Heart and Muscle Disease
Chair: Ami Mankodi, FDA. Speakers from University of Rochester Medical Center, Atrium Therapeutics and Sarepta Therapeutics
Session 9, Track 2: From Data to Decisions, Evolving the Regulatory Landscape
Chairs: Xuan Chi, CDER, FDA; Ronald Wange, Aclairo. Speakers from the Dutch Medicines Evaluation Board, FDA, Ionis and the PMDA
Session 9, Track 3: Evolving Regulatory Landscape for Oligonucleotide Control Strategy and Comparability
Chair: Claus Rentel, Ionis Pharmaceuticals. Speakers from CBER, Ionis, Genentech and the EMA
Session 10, Track 1: Safety of Oligonucleotide Therapeutics, Lessons from Clinical Development and Post-Marketing
Chairs: Dan Swerdlow, GSK; Hobart Rogers, CDER, FDA
Session 10, Track 2: Extra-Hepatic Delivery Strategies in Translational Models
Chairs: Tae-Won Kim, Ionis Pharmaceuticals; James Wild, CDER, FDA
Session 10, Track 3: Real-World Regulatory Experiences with Clinical and Commercial Oligonucleotides
Chair: Firoz Antia, Denali Therapeutics
Session 11: Grand Q&A Panel
Chair: René Thürmer, BfArM. Panelists from CDER FDA, Alnylam Pharmaceuticals and Eli Lilly
Conference adjourns
Useful DIA Oligonucleotide Conference Resources
The official event page.
AgendaThe full three-day programme across all tracks.
SpeakersThe published faculty.
RegisterRates, windows and group terms.
Hotel InformationThe Crystal Gateway Marriott block.
ExhibitsExhibit and marketing opportunities.
Terms and ConditionsCancellation and transfer policy.
DIA/FDA Oligonucleotide-Based Therapeutics Conference FAQ
General
Registration & travel
See You in Arlington
Arlington, September 23 to 25. Tell us what your sampling plan looks like and we'll block out time to go through how we would run it.