Agenda

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Day 1 Sep 23, 2026

8:15 AM — 9:15 AM

Networking Breakfast

8:15 AM — 4:45 PM

Registration

9:15 AM — 9:30 AM

Welcome and Opening Remarks

9:30 AM — 10:30 AM

Session 1: Keynote Address

10:30 AM — 11:15 AM

Refreshment and Networking Break

10:35 AM — 11:05 AM

Case Study Sponsored by Agilent: Analytical Validation Approaches at Every Phase of Oligonucleotide Development

11:15 AM — 12:45 PM

Session 2 Track 1: The Brains Behind Delivery of Oligos to the CNS

11:15 AM — 12:45 PM

Session 2 Track 2: Extrahepatic Delivery 1: Engineering LNPs and Ligand Conjugates for Oligonucleotide Delivery to the Kidney and Lung Tumors

11:15 AM — 12:45 PM

Session 2 Track 3: Unlocking Faster, Sustainable Oligonucleotide Manufacturing Through Regulatory Innovation and Excellence

12:45 PM — 1:45 PM

Networking Luncheon

1:45 PM — 3:15 PM

Session 3 Track 3: Advancing the Analytical Toolbox for mRNA-Based Medicines

1:45 PM — 3:15 PM

Session 3 Tracks 1 and 2: Regulatory Considerations of Novel Conjugates: Translational and Clinical Pharmacology Perspectives

3:15 PM — 3:45 PM

Refreshment and Networking Break

3:45 PM — 5:15 PM

Session 4 Track 1: Translational Safety of Genetically Targeted Oligonucleotides: Managing Mechanistic Risks, Immunogenicity, and AOC Platforms

3:45 PM — 5:15 PM

Session 4 Track 2: Optimizing Oligonucleotide Therapeutics: Translating PK/PD and Tissue Half-Life into Smarter Dose Selection and Risk Assessment

3:45 PM — 5:15 PM

Session 4 Track 3: Advance Enzymatic Oligonucleotide Manufacturing: From Scalable Chemistry to Regulatory CMC Readiness

5:15 PM — 6:15 PM

Networking

Day 2 Sep 24, 2026

8:00 AM — 8:30 AM

Networking Breakfast

8:00 AM — 4:15 PM

Registration

8:30 AM — 9:30 AM

Welcome to Day Two and Session 5: Fireside Chat: Implementing the Plausible Mechanism Pathway: From Concept to Clinic

9:30 AM — 10:00 AM

Refreshment and Networking Break

10:00 AM — 11:30 AM

Session 6 Track 1: Different Paths, Common Goals: Global Regulatory Perspectives on FIH Trials for Oligonucleotide Therapies

10:00 AM — 11:30 AM

Session 6 Track 2: Mind Over Matter: Cracking the Code of CNS Delivery

10:00 AM — 11:30 AM

Session 6 Track 3: Navigating Change: Unlocking Opportunities and Overcoming Challenges in Recent US CMC Policy Developments

11:30 AM — 12:45 PM

Networking Luncheon

12:45 PM — 2:15 PM

Session 7 Track 3: Oligonucleotide Delivery: New Developments and Regulatory Strategies

12:45 PM — 2:15 PM

Session 7 Tracks 1 and 2: Navigating the Testing Strategy for ONTs based on the Updated Q&A’s of ICH E14 and S7B

2:15 PM — 2:45 PM

Refreshment and Networking Break

2:45 PM — 4:15 PM

Session 8: Hot Topics

4:15 PM — 5:15 PM

DIA Oligonucleotide Safety Working Group (OSWG) – Open Meeting

Day 3 Sep 25, 2026

7:45 AM — 8:15 AM

Networking Breakfast

7:45 AM — 12:45 PM

Registration

8:15 AM — 9:30 AM

Session 9 Track 1: Targeting Muscle Diseases with Oligonucleotides

8:15 AM — 9:30 AM

Session 9 Track 2: From Data to Decisions: Evolving the Regulatory Landscape for Oligonucleotide Therapeutics

8:15 AM — 9:30 AM

Session 9 Track 3: Evolving Regulatory Landscape for Oligonucleotide Control Strategy and Comparability

9:30 AM — 10:00 AM

Refreshment and Networking Break

10:00 AM — 11:15 AM

Session 10 Track 2: Extra-Hepatic Delivery Strategies to Optimize Distribution and Exposure for Improved Efficacy and Safety in Translational Models

10:00 AM — 11:15 AM

Session 10 Track 3: Real-World Regulatory Experiences with Clinical/Commercial Oligonucleotides

11:20 AM — 12:35 PM

Session 11: Grand Q&A Panel

12:35 PM — 12:45 PM

Closing Remarks

12:45 PM — 12:45 PM

Conference Adjourns

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DIA/FDA Oligonucleotide-Based Therapeutics Conference

Agenda

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