Agenda

Day 1 Apr 25, 2022

7:00 AM — 4:45 PM

Forum Registration

7:00 AM — 8:00 AM

Networking Breakfast

8:00 AM — 9:00 AM

Welcoming Remarks and Session 1: Keynote Address - The Coming of Age of Oligonucleotide-Based Therapeutics

9:00 AM — 10:30 AM

Session 2: Plenary Session: When Innovation and Need Meet: Development of COVID-19 mRNA Vaccines

10:30 AM — 10:45 AM

Refreshment and Networking Break

10:45 AM — 12:15 PM

Session 3 Track 1: Clinical Development of Oligonucleotide Therapeutics for Viral and Kidney Diseases

10:45 AM — 12:15 PM

Session 3 Track 2: Advances in Oligonucleotide Delivery

10:45 AM — 12:15 PM

Session 3 Track 3: Platform Approaches and the Application of Prior Knowledge to the Development of Therapeutic Oligonucleotides

12:15 PM — 1:15 PM

Networking Luncheon

1:15 PM — 2:45 PM

Session 4 Track 1: Oligonucleotide Therapies for Brain and Eye Diseases: Learnings From Recent Clinical Trials

1:15 PM — 2:45 PM

Session 4 Track 2: Off-Target Effects

1:15 PM — 2:45 PM

Session 4 Track 3: CMC Perspective on Early and Late Stage Oligonucleotide Programs

2:45 PM — 3:15 PM

Refreshment and Networking Break

3:15 PM — 4:45 PM

Session 5 Track 1: Liver Targeted Therapeutics, Clinical Experience

3:15 PM — 4:45 PM

Session 5 Track 2: Advances in CNS Delivery of Oligonucleotides

3:15 PM — 4:45 PM

Session 5 Track 3: ICH Q14 Regulatory Perspective and the Impact on Process Analytical Technology

4:45 PM — 5:45 PM

Poster Reception

Day 2 Apr 26, 2022

8:00 AM — 9:00 AM

Networking Breakfast

8:00 AM — 4:30 PM

Registration

9:00 AM — 10:00 AM

Welcome to Day 2 and Session 6: Keynote Address - Delivery of Oligonucleotide Therapeutics – Going Beyond the Liver

10:00 AM — 10:30 AM

Refreshment and Networking Break

10:30 AM — 12:00 PM

Session 7 Track 1: Clinical Pharmacology Considerations in the Development and Approval of Oligonucleotide Therapeutics

10:30 AM — 12:00 PM

Session 7 Track 2: RNA Activation

10:30 AM — 12:00 PM

Session 7 Track 3: Oligonucleotide Delivery

12:00 PM — 1:15 PM

Networking Luncheon with Round Table Discussions

1:15 PM — 2:45 PM

Session 8 Track 1 and 2 – Individualized Antisense Oligonucleotide Drug Products

1:15 PM — 2:45 PM

Session 8 Track 3: CMC Perspective on mRNA Therapeutics

2:45 PM — 3:15 PM

Refreshment and Networking Break

3:15 PM — 4:45 PM

Session 9: Hot Topics

4:45 PM — 5:45 PM

DIA Oligonucleotide Safety Working Group (OSWG) – Open Meeting

Day 3 Apr 27, 2022

7:30 AM — 8:00 AM

Networking Breakfast

7:30 AM — 12:00 PM

Registration

8:00 AM — 9:30 AM

Session 10 Track 1 and 2 – Alternative Approaches to Other Extrahepatic Delivery

8:00 AM — 9:30 AM

Session 10 Track 3: CMC and Regulatory Experience for Novel Oligonucleotide Therapeutics

9:40 AM — 10:20 AM

Session 11: PMDA Highlight - Recent Publication of Japanese Guideline for Non-clinical and CMC Topics Related to Oligonucleotide Medicines

10:20 AM — 10:45 AM

Refreshment and Networking Break

10:45 AM — 12:00 PM

Session 12: Co-track Grand Q&A Panel and Closing Remarks

12:00 PM — 12:00 PM

Conference Adjourns

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DIA/FDA Oligonucleotide-Based Therapeutics Conference

Agenda

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