Agenda

Day 1 Oct 28, 2019

7:00 AM — 8:00 AM

Continental Breakfast, Exhibits, and Networking

7:00 AM — 5:00 PM

Registration

8:00 AM — 8:10 AM

Mobile App Demonstration

8:10 AM — 8:30 AM

Welcome Remarks and Overview of the 2019 Conference

8:30 AM — 9:30 AM

Keynote Address

9:30 AM — 11:00 AM

Session 1: Rare Diseases

11:00 AM — 11:30 AM

Refreshment, Exhibits, and Networking Break

11:30 AM — 1:00 PM

Session 2 Track A: Clinical Experience with Immune-Targeting Oligonucleotides and MicroRNAs

11:30 AM — 1:00 PM

Session 2 Track B: Targeted Delivery

11:30 AM — 1:00 PM

Session 2 Track C: Recently Approved Oligonucleotide Drugs

1:00 PM — 2:00 PM

Luncheon, Exhibits, and Networking

2:00 PM — 3:30 PM

Session 3 Track A: Oligonucleotide Conjugate Approaches in the Clinic

2:00 PM — 3:30 PM

Session 3 Track B: Toxicology Updates on Renal and Platelet Effects of ASOs and 2’-Fluoro Nucleotide Effects of siRNAs

2:00 PM — 3:30 PM

Session 3 Track C: CMC Strategies for Accelerated Approval (Fast Track, Breakthrough, PRIME, etc) of Oligonucleotide Drugs

3:30 PM — 4:00 PM

Refreshment, Exhibits, and Networking Break

4:00 PM — 5:30 PM

Session 4 Track A & B: Evaluation of QT Prolongation Potential and Assessment of Immunogenicity

4:00 PM — 5:30 PM

Session 4 Track C: Developing Oligonucleotides with Current CMC Guidelines and an Introduction to EPOC

5:30 PM — 6:30 PM

Poster Session and Networking Reception

Day 2 Oct 29, 2019

8:00 AM — 9:00 AM

Continental Breakfast, Exhibits, and Networking

8:00 AM — 5:00 PM

Registration

8:15 AM — 9:00 AM

Breakfast Plenary Session: Global Regulatory

9:00 AM — 9:05 AM

Welcome to Day Two

9:05 AM — 10:05 AM

Keynote Address

10:05 AM — 10:30 AM

Refreshment, Exhibits, and Networking Break

10:30 AM — 12:00 PM

Session 5 Track A: Clinical Experience with Lipid Nanoparticle- Based Delivery of Oligonucleotides

10:30 AM — 12:00 PM

Session 5 Track B: Progress In Developing Rna Targeted Drugs For the Treatment of Neurological Diseases

10:30 AM — 12:00 PM

Session 5 Track C: Oligonucleotide Degradation, Stability, and the Question of Terminal Sterilization

12:00 PM — 1:30 PM

Round Table Discussion Luncheon, Exhibits, and Networking

1:30 PM — 3:00 PM

Session 6 Track A & B: Evaluation of Intrinsic Factors/Organ Impairment Studies and of Extrinsic Factors/Drug-Drug Interaction Liability

1:30 PM — 3:00 PM

Session 6 Track C: Control Strategy and Regulatory Considerations for Manufacture of mRNA Drug Substance

3:00 PM — 3:30 PM

Refreshment, Exhibits, and Networking Break

3:30 PM — 5:30 PM

Session 7: Hot Topics

5:30 PM — 6:30 PM

DIA Oligonucleotide Safety Working Group (OSWG) – Open Meeting

Day 3 Oct 30, 2019

7:00 AM — 8:00 AM

Continental Breakfast and Networking

7:00 AM — 12:30 PM

Registration

8:00 AM — 10:00 AM

Session 8 Track A & B: Hybridization-Dependent Off-Target Events

8:30 AM — 10:00 AM

Session 8 Track C: General CMC Q&A Session

10:00 AM — 10:15 AM

Refreshments and Networking Break

10:15 AM — 11:45 AM

Session 9: ON Therapeutic Survey Sponsored by EFPIA

11:45 AM — 12:30 PM

Closing Session: Panel Discussion

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DIA/FDA Oligonucleotide-Based Therapeutics Conference

Agenda

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