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Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 7:00 AM - Oct 30, 2019 12:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Agenda

Day 1 Oct 28, 2019

11:30 AM — 1:00 PM

Session 2 Track C: Recently Approved Oligonucleotide Drugs

2:00 PM — 3:30 PM

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

4:00 PM — 5:30 PM

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

Day 2 Oct 29, 2019

10:30 AM — 12:00 PM

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

1:30 PM — 3:00 PM

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

Day 3 Oct 30, 2019

8:30 AM — 10:00 AM

Session 8 Track C: General CMC Q&A Session

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