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10.28 - 10.30

美国，华盛顿 DC

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Co-sponsored with FDA
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The DIA/FDA Oligonucleotide-Based Therapeutics Conference brings together leading experts to inform, educate, and share advancements in oligonucleotide-based therapeutic product development. Developed collaboratively by regulators, industry professionals, and academics, the program covers a wide range of topics from the nonclinical, CMC, and clinical areas, including emerging CMC guidances and considerations, learnings from recent regulatory filings, extra-hepatic and CNS delivery of oligonucleotides, toxicology testing, gene editing, and safety assessments. The conference offers a unique three-day experience with multiple perspectives presented, and the opportunity to interface with regulators from around the globe.

Learning Objectives:

At the conclusion of this activity, participants should be able to:

• Analyze the latest strategies for clinical use of oligonucleotide therapies and explain the specific challenges of developing RNA-based therapeutics
• Describe the chemistry, manufacturing, and controls challenges associated with the development of oligonucleotides, including formulation and specification issues
• Describe the technology landscape, CMC challenges, and regulatory considerations associated with novel oligonucleotide delivery approaches
• Explain the latest global regulatory updates in oligonucleotide therapeutic developments