Highlights & Features
What is happening at FDA/DIA Oligonucleotide-Based Therapeutics Conference
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Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
- Learn about the latest advancements, regulatory updates, and emerging trends in oligonucleotide therapies directly from leading industry experts and global regulators
- Our three tracks (Clinical, Nonclinical, and CMC) will comprehensively cover a wide range of aspects of oligonucleotide therapeutics—from development to regulatory collaboration—and provide practical insights into current challenges and successful strategies for overcoming hurdles in clinical use, safety assessments, and CMC
- This conference offers a networking opportunity to engage with peers, innovators, and regulators in sessions designed to foster meaningful collaboration and knowledge exchange
- The final session, a Grand Question & Answer panel, will encourage discussion between the audience and an esteemed panel of experts, allowing participants to ask any remaining questions and contribute to conversations on key developments shaping the future of this field
Keynote Address!
October 28 | 9:30-10:30PM Session 1: Keynote
Peter P. Stein, MD, FDA, United States, Director, Office of New Drugs, CDER
Three Track Meeting!
Track 1: Clinical
There are more than a dozen oligonucleotide based products approved for therapeutic use and nearly 100 currently in clinical testing. Track 1 will explore the lessons learned and the ongoing challenges to clinical use of oligonucleotide therapies.
Track 2: Nonclinical
As oligonucleotide-based therapeutics advance, understanding their nonclinical development and safety is critical for their success in clinical and commercial stages. This track offers an in-depth look at the latest safety assessments, preclinical models, and regulatory expectations for nonclinical data.
Track 3: CMC
This track provides a collaborative forum for innovators and regulators to present and discuss cutting edge topics in oligonucleotide chemistry, manufacturing, and controls (CMC). Emphasizing emerging topics that require ongoing global regulatory collaboration, attendees will gain a deeper understanding of key insights into current challenges and successful strategies for navigating this evolving field.
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