Highlights & Features
What is happening at FDA/DIA Oligonucleotide-Based Therapeutics Conference
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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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