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Session 5A (Nonclinical Track): Oligonucleotide Regulatory Experience
Session Chair(s)
Arthur A. Levin, PhD
CSO
Avidity Biosciences , United States
Barbara Wilcox, PhD
Pharmacologist, OMPT, ODEI, DNP, OND, CDER
FDA, United States
Do oligonucleotide therapeutics represent a special class of drugs warranting specific regulatory policies? Is sufficient evidence available to guide new regulatory policy? This session will be devoted to examining what evidence is available to support class-specific regulation for oligonucleotides. Specifically, the contributions of structure and sequence to oligonucleotide toxicity will be discussed in complementary presentations from Pharma and FDA representatives.
Speaker(s)
Development of siRNA Lipid Nanoparticle Formulations
Garvin L Warner, PhD
Alnylam Pharmaceuticals, United States
Vice President, Preclinical Development
Oligonucleotide Toxicity and its Relationship to Compound Structure: FDA Experience from Nonclinical Testing
Paul C. Brown, PhD
FDA, United States
Associate Director for Pharmacology and Toxicology, OND, CDER
Potential Attributes of a Platform Technology: How Best to Capitalize on Cumulative MOE Oligonucleotide Safety Data
Scott Henry, PhD
Ionis Pharmaceuticals, Inc., United States
Vice President, Nonclinical Development
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