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Session 2 Track 3: Regulatory Experiences with Clinical/ Commercial Oligonucleotides
Session Chair(s)
Firoz Antia, PhD
Vice President, Oligonucleotide and Small Molecule CMC
Denali Therapeutics, United States
Recent filings of siRNAs and ASOs have come with interesting challenges for regulators and industry alike. Hot topics and learnings from recent filings will be discussed with two talks from industry, one on experiences with siRNA molecules and the other on the subject of Solution API, followed by a panel discussion with regulatory agency and industrial participants.
Learning Objective : - Identify key regulatory challenges associated with siRNA molecules
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Recognize benefits and concerns of liquid API for oligonucleotide molecules
- Compare perspectives of US /EU regulators and industrial practitioners on the above topics in the panel discussion
Speaker(s)
Oligonucleotide Solution API: Navigating the Regulatory Landscape
Chris Chorley
Biogen, United Kingdom
Associate Director, Regulatory Affairs CMC
Regulatory CMC Learnings and Perspectives from recent RNAi Filings
Erik McKinney, MS
Alnylam Pharmaceuticals, United States
Senior Director, CMC Regulatory Affairs
Panel Discussion
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Quality Assessor
Panel Discussion
Katharine Duncan, PhD
FDA, United States
Senior Pharmaceutical Quality Assessor (SPQA), Office of Product Quality Assessm