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Session 9 Track 3: Evolving Regulatory Landscape for Oligonucleotide Control Strategy and Comparability
Session Chair(s)
Claus Rentel, PHD
Vice President, Analytical Development and Quality Control, Ionis Pharmaceuticals, Inc., United States
A significant number of oligonucleotide therapies obtained marketing approval in recent years. Nevertheless, regulatory expectations for CMC approaches are still evolving, and inclusion of oligonucleotides as a molecular class in global guidances like ICH may impact established control strategies. Speakers from regulatory agencies and industry will address the related topics of planned revisions to ICH Q6 on the setting and justification of acceptance criteria for drug substances and products, and experiences with regulatory acceptance of platform analytical data in IND and NDA filings in CMC areas like specification limits, stability, forced degradation, retest/expiration setting, method validations, and starting material testing.
Learning Objective : - Understand how a revised ICH Q6 guidance may change regulatory expectations
- Identify how oligonucleotide drug substances and products could be impacted when it comes to setting specifications, test procedures and acceptance criteria
- Recognize advantages and issues with the use of platform data for justifying specification limits, setting retest / expiration dates, and reduced stress testing and method validation
Speaker(s)
Robin Levis, PHD
Regulatory Chair of the ICH Q6 EWG, CBER, FDA, United States
Speaker
Representative Invited
Executive Director, Analytical Development and Quality Control, Ionis Pharmaceuticals, United States
Speaker