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Session 6AB: CMC and Non Clinical Track Combination: Impurities
Session Chair(s)
Daniel Capaldi, PhD
Vice President, Analytical and Process Development
Ionis Pharmaceuticals, Inc, United States
This joint session for the CMC and non-clinical tracks will focus on impurities in oligonucleotide and RNA-based therapeutics. The first presenter will discuss recently published guidelines on genotoxic impurities (ICH M7) and elemental impurities (ICH Q3D). The second presentation will be given by CMC and non-clinical representatives and aims to discuss oligonucleotide impurities. The presentations will be followed by a 30-minute panel discussion. Questions for discussion may include:
• Does ICH M7 apply to oligonucleotides?
• What are appropriate identification and qualification thresholds for oligonucleotide impurities;
• Impurities vs related substances: Is there a difference?
Speaker(s)
M7 and Q3D
Andrew Teasdale, PhD
AstraZeneca , United Kingdom
Principal Scientist, Chair of Impurities Advisory Group
Qualification of Oligonucleotide Impurities
Brigitte Burm, PhD
BioMarin Nederland BV, Netherlands
Sr. Manager Analytical Development
Impurities in Oligonucleotides: A Pragmatic Approach to Qualification Strategies
Cathaline Den Besten, PhD, PMP
Proqr Therapeutics, Netherlands
VP Toxicology
Q&A Panel Discussion (Joining the Speakers):
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
Scott Henry, PhD
Ionis Pharmaceuticals, Inc., United States
Vice President, Nonclinical Development
Additional Panelists Invited
United States
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