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Session 5A: CMC Track: Conjugates
Session Chair(s)
Mohan K. Sapru, PHD, MS
CMC Lead, Office of Pharmaceutical Quality, CDER
FDA, United States
This session will feature two presentations on the manufacture and analysis of oligonucleotide conjugates, followed by a panel discussion. The first presentation will focus on pegylated Spiegelmers, while the second speaker will discuss GalNAc-conjugated double-stranded RNAi molecules. Discussion topics may include:
• Definitions of starting materials
• Characterization expectations
• Pro-drug considerations
Speaker(s)
Characterization and Control Strategy for Pegylated Aptamers
Stefan Vonhoff, PHD
NOXXON Pharma AG, Germany
Vice President Chemistry Manufactuting and Controls
Speaker
Matthias Kretschmer, PHD
Alnylam Pharmaceuticals, United States
Senior Director, Analytical Development
Q&A Panel Discussion (Joining the Speakers)
Fran Wincott, PHD
Wincott & Associates, LLC, United States
President