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Session 9A: CMC Track: Standards for Therapeutic Oligonucleotides
Session Chair(s)
Jim Zisek
Director, Global CMC Regulatory Affairs
GlaxoSmithKline, United States
This session will feature presenters from the National Institute of Standards and Technology (NIST) and The RNA Institute. Session topics will include a discussion of how measurement science and standards support development of biosimilars and new therapeutics. Examples of research areas and projects, including protein particle measurements, development of a mAb reference material and NMR fingerprint-like characterization of protein therapeutics will be presented. The session will conclude with a panel discussion to determine how NIST and The RNA Institute might contribute in developing methods, tools and analytics for oligonucleotide and RNA-based therapeutics.
Speaker(s)
Measurements and Standards for Biotherapeutic Drugs: Proteins are the Present. Are Nucleic Acids the Future?
Andrea L. Szakal, PhD
National Institute of Standards and Technology, United States
Research Chemist
Power and Promise of Oligonucleotide Therapeutics: Need for Standards, Measurements and Tools in CMC
Paul Agris, PhD
The RNA Institute - University of Albany - SUNY, United States
Professor of Biological Sciences and Chemistry, Director
Q&A Panel Discussion (Joining the Speakers)
Ramesh Raghavachari, PhD
FDA, United States
Chief, Branch I, DPMA1, OLDP, OPQ, CDER
Claus Rentel, PhD
Ionis Pharmaceuticals, Inc., United States
Vice President, Analytical Development and Quality Control
Peter Vallone, PhD
National Institute of Standards and Technology (NIST), United States
Leader, Applied Genetics Group
Additional Panelists Invited
United States
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