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Session Chair(s)
Anthony Scozzari
VP, Development Chemistry & Manufacturing
Ionis Pharmaceuticals, Inc., United States
Speaker(s)
Process Development and Validation
Daniel Capaldi, PHD
Ionis Pharmaceuticals, Inc, United States
Vice President, Analytical and Process Development
Establishing Specification Limits for Phosphorothioate Oligonucleotides
Claus Rentel, PHD
Ionis Pharmaceuticals, Inc., United States
Vice President, Analytical Development and Quality Control
Panelist
Daniel Capaldi, PHD
Ionis Pharmaceuticals, Inc, United States
Vice President, Analytical and Process Development
Panelist
Claus Rentel, PHD
Ionis Pharmaceuticals, Inc., United States
Vice President, Analytical Development and Quality Control
Panelist
Ramesh Raghavachari, PHD
FDA, United States
Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER
Panelist
Fran Wincott, PHD
Wincott & Associates, LLC, United States
President