Carolyn Mazzitelli, PhDExecutive Director at Ionis PharmaceuticalsSpeaker
Profile
Carolyn is an Executive Director in the Analytical Development & Quality Control department at Ionis Pharmaceuticals where she leads a team responsible for the analytical activities of oligonucleotides in all phases of development. Her expertise includes method development, validation, stability testing, establishing specifications, authoring regulatory submissions, and supporting commercial product launches. Prior to joining Ionis, she worked at Dart NeuroScience, Gilead Sciences, and Vertex Pharmaceuticals where she was responsible for the analytical development of small molecule drug substances and drug products. She earned a B.S. in Chemistry from the University of North Carolina at Chapel Hill and Ph.D. in Chemistry from the University of Texas at Austin.
Agenda Sessions
Strategies for Demonstrating Comparability of Oligonucleotide Therapeutics Following Manufacturing Changes
, 9:40amView Session
