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Session 4 Track 3: Demonstrating Comparability for Oligonucleotides Therapeutics
Session Chair(s)
Daniel Capaldi, PhD
Vice President, Analytical and Process Development
Ionis Pharmaceuticals, Inc, United States
Fran Wincott, PhD
President
Wincott & Associates, LLC, United States
Oligonucleotide therapeutics are larger and more complex than traditional small molecule drugs. Consequently, the task of demonstrating comparability of materials made by different manufacturing processes, may be more challenging for oligonucleotide therapeutics than for small molecule drugs. The session will include presentations from regulatory authorities, and industry scientists. The presentations will be followed by a panel discussion. Topics for discussion may include how to define comparability, the types of chemical and physicochemical characteristics that should be evaluated, analytical methods for assessing comparability, and the potential impact of observed differences in chemical and physicochemical properties.
Learning Objective : At the conclusion of this session, participants should be able to:- Define comparability requirements for oligonucleotide therapeutics
- Discuss how to evaluate the impact of manufacturing changes on oligonucleotide therapeutics
- Discuss how to demonstrate comparability between generic and brand name oligonucleotide therapeutics
Speaker(s)
Comparability in Generic Oligonucleotide Drug Development: Regulatory Considerations and Case Studies
Deyi Zhang, PhD, MS
FDA, United States
Senior Chemist, Office of Generic Drugs
Demonstrating Comparability of Oligonucleotide Therapeutics Following Manufacturing Changes
Carolyn Mazzitelli, PhD
Ionis Pharmaceuticals, United States
Executive Director, Analytical Development and Quality Control
Panelist
Lawrence Perez, PhD
FDA, United States
Senior Pharmaceutical Quality Assessor, CDER
Panelist
Lubo Nechev, PhD
Alnylam Pharmaceuticals, United States
Chief CMC Officer
Panelist
Lori Troup
Novo Nordisk, United States
Director, Analytical Development