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Session 7 Track 3: Challenges Around Oligonucleotides Control Strategies
Session Chair(s)
Christian Wetter, PhD
Senior Regulatory Portfolio Director
Roche, Switzerland
Katherine Windsor, PhD
Senior Pharmaceutical Quality Assessor, CDER
Food and Drug Administration, United States
Close to a decade ago, pioneering papers were written on how to set up oligonucleotide control strategies, including proposed impurity grouping. Since then, industry and regulators have expanded their knowledge and their experience in this area. At the same time, the complexity of the oligonucleotide landscape is increasing, in particular because of the development of conjugates and new modifications. Because of the reached level of maturity, oligonucleotides are in scope of new or to-be-revised guidelines. The current session aims at exchanging on experiences and challenges pertaining to oligonucleotide control strategies in general and in view of the changing guideline landscape.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the current trends pertaining to oligonucleotide control strategies
- Understand the current challenges and how they could influence the content of new guidelines
Speaker(s)
Senior Pharmaceutical Quality Assessor (SPQA), Division of New Drug API, Office of New Drug Products
Katharine Duncan, PhD
FDA, United States
Senior Pharmaceutical Quality Assessor (SPQA), Office of Product Quality Assessm
Evaluating the Requirements for Multiple Identity and Purity Methods
Lori Troup
Novo Nordisk, United States
Director, Analytical Development
Speaker
Carolyn Mazzitelli, PhD
Ionis Pharmaceuticals, United States
Executive Director, Analytical Development and Quality Control
Speaker
Lubo Nechev, PhD
Alnylam Pharmaceuticals, United States
Chief CMC Officer