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Session 3 Track 3: Platform Approaches and the Application of Prior Knowledge to the Development of Therapeutic Oligonucleotides
Session Chair(s)
Daniel Capaldi, PhD
Vice President, Analytical and Process Development
Ionis Pharmaceuticals, Inc, United States
Monica Cooper, PhD
Review Chemist, ONDP, OPQ, CDER
FDA, United States
Synthetic therapeutic oligonucleotides are commonly manufactured using the same basic unit operations, i.e., solid phase synthesis, cleavage, purification, and isolation. The platform nature of oligonucleotide manufacturing provides opportunities to streamline process development and expedite regulatory submissions through the application of prior knowledge. The session will include presentations from regulatory authority and industry scientists. The presentations will be followed by a panel discussion. Topics for discussion may include how best to define prior knowledge, the areas and extent to which prior knowledge may be applied, limitations and issues associated with the application of prior knowledge, and how such information might be presented in regulatory filings.
Learning Objective : At the conclusion of this session, participants should be able to:
- Define prior knowledge
- Discuss how prior knowledge can be leveraged to facilitate therapeutic oligonucleotide development
- Describe any limitations and issues associated with the application of prior knowledge
Speaker(s)
Speaker
Dominik Altevogt, PhD
Novartis, Switzerland
Associate Director Regulatory Affairs CMC
Speaker
Brian Dooley, MPharm, MSc
European Medicines Agency, Netherlands
Quality Specialist
Panelists
Ashley Boam, MS
FDA, United States
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Panelists
Lubomir Nechev, PhD
Alnylam Pharmaceuticals, United States
Cjief CMC Officer
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