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Session 2 Track 3: Regulatory Considerations for Innovative and Sustainable Oligonucleotide Manufacturing Technology
Session Chair(s)
Benjamin Stevens, PHD, MPH
Director CMC Policy and Advocacy
GlaxoSmithKline, United States
Katherine Windsor, PHD
Senior Pharmaceutical Quality Assessor, CDER
Food and Drug Administration, United States
The growing importance of oligonucleotide therapies in the therapeutic armamentarium requires a progressive approach to establishing robust global supply chains and streamlined regulatory pathways for commercialization and lifecycle management. Digitalization and sustainability are two areas of significant focus from the perspectives of innovators and regulators alike. In addition, new classes of oligonucleotide therapeutics continue to emerge alongside novel process chemistry and analytical technologies; oligonucleotide “longmers” are one such example. This session will address new developments in the rapidly evolving field of oligonucleotide development and manufacturing, with particular emphasis on where these technologies dovetail with emerging regulatory frameworks. Speakers from industry will present two unique cases in which such technologies are beginning to see broader application, along with the associated regulatory considerations. A joint panel of industry members and regulators will discuss the implications and the path forward to support the needs of patients.
Learning Objective : At the conclusion of this session, participants should be able to: - Describe some of the emerging technologies for oligonucleotide CMC development and commercialization
- Explain what some of the potential regulatory hurdles may be for some of these innovative technologies
- Outline some potential opportunities for alignment between industry and regulators to facilitate successful implementation of these technologies
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