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Session 3 Track C: CMC Strategies for Accelerated Approval (Fast Track, Breakthrough, PRIME, etc) of Oligonucleotide Drugs
Session Chair(s)
Fran Wincott, PhD
President
United States
There is a growing trend in the pharmaceutical industry towards accelerated development of therapeutics to address unmet medical needs. The shorter timelines coupled with increasing complexity of the development candidates presents extraordinary challenges for managing the chemistry, manufacturing, and controls activities. This session will provide a background on the existing regulatory expedited pathways. Approaches for successful clinical development, regulatory approval, and commercialization of therapeutic oligonucleotides within the framework of accelerated development will be discussed.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the different expedited pathways available
- Understand CMC strategies to facilitate successful accelerated development
Speaker(s)
CMC Strategies for Accelerated Approval (Development) of Oligonucleotide Drugs
Olen M. Stephens, PhD
FDA, United States
Chemist Reviewer, CMC Reviewer, CDER/OPQ/ONDP
Speaker
Nicole Del Canto
Biogen Inc., United States
Director, Global Regulatory CMC
Speaker
Veronika Jekerle, PhD, RPh
European Medicines Agency, Netherlands
Head of Pharmaceutical Quality
Panelist
Benjamin Stevens, PhD, MPH
GlaxoSmithKline, United States
Director CMC Policy and Advocacy
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