Session 3 Track C: CMC Strategies for Accelerated Approval (Fast Track, Breakthrough, PRIME, etc) of Oligonucleotide Drugs
Fran Wincott, PhD
Wincott & Associates LLC, 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
CMC Strategies for Accelerated Approval (Development) of Oligonucleotide Drugs