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DIA/FDA Oligonucleotide-Based Therapeutics Conference

Session 3 Track C: CMC Strategies for Accelerated Approval (Fast Track, Breakthrough, PRIME, etc) of Oligonucleotide Drugs

Session Chair(s)

Fran  Wincott, PhD

Fran Wincott, PhD

  • President
  • 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


Olen M. Stephens, PhD

CMC Strategies for Accelerated Approval (Development) of Oligonucleotide Drugs

Olen M. Stephens, PhD

  • Chemist Reviewer, CMC Reviewer, OND
  • FDA, United States
Nicole  Del Canto


Nicole Del Canto

  • Director, Global Regulatory CMC
  • Biogen Inc., United States
Veronika  Jekerle, PhD, RPh


Veronika Jekerle, PhD, RPh

  • Head of Pharmaceutical Quality
  • European Medicines Agency, Netherlands
Benjamin  Stevens, PhD, MPH


Benjamin Stevens, PhD, MPH

  • Associate Director, Regulatory Affairs CMC
  • Alnylam Pharmaceuticals, United States