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Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 7:00 AM - Oct 30, 2019 12:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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


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

FDA, United States

Chemist Reviewer, CMC Reviewer, CDER/OPQ/ONDP

Nicole  Del Canto


Nicole Del Canto

Biogen Inc., United States

Director, Global Regulatory CMC

Veronika  Jekerle, PhD, RPh


Veronika Jekerle, PhD, RPh

European Medicines Agency, Netherlands

Head of Pharmaceutical Quality

Benjamin  Stevens, PhD, MPH


Benjamin Stevens, PhD, MPH

GlaxoSmithKline, United States

Director CMC Policy and Advocacy

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