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Bethesda North Marriott Hotel and Conference Center

2017年10月25日 (水) 午前 7:00 - 2017年10月27日 (金) 午後 3:00

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

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Convening industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development.

戻る Agenda

Session 4AB: Chemistry and Safety Considerations for Impurities in Oligonucleotide Therapeutics

Session Chair(s)

Andrew Teasdale, PHD

Andrew Teasdale, PHD

Principal Scientist, Chair of Impurities Advisory Group, AstraZeneca , United Kingdom

Members of the Oligonucleotide Safety Working Group (OSWG) met regularly over the past 12 months to discuss oligonucleotide impurities. This joint session for the CMC and nonclinical tracks will feature two presentations that attempt to summarize the output of these discussions. Chemistry and safety aspects of oligonucleotide impurities will be presented. The presentations will be followed by a 30 minute panel discussion.

Questions:

  • What types of oligonucleotide impurities are commonly observed?
  • What are appropriate characterization expectations for oligonucleotide impurities?
  • What are appropriate reporting, identification, and qualification thresholds for oligonucleotide therapeutics?
  • How should oligonucleotide impurities be qualified?
  • Can platform data be used to help characterize and qualify oligonucleotide impurities?

    • Learning Objective :
  • Understand the importance of the reporting, identification, and qualification thresholds and their relationship to drug substance and drug product specifications
  • Discuss how oligonucleotide impurities may differ from impurities in small molecule drugs
  • Explain strategies for qualifying oligonucleotide impurities

    • Speaker(s)

    Daniel Capaldi, PHD

    Daniel Capaldi, PHD

    Vice President, Analytical and Process Development, Ionis Pharmaceuticals, Inc, United States

    Chemistry Considerations for Oligonucleotide Impurities

    Scott Henry, PHD

    Scott Henry, PHD

    Senior Vice President, Nonclinical Development, Ionis Pharmaceuticals, Inc., United States

    Safety Considerations for Oligonucleotide Impurities

    Panel Discussion

    Panel Discussion

    , All Session Speakers, United States

    James Wild, PHD, MS

    James Wild, PHD, MS

    Pharmacologist, CDER, FDA, United States

    Panelist: Joining the Speakers

    Cathaline Den Besten, PHD, PMP

    Cathaline Den Besten, PHD, PMP

    VP Toxicology, Proqr Therapeutics, Netherlands

    Panelist: Joining the Speakers

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