Novel or Not? Our Inadvertent Journey Filing a Novel Excipient

Wednesday, July 22, 2020 - 11:00am

This webinar was a first-hand account of the challenges to realizing, determining, and confirming the novel status of an inactive ingredient in a Phase III Clinical drug product. Quickly followed by lessons learned on the proactive characterization of inactive ingredients, whether novel or not.

The goal of the presentation is to inform the audience on the inherent complexities to effectively identifying, defining, and characterizing a novel excipient.

Learning Objectives

The presentation reviewed a first-hand account of:

  • The factors influencing the internal debate
  • The strategies developed to solicit regulatory confirmation
  •  The approach to "retrospective" characterization
  • Necessary remediation efforts 
  • Hindsight is 20/20, I wish I knew then...
  • Remaining challenges to the effective identification of novel excipients today

The attendee will take away a practical example of one company's journey in the perceived "flying blind" process of novel excipient approval and guidance for proactively navigating, if you must.


    Kara Quinn

    Associate Director Engineering
    Merck & Co.

    Kara Quinn has over 25 years of experience in the Biopharmaceutical industry supporting large molecule (biologics & vaccine) development, commercialization, and licensure through a range of disciplines including Quality, Regulatory, Process Technology, and Clinical. Currently at Merck & Co., Inc., Kara serves as a subject matter expert in the fit-for-use qualification of procured raw materials and excipients. Kara's participation in industry forums have enabled her to drive alignment between biopharmaceutical manufacturers and raw material suppliers on a shared standard for risk assessments published September 2019 at

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