Skip to main content

Recording: Novel or Not? Our Inadvertent Journey Filing a Novel Excipient

Recording from Wednesday, July 22, 2020

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 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.