Entering first-in-human clinical trials: A five point strategy for building a robust CMC dossier

On Demand Webinar

Getting biological drug products to first-in-human (FIH) trials requires a deep and nuanced understanding of the scientific and regulatory challenges unique to these complex large molecule substances. Prioritizing regulatory CMC guidance and careful preparation of quality dossiers are integral to success from the very early stages and throughout clinical development.

This webinar discusses the five strategies to build a robust CMC package, help streamline the path to FIH trials for biologics and establish the quality foundation needed to support all of the development phases toward commercialization:

  • Including regulatory CMC in early development teams
  • Keeping patient and clinical experience in mind
  • Building a phase-appropriate dossier
  • Considering and conveying the basis for the strategy
  • Obtaining regulatory advice at every opportunity