By Daniela Decina, Sr. Director, Regulatory Affairs, Thermo Fisher Scientific, and Michele Duggan, Sr. Manager, Regulatory Affairs, Thermo Fisher Scientific
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 is integral to success from the very early stages throughout clinical development. This report identifies key strategies for developing a carefully executed, robust CMC dossier and avoiding common deficiencies that lead to clinical holds.