Navigating Regulatory Pathways in Cell Therapy: Insights for Researchers
Join Nidhi Kotecha, Regulatory Affairs Program Director at the Gates Institute, as she unpacks the intricate regulatory landscape of Phase-I GMP Manufacturing for Cell Therapy. In this episode, Nidhi shares vital insights on various products and research approaches targeting different disease modalities. Discover how early considerations in process development can significantly influence timelines and costs, empowering researchers to streamline their journey from lab to clinic. Tune in for an essential guide to regulatory compliance in cell therapy!