Live Biotherapeutics: Navigating the Next Frontier in Drug Development

In this episode, Boyds' experts explore the emerging field of live biotherapeutic products (LBPs), explaining what they are, how they differ from everyday probiotics, and their roots in microbiome-based therapies, including fecal microbiota transplantation (FMT).

Katherine and Celine discuss the evolving regulatory landscape, comparing the FDA's guidance and recent approvals with the more cautious approach taken by the EMA and national authorities across Europe. They also examine the scientific, manufacturing, and clinical development challenges facing LBP developers, including product consistency, mechanism of action, safety considerations, and clinical trial design.