Xenotransplantation: Considerations for First-in-Human Trials

Judith Arcidiacono, MS, International Regulatory Expert at the FDA Center for Biologics Evaluation and Research provides a high-level overview of what xenotransplantation products are, the progress that has been made, and what questions remain from a regulatory perspective.

Timestamps:

• 0.36 – 3:35 What is Xenotransplantation?
• 3:36 – 4:10 Who Regulates Xenotransplantation?
• 4:11 – 5:02 Why Pigs?
• 5:03 – 7:19 Genetic Modifications
• 7:20 – 9:43 Product Development Process
• 9:44 – 11:58 Risks
• 11:59 – 13:17 FDA Advisory Group Meeting