Melanie Eacho

Melanie Eacho, PhD, is the Director of the Division of Cell Therapy 1 (DCT1) in the Office of Cellular Therapy and Human Tissue CMC within the Office of Therapeutic Products (OTP) at the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER). She previously served as Cell Therapies Branch Chief within the Office of Tissues and Advanced Therapies (now OTP) from 2018 to 2023. At OTP, her rapidly growing division is responsible for the review of chemistry, manufacturing, and controls information in regulatory applications for investigational studies and market approvals for cell therapy products that include stem cells, functionally mature/differentiated cells, cell-based cancer vaccines and immunotherapies, xenotransplant cells/organs, and more. Previous to CBER, her experiences include medical product development - to transition medical devices, drugs, and biologics from bench to bedside - at the U.S. Army Medical Research and Materiel Command to protect, treat, and sustain the health of our Service Members and at the Biomedical Advanced Research and Development Authority to develop medical devices for national medical countermeasures. She also served as a lead reviewer for anesthesiology and respiratory devices at the Center for Devices and Regulatory Health for five years. She holds a Doctor of Philosophy in Biomedical Engineering from Northwestern University and a Bachelor of Science in Chemical Engineering from the University of Maryland, College Park.