Melanie Eacho, PhD, RAC, 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. FDA/CBER. Her division is responsible for the review of chemistry, manufacturing, and controls information for cell therapy products submitted in regulatory applications. Her previous experiences included medical product development at the U.S. Army Medical Research and Materiel Command and at the Biomedical Advanced Research and Development Authority. She also served as a lead reviewer for anesthesiology and respiratory devices at the Center for Devices and Regulatory Health. 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.