Melek Michelle Erdinc Sunay received her doctoral degree in Pathobiology at Johns Hopkins School of Medicine in 2015. As a graduate student, Melek conducted research on the mechanisms of immune modulation by tyrosine kinase inhibitors to enhance the efficacy of cellular immunotherapies for the treatment of breast cancer. She then moved to US Army Research Institute on Infectious Disease (USAMRID) for her postdoctoral work on the development of filovirus vaccines, specially Ebola vaccines, using murine and nonhuman primate models of Ebola infection . Melek joined CBER FDA in April 2020 as a P/T Reviewer in the previous Office of Tissues and Advanced Therapies (OTAT) and then became Acting Team Lead, her current role, in the newly established super Office of Therapeutic Products (OTP) in the Office of Pharmacology/Toxicology (OPT) in May 2023. In March 2024, she assumed her current role as Team Leader In OPT. In her tenure, she has worked on the diverse array of OTP products including CAR T cells, oncolytic viruses, AAVs, gene editing technologies, and engineered virus-like particles spanning hematology, oncology, and general medicine indications.
Melek Michelle Erdinc Sunay received her doctoral degree in Pathobiology at Johns Hopkins School of Medicine in 2015. As a graduate student, Melek conducted research on the mechanisms of immune modulation by tyrosine kinase inhibitors to enhance the efficacy of cellular immunotherapies for the treatment of breast cancer. She then moved to US Army Research Institute on Infectious Disease (USAMRID) for her postdoctoral work on the development of filovirus vaccines, specially Ebola vaccines, using murine and nonhuman primate models of Ebola infection . Melek joined CBER FDA in April 2020 as a P/T Reviewer in the previous Office of Tissues and Advanced Therapies (OTAT) and then became Acting Team Lead, her current role, in the newly established super Office of Therapeutic Products (OTP) in the Office of Pharmacology/Toxicology (OPT) in May 2023. In March 2024, she assumed her current role as Team Leader In OPT. In her tenure, she has worked on the diverse array of OTP products including CAR T cells, oncolytic viruses, AAVs, gene editing technologies, and engineered virus-like particles spanning hematology, oncology, and general medicine indications.