Dr. Shonoi Ming joined ELIQUENT Life Sciences after more than a decade at the FDA, where she served as a CMC reviewer in CBER’s Office of Vaccines Research and Review (OVRR). She brings extensive experience in regulatory review, CMC assessment, and evaluating manufacturing and analytical data for complex biologics. At ELIQUENT, Dr. Ming supports clients through all phases of CMC development, from early-stage regulatory strategy and IND preparation to BLA submissions to post-approval changes, offering practical, science-driven guidance to ensure regulatory compliance and product success.

Dr. Ming brings over 15 years of experience in chemistry, enzymology, and regulatory science, with expertise spanning both small-molecule and biologic product development. During her tenure at the FDA, she served as a CMC reviewer in CBER’s Office of Vaccines Research and Review (OVRR), where she evaluated analytical, manufacturing, and quality data in support of IND and BLA submissions. Her review work involved assessing compliance with regulatory requirements and collaborating with cross-disciplinary teams to address complex product quality issues.

Prior to joining the FDA, Dr. Ming conducted postdoctoral research at Johns Hopkins University School of Medicine on small-molecule inhibitors targeting the histone demethylase LSD1, leading to a U.S. patent and multiple publications. She earned her Ph.D. in Chemistry and B.S. in Medicinal Chemistry from the University at Buffalo, SUNY. Her combined background in enzymology, analytical characterization, and CMC review enables her to guide clients in developing robust, regulatory-compliant strategies for small-molecule and biologic drug products.