Jean Dehdashti is a health program specialist in the NCATS Office of the Director, where she supports the Center’s chief medical officer in administering clinical research initiatives. In particular, she assists in managing scientific and operational requirements, assigning tasks and reporting requests, and communicating with staff assigned to trans-NCATS and trans-NIH initiatives. In addition, Dehdashti provides regulatory expertise and support for NCATS’ clinical programs for investigational products (i.e., biologics, drugs [small molecules], medical devices or a combination thereof).
Dehdashti rejoined NCATS in June of 2020 with more than 17 years of experience in scientific research and medical product development. From 2017 to 2020, she served as a regulatory project manager at the U.S. Food and Drug Administration (FDA) in its Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies, where she was the lead project manager on multiple marketing and pre-market biologics and device-related submissions for gene and cell therapy, as well as tissue-engineered and blood-derived products. She also served as a lead scientific reviewer at the FDA’s Center for Devices and Radiological Health, where she was responsible for the review of in vitro, diagnostic, and hematology-related device submissions. Prior to her tenure at the FDA, Dehdashti served as a regulatory consultant at Cardinal Health for various drug, combination product and device-development programs. She previously held positions at NCATS as a scientific project analyst and a scientific lead in the Therapeutics for Rare and Neglected Diseases program, for which she administered several orphan drug development programs. Dehdashti also has served as a research associate at Purdue University.
Dehdashti has received several public health achievement awards, including the FDA CBER Public Health Achievement Award in 2019, the National Institutes of Health Director’s Award in 2013 and 2015, and the NCATS Merit Award in 2012. Dehdashti was nominated as a Regulatory Affairs Professional Society Ambassador in 2017, where she actively engaged in mentoring, training and outreach.
Dehdashti holds a bachelor’s degree in biochemistry from the University of Kansas and a master’s degree in cell and molecular biology from the University of Missouri. In addition, Dehdashti is U.S. Regulatory Affairs Certified (RAC), and she received her master’s certificate in project management from The George Washington School of Business in December 2019.
As an academic, Dehdashti was interested in implementing and executing miniaturized high-throughput, in vitro studies in support of medicinal chemistry efforts to establish proof-of-concept (POC) studies and to identify potential lead small-molecule inhibitors against various rare and neglected disease targets. During that time, Dehdashti provided technical expertise to upper management and advised project teams on appropriate experimental approaches for in vitro POC studies to help advance translational sciences for rare and neglected diseases.