Biography

Jean Dehdashti, MSc, RAC, is a program officer in NCATS’ Division of Rare Diseases Research Innovation, where she works with the deputy director in overseeing and managing several gene-targeted therapy programs. In this capacity, she provides programmatic and project management and contracting oversight, as well as her regulatory science expertise, to help administer the following NIH Common Fund programs: Somatic Cell Genome Editing, the Platform Vector Gene Therapy (PaVe-GT) pilot project and the Bespoke Gene Therapy Consortium.

Before rejoining NCATS in July 2023, Dehdashti served as the special assistant to the director and a senior project manager at the U.S Food and Drug Administration (FDA) Office of Orphan Products Development from 2022 to 2023, where she was an integral part of operations, budget and contracting, outreach, and programmatic-related initiatives. Prior to her most recent tenure at the FDA, she was a health program specialist in NCATS’ Office of Translational Medicine from 2020 to 2022, where she supported the center’s chief medical officer in administering clinical research initiatives. In addition, Dehdashti provided regulatory expertise and support for NCATS’ clinical programs for investigational products (i.e., biologics, drugs [small molecules] and/or, medical devices). She also 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 efforts.

Dehdashti was a regulatory project manager at the FDA Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies, from 2017 to 2020, where she served as 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 reviewing in vitro, diagnostic and hematology-related device submissions. Before originally joining the FDA in 2017, Dehdashti served as a regulatory consultant at Cardinal Health for drug, combination product and device-development programs. She also has served as a research associate at Purdue University.

Dehdashti has more than 20 years of experience in scientific research and medical product development and 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 B.S. in biochemistry from the University of Kansas and a MSc in cell and molecular biology from the University of Missouri. In addition, she is U.S. Regulatory Affairs Certified and received her master’s certificate in project management from The George Washington School of Business in December 2019 and her contracting officer representative, level II (COR-II) certification in December 2020.

Research Topics

As an academic, Dehdashti is interested in developing investigational drugs, particularly cell and gene therapy modalities, for rare diseases and underserved populations. She is driven by helping to address the challenges associated with translating preclinical development of cell and gene therapy investigational products to clinical development for patient treatment.