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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Interview
Spotlight Article

Regulatory insights and lessons learned for a new decade in cell & gene therapy

2020 vision - Tools and Technologies of Tomorrow

Joyce L Frey-Vasconcells

Joyce L Frey-Vasconcells PhD is considered one of the foremost regulatory experts regarding cell therapies, combination products, gene therapies, tumor vaccines, and tissues and brings extensive regulatory expertise and experience for this unique group of products. Prior to starting Frey-Vasconcells Consulting, Dr. Frey-Vasconcells served 6 years as a regulatory consultant for Pharmanet. Prior to joining Pharmanet, she served more than 12 years at the FDA as the Deputy Director, Office of Cellular, Tissue, and Gene Therapies (OCTGT) with the Center for Biologics Evaluation and Research (CBER). She was instrumental in developing many of CBER’s science and public health policies regarding the regulation of cells, tissues, gene therapies, tumor vaccines, and combination products (tissue engineered products). In 2001, Dr. Frey-Vasconcells was named the Regulatory Expert for Cell Therapies at FDA. Since starting Frey-Vasconcells Consulting, Dr. Frey-Vasconcells has continued working with industry on an individual basis and with organizations whose mission is to foster product development in these unique areas of medical science. She brings extensive regulatory expertise and experience for this unique group of products.

DOI: 10.18609/cgti.2019.158
Citation: Cell & Gene Therapy Insights 2019; 5(12), 1533-1540.
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