Expertise: Cellular therapy, gene therapy, tumor vaccines, tissue-based, and combination (tissue-engineering) products

Prior to joining PharmaNet, Dr. Frey-Vasconcells served more than 12 years at the FDA, most recently as Deputy Director, Office of Cellular, Tissue, and Gene Therapies (OCTGT) with the Center for Biologics Evaluation and Research (CBER). At FDA, Dr. Frey-Vasconcells 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). Dr. Frey-Vasconcells fostered unique innovations to cell therapy regulation, and has been instrumental in strategizing regulations for cell therapies including stem cells, pancreatic islet cells, and cord blood. She made significant contributions to the development of the newly published tissue rules, which outline the regulatory requirements for cellular and tissue based products.

Since joining PharmaNet Consulting, she has continued working with industry on an individual basis and with organizations whose mission is to foster product development in the areas of cell therapy, tissues, gene therapy, and tissue engineered products. She is considered one of the foremost regulatory experts regarding tissues, cell therapies, combination products, gene therapies, and tumor vaccines, and brings extensive regulatory expertise and experience for this unique group of products.