FDA: Is it Really a Black Hole?

Frey-Vasconcells Consulting, LLC, Sykesville, USA

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

Prior to forming Frey-Vasconcells Consulting, 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, I 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).  I also served on various committees related to combination products, tissue reference group, and HHS committee on tissue engineering to name a few.  

In 2005 I joined PharmNet Consulting where I continued working with industry 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 cell therapies, combination products, and gene therapies and brings extensive regulatory expertise and experience for this unique group of products.

Dr. Frey-Vasconcells received her Ph.D. in Immunology from Kansas Statue University and prior to joining FDA/CBER was a Post-Doctoral fellow and Senior Staff Fellow at the National Cancer Institute of NIH.