Robin Levis, PhD US FDA

Dr. Robin Levis has worked at the US Food and Drug Administration since 1995. She is currently the Deputy Director of the Division of Viral Products in the Office of Vaccines Research and Review at CBER/FDA; a position she has held since 2006. Prior to this position, she served as the Regulatory Coordinator for the Division of Viral Products (2002-2006) and served as a Senior Staff Fellow in the Laboratory of Vector Borne Viral Diseases (1995-2002). Her initial research work at the FDA related to flavivirus replication and the role of the NS1 protein. She then transitioned to be the lead CMC reviewer for licensed rabies virus vaccine products and rabies vaccine and related products under development.

In addition to her work in the Office of Vaccines at CBER, she serves as the CBER representative to ICCVAM, as an observer to EDQM Group 15 for vaccines, a member of the WHO/NC3Rs working group, and serves on several vaccine working groups for the Coalition for Pandemic Preparedness Innovations. Her role on these International working groups is to provide regulatory support related to CMC development and product quality for viral vaccines and to the development of alternative, non-animal based quality assays.

Prior to coming to the FDA, Dr. Levis received her PhD from Washington University in St. Louis, Missouri. She conducted two post-doctoral fellowships. One at the NIH working on polyoma- and papillomavirus replication and the second at The Uniformed Services University of Health Sciences on species specificity of viral replication of human coronaviruses.