Destry Sillivan

CDR Destry Sillivan has been employed by the FDA for ten years. He has been in his current position with CBER/DMPQ for nearly six years, and is currently a senior reviewer/inspector. During his tenure at DMPQ, he has led many pharmaceutical manufacturing facility inspections, and has been either a reviewer or review chairperson for numerous other applications. His current areas of responsibility are review of manufacturing information submitted in Biologic License Applications (BLAs); conducting pre-approval and pre-license inspections for new facilities; review of investigational new drug submissions (INDs); and review of compliance actions arising from biennial post-licensure inspection of biopharmaceutical firms. He also assists OCBQ/DMPQ management in development, recommendation, and implementation of regulatory policy. Prior to his current position, CDR Sillivan worked as a Senior Regulatory Project Manager in the Division of Viral Products, FDA/CDER/ODEIV. His responsibilities during that assignment included management of numerous New Drug Applications (NDA) and IND applications, to include but not limited to the planning, coordination, and execution of all activities, meetings, and goals related to each application. Before joining the FDA, CDR Sillivan worked at Antex Biologics. His duties there included research development of novel vaccines. Prior to joining Antex Biologics, LCDR Sillivan conducted scientific research at United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD. His research included the areas of molecular biology, immunology, and viral biology, with emphasis on development of novel viral vaccines and development of quantitative assays. LCDR Sillivan received a M.S. in Biomedical Sciences from Hood College, Frederick, MD in 1998 and a B.S. in Biology from the Colorado State University in 1988.