Destry Sillivan

  PhotoCDR Destry Sillivan has been employed by the FDA for 15 years. He has been in his current position with CBER/DMPQ for seven years, and is currently the Team Leader/Branch II. 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 and/or overseeing 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 is part of the OCBQ/DMPQ management team, participating 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, CDR 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. CDR 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.