1. Overview Division of Viral Products Office of Vaccines Research and Review Laboratory of Methods Development Site Visit January 9, 2003

2. Division of Viral Products Office of Vaccines Research and Review Office of the Director –Director, Jerry P. Weir, Ph.D. –Deputy Director, Philip Krause, M.D. Laboratories of DVP –Laboratory of Hepatitis Viruses –Laboratory of Vector-Borne Viral Diseases –Laboratory of Retroviruses –Laboratory of DNA Viruses –Laboratory of Pediatric and Respiratory Diseases –Laboratory of Immunoregulation –Laboratory of Methods Development

3. Division of Viral Products Mission and Functions Regulate viral vaccines and related biological products Facilitate the development, evaluation, and licensure of new viral vaccines that positively impact the public health

4. Division of Viral Products Review and research Activities Review activities –Investigational New Drug Applications –Biologic License Applications –Lot release review and testing –Post-marketing activities –Manufacturer inspections Research Efforts –Viral pathogenesis –Vaccine development & evaluation –Viral vector evaluation –Vaccine safety and efficacy –Methods development

5. Division of Viral Products Staff and Budget Current Full-time Staff of approximately 80 –Total staff of approximately 120 –Recent increases in FY02 of 13 full-time staff as a result of counter-bioterrorism initiative FY03 Budget approximately $1.0 M –Increase from a low of ~ $750-800K in FY99-00 –Slight decrease from FY02 (~$1.2 M) in spite of added staff –Supplemental funding from outside sources now greater than internal funding

6. Division of Viral Products Laboratory of Methods Development Research Efforts –Development of molecular tests (e.g., MAPREC, microarrays, etc.) –Development of animal models (e.g., transgenic mice for neurovirulence assays) –Development of in vitro tests (e.g., IPV ELISA) Regulatory Responsibilities –Regulation of poliovirus vaccines

7. Site Visit Evaluation January 9, 2003 Committee reviewed the research programs of LMD Evaluated the progress of individuals in the Laboratory Assessed the future directions of the Laboratory