Introduction to FDA’s Office of Vaccines Research and Review

1. Introduction to FDA’s Office of Vaccines Research and Review Norman W. Baylor, Ph.D. Director, Office of Vaccines Research and Review

2. OVRR Mission Statement Protect and enhance the public health by assuring the availability of safe and effective vaccines, allergenic extracts, and other related products.

3. We accomplish our mission by performing the following activities • Review, evaluate and take appropriate action on INDs, BLAs, and amendments and supplements to these applications for vaccines and related products • Plan and conduct research related to the development, manufacture and testing of vaccines, and related products • Develop policy and procedures governing the pre-market review and evaluation of vaccines and related products • Evaluate and test licensed vaccines and related products as appropriate prior to release and distribution of these products into the market by manufacturers

4. We accomplish our mission by performing the following activities (cont’d) • Evaluate and monitor clinical experience and reports of adverse events as necessary in coordination with CBER’s Office of Biostatistics and Epidemiology • Participate in inspections of manufacturing facilities • Participate in national and international outreach activities, including collaborations with global National Regulatory Authorities

5. OFFICE OF VACCINES RESEARCH AND REVIEW DIRECTOR Norman Baylor Ph.D. DEPUTY Vacant SPECIAL ASSISTANT: Maureen Hess, M.P.H. Associate Director For Management and Scientific Affairs Erik Henchal, Ph.D. FAAM Associate Director for Regulatory Policy: Marion Gruber, Ph.D. Associate Director of Research: Michael Brennan, Ph.D. Associate Director of Quality Assurance: William McCormick, Ph.D. Division of Bacterial, Parasitic and Allergenic Products. Director: Richard Walker, Ph.D. Deputy: Milan Blake, Ph.D. Division of Vaccines and Related Products Applications Director: Karen Goldenthal, M.D. Deputy: Donna Chandler, Ph.D. Division of Viral Products Director: Jerry Weir, Ph.D. Deputy: Philip Krause M.D. Updated 4/13/06

6. Who are We? • OVRR is the largest product office in CBER • Has a staff of over 300 employees • Divided among 3 Divisions and the Immediate Office of the Director (IOD) • Product testing laboratories are also under the OVRR IOD • Division of Vaccines and Related Products Applications (DVRPA) • non-laboratory based regulatory review scientists and clinical reviewers • Division of Bacterial, Parasitic, and Allergenic Products (DBPAP) • laboratory-based scientists who conduct research and regulatory review • Division of Viral Products (DVP) • laboratory-based scientists who conduct research and regulatory review

8. The Role of Research in OVRR • Supports science-based regulatory review and decision making. • Provides expert review of regulatory submissions, e.g., INDs and BLAs, in various scientific disciplines • Addresses product-related issues in the laboratory, as the need arises • Influences policy and guidance on new technologies and the application of existing technologies to new areas • Essential component of the regulatory review process to assure the safety, purity, potency, and effectiveness of vaccines and related products. • Needs to be sufficiently open-ended to provide the ability to respond to new areas • Serves to recruit and maintain highly qualified scientists.

9. Research Priorities • Within the broad range of scientific disciplines, certain programs must be maintained for their importance to the general needs of OVRR. • These areas are established by the OVRR leadership, in concert with the scientific staff • The needs of the regulatory review process drives research priorities. • Broad research expertise in vaccine-related disciplines, e.g., bacteriology, virology, immunology and biochemistry. • Allows OVRR to shift priorities when public health emergencies arise. • Research projects and their relative priority change over time, • Necessary to continually evaluate research needs.

10. The Process of Setting Priorities • The ultimate decision on prioritization results from a subjective, but reasoned, evaluation of the following: • Priority setting by relevance • Nature of research programs depends on the importance, and outcomes have implications for an extensive set of existing issues, e.g., product safety and characterization. • Priority setting by uniqueness and feasibility • Are there specific considerations that compel the project to be done by OVRR scientists, i.e., are OVRR scientists in a special position, due to specialized knowledge, availability of reagents or technical expertise, to conduct the research. • E.g., potency and serological assay development • Special Considerations • Research programs must be able to rapidly respond to emergencies as they arise.

11. High Priority Research Areas • Safety issues related to vaccines and related products • Product characterization • Identification of immunological mechanisms • Mechanisms of pathogenicity • Emerging Issues

12. Current Research Areas with Increased Attention • Counter-terrorism • Anthrax, smallpox, plague • Development of animal models for the “animal rule” • Pandemic Influenza • Use of “new technologies such as adjuvants, cell cultures, recombinant and subunit vaccines, • Development of new assays for potency and measuring clinical effectiveness • Cell Substrates • adventitious agent testing • Tumorigenicity • Allergen structure and function

13. Summary OVRR’s research program serves to recruit, train and retain highly qualified scientists who possess the necessary knowledge and technical skills to conduct research and review that will facilitate the development of new and innovative vaccines and related products that are safe and effective, and will contribute to the health and well-being of the public.