1. Laboratory of Respiratory and Special Pathogens

2. History of the Laboratories Laboratory of Pertussis Laboratory of Respiratory and Special Pathogens Laboratory of Methods Development and Quality Control Product area specialistsTest development specialists

3. Structure of LRSP Drusilla Burns, Chief Drusilla Burns Anissa Cheung Ishrat Rahman Anita Verma Steven Zink Tod Merkel Vanessa Grippe Gloria Lee Karen Meysick Jason Falconio

4. LRSP Responsibilities Pertussis vaccines Anthrax vaccines Plague vaccines

5. Pertussis Vaccines Changes in formulation (Tdap, combination vaccines, removal of thimerosal) Changes in manufacturing process Ongoing monitoring

6. Anthrax Vaccines Monitoring of licensed vaccine (AVA) Assess new generation vaccines Use of Animal Rule to demonstrate efficacy

7. Plague Vaccines New generation plague vaccines Use of Animal Rule to demonstrate efficacy

8. Structure of LRSP Drusilla Burns, Chief Drusilla Burns Anissa Cheung Ishrat Rahman Anita Verma Steven Zink Tod Merkel Vanessa Grippe Gloria Lee Karen Meysick Jason Falconio Pertussis Anthrax Pertussis Anthrax Plague

9. Regulatory Workload since 2000 365 INDs and amendments reviewed 62 BLAs and BLA supplements reviewed Taken a lead role within the Center on implementation of the Animal Rule

10. Research Program: Drusilla Burns Bordetella pertussis Structure/function studies of PT Studies on the mechanism of secretion of PT Bacillus anthracis Role of surface proteins in virulence

11. Research Program: Tod Merkel Bacillus anthracis Identification of important virulence factors Development of a mouse aerosol challenge model for inhalation anthrax Bordetella pertussis Characterization of critical virulence regulatory pathways

12. Research Program: Karen Meysick Yersinia Analysis of a novel type III secretion system of Y. pestis/Y. pseudotuberculosis Characterization of the phospholipases of Y. pestis/Y. pseudotuberculosis Development of biological assays to demonstrate correlates of protection for plague vaccines

13. Impact of Research on Regulatory Mission Design release tests for DTaP vaccines Helps manufacturers optimize production of PT Conduct proof of concept studies that justify further development of anthrax vaccines and therapeutics Identification of new candidate vaccine antigens for plague vaccines Development of functional assays that can be used to define correlates of protection for plague vaccines

14. Relevance of Research to Regulation State-of-the-art knowledge of the areas we regulate Expertise to best evaluate tests to assess the safety, purity and potency of vaccines Expertise to design and evaluate the efficacy studies for vaccines licensed under the Animal Rule Credibility in the field Problem solving approach