1 / 14

Laboratory of Respiratory and Special Pathogens

Laboratory of Respiratory and Special Pathogens. History of the Laboratories. Laboratory of Pertussis. Laboratory of Respiratory and Special Pathogens. Laboratory of Methods Development and Quality Control. Product area specialists. Test development specialists. Structure of LRSP.

opal
Download Presentation

Laboratory of Respiratory and Special Pathogens

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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 specialists Test development specialists

  3. Structure of LRSP

  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 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

More Related