Laboratory of Respiratory and Special Pathogens. History of the Laboratories Laboratory of Pertussis Laboratory of Respiratory and Special Pathogens Laboratory.

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Presentation transcript:

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 specialistsTest development specialists

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

LRSP Responsibilities Pertussis vaccines Anthrax vaccines Plague vaccines

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

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

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

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

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

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

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

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

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

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