FDA Employment
- Retired from US Food and Drug Administration in 2007
- 32-year career with the US Government, including 27 years of experience with the Office of Vaccines in the Center for Biologics Evaluation and Research
- FDA position included research and regulatory responsibilities
- Specialized in bacterial vaccines, with emphasis on pertussis and anthrax vaccines
FDA Research program
- Laboratory program emphasized development and evaluation of assays and animal models used to evaluate vaccine manufacturing and clinical performance
- Laboratory played a significant role in the international harmonization of assays to measure the antibody response to pertussis infection and vaccination
FDA Regulatory activities
- Chair or member of numerous product license applications and amendments
- Review of Investigational New Drug applications
- Supervision of batch release of pertussis and anthrax vaccines
- Inspection of US-licensed vaccine manufacturers
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