LinkedIn:Deputy DirectorDeputy...

LinkedIn:

Deputy DirectorDeputy DirectorFDA/CBER/OVRRFDA/CBER/OVRROct 2010 - Dec 2021 · 11 yrs 3 mosOct 2010 - Dec 2021 · 11 yrs 3 mos I help to oversee activities associated with regulatory review of products regulated by FDA's Office of Vaccines Research and Review. This portfolio includes all vaccines against infectious diseases, allergenic products, and live biotherapeutics. Along with regulatory experts and clinical reviewers, the >250 professionals in OVRR include laboratory-based scientists who help to assure that decisions are based on the most current science. My own research laboratory addresses scientific questions surrounding viral latency and immune evasion to support this regulatory work. I contribute to global public health as an ad hoc advisor to the World Health Organization on topics ranging from clinical trial design and analysis, vaccine stability, and recently, as chair of the WHO's R&D Blueprint Working Group on COVID-19 Vaccines, the development of a research roadmap for vaccines against SARS-CoV-2, the cause of the clinical illness known as COVID-19. I am a member of the International Conference on Harmonization (ICH) Working Group for E8(R1) (Guideline on General Considerations for Clinical Studies), and am a member of the Scientific Advisory Committee of the Coalition for Epidemic Preparedness Innovations (CEPI), which supports the development of vaccines against emerging infectious diseases.