Elena Smith, PhD, is Quality Analytical Expert at Sanofi Pasteur and a lead of subgroup for early availability of reagents at WHO Pandemic SWITCH Potency Assay Working Group contributing to WHO operation plan for Pandemic Influenza Vaccine Response. Dr Smith contributes to the analytical strategy of the new products and provides expert support to the launches worldwide. Dr Smith joined Protein Sciences Corporation (acquired by Sanofi in 2017) in 2013 and led Quality Control for the commercialization of the new product, world's first recombinant Influenza vaccine, with several seasons of product scale-up on the market. Dr. Smith obtained her Ph.D. in Molecular Biology in 2004 from State Research Center of Virology and Biotechnology Vector, Russia on HIV antivirals and completed her postdoctoral training on HIV antiviral/host infection mechanisms at U.S. National Institutes of Health. Dr. Smith focuses her industrial operations interests on analytical strategy for new products, standards, manufacturing process, and microbiological control of manufacturing sites.