Science Advisor

Lee Mia Nagao, Ph.D. is a senior science advisor on the Pharmaceutical Team of the Government & Regulatory Affairs Practice Group.  Lee advises domestic and international clients in the areas of evaluation and regulation of container closure and device components, pharmaceutical development and manufacturing, pre-clinical toxicology, auditing, current Good Manufacturing Practices (cGMPs), supply chain issues and drug master files and other regulatory submissions.  She also has experience with the development of methods and standards requirements for drug products and the scientific development and regulation of medical countermeasures (vaccines and therapeutics) for biosecurity applications.  Lee has broad scientific interests and expertise, and represents industry groups before the FDA, Health Canada, EMEA, MHRA, USP and other regulatory and scientific agencies and standards organizations in the United States, Canada and Europe. 

In General.  Lee received her undergraduate degree in chemistry and biochemistry from the University of California, San Diego, and her PhD focusing on physical organic chemistry in the solid state from Yale University.  Lee is a member of the American Chemical Society, the American Association for the Advancement of Science, the American Association of Pharmaceutical Scientists, the Parenteral Drug Association and the Product Quality Research Institute.