Senior Director, Science, Regulation & Policy
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ELSIE
Lee Mia Nagao, Ph.D. advises domestic and international clients in the areas of evaluation and
regulation of pharmaceutical development and manufacturing. She also advises clients on
pharmaceutical packaging and materials issues, pre-clinical toxicology, auditing, current Good
Manufacturing Practices (cGMPs), supply chain issues, drug master files and other regulatory
submissions. Lee 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. She has broad scientific interests and experience, and
represents industry groups before the FDA, Health Canada, EMA, MHRA, CFDA, ANVISA, USP and other regulatory, standards, industry and scientific organizations world-wide.