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.
Lee advises on a variety of topics including:
- Drug development process, quality and CMC
- Pharma/biopharma and device packaging, and manufacturing process materials
- Supply chain quality.
Awards Methodology (www.drinkerbiddle.com/content/awards)
- Yale University, Ph.D., 1998
- University of California, San Diego, B.A., 1990
- American Association for the Advancement of Science
- American Association of Pharmaceutical Scientists
- American Chemical Society
- Parenteral Drug Association