Senior Director, Science, Regulation & Policy
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ELSIE
Lee M. Nagao, Ph.D., is a Senior Director of Science, Regulation and Policy at the law firm of Faegre, Drinker, Biddle and Reath, LLP, and is a member of the Firm’s Life Sciences Consortium Management and Regulatory Affairs Practice Group. The Group works extensively with pharmaceutical, biopharmaceutical and medical device companies on a range of scientific and regulatory collaborations and provides strategic and regulatory guidance to individual life sciences companies. Lee plays a lead role serving scientific and regulatory consortia including the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), the Extractables and Leachables Safety Information Exchange (ELSIE), and the International Pharmaceutical Consortium on Innovation and Quality (IQ). Lee has extensively published and presented on many aspects of pharmaceutical development including supply chain, CMC, and translational sciences. She has represented various industry groups before regulatory and scientific agencies and organizations in the US, Europe and Asia, including the FDA, EMA, China NIFDC, Chinese Pharmacopoeia, ANVISA, Taiwan CDE, Japan PMDA, and USP.