David Keire

Dr. Keire received a Ph.D. in Analytical Chemistry at the University of California, Riverside in 1990 with a focus on NMR spectroscopy. In 2008, Dr. Keire joined CDER/OPQ/Office of Testing and Research (OTR) and his since then analytical chemistry skills have been applied to issues that arise with complex drugs (e.g., heparin, protamine sulfate, glatiramer acetate, transdermal systems, inhalers, modified release dosage forms and protein-based therapeutics). In 2019, David won the prestigious St. Louis American Chemical Society Award for his contributions to the chemical profession. Currently, he is the office director of OTR that has about 130 staff across St Louis, Missouri and White Oak, Maryland sites. He has over 110 peer reviewed research articles and book chapters describing his work. Since 2018 he has participated as the Regulatory Chair of the ICH Q2(R2)/Q14 Expert Working Group revising and creating analytical procedure development and analytical procedure validation guidances.