Deputy Direct CDER/OPQ/OTR
US Food and Drug Administration
Silver Spring, Maryland
David Keire received a Ph.D. in Analytical Chemistry at the University of California, Riverside in 1990. Currently he is the Deputy Director of the Office of Testing and Research (OTR) which is located St Louis and part of US FDA/CDER/OPQ. Dr. Keire joined the FDA in 2008 and attained a a Senior Biomedical Research Scientist (SBRS) designation in 2018. At FDA, David’s analytical chemistry skills have been put to use at the FDA on studies of complex drugs (e.g., heparin, protamine sulfate, glatiramer acetate, transdermal systems, inhalers, modified release dosage forms and protein based therapeutics). He maintains a research program in the identification and evaluation of state-of-the-art analytical technologies for complex drug analysis to provide scientific input on drug quality questions to FDA review staff. He has over 100 peer reviewed research articles and 8 book chapters describing his work. For the past two years he has been involved in developing and implementing tests for nitrosamine impurities in pharmaceuticals.