David Keire, 2019 Saint Louis Award winner
Dr Keire obtained his BS in Chemistry from the University of Washington in 1985. He completed his PhD in Analytical Chemistry, specializing in NMR spectrometry, at the University of California–Riverside in 1990 under Dallas Rabenstein. Upon graduation, he held a postdoctoral appointment at Purdue University with David Gorenstein before joining the Division of Immunology of the Beckman Research Institute of the City of Hope National Medical Center in 1992 as an Assistant Research Scientist and Director of the NMR facility.
In 1999 he was hired into the Digestive Diseases Division of the David Geffen School of Medicine at UCLA as an Associate Researcher with a joint appointment as a Research Chemist at the Greater Los Angeles Veterans Administration Hospital; in 2005, he was promoted to Researcher. Finally, in October, 2008, he joined the FDA as Chemist in the Pharmaceutical Analysis division (DPA) of CDER. In 2010, he was promoted to Research Chemist and in 2013, to Senior Research Chemist. In 2016, he became Director of Division of Pharmaceutical Analysis, the position he now holds. He was appointed to a Senior Biomedical Research Service (SBRS) position in 2018, one of fewer than 80 in the agency.
Dr Keire has contributed greatly to FDA research and regulatory priorities by acquiring and applying state-of-the-art NMR spectroscopy and mass spectroscopy (MS) instrumentation to develop analytical methods for complex drug substances and biologics. His first major accomplishment after joining the FDA was to lead the development of improved analytical methods for the analysis of heparin products leading to regulatory specifications to ensure the quality, purity and potency of these products. He then went on to lead the development of orthogonal state-of-the-art NMR and MS methods for the analysis and quality assessment of biologics such as insulin, human growth hormone, and antibodies. He also led the development of a novel in vitro approach involving high resolution analytical techniques with multi-variate analysis to assess similarity or equivalence for complex drugs, which was used to support approval of the first generic glatiramer acetate for multiple sclerosis. Most recently, he has led method development for detecting carcinogenic impurities in cardiovascular drugs such a valsartan.
To date, Dr Keire has 97 peer-reviewed publications, 7 book chapters, and 7 popular publications, as well as 62 internal technical reports. He has presented 65 invited seminars at internal, national, and international meetings, and was appointed to the editorial advisory board of Analytical Chemistry in 2017. In 2018, Dr Keire was selected as the Regulatory Chair of the ICH Expert Working Group to revise analytical method development and validation guidance documents. For the past three years, Dr Keire has served as a member of the CDER Committee for Advanced Scientific Education (CASE), which promotes continuing education of CDER employees. Dr Keire’s expertise has led to him being a member of the team developing CDER guidance on heparin drugs and serving as an FDA representative at the United States Pharmacopeia (USP) Heparin/Protamine Expert Panel.
The Saint Louis Award, sponsored by the Monsanto Company and administered by the Saint Louis Section–ACS, is presented to an individual who has made outstanding contributions to the profession of chemistry and demonstrated potential to further the advancement of the chemical profession. The award, consisting of a $1,500 honorarium and a plaque, will be presented at the Saint Louis Award Banquet that will be held Friday evening, October 25, 2019, at the Glen Echo Country Club. Details on the Banquet and the St Louis Award Symposium, which will be held that Friday afternoon at the Saint Louis College of Pharmacy, will follow.
“Computers and the physics of complex biological systems”
