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 David E. Hughes, Ph.D, has 30 years of pharmaceutical and biotechnology industrial experience. His expertise is in analytical method development for methods of analysis of conventional and biologic drug entities, specializing in separation science (liquid chromatography and capillary electrophoresis methodology) . He has dealt with a wide array of analytical techniques and solved an extensive number of complex problems, as evidenced by over 70 publications and presentations in the field. His contributions to the chemical literature include multiple-mechanism LC separations of pharmaceutical compounds, the first theory of solid-phase extraction specificity followed by a second paper demonstrating the theory’s applicability, and pioneering capillary electrophoretic studies on antibodies, fusion proteins, and oligosaccharides. He has authored a number of publications with world-renowned separations scientists, and he has directed Ph.D. activities. Dr. Hughes was employed by P&G Pharmaceuticals where he was quickly promoted and headed a group of Ph.D. scientists and associate scientists. His responsibilities included the development of analytical methods for quality control of dosage forms, stability testing, bioanalytical assays, product and raw material impurities, reference standards, and identity testing by HPLC, GC, TLC, AA, UV, fluorometric and wet chemical methods. He was involved with the development of all IND and NDA submissions while at P&G and developed the chromatographic methods for the Buprenex, Asacol, skeletal muscle relaxant, cardiotonic, and anti-arrhythmic submissions. Dave joined the Bristol-Myers Squibb Company in 1990 and was promoted several times culminating with the title of Senior Principal Scientist, the only separation scientist at BMS promoted to that level. In addition to his scientific contributions, he was responsible for a team of (7-10) Ph.D’s and associate scientists; departmental validation coordination, and all aspects of method development for both conventional and biotechnological products. He was involved with many BMS products: Cefzil, Maxipime, Serzone, Mutamycin, Videx, and Zerit. Dave was also heavily involved with methods development for biologics for RA, immunosuppressant therapy, and antibody/cytotoxin conjugates as anticancer agents. He directed the creation of a GLP/GMP compliant laboratory at the Princeton , New Jersey BMS site and was involved with ongoing regulatory activities including representing BMS during FDA audits. During his tenure at Princeton, he was the recipient of the President's Award. He was the organizer and leader of the multi-site Community of Separation Sciences (2000-2003) and served as the senior collaborator on separation science issues at all BMS sites. Dr. Hughes was awarded a patent for an atropisomeric cardiovascular drug he isolated in 2002. David founded Chromatographic Excellence in 2003. He currently consults in all areas of pharmaceutical and biotechnological analytical chemistry with special expertise in conventional and capillary liquid chromatographic method development, capillary electrophoresis, validation, and applications. Most recently, he has been extensively involved in capillary LC applications development for single and multi-channel instruments.
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