CPSA Charitable Foundation

Leadership

Mike S. Lee, Ph.D.

Dr. Mike S. Lee is a biotechnology entrepreneur and Founder and President of Milestone Development Services. He actively participates in the development of new technologies and their integration into industrial settings.

Dr. Lee has more than 25 years of pharmaceutical industry experience. He has pioneered the application of LC/MS for research dealing with biomolecules, optimization of ADME and physicochemical properties, natural products, drug metabolites, impurities, and degradants. He works closely with industry leaders involved with clinical and pharmaceutical analysis to connect industry needs with innovative technologies and solutions via consulting, workshops, and symposia.

Prior to founding Milestone Development Services, Dr. Lee was with Bristol-Myers Squibb. As Director of Analytical Research & Development, Dr. Lee was responsible for departments in research facilities located in Princeton, NJ, Wallingford, CT, Hopewell, NJ, and New Brunswick, NJ providing MS, NMR, IR, HPLC, CE, and physical chemistry support. Under his direction, novel analytical strategies for preclinical development facilitated the shortening of IND development from 2 years to 6 months. He led interdisciplinary teams responsible for rapid analysis of discovery leads and preclinical drug candidates that contributed to the Food & Drug Administration approval of Buspar®, and Serzone®, and the accelerated development and approval of TAXOL®.

Dr. Lee is a founder of the Annual Symposium on Clinical and Pharmaceutical Solutions through Analysis (CPSA). These unique events, held in the US, China and Brazil, highlight industry-related applications and feature sessions promoting discussion on real-world experiences with the latest analytical technology and industry initiatives. Industry scientists and professionals focus on needs, issues, and analytical performance benchmarks necessary for accelerated product development.

An editor with John Wiley & Sons, Dr. Lee is responsible for a book series on Pharmaceutical and Biotechnology: Practices, Applications and Methods. His books entitled “Mass Spectrometry in Drug Metabolism and Disposition: Basic Principles and Applications” and “Characterization of Impurities and Degradants Using Mass Spectrometry” was recently published by Wiley in the Spring of 2011.

Dr. Lee is the author or co-author of over 50 scientific papers and patents. His recent patent on segmented flow technology is the basis of a new start up company he has founded, Mozaic Solutions, to address the primary targets for personalized medicine. He received his BS degree in Chemistry at the University of Maryland in 1982. In 1985 and 1987, he completed his MS and PhD, respectively, in Analytical Chemistry from the University of Florida under the direction of Professor Richard A. Yost. He currently serves on the Leadership Board for the Department of Chemistry at the University of Florida.

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Shane R. Needham, Ph.D.

Dr. Shane Needham received his B.S. degree in chemistry from Washington State University and his Ph.D. in chemistry from the University of Rhode Island.  Dr. Needham is Co-Founder and Laboratory Director of Alturas Analytics, Inc.  Dr. Needham manages all scientific aspects of the HPLC/MS/MS bioanalytical contract laboratory at Alturas Analytics, Inc.  Currently, Dr. Needham’s work is focused on the development and validation of assays for the determination of therapeutic agents and biomarkers from biological matrices.  His laboratory has been a leader in the area of dried blood spot (DBS) analysis and microflow HPLC-MS/MS to support DMPK research.

Dr. Needham has over 100 publications and external presentations in the area of LC/MS.  He has over 20 years of LC/MS and analytical lab experience in the drug discovery through drug development stage in the pharmaceutical industry.  He previously worked for Pfizer in Groton, CT where he developed and validated GLP and non-GLP LC/MS/MS methods for the trace analysis of drugs and metabolites in biological fluids.  He also performed in vivo and in vitro structure elucidation studies of drugs and metabolites using HPLC/MS/MS and HPLC/MSn instrumentation.  Dr. Needham has LC/MS experience working with triple quadrupole, single quadrupole, ion trap, time-of-flight and quadrupole time-of-flight instrumentation.  His area of academic research included the development of optimized stationary phases to improve the assay of pharmaceuticals by HPLC/MS.

Dr. Needham has been the chair and organizer of several workshops at national conferences.  Dr. Needham was program chair of the 2013 CPSA-USA conference.  Dr. Needham also teaches LC/MS courses at international conferences including, Pittcon and AAPS conferences.  Dr. Needham is also a reviewer for several peer reviewed journals including, Bioanalysis, Journal of Chromatography, Analytical Chemistry and Journal of Chromatographic Science.  Dr. Needham also serves on the editorial board for the publication, American Pharmaceutical Review.  Dr. Needham is a member of the American Chemical Society, American Society for Mass Spectrometry, American Association of Pharmaceutical Scientists and the International Society of the Study of Xenobiotics.

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Paul G. Corcoran

Paul G. Corcoran, currently President and CEO of McKinley Scientific, LLC has over 30 years of industry experience and product development in the high-end technology equipment leasing and asset management business.  Mr. Corcoran is an active participant in the scientific community. He is dedicated to providing services to support the clinical, academic and pharmaceutical markets.

He started his career at Siemens Corporation where he was one of the leading sales people. Subsequent to his time at Siemens, Mr. Corcoran directed the marketing activities for Cable and Wireless’s Carterfone Division, an IBM plug compatible vendor, in the New York region. After a short time as a sales representative, Mr. Corcoran became the Vice President in charge of remarketing a portfolio of IBM mainframe computers at Computer Leasing Inc., a large New Jersey based global equipment lessor. As Senior Vice-President at Computer Leasing, he founded the Advanced Technologies Group serving the semi-conductor manufacturing industry. After a brief time at the Laboratory and Scientific Group of Comdisco, he and his partners founded McKinley Scientific in 2000.

After founding McKinley Scientific, Mr. Corcoran introduced a unique strategy of global instrumentation management to the scientific industry. As a service provider in the scientific community, Mr. Corcoran has become an interested and active supporter of industry related needs and issues.