Mike Lee
Milestone Development Services

Mike Lee

Milestone Development Services

Partner

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 30 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.

Dr. Lee is also a founding member of the CPSA Charitable Foundation, a publically registered non-for-profit organization incorporated in Idaho. The Foundation is dedicated to the progress of scientific discoveries – from research to the bedside – focusing technology, resources and expertise to advance human health.

Dr. Lee is the author or co-author of over 50 scientific papers and patents. An editor with John Wiley & Sons, Dr. Lee is responsible for a book series on Pharmaceutical and Biotechnology: Practices, Applications and Methods. 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.