Michael J. Roy

Michael J. Roy, Ph.D., RAC, is an Adjunct Professor in the Master of Science Biotechnology Program in the School of Medicine and Public Health at the University of Wisconsin-Madison, teaching Biotechnology Operations and Project Management and Leadership in the Master of Science, Biotechnology Program. He has successfully developed biopharmaceutical and medical device products for more than 22 years, serving as a consultant since 2001 with BioDevelopment Resources, Inc., Science Applications International Corporation and, more recently, at Michael Roy and Associates. Much of his work has focused upon early development of novel biotechnology products and medical devices with emphasis on product development planning, regulatory affairs, quality systems and project management. He has worked with a variety of biopharmaceutical products with an emphasis on vaccines and therapeutic proteins. At PowderJect Vaccines, Inc., he was Vice President of Regulatory Affairs, responsible for national and international regulatory strategies and programs and he managed clinical and regulatory efforts for the firm’s vaccine development programs. Prior to its merger with PowderJect, he served as Director of Regulatory Affairs at Agracetus, Inc. In these roles he established and managed manufacturing, quality assurance, quality control and regulatory affairs and was involved in development of vaccines, genetic therapies, medical delivery devices and biopharmaceutical products raised in plants. Before this he was Director, Regulatory Affairs at MedImmune, Inc., where he was responsible for regulatory submissions of several vaccines, monoclonal antibodies and intravenous immunoglobulin products. He spent 10 years as a civilian scientist at the U.S. Army Medical Research and Development Command where he managed and led biopharmaceutical development projects aimed at developing over 20 products. He is a graduate of the University of Wisconsin-Madison with Ph.D. in Pathology, of Louisiana State University Medical Center with a M.S. in Tropical Medicine and Medical Parasitology, and of the University of Wisconsin-Platteville with a B.S. in Biology. He holds Regulatory Affairs Certification (RAC). He retired as a Colonel in the U.S. Army Reserves, where he was involved in the development of in vitro diagnostics and established ISO quality systems for diagnostic laboratories at USAMRIID, Ft. Detrick, MD. He enjoys growing hardwood trees and spending time on land in southwestern Wisconsin.