Mike Roy, Ph.D., R.A.C.

Back to last page

Mike Roy has successfully developed medical products--biotechnology, pharmaceutical and medical device--for more than 15 years. He is a consultant for Science Applications International Corporation, SAIC, a leading firm in technology development. He specializes in biotechnology product development, regulatory affairs, project management and quality systems.

Prior to joining SAIC, he was founder and principal of BioDevelopment Resources. Before that he was at PowderJect Pharmaceuticals, plc and PowderJect Vaccines, Inc., an international vaccine, device and pharmaceutical firm where he developed biologicals and drug and vaccine delivery devices. As Vice President, Regulatory Affairs, he was responsible for national and international regulatory strategies, he initiated the firm’s Quality Systems programs, and he managed the regulatory and clinical efforts in vaccines. From 1994 to 1996, and prior to its merger with PowderJect, Dr. Roy served as Director, Regulatory Affairs, Agracetus, Inc. In this role, he established and maintained manufacturing, quality assurance, quality control, clinical and regulatory affairs. These efforts led to successful clinical trials of medical devices, novel DNA vaccines and cancer therapeutics, and subsequently provided the basis for a major partnership between PowderJect and a large pharmaceutical firm.

Prior to joining Agracetus, Dr. Roy was Director of Regulatory Affairs at MedImmune, Inc., where he was responsible for regulatory submissions of several vaccines, monoclonal antibodies and intravenous immunoglobulin products. Before this, he spent 10 years as a civilian scientist at the U.S. Army Medical Research and Development Command, where he led research, preclinical and clinical programs for development of over 20 biotechnology and pharmaceutical products.

He also serves as a Colonel in the U.S. Army Reserves, developing in vitro diagnostic devices and ISO quality systems for diagnostic laboratories at Ft. Detrick, MD.