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Michael Drues, PhD, is president of Vascular Sciences, an education, training, and consulting company offering a broad range of services to medical device, pharmaceutical, and biotechnology companies. This includes stimulating and innovative educational programing, creative regulatory strategy and completive regulatory intelligence, regulatory submission design, FDA presentation preparation and defense, brain-storming sessions, prototype design, product development, benchtop and animal testing, clinical trial design, reimbursement, clinical acceptance, business development and technology assessment. Dr. Drues received a B.S., M.S., and PhD in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical, and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the US Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world. Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical, and biotechnology companies, the US Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world. Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, Dr. Drues teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools on-ground and online.