Mike Drues, PhD
Michael Drues, Ph.D. is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including educational programing, regulatory strategy and regulatory intelligence, clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment.
Dr. Drues received his B.S., M.S., and Ph.D. degrees 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 U.S. 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 U.S. 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, Dr. Drues is an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology at several universities and medical schools. He regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs and Product Development, Combination Products, Pathophysiology, Medical Technology, Translational Medicine and Biotechnology.
- FDA's Breakthrough Designation Program: Better Practices for Getting to Market Sooner | Tue. February 5 - 10:15 AM - 11:00 AM
- Conducting Effective FDA Pre-Submission Meetings: Getting to Market Faster | Thu. February 7 - 8:30 AM - 10:00 AM