Michael Drues, Ph.D., , is President of Vascular Sciences, an education, training and consulting company offering a broad range of services to medical device, pharmaceutical and biotechnology companies including stimulating and innovative educational programming, brainstorming sessions, prototype design, product development, benchtop and animal testing, innovative regulatory strategy and completive regulatory intelligence, clinical trial design, U.S. Food and Drug Administration (FDA) presentation preparation and defense, reimbursement, clinical acceptance, business development and technology assessment.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in biomedical engineering from Iowa State University in Ames, Iowa. An internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs, he has conducted seminars and short courses, worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies, and for the FDA, Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid
As an Adjunct Professor of Medicine, Biomedical Engineering and 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 and Biotechnology at several universities and medical schools, both on campus and online. Services and other regulatory and governmental agencies around the world.
has more than over 27 years of business experience in biotechnology, including new product assessment, strategy and business development as a consultant, and has held management roles with the Diagnostics Division of Abbott Laboratories and Genzyme Corporation. While at Genzyme, she managed the early development of Ceredase® for the treatment of Gaucher's Disease and participated in the successful raising of the R&D limited Partnership to fund the drug's development. At Abbott, she was responsible for global business unit product management for immunoassay, CNS diagnostics, high-volume automation and data management products.
Since 1992, Levy has been consulting to pharmaceutical and biotechnology companies, venture capital firms and academic institutions. She has also played an active role as an investor for a corporate life science venture fund of a healthcare system. In these roles, she has been involved in the due diligence, start up and growth of new ventures and corporate product development programs in clinical diagnostics and personalized medicine, new research tools, stem cells and new biologics and pharmaceuticals.
She served on the Board of Directors and as an Officer of HBS Health, a network of Harvard Business School alumni in healthcare, and was a board member of Mitomics, Inc., which focuses on the commercialization of novel molecular tests based on the mitochondrial genome. Levy currently serves on the board of the Association for Frontotemporal Degeneration and co-founded the Boston area support group for caregivers of patients with these disorders. She holds an MBA from the Harvard Business School and a BA in chemistry from Swarthmore College.
James P. McNamara, Ph.D has more than 25 years of experience in life sciences business development, licensing, project management, intellectual property management, drug discovery, and drug development. He has extensive experience in business development and industry-sponsored research, having successfully interacted with small biotech, virtual companies, large domestic pharmaceutical companies, and international pharmaceutical companies in Europe and Asia. Dr. McNamara began his research career as a postdoctoral fellow at SRI International (formerly Stanford Research Institute). Over the course of his 18-year career there, he rose through the ranks of drug discovery, drug development, research management and business development to serve as the Senior Director of Business Development for the Biosciences Division of SRI with functional reports in government and commercial marketing, project management, and patenting and licensing.
Gail E. Radcliffe, Ph.D., has more than 20 years of experience assisting medical device and diagnostics companies with technical assessment, marketing and clinical/regulatory issues. She founded Radcliffe Consulting in 1998 after having worked at GENE-TRAK, where she developed IVD assays for several infectious disease organisms and was also responsible for instituting the clinical affairs group. She then joined Cytyc Corporation and worked in both technical and business development roles.
Dr. Radcliffe obtained a Ph.D. in Molecular Biology from Brown University in 1986 and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School. She holds several patents, is on the board of the Massachusetts Biomedical Initiatives, and acts as an advisor to VC firms and to several venture-backed biotech companies.