Michael Walker received his Ph.D. from Stanford University, and has taught statistics and clinical trial design at Stanford and UC San Diego for 25 years. He is a statistics consultant for pharmaceutical and biotechnology companies. His FDA experience includes IND, NDA, IDE, 510k, PMA, SPA and other submissions. His consulting work has led to FDA and CLIA approvals, publications in the New England Journal of Medicine and in Lancet, many patents, and products with over one billion dollars in revenues. He also consults for venture capital companies to evaluate investments in life sciences and advises life science start-ups on corporate strategy and product development.