Michael Levy is Vice President, Head of USP’s Quality Institute, and Head of Research & Innovation. The Quality Institute focuses on generating a rigorous evidence base for global discussions on public and regulatory policy reforms to advance quality of medicines. The Institute strives to improve public health outcomes and provide the rationale for investments in quality.
Research & Innovation is the scientific team responsible for the identification, assessment, and as appropriate, incubation of emerging technologies and capabilities relevant to USP’s standard-setting processes and allied programs.
Mr. Levy’s diverse background includes shaping public policy through advocacy, counseling biopharmaceutical and healthcare regulatory executives and staff as a management consultant, and providing deep scientific and technical expertise to academic and industry researchers. He previously served as Deputy Vice President, Science & Regulatory Advocacy, at the Pharmaceutical Research and Manufacturers of America (PhRMA), where he shaped the drug development and regulatory review processes—with an emphasis on using non-traditional data and advanced analytics to inform clinical trial design and regulatory decision making. Mr. Levy also served as an Associate Principal at McKinsey & Company, where he supported biopharmaceutical companies and regulators on a broad set of topics in Research and Development and technology enablement. Earlier in his career, Mr. Levy was part of the team that sequenced Human Chromosome XIV as part of the Human Genome Project, and was lead bioinformatician in a bioinformatics start-up.
Mr. Levy earned his Masters of Business Administration Degree from Cornell University’s Johnson Graduate School of Management, and his Master of Science and Bachelor of Science degrees from Concordia University in Montreal, Canada.