Presenters
Michael S. Labson, JD
Partner, Covington & Burling LLP, United States
Mike is a partner in the Food, Drug & Device practice at Covington & Burling LLP. He provides strategic advice to biopharmaceutical clients in dealing with FDA and other agencies. He has litigated extensively and works actively on transactional and legislative matters. Mike graduated magna cum laude from Harvard College, and magna cum laude from Harvard Law School. He was an officer of the Harvard Law Review, and clerked for the Hon. David Ebel on the U.S. Court of Appeals for the 10th Circuit.
Mark Gaydos
Head of Labeling and Advertising & Promotion, Global Regulatory Science, Moderna, United States
Mark most recently served as Global Head of Advertising & Promotion within Sanofi's Global Regulatory Affairs organization, with responsibility spanning the General Medicine, Specialty Care, and Vaccine portfolios. In this role, Mark was accountable for regulatory leadership and strategy in supporting impactful product promotion and maintaining strict regulatory compliance in the interest of promoting and protecting patient health. During more than 30 years in industry, Mark has held leadership roles across numerous therapeutic areas, including responsibility for regulatory strategies across the product lifecycle.