Susan S. Lee
Prior to practicing law, Susan S. Lee served as both a vice president for economic policy at a Washington, D.C. policy institute and as a consultant and manager at a premier global management consulting firm, where she provided strategic business advice to innovative life sciences and healthcare companies.
Today, she applies her prior economic and business experience to advise life sciences companies with an approach that is legally rigorous, but also pragmatic and grounded in a solid understanding of each client's business objectives and corporate dynamics.
Susan focuses on the U.S. Food and Drug Administration's (FDA) regulation of drugs and biological products. She addresses legal issues involving advertising and promotion; interactions with healthcare professionals and payers; and regulatory issues that arise in acquisitions, collaborations, and other types of transactions.
Susan has reviewed promotional and medical information materials in numerous therapeutic areas, served on promotional review committees, and reviewed and drafted policies and procedures. She has also conducted internal investigations and audits, developed and delivered compliance training, and defended companies under government investigation.
In addition, Susan identifies potential approval pathways for products under development, helps clients prepare for interactions with FDA, and guides clients in emerging areas such as digital health. In her transactional practice, she conducts and supports regulatory due diligence; develops definitions, representations, and warranties for agreements; and advises companies on appropriate regulatory disclosures in SEC filings.
Susan graduated from Harvard College summa cum laude, where she studied neurobiology, and from Harvard Law School, where she was a member of the Board of Student Advisers.
Led extensive review and evaluation of promotional materials across 10 promotional review committees of a biotechnology company.
Provided regulatory and transactional support to facilitate a leading information technology company's entry into the life sciences sector.
Secured orphan designation and related tax benefits for a drug that received FDA approval prior to granting of orphan drug designation.
Supported filings and preparations for unprecedented Part 15 hearing on FDA's proposed withdrawal of an indication for a biological product.