Susan Lee is a partner in Goodwin's Life Sciences group and FDA practice.
Ms. Lee advises innovative biologics and drug companies on regulatory and compliance matters that arise in the development and commercialization of new products and indications. She applies her prior business experience in the life sciences industry to provide practical, risk-calibrated solutions. Ms. Lee has counseled clients across the spectrum of the industry, from early clinical-stage companies to established global players.
Ms. Lee's areas of expertise include FDA development pathways; clinical trial recruitment and compliance; expanded access programs; launch preparation, including labeling negotiations, development of core promotional claims, provider and patient engagement strategies, and field training; companion diagnostics and digital health tools; and interactions with patients, health care practitioners, and payors.
Ms. Lee routinely collaborates with colleagues in related legal areas, such as health care, data privacy, intellectual property and antitrust, to provide holistic advice to clients. She draws on her broad expertise to provide strategic advice in the context of investigations, litigation, corporate transactions, and securities disclosures. Ms. Lee has extensive experience with handling FDA matters in due diligence, SEC filings and press releases, licensing and collaboration agreements, and agreements with distributors, specialty pharmacies, CRO/CMOs, consultants and other key partners.
Before joining Goodwin, Ms. Lee was a partner at Hogan Lovells. Prior to practicing law, Ms. Lee was a management consultant with McKinsey & Company and served as Vice President of Economic Policy at a Washington, DC think tank.
