- FDA and health care due diligence of a CAR-T company and negotiation of key terms in merger agreement to reflect due diligence findings*
- Training for field sales force and medical science liaisons in advance of company's first drug product launch*
- Advice and drafting for competitor complaint correspondence in a highly competitive orphan disease state*
- Comprehensive compliance evaluation of current and proposed investigator-initiated study policies and practices for an established pharmaceutical company*
- Drafting sections of FDA briefing book to clarify desired regulatory pathway for investigational CRISPR therapeutic*
- Presentation to government regarding key FDA issues in DOJ investigation of pharmaceutical company*
- FDA matters in a pharmaceutical company's acquisition of a gene therapy company and subsequent agreements for commercialization of the gene therapy product*
- Advice and contract review for offering telemedicine services associated with a drug*
- IPO support for a company with therapeutic products in transition from one FDA regulatory classification to other FDA regulatory classifications*
- Response to FDA warning letter citing company executive's statements on a television program*
- FDA and risk-sharing considerations for a pharmaceutical company participating in a novel basket clinical trial sponsored by a patient advocacy organization*
- Evaluation for a proposed cell therapy product of pursuing development as a Section 361 HCT/P, medical device, or biological product*
- Compliance audits for a leading biotechnology company of promotional materials and field interactions for numerous brands and cross-functional teams*
- Regulatory and transactional support to facilitate an information technology company's entry into the life sciences sector*
- Securing orphan drug designation and related tax benefits for a drug that received FDA approval prior to granting of orphan drug designation*
- Participation in numerous promotional and medical materials review committees across a range of therapeutic areas*
- Preparation for unprecedented Part 15 hearing on FDA's proposed withdrawal of accelerated approval for an indication of a biological product*
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.
Harvard Law School
(summa cum laude)