Susan Lee

Susan Lee is a partner in Goodwin's Life Sciences group and Life Sciences Regulatory & Compliance practice.

Susan advises innovative biologics and drug companies on FDA 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. Susan has counseled clients across the spectrum of the industry, from early clinical-stage companies to established global players.

Susan's areas of expertise include FDA development pathways; clinical trial recruitment and compliance; 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.

Susan 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. Susan has extensive experience with FDA matters that arise 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.

• FDA due diligence of numerous biopharmaceutical companies, and related advice on key terms in definitive agreements and disclosure schedules 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*
• Advice to telemedicine providers offering access to therapeutics
• 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*
• IPO support for a company with therapeutic products in transition from one FDA regulatory classification to other FDA regulatory classifications*
• Responses to FDA warning and untitled letters*
• Evaluation of potential FDA regulatory pathways for a proposed cell therapy product 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 is a member of the Food & Drug Law Institute (FDLI).

Before joining Goodwin, Susan was a partner at Hogan Lovells and an associate at Covington and at McDermott, Will and Emery. Prior to practicing law, Susan was an engagement manager and consultant with McKinsey & Company in its New York and Washington DC offices, and served as Vice President of Economic Policy at the Center for American Progress in Washington DC.

Susan has been ranked by Legal 500 as a Life Sciences, Next Generation Partner in 2017, 2018, 2019, and 2020.

Susan’s recent publications include:

• Quoted, “Texas Abortion Drug Ruling Could Create ‘Slippery Slope’ For FDA Approvals, Drug Research and Patients, Experts Say,” CNN, April 14, 2023
• Quoted, “Access to Abortion Pills at Risk in US as Judge Weighs ‘Unprecedented’ Case,” Financial Times, March 1, 2023
• Quoted, “What Will FDA Do in Battle Over Medication Abortion Access,” The Pink Sheet, December 2022
• Quoted, “Five FDA Policy Themes to Watch For Under New Leadership,” Modern Healthcare, November 18, 2021
• Mentioned, “October 2021: Law Firm Hiring, Legal Innovation & Pro Bono in the Legal Industry,” The National Law Review, October 28, 2021 
• Quoted, “Drug Promotion During Pandemic: Website Links to Telemedicine Prescribers Require Caution,” Pink Sheet, May 21, 2021
• Quoted, “8 Promo Pitfalls Pharma Compliance Chiefs Need To Know,” Law360, January 22, 2019

Susan’s recent speaking engagements include:

• Presenter, New Drug Research and Development, 2023 FDLI Introduction to Drug Law and Regulation
• Discussant, Parallel Enforcement: SEC Authorities and How They Can Impact FDA’s Civil and Criminal Enforcement, 2022 FDLI Symposium
• Speaker, FDCA Impact of Dobbs, 2022 FDLI Litigation & Enforcement Conference
• Speaker, Promoting & Marketing in the Digital and Virtual World: What Regulatory, Compliance & Marketing Professionals Need to Know, 2021 FDANews Webinar 
• Speaker, The Future of Drug Advertising and Promotion, 2021 FDLI Annual Conference
• Moderator, Diversity in Clinical Trials, 2021 California Life Sciences Institute (CLSI)
• Moderator, Digital Health, 2020 Biotech Showcase