Susan S. Lee > Hogan Lovells US LLP > Washington DC, United States > Lawyer Profile
Hogan Lovells US LLP Offices
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON DC 20004
DISTRICT OF COLUMBIA
United States
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Susan S. Lee
Work Department
Global Regulatory
Position
Partner
Career
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 health care 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 health care 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 innovative products under development, helps clients prepare for interactions with FDA, and guides clients in emerging areas such as digital health and gene therapy. 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 U.S. Securities and Exchange Commission 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.
Languages
English
Memberships
Member, Publications Peer Review Committee, Food and Drug Law Institute (2017-2019)
Education
J.D., Harvard Law School, 2002
A.B., Harvard College, summa cum laude, 1996
Top Tier Firm Rankings
- Transport > Aviation and air travel: litigation and regulation
- Antitrust > Cartel
- M&A/corporate and commercial > Corporate governance
- Media, technology and telecoms > Cyber law (including data privacy and data protection)
- Industry focus > Education
- Government > Government relations
- Dispute resolution > Appellate: courts of appeals / Appellate: supreme courts (states and federal)
- Dispute resolution > Product liability, mass tort and class action - defense: consumer products (including tobacco)
- Transport > Rail and road: litigation and regulation
- Real estate > Real estate investment trusts (REITs)
- Media, technology and telecoms > Telecoms and broadcast: regulatory
- Media, technology and telecoms > Telecoms and broadcast: transactions
- International Trade > Trade remedies and trade policy
Firm Rankings
- Dispute resolution > Appellate: courts of appeals / Appellate: supreme courts (states and federal)
- International Trade > CFIUS
- International Trade > Customs, export controls and economic sanctions
- Labor and employment > Employee benefits, executive compensation and retirement plans: transactional
- Energy > Energy regulation: oil and gas
- Environment > Environment: litigation
- Environment > Environment: regulatory
- Government > Government contracts
- Healthcare > Health insurers
- Healthcare > Life sciences
- Healthcare > Service providers
- Tax > US taxes: non-contentious
- Insurance > Advice to insurers
- Dispute resolution > Appellate: courts of appeals / Appellate: supreme courts (states and federal)
- Finance > Capital markets: debt offerings
- Finance > Capital markets: equity offerings
- Finance > Capital markets: global offerings
- Energy > Energy regulation: electric power
- Finance > Fintech
- Labor and employment > Immigration
- Dispute resolution > International litigation
- Tax > International tax
- M&A/corporate and commercial > M&A: large deals ($1bn+)
- Antitrust > Merger control
- M&A/corporate and commercial > Shareholder activism
- Finance > Structured finance: derivatives and structured products
- Media, technology and telecoms > Technology transactions
- M&A/corporate and commercial > Venture capital and emerging companies
- Antitrust > Civil litigation/class actions: defense
- Energy > Energy litigation: oil and gas
- Finance > Project finance
- Energy > Renewable/alternative power
- Finance > Restructuring (including bankruptcy): corporate
- Finance > Project finance
- Dispute resolution > International arbitration
- Finance > Financial services regulation
- Investment fund formation and management > Private equity funds (including venture capital)