Lois Sheng Liu
Biography
Lois Liu is Counsel in Baker McKenzie’s Transactional Practice Group, based in Washington, DC. Her practice focuses on FDA and healthcare regulatory and compliance matters, with particular depth in FDA regulations, federal and state health fraud and abuse issues, state pharmacy law, and transactional risk advisory. Lois was shortlisted for the LMG Life Sciences Awards 2025 Americas: US Rising Star – Regulatory.
Drawing on her background as a pharmacist and former research fellow at a major teaching hospital, Lois has an extensive understanding of the regulatory landscape governing drug research and development, clinical investigations, product approval pathways, marketing practices, and government enforcement.
Practice Focus
Lois advises a broad range of clients across highly regulated industries, including pharmaceutical, biotech, device, food, dietary supplement, and cosmetic companies, distributors, contract research organizations, academic medical centers, hospital systems, and pharmacies.
Lois’s FDA regulatory work covers the full product lifecycle, including clinical research and development, product approval and commercialization strategies, promotional and labeling compliance, postmarket regulatory obligations, and responses to government enforcement activities.
Her healthcare regulatory practice focuses on healthcare fraud and abuse laws, including the federal Anti-Kickback Statute, Stark Law, Physician Payments Sunshine Act, and comparable state laws. She also advises on the design and implementation of compliance programs governing patient assistance programs and interactions with healthcare providers, including consulting and advisory arrangements, speaker programs, grants and sponsorships, research collaborations, investment structures, and other provider-facing commercial activities.
In addition, Lois regularly counsels on state healthcare regulatory matters, including state pharmacy law, state healthcare transaction notification requirements, and state corporate practice of medicine restrictions. She helps healthcare and life sciences companies, management services organizations, and investors navigate complex state licensing, ownership, and operational requirements that affect healthcare delivery models and strategic investments. Her expertise guides companies and investors through transactional matters in the healthcare and life sciences space, with a focus on identifying and mitigating the regulatory risks in mergers and acquisitions, licensing and collaborations, commercial contracts, and other strategic transactions.
Representative Legal Matters
- Counseled Cigna Healthcare on healthcare regulatory matters and due diligence in connection with its exclusive agreement with UnitedHealthcare Global that advances Cigna's international health growth strategy and expands access to Cigna's global health capabilities for globally mobile populations.
- Advised McKesson on healthcare regulatory due diligence in connection with its USD 2.25 billion acquisition of Precision Medicine Group, LLC, a global provider of clinical research and biopharma commercialization services.
- Advised Bayer in its acquisition of Perfuse Therapeutics for up to USD 2.45 billion including USD 300 million upfront and additional development, regulatory and commercial milestone payments based on success criteria.
- Advised Lone Star Funds in connection with its acquisition of the Capsules & Health Ingredients division of Lonza Group AG.
- Advised Merit Medical Systems, the NASDAQ listed global developer, manufacturer and marketer of medical devices used in interventional and diagnostic procedures, on multiple transactions
- Advised AbbVie on multiple transactions, including its acquisition of Allergan, the acquisition of a clinical stage pharmaceutical company and the acquisition and divestitures of various manufacturing and R&D sites.
- Advised Lotus Pharmaceutical Co. Ltd. in its USD 2.2 billion agreement to acquire 100% equity interests in New Alvogen Group Holdings, Inc., which owns Alvogen US, a fully integrated specialty pharmaceutical company based in New Jersey.
- Advised H.Lundbeck A/S (Lundbeck) on its acquisition of Longboard Pharmaceuticals, Inc. The transaction is valued at approximately USD 2.6 billion equity value and USD 2.5 billion (approximately DKK 17 billion) net of cash.
- Advised Acorda Therapeutics in its asset purchase agreement with Merz Therapeutics for Inbrija, (F)ampyra and related assets of Acorda pursuant to a Section 363 sale.
- Advised Vandemoortele, a leading European family-owned food group, in a strategic partnership with Banneton, a high-quality manufacturer of premium freezer-to-oven croissants, Danishes and pastries in North America.
- Assisted a US publicly traded medical device company in connection with SEC investigation into its marketing and distribution activities by its China subsidiary, providing risk assessment and compliance enhancement recommendations.
- Advised a European major pharmaceutical company on conducting clinical trials and investigator-initiated trials in China.
Professional Associations and Memberships
- American Health Law Association - Member
- Food and Drug Law Institute - Member
Admissions
- New York~United States (2020)
- District of Columbia~United States (2018)
Education
- Harvard Medical School (Fellow) (2020)
- American University (JD) (2017)
- Duke University (MS) (2013)
- China Pharmaceutical University (BS) (2011)
Languages
- English
- Mandarin