Biography

To move life-changing medical therapies from development to market, biotechnology companies need legal infrastructures that are pragmatic, business-centric, and compliant with the nation’s most complex regulations. Lauren Sullivan has launched several billion-dollar, blockbuster drugs by building that infrastructure. Her decades of experience as in-house counsel for global pharmaceutical companies influence the efficient, comprehensive, and diplomatic counsel biotech innovators rely on to commercialize mission-defining drugs and medical devices.

Lauren’s clients range from biotech startups launching their first products to well-established pharma manufacturers. She shares her clients’ commitment to patients—and is driven by the responsibility of providing real solutions to real people.

Companies gain long-term value from the legal teams and structures Lauren builds to transition therapies to the commercial stage. Her actionable plans integrate all the vital components for product success: FDA and health care compliance, finance, government pricing, antitrust, advertising and promotion, patient support programs, advocacy, and more.

In the era of COVID-19, Lauren has used her signature market-access strategies to support clients’ groundbreaking treatments for the novel coronavirus. Her therapeutics background includes oncology, cellular therapies, gene therapies, antibodies, and other disease treatments. Lauren’s solution-focused negotiation style has earned the trust of her clients. They count on her agile counsel across a dynamic landscape.

Experience

  • Counseled various pharmaceutical and biotechnology company clients on product launch, market access, advertising and promotion, government pricing and reimbursement, FDA regulatory matters, labeling, and antitrust compliance.
  • Represented pharmaceutical and biotechnology company clients in domestic and international commercial transactions. Lauren provided advice and negotiated transactions involving biotechnology products, platform and tool technologies, medical devices, and late-stage and marketed biopharmaceutical products.
  • Advised life sciences clients on issues relating to the conduct of clinical research. Lauren provided counsel on institutional review board issues, FDA compliance, the ICH Guideline for Good Clinical Practice, genetic testing, informed consent, and data and privacy issues.
Education
  • Widener University School of Law (J.D., 1994)
  • Widener University (B.S., 1990)
Bar Admissions
  • Connecticut