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Denise Esposito is the co-chair of the firm’s Food, Drug, and Device Practice Group. Her practice focuses on a broad range of regulatory, strategic, and policy matters affecting pharmaceutical, biotechnology, device, and medical technology companies. With more than two decades of experience in the industry, including senior leadership roles within FDA and as the general counsel of a publicly traded biotechnology company, Ms. Esposito has deep expertise on issues critical to her life sciences clients. Her experience encompasses a wide range of issues relating to medical product development, approval, and marketing, including digital health, combination products, personalized medicine, expedited review and approval, exclusivity determinations, and marketing and promotion. She engages frequently with the U.S. Food and Drug Administration (FDA), both formally and informally, to solve complex strategic and regulatory challenges and to facilitate successful resolution of issues of importance to our FDA-regulated clients.

Previous Experience

  • U.S. Food and Drug Administration, Chief of Staff to the Commissioner; Deputy Chief Counsel, Drugs and Biological Products, Office of Chief Counsel; Deputy Director for Policy, Center for Drug Evaluation and Research (CDER)
  • Emergent BioSolutions Inc., Senior Vice President and General Counsel
  • Partner in Life Sciences and Litigation Practices at Major International Law Firm
  • Chambers USA, Life Sciences: Regulatory/Compliance (2017, 2019)
  • Chambers Global, Life Sciences: Regulatory/Compliance (2020)
  • Legal 500 US, Healthcare - Life Sciences (2017)