Denise Esposito

Denise Esposito is the co-chair of Covington & Burling’s global Food, Drug, and Device Practice Group. Denise has more than 25 years of experience in the life sciences industry, including senior leadership roles within U.S. Food and Drug Administration (FDA), as the general counsel of a publicly traded biotechnology company, and as a partner in private practice. She provides strategic, policy, and regulatory advice to biotechnology, pharmaceutical, and medical device clients, with a focus on matters that involve navigation of FDA and the complex political and policy challenges that FDA-regulated companies are facing. Denise’s practice includes advising clients on marketing authorization strategies, expedited approval programs, life cycle management, and the promotion of medical products. She works with clients on FDA engagement strategies, formal and informal FDA dispute resolution, and crisis management around FDA actions. Denise’s work runs the gamut of therapeutic areas and product types, including infectious disease, oncology, regenerative medicine and other biological products, combination products, digital health, and personalized medicine. She also has specialized expertise in the development and approval of medical countermeasures (MCMs) against pathogens that can cause global pandemics or be used in acts of bioterrorism or bio-warfare and was part of the FDA's Medical Countermeasures Initiative MCMi team while at the Agency. She has worked with FDA, the Biomedical Advanced Research and Development Authority (BARDA), and other agencies involved in the U.S. government's response to national public health emergencies and has been heavily involved in the industry’s response to the Coronavirus Disease 2019 (COVID-19) pandemic.