Insider Names Denise Esposito a Life Sciences "Power Player"

WASHINGTON—Insider named Denise Esposito as one of its "power-player lawyers advising life sciences companies through the biotech feeding frenzy." Insider spoke with recruiters, lawyers, and industry experts to identify 13 power players in the field.

Denise is the co-chair of Covington's global Food, Drug, and Device Practice. Denise regularly provides strategic, policy, and regulatory advice to life sciences clients, with a focus on matters that involve navigation of complex issues before the U.S. Food and Drug Administration. Her 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.

Insider's profile of Denise highlighted her expertise on medical countermeasures and how she used that experience to advise dozens of companies on vaccines and treatments for COVID-19, helping them navigate FDA as the agency resorted to emergency decision-making protocols. Denise's practice often involves helping clients understand the FDA's priorities and how those priorities relate to her client's medical projects. As she stated: "This is particularly important in the context of novel therapies, such as regenerative medicine, and innovative combination products, particularly in the areas of digital health and personalized medicine."