Denise is Vice President, Regulatory Counsel & Compliance Strategies and brings to AESARA more than 20 years of experience at the intersection of regulatory policy, compliance, science, and real-world business application. With senior roles spanning the NIH, FDA, industry, and consulting practice, Denise helps organizations understand and implement regulatory policies, anticipate and plan for regulatory change, and develop practical, evidence-based solutions that support innovation while maintaining regulatory compliance, including navigating the grey spaces where FDA policy is silent.

As a former FDA Regulatory Counsel for Policy at both the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), Denise led policy initiatives reflecting agency thinking on clinical outcome assessments, artificial intelligence in medical product development, digital health technologies, and clinical trial diversity, among others. She has worked directly with Congress as an FDA technical expert on statutory amendments to the Federal Food, Drug, and Cosmetic Act, including provisions governing pre-approval information exchange. Her senior industry roles and former consulting practice focused heavily on regulatory oversight of product communications, including advertising and promotion for healthcare professionals and consumers, payer communications, scientific exchange, and corporate communications.  

Denise’s expertise spans the full product lifecycle, from compliance framework development and launch planning to optimization of evidence communication pathways and cross-functional training and strategy. She is drawn to novel and complex issues where regulatory, scientific, legal, and commercial considerations intersect. It is precisely at these intersections that full cross-functional collaboration becomes possible and where Denise does her most meaningful work.