Dinesh Kumar

Dinesh Kumar brings more than a decade of experience at the U.S. Food and Drug Administration (FDA), where he served in both legal and policy roles, including Associate Chief Counsel in the Office of the Chief Counsel (OCC), Regulatory Counsel in the Office of Regulatory Affairs (now the Office of Inspections and Investigations), and a senior leadership role as a Senior Adviser to the FDA Commissioner. His practice focuses on regulatory, legislative, compliance, and commercialization strategies for clients across the pharmaceutical, biotechnology, and medical device sectors.

During his tenure at the FDA, Dinesh served as a senior legal adviser on regulatory strategy, risk management, and compliance throughout the lifecycle of FDA-regulated products. He led cross-functional efforts addressing pre- and post-market issues and advised senior leadership at the FDA and the U.S. Department of Health and Human Services (HHS) on complex matters involving government shutdowns, emergency responses, and the implementation of evolving Administration priorities. His emergency response work includes advising FDA officials on medical countermeasures, emergency authorities, and drug supply chain and shortage issues during natural disasters and the COVID-19 pandemic.

Dinesh has extensive advisory experience on high-profile, strategic priorities at the intersection of public health, market competition, and innovation, including the integration of AI into development of medical products, and efforts to modernize and accelerate clinical research and development.