Cooley’s Life Sciences and Healthcare Regulatory Group Continues Expansion, Adds Former FDA Senior Counsel

Washington, DC – November 13, 2023 – Cooley has further enhanced its life sciences regulatory and enforcement capabilities with the addition of Son Nguyen in the firm’s Washington, DC, office. Nguyen arrives from the US Food and Drug Administration, where he most recently served as senior counsel in the Office of the Chief Counsel, handling a range of matters involving devices and combination products regulated by the agency. Previously, Nguyen was an associate chief counsel for enforcement, and he also worked for nearly a decade as a litigation and regulatory attorney in private practice before joining the FDA. As special counsel in Cooley’s global life sciences and healthcare regulatory practice group, Nguyen will advise clients on complex device, pharmaceutical and combination products matters, as well as on other emerging FDA developments and litigation.

“We are thrilled to welcome Son as we continue our strategic investment in building a market-leading practice of accomplished and versatile litigators and regulatory advisers,” said Sonia Nath, chair of Cooley’s global life sciences and healthcare regulatory practice and an FDA alumna. “His comprehensive understanding of FDA law in his 14-year tenure as a litigator and counselor within the FDA’s Office of the Chief Counsel, paired with deep agency experience across matters involving medical devices and combination products – including in vitro diagnostic products, laboratory developed tests, pharmacogenetic tests, companion diagnostics, artificial intelligence and machine learning, prescription drug use-related software, and devices referencing drugs – will undoubtedly add tremendous value for our clients, who are contending with an unprecedented and rapidly evolving regulatory landscape.”

“Son brings a wealth of valuable experience and a deep understanding of the litigation and enforcement challenges facing Cooley’s life sciences and healthcare clients, especially those in the pharmaceutical and device manufacturing industry,” said Michael Attanasio, chair of Cooley’s global litigation department. “His ability to elevate our services through his experience and work as an FDA lawyer will be hugely additive to this growing team.”

Nguyen earned his JD with honors and membership in the Order of the Coif from the University of Maryland Francis King Carey School of Law, and he earned his BA in history, political science and international relations from Carroll College. During law school, he served as an Asper Fellow with now-retired Judge Andre M. Davis of the US Court of Appeals for the Fourth Circuit. After graduation, Nguyen clerked for now-retired Judge Marvin J. Garbis of the US District Court for the District of Maryland.

“Cooley’s reputation for advising the most innovative, cutting-edge life sciences and healthcare companies is unmatched in the industry,” Nguyen said. “I am excited to work with leaders across the industry to help guide clients through the myriad challenges and opportunities they are currently facing – especially during this period of constantly changing laws and regulations in this dynamic marketplace.”

Nguyen is the latest addition to the firm’s expanding global life sciences and healthcare capabilities, following the hiring of lateral partner Alexis Bortniker, whose practice focuses on digital health regulatory counseling. Cooley’s top-tier life sciences and healthcare corporate, regulatory and litigation lawyers have extensive global and US experience counseling on a vast scope of complex deals, regulatory issues and investigations. The firm has represented leading global life sciences companies for 40+ years and advises entities across the life sciences landscape. Cooley is consistently ranked as a market leader in the field by Law360, LMG Life Sciences, Chambers and The Legal 500, among others. Most recently, Cooley was named Law360’s Life Sciences Practice Group of the Year, and LMG Life Sciences has recognized the firm in consecutive years in the US and UK.

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