Justin Coen, JD

Justin Coen, JD

 Partner, Venable LLP

Bio:

Justin Coen is a partner in Venable’s FDA law group, where he guides companies through the complexities of drug, biologic, and device development. He advises clients on every stage of product development, pre-and post-approval regulatory compliance, and commercialization strategies. Justin also has extensive experience negotiating research and development agreements, licenses, and purchase contracts, including contracts with the federal government. 

Prior to joining Venable, Justin served as a senior regulatory attorney at the Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Development Command (USAMRDC), and he has advised the U.S. Senate Committee on Finance.

Justin works with a range of clients, including pharmaceutical companies, medical device manufacturers, and biotech startups, to help them navigate complex regulatory requirements and achieve their business objectives. His expertise includes evaluating marketing application approaches, marketing exclusivity claims, pre- and post-approval GxP compliance, expedited approval mechanisms, priority review vouchers, product labeling issues, animal rule product development, combination products, and advertising and promotion. He also draws on his experience in healthcare policy to help clients understand and shape potential legislative and regulatory changes and, when necessary, respond to government investigations.

Attorney Spreeha Choudhury brings her dedication and detail-oriented approach to supporting the legal needs of pharmaceutical companies and other life sciences clients. She assists clients with issues relating to pharmaceutical development, testing, approval, and marketing.

Spreeha also represents health care organizations in matters concerning telemental health, the coordination of federal health care benefits, and the COVID-19 pandemic.

Before entering law school, Spreeha earned a Doctor of Pharmacy degree, bringing both her knowledge of and passion for pharmaceutical innovation to her work. As a student at the University of Maryland Francis King Carey School of Law, she coauthored an opioid certification program to be used by the state of Maryland for opioid-related training; served as an extern for the law school’s Center for Health and Homeland Security; and, as a student attorney for the Maryland Intellectual Property Legal Resource Center, helped clients file trademark and patent applications. She also served as a reproductive health legal intern at a nonprofit advocacy organization dedicated to improving the lives of women and families. Earlier in her career, Spreeha was a medical copywriter at a pharmaceutical advertising agency.