JUSTIN A. COEN specializes in guiding companies through the complexities of drug, biologic, and device development regulated by the U.S. Food and Drug Administration (FDA). 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. He negotiated development agreements with private industry partners employing a variety of federal government contract vehicles, including Federal Acquisition Regulation (FAR) contracts, Other Transaction Authority (OTA) agreements, Cooperative Research and Development Agreements (CRADAs), cooperative agreements and grants, material transfer agreements, and licenses. During the COVID-19 pandemic, he led successful negotiations on research and development contracts for vaccines, therapeutics, and diagnostics contracted through Operation Warp Speed and the federal government response, contributing to the more than $83B in contracts awarded by the JPEO-CBRND. Prior to joining Venable, he also advised the U.S. Senate Committee on Finance, where he performed healthcare and tax oversight, and the Social Security Administration Office of General Counsel, where he focused on federal government contract formation and litigation. He also has litigation experience with the False Claims Act and Anti-Kickback Statute, product liability risks, and alternative dispute resolution, gained during his time at an international law firm.