Justin A. Coen
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.
In his most recent government position prior to joining Venable, Justin served as the primary legal advisor on regulated medical products to the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). In that capacity, he shepherded medical countermeasures (MCMs) and other priority public health products through the FDA regulatory process, helping his clients develop novel strategies necessary to secure FDA approvals, licensures, clearances, authorizations, and label expansions. 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.
Related Practices
Experience
Government Experience
- Senior regulatory attorney, Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Development Command
- Senior oversight counsel, United States Senate Committee on Finance
- Senior attorney, Social Security Administration, Office of the General Counsel
Insights
Credentials
Education
- J.D. with honors Duke University 2006
- B.A. / B.S. Accounting and English cum laude University of Maryland 2002
Bar Admissions
- District of Columbia
- Maryland
Court Admissions
- U.S. District Court for the District of Maryland
Professional Memberships and Activities
- Health Law Section, American Bar Association
- Food and Drug Law Institute
- Regulatory Affairs Certification (Drugs), Regulatory Affairs Professionals Society
- Certified Public Accountant, Maryland (inactive)
Recognition
- President Joseph R. Biden, Letter of commendation, legal support for COVID-19 vaccine donation program, 2021
- U.S. Army, Meritorious Civilian Service Medal, legal support for COVID-19 federal government response, 2021
- United States Army General Gustave F. Perna, Four-Star Note of Commendation, legal support to Operation Warp Speed for vaccine contracts, 2020
- U.S. Army, Civilian Service Achievement Medal, legal support to JPEO-CBRND on medical countermeasure development, 2019
Community
Volunteerism
- Board member, Religious Coalition for Emergency Human Needs