Justin A. Coen
Justin’s work spans the full product life cycle, from negotiating research and development agreements, licenses, and government contracts to guiding clients through GxP compliance, expedited approval pathways, and product labeling considerations. When it’s time to bring a product to market, he helps clients evaluate marketing strategies, exclusivity claims, and promotional efforts while also advising on potential legislative and regulatory changes that may impact their industry.
Before joining Venable, Justin served as the primary legal advisor on regulated medical products to the U.S. military’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) as a member of the Office of the Staff Judge Advocate, U.S. Army Medical Research and Development Command (USAMRDC). There he shepherded medical countermeasures and other priority public health products through the FDA regulatory process, helping his clients develop the novel strategies necessary to secure approvals, licensures, clearances, authorizations, and label expansions. He also 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, Justin led successful negotiations on research and development contracts for vaccines, therapeutics, and diagnostics contracted through Operation Warp Speed (OWS) and the federal government response, contributing to the more than $83 billion in contracts awarded by the JPEO-CBRND.
Before that, he worked for the U.S. Senate Committee on Finance, where he performed healthcare and tax oversight, and the Social Security Administration (SSA) Office of General Counsel (OGC), where he focused on federal government contract formation and litigation. Justin also has litigation experience with the False Claims Act (FCA) and Anti-Kickback Statute (AKS), product liability risks, and alternative dispute resolution, gained during his time at an international law firm.
Related Practices
Related Industries
- Drugs, Biologics, and Medical Devices
- COVID-19 Task Force
- Pharmaceuticals - Food and Drug Law
- Pharmaceuticals - Licensing/IP Transactions
- Healthcare
- Healthcare: Enforcement, Litigation, Investigations, and Audits
- Healthcare: Technology and Digital Health Law
- Artificial Intelligence
- Animal Health and Agribusiness Law
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. English and Accounting 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 (CPA), 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, Beyond Shelter Frederick