Justin A. Coen

High-Stakes Regulatory Engagement

Justin provides a steady hand to guide clients through critical regulatory issues. In the premarket phase, he helps clients assess regulatory pathways, shape development strategy, and navigate key FDA interactions. He works to identify efficient paths to market, including opportunities to pursue expedited approval pathways, and helps align FDA strategy with coverage and reimbursement objectives. He also advises on regulatory incentives, including Priority Review Vouchers and enhanced FDA engagement for military health products under Public Law 115-92. In addition, he helps animal health companies navigate FDA and US Department of Agriculture pathways for animal drugs, biologics, and veterinary devices.

For commercialized products, Justin advises on the regulatory and business issues that arise after market entry, helping clients manage risk while supporting growth and long-term product success. He counsels on labeling, promotion, manufacturing and quality systems, life cycle management, post-approval and post-clearance changes, export controls, import and export issues, and other ongoing compliance matters. He also advises on commercialization strategy, strategic partnerships, and supply and distribution arrangements involving approved or cleared products.

The Business of Life Sciences & FDA-Regulated Product Development

Justin structures and negotiates the agreements that support medical product development and commercialization, including development, licensing, supply and distribution, clinical trial, quality, contract development and manufacturing organization (CDMO), contract research organization (CRO), material transfer, and licenses. Drawing on his experience advising the Army Surgeon General and, during Operation Warp Speed, the US Department of Health and Human Services (HHS), he brings substantial experience with government contracting involving HHS, the Biomedical Advanced Research and Development Authority (BARDA), the Advanced Research Projects Agency for Health (ARPA-H), the National Institutes of Health (NIH), and the Department of Defense (DoD).

Investment & Due Diligence

Justin advises investors conducting due diligence on pharmaceutical, biotechnology, and medical device opportunities, with a focus on identifying regulatory, transactional, and commercialization risks. He also uses that experience to help emerging life sciences companies prepare for capital investment, anticipate investor concerns, and navigate the diligence process more effectively. His practical approach helps clients present their products, platforms, and regulatory strategy in a way that supports successful financings and strategic transactions.

Prior Experience

Prior to joining Faegre Drinker, Justin was a partner in the food and drug law practice group at a national firm, where he advised pharmaceutical, medical device, biotechnology, and animal health companies on regulatory, transactional, and product development matters.

Previously, Justin served as a senior regulatory attorney with the Defense Health Agency and as the primary legal advisor on regulated medical products to the US military’s Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense, advising on the development, regulation, and acquisition of medical countermeasures and other priority public health products. During the COVID-19 pandemic, he co-led a legal team that negotiated $83 billion in federal contracts on behalf of HHS in support of vaccines, therapeutics, and diagnostics, while advising on related oversight and intellectual property issues. He also held senior legal roles at the US Senate Committee on Finance and the Social Security Administration, where he advised on health care oversight, investigations, and federal procurement matters.

Personal Interests

Outside the office, Justin enjoys listening to and playing bluegrass music (fiddle, banjo, guitar), skiing, hiking and biking in the Appalachians, and spending plenty of time on the sidelines and in the stands at his kids’ sports practices and games. In his spare time, he also dabbles in questionable home engineering, takes the search for great barbecue and strong coffee far too seriously, and remains convinced that most problems can be improved by a road trip through the mountains. He has also been known to pursue odd bits of trivia, overcommit to ambitious weekend projects, and speak with unnecessary confidence about banjos, birdwatching, and the proper conditions for campfire cooking