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Faegre Drinker announced today that Jeremiah Kelly and Justin Coen have joined the firm as partners in its government and regulatory affairs practice in Washington, D.C. Their joining further expands the firm’s health and life sciences capabilities, with specific emphasis on U.S. Food and Drug Administration (FDA) matters.
Kelly’s practice focuses on helping companies navigate the complex FDA regulatory framework from “bench to bedside” – from the development stages to post-market compliance. With a particular focus on FDA approval, licensure, clearance, and authorization, Kelly works hand in hand with pharmaceutical, biotechnology, and medical device manufacturers to help ensure their products are ready to meet the demands of the marketplace and FDA regulations. As a nationally-recognized leader in FDA law, he brings a unique depth and breadth of experience that allows for strategic alignment across a company’s regulatory, intellectual property, and R&D partnership strategy to accelerate medical product development for commercial success and public health impact.
Coen advises medical device, pharmaceutical, biotechnology, and animal health companies across the full product life cycle, from early development and FDA strategy to commercialization, transactions, and market expansion. With a legal and business-minded perspective, he brings a collaborative and creative approach to each client’s technology, development goals, and business objectives before charting a tactical plan toward regulatory approval and market viability. He uses that experience to help emerging life sciences companies prepare for capital investment and navigate buy- and sell-side due diligence, with a focus on identifying the regulatory, transactional, and commercialization risks most likely to affect deal value and execution.
“I am thrilled Jeremiah and Justin have joined us as we continue to invest in the firm’s food and drug practice, and both are uniquely equipped to help clients through the challenging FDA regulatory framework of today,” said Scott Chinn, leader of Faegre Drinker’s government and regulatory group. “Life sciences clients need advisors with experience in advocating not just on the legal front, but from a business standpoint as well. Jeremiah and Justin can offer clients both.”
Both Kelly and Coen bring significant experience working within the federal regulatory framework, highlighted by Kelly’s work in the FDA Commissioner’s office, both in its Office of the Chief Counsel and in its Office of Legislation, and Coen’s service to the Senate Finance Committee. More recently, they worked together for the U.S. Army Medical Research and Development Command, where they advised the Department of Defense on medical product development to meet the unique needs of the U.S. military. During the COVID-19 pandemic, Kelly and Coen supported Operation Warp Speed, where they successfully led complex R&D contract negotiations that resulted in over $83 billion in total contracts for the government’s COVID response, including the rollout of the COVID vaccine. Since returning to private practice, Kelly and Coen have drawn on their public health, military, and regulatory experience to guide clients in developing a wide range of FDA-regulated drugs, biologics, medical devices and combination products with speed and strategic clarity.
“Jeremiah and Justin’s extensive experience advocating before the FDA and other regulators on critical military and public health products puts them in a unique position to help clients meet their business needs,” said Tore DeBella, leader of the firm’s Washington, D.C. office. “I’m excited to see them join our growing team as we continue to prioritize recruiting results-oriented leaders in the FDA regulatory space.”
Kelly earned his J.D. from the University of Maryland School of Law and Master of Public Policy from George Washington University School of Business and Public Management. Coen graduated, with honors, from Duke University School of Law and from the University of Maryland, cum laude.
Kelly and Coen join a Faegre Drinker FDA practice team that also includes former U.S. Senate HELP Committee general counsel Barrett Tenbarge, who joined the firm last year to concentrate his practice on FDA regulatory and policy matters. Faegre Drinker’s government and regulatory practice comprises of attorneys and consultants, including lobbyists, policy authorities and scientists, that have a deep understanding of how government functions at all levels and across an array of subject matter and technical areas. Our professionals represent clients in legislative, regulatory and administrative matters with extraordinary passion and depth of experience.
