Venable LLP is pleased to announce the expansion of its FDA group with the addition of Jeremiah Kelly and Justin Coen as partners in the Washington, DC office. Mr. Kelly and Mr. Coen are joining the firm from the Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Development Command (USAMRDC).
Claudia A. Lewis, a co-chair of the firm’s FDA Group, said, “Venable has established itself among the premier practices in the FDA regulatory space and is regularly called upon to handle a myriad of issues involving the development and marketing of products regulated by the FDA. With the addition of Jeremiah and Justin, our services now include robust legal capabilities for companies navigating the FDA regulatory framework to commercialize drugs, biologics, devices, and combination products, among other product categories.”
Todd A. Harrison, a co-chair of the firm’s FDA Group, said, “Jeremiah and Justin’s unique experience advising on the development of medical products regulated by the FDA will be extremely valuable to our clients. We look forward to welcoming them to the team.”
Commenting on their move to Venable, Mr. Kelly and Mr. Coen said, “Venable has a distinguished FDA regulatory group and a strong platform designed to help us solve our clients’ most pressing FDA regulatory challenges. Both of us have successfully worked with private entities—across multiple product categories—to obtain FDA approval, licensure, or clearance of safe and effective medical products. Furthermore, we have a unique depth of experience in drafting and negotiating research and development agreements with federal agencies to help firms protect intellectual property and technical data rights, while ensuring medical products are developed to the high standards required by the FDA’s regulatory paradigm. We are excited to complement Venable’s already considerable capabilities.”
Mr. Kelly’s practice concentrates on helping companies navigate the FDA’s complex regulatory framework for drugs, biologics, medical devices, and combination products. Mr. Kelly has helped companies from “bench to bedside,” with experience at every stage of product development, from the pre-clinical, clinical, and pre-market application phases to post-market compliance. He has helped his clients obtain FDA approval, licensure, clearance, or authorization of over 20 medical products. Mr. Kelly brings a unique depth of experience in full-scale and 505(b)(2) NDAs, BLAs, and EUAs for drugs and biologics and 510(k)s and De Novo Requests for medical devices. In addition, Mr. Kelly brings years of experience with GxPs, expedited approval mechanisms, Hatch-Waxman and BPCIA regulatory incentives (e.g., patent term restoration and marketing exclusivity), priority review vouchers (PRVs), product labeling, risk evaluation and mitigation strategies (REMS), advertising and promotion, responding to negative 483s and Warning Letters, and challenging FDA rulemaking under the Administrative Procedures Act (APA). Mr. Kelly has helped his clients shape legislative changes to the FD&C Act and the Public Health Service Act (PHSA). Mr. Kelly previously served as the chief of the FDA Regulatory Law Division of the U.S. Army Medical Research and Development Command (USAMRDC), where he led the Army legal team responsible for negotiating over $83B in COVID-19 vaccine, therapeutic, and diagnostic awards for Operation Warp Speed and the related pandemic response. Mr. Kelly, a seven-year veteran of the Commissioner’s Office of the U.S. Food and Drug Administration, served in its Office of the Chief Counsel and Office of Legislation.
Mr. Coen’s practice focuses on guiding companies through the complexities of drug, biologic, and device development regulated by the FDA. He advises clients on every stage of product development, pre- and post-approval regulatory compliance, and commercialization strategies.
His experience 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. Mr. Coen also has extensive experience negotiating research and development, licenses, and purchase contracts, including contracts with the federal government. Prior to joining Venable, Mr. Coen served as a senior regulatory attorney at JAG, USAMRDC, where he was the primary legal advisor on regulated medical products to the Joint Program Executive Order for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). 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 more than $83B in contracts awarded by the JPEO-CBRND. He has also served as an advisor to the U.S. Senate Committee on Finance, where he performed oversight of the healthcare and tax systems.
Mr. Kelly received his J.D. from the University of Maryland Francis King Carey School of Law, his masters of public policy from the George Washington University School of Business & Public Management, and his B.A. in political science from McDaniel College. Mr. Coen received his J.D. from Duke University School of Law and his B.S. in accounting and B.A. in English from the University of Maryland.
Venable LLP is an American Lawyer Global 100 law firm headquartered in Washington, DC that serves as primary counsel to a worldwide clientele of large and mid-sized organizations, nonprofits, high-net-worth entrepreneurs, and other individuals. With more than 850 professionals across the country, including in California, Delaware, Florida, Illinois, Maryland, New York, Virginia, and Washington, DC, the firm strategically advances its clients’ objectives in the United States and around the globe. Venable advises clients on a broad range of business and regulatory law, legislative affairs, complex litigation, and the full range of intellectual property disciplines. For more information, please visit https://www.venable.com/.