February 28, 2023

Coverage of Jeremiah Kelly and Justin Coen’s Arrival at Venable

3 min

Coverage of Jeremiah Kelly and Justin Coen’s Arrival at Venable

The arrival of Jeremiah Kelly and Justin Coen at Venable was covered by Law360, Bloomberg Law, CityBiz, and Attorney at Law on February 28. The attorneys join Venable’s FDA Group as partners in the Washington, DC office.

Mr. Kelly’s practice concentrates on helping companies navigate the FDA’s complex regulatory framework for drugs, biologics, medical devices, and combination products. He 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.