Arnold & Porter announced today that Eva Temkin, former FDA Counsel and Acting Director for Policy at the U.S. Food and Drug Administration’s Office of Therapeutic Biologics and Biosimilars, has joined the firm’s Life Sciences & Healthcare Regulatory practice as a partner, resident in Washington, D.C.
In welcoming Temkin, Mahnu Davar, co-chair of the firm’s Life Sciences & Healthcare Regulatory practice, said: “Eva’s tenure at the FDA, along with her experience handling the complex issues facing FDA-regulated companies, makes her an excellent fit for our leading Life Sciences & Healthcare Regulatory practice. In particular, her deep experience in a wide range of biomedical-product issues, litigation, and legislative initiatives will further strengthen the ability of our practice to meet the ever-evolving needs of our clients.”
With nearly 20 years of experience, including almost a decade at the FDA, Temkin advises pharmaceutical, biotechnology, and medical device companies on a wide array of issues faced by the FDA-regulated industry. In both the premarket and postmarket arenas, she helps clients reach their objectives through sophisticated regulatory, legislative, and litigation strategies. Temkin has counseled clients through formal and informal FDA dispute resolution proceedings, served as the regulatory lead for numerous transactions, and was lead FDA counsel on various complex litigation matters. In addition to her extensive work on FDA’s policies relating to therapeutic biologics (vaccines, cell and gene therapies, immune modulators, and monoclonal antibodies) and biosimilars, Temkin served as Associate Chief Counsel in the FDA’s Office of Chief Counsel, where she provided strategic counseling to government regulators on numerous biomedical-product issues and initiatives.
In joining the firm, Temkin said, “I was drawn to Arnold & Porter for its globally renowned life sciences practice, as well as its culture of excellence and collaboration. I am excited to leverage my experience in the government and private sector to work with my new colleagues in the regulatory practice, as well as across the firm’s integrated cross-practice life sciences platform.”
Temkin earned her J.D. from New York University School of Law, where she was the Law and Economics Fellow and editor of the NYU Annual Survey of American Law. She received her B.A. from the University of Michigan. Temkin clerked for The Honorable John Gleeson, U.S. District Court for the Eastern District of New York.
Over the past several years, Arnold & Porter has expanded its U.S. and European life sciences regulatory footprints with partners Joshua Barlow (Boston), Gina Cavalier (Los Angeles), Hemmie Chang (Boston), Philip Desjardins (Washington, D.C.), Fred Kelly (Boston), Liz Lindquist (Denver), and Brandon Neuschafer (Chicago), counsel Monique Nolan (Washington, D.C.), and partners Carla Schoonderbeek and Bart Jong (Amsterdam). The firm also bolstered its life sciences Intellectual Property team with partner Abigail Struthers (New York) and its Life Sciences Transactions practice with partners Betty Yan and Niket Rele (New York).