Georgetown Law

Coleen Klasmeier is a Chambers Band 1-ranked life sciences regulatory lawyer with deep experience representing biopharmaceutical and medical device clients in litigation, transactions, and regulatory matters. Her professional background includes experiences in two preeminent global law firms and service as a lawyer in the Office of the Chief Counsel at the US Food and Drug Administration. Coleen is both the first and the immediate former head of Sidley Austin LLP’s top-ranked global Food, Drug and Medical Device Regulatory practice. Under her leadership the group grew into a full-service regulatory practice and was honored by various ratings and rankings organizations, including as practice of the year in US News. She was appointed to Sidley’s Executive Committee in 2015 and served in that capacity until her departure from the firm to accept an in-house position with firm client Roche. Coleen began her career with Covington & Burling where she worked as an associate before her government service.

A nationally recognized author and speaker on FDA matters, Coleen has been quoted in the Associated Press, ABC News, Business Week, Bloomberg, Legal Times, The New York Times, Politico, Reuters, The Wall Street Journal, The Washington Post, and US News. Her work has appeared in Health Affairs, the American Journal of Law & Medicine, Food & Drug Law Journal (forthcoming), and various trade and lay publications. She has testified on Capitol Hill on First Amendment issues affecting the life sciences industry, and has served on two Duke-Margolis Center working groups addressing policy and legal issues arising out of biomedical research and regulation. Coleen is a member of the Washington Legal Foundation’s Legal Advisory Board.

Coleen is a magna cum laude graduate of the Boston University School of Law, where she was an editor of the law review and received the Melville Madison Bigelow Prize. She currently serves as Head of Legal—Regulatory Affairs & Patient Safety at Roche Diagnostics.