Kurt Karst is a Director at Hyman, Phelps & McNamara, P.C. Mr. Karst provides regulatory counseling to pharmaceutical manufacturers concerning Hatch-Waxman patent and exclusivity issues, myriad drug development issues, pediatric testing issues, and orphan drug issues. Previously, he was a lobbyist for F. Hoffman-La Roche Inc. Mr. Karst served as an articles editor for the American University Law Review, and in 1995, was awarded a Fulbright Scholarship for post-graduate studies in Germany. He has published in the American University Law Review, the Food and Drug Law Journal and Update, RAPS FOCUS, and many other publications, and is co-author of the Food and Drug Law Institute’s Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives. Mr. Karst is a graduate of the American University Washington College of Law, and holds a Bachelor of Arts degree in political science and German from Marquette University. He is admitted to practice law in Maryland and the District of Columbia, and is a primary author of the FDA Law Blog (www.FDAlawblog.net).