Laurie Lenkel, JD Food and Drug Administration

Laurie Lenkel is the Director of the FDA Office of the Ombudsman. In this role she is responsible for facilitating the resolution of disputes between FDA and the industries it regulates. As FDA Ombudsman she works to ensure that companies are treated fairly and that their opinions and views are heard. Dr. Lenkel came to the Ombudsman position in 2003 after spending three years in FDA's Center for Drug Evaluation and Research in the Division of Drug Marketing, Advertising, and Communication. Prior to joining FDA, Dr. Lenkel worked in the pharmaceutical and medical device industries. Her experience in regulatory affairs includes phase four clinical trial development, drug labeling, promotion and continuing medical education program review. Her current professional activities include serving on the Editorial Advisory Board of the Food and Drug Law Journal (including two terms as Chair), member of the Executive Committee of the Food, Drug and Cosmetic Section of the New York State Bar Association, and past Chair of the Federal Chapter of the United States Ombudsman Association. In addition to being a trained mediator, Dr. Lenkel is both a licensed pharmacist and attorney. She also earned a doctorate in law and policy from Northeastern University.