Vice President, Regulatory
Dr. Wekselman is a senior drug development expert with extensive experience in drug development, clinical protocol development and execution, and interactions with regulatory authorities, including leading or developing marketing application submissions to the U.S. Food and Drug Administration (FDA), the European Medicines Agency and Health Canada for drugs, biologics and medical devices. She has 10 years of clinical research organization experience as a consultant to pharmaceutical, biotechnology, and device companies, and nine years at Procter & Gamble Pharmaceuticals, where she held positions in medical writing, medical monitoring, and project leadership. Dr. Wekselman earned her BSN (summa cum laude) and PhD in nursing from the University of Cincinnati. She had 10 years of clinical and academic experience in nursing before joining the industry to work in drug development. She has authored more than 25 journal articles or book chapters and has presented more than 30 posters, conference sessions, guest lectures and professional education seminars.