Lee Leichter has over 35 years' experience in the health care industry. He has been providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 15 years. Projects have encompassed a multitude of business, technical, regulatory and quality issues, mostly relating to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies and start-ups successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems.
He serves as an independent expert on the ISO technical committees for Injection and respiratory products, infusion pumps, needles and catheters, and AAMI Injection and Infusion Devices committees, helping establish the international standards for safety and performance of these products. He has also directly proposed and responded to FDA positions and proposals covering combination products, most recently as a consultant to the Combination Products Coalition.
He holds a Bachelor's degree from the State University of New York at Stony Brook and an MBA with Honors from Florida Gulf Coast University. He is certified in USA and EU Regulatory Affairs.