Dr. Hurley manages a consulting firm, which she founded in 1987, and whose clients include major companies within the healthcare industry. As President and Chief Executive Officer, Dr. Hurley is responsible for the general management of the company known for its analytical thinking and drug development expertise. She has overall responsibility for the company’s product quality. She has directed the development of the company’s expertise, computer systems, and the design and implementation of the quality process. She is recognized as an expert in drug development and she has directed the development of data packages for simultaneous submission in Europe, Canada, and the United States. In 2010, the Regulatory Affairs Professionals Society honored Dr. Hurley among its 2010 class of RAPS Fellows.
Dr. Hurley began her career in industry at Ciba-Geigy, currently Novartis, and was a Director, Cardiovascular Drug Development. In this position, she was responsible for the design of Phase I through Phase III clinical research including the development of ACE inhibitors to support approvability of compounds in different indications and the design of
pre-marketing programs. She provided guidance and rationale for new indications, organized consultant meetings, and provided the clinical research recommendation for the GO/NO GO criteria on which to choose products for development and on which compounds in development were assessed. She was the primary participant in five FDA meetings. The responsibilities also included coordination of international global development projects and supervising the CRO activities. Within the drug development department, Dr. Hurley was responsible for the technical assessment and drug development strategy to achieve commercial objectives for eight strategic plans. In conjunction with a task force, she developed and implemented a plan to automate the Drug Development Department, and was chairperson of the Office Automation Standards and Procedures Committee.
Before entering the pharmaceutical industry, Dr. Hurley was the Medical Director of the Hemodialysis Unit at Bellevue Hospital Center, New York. She was a National Kidney Foundation Fellow and completed a
Fellowship in Nephrology at New York University. She completed her internal medicine training at New York University. Dr. Hurley holds a medical degree from The Medical College of Pennsylvania in
Philadelphia, Pennsylvania, and a bachelor’s degree in chemistry from Fordham University.