John C. Talian, Ph.D., is Vice President, Regulatory Affairs at Hurley Consulting. He is a senior regulatory affairs leader with over 20 years’ experience in the development, registration and life cycle management of novel therapeutic compounds in the global marketplace. He has interacted extensively with FDA, EMA, and other health authorities worldwide. His expertise includes critical issue management that has global implications. His regulatory affairs experience spans multiple therapeutic areas including oncology, cardiovascular, CNS, metabolic-endocrine and blood products.
As Vice President, Regulatory Affairs at Hurley Consulting, Dr. Talian is responsible for regulatory management of drug product development for clients, critical review of submission documents, and general regulatory activities related to preparation of client documents. He advises clients on regulatory strategy, and at their request, Dr. Talian represents sponsors with FDA and other health authorities to facilitate review and approval of product applications and resolution of regulatory issues.
Before joining Hurley Consulting, Dr. Talian was Vice President, US Head of Regulatory Affairs, Global Regulatory Affairs at Bayer Healthcare Pharmaceuticals from 2008 to 2013. He led a staff of 80 professionals with both local and global responsibilities for development projects and marketed products, as well as compliance activities. He also managed critical US regulatory activities for the Bayer portfolio of products. In 2007 and 2008 Dr. Talian was Global Head for Specialized Therapeutics, Global Regulatory Affairs, where he provided strategic input on all development and marketed product activities and coordinated global regulatory strategies.
From 1994 to 2007 Dr. Talian was employed by Hoffmann-LaRoche Pharmaceuticals, Inc., in various positions. He was Group Director, Oncology Management, Drug Regulatory Affairs from 2002 through 2007. In this capacity he was responsible for strategic regulatory and operational activities for the oncology portfolio of products. He also served as International Regulatory Director in Basel, Switzerland, where he was Group Global Leader for Xenical. As Program Manager/Director, Regulatory Leader US and Global, Dr. Talian contributed to the development of projects in oncology and CNS therapeutic areas including the development of bosentan (Tracleer) and Vesanoid.
Dr. Talian began his career in regulatory affairs at R.W. Johnson Pharmaceutical Research Institute, where he was Regulatory Associate/Senior Associate from 1991 to 1994. There he provided regulatory support for Procrit, a marketed product, and various INDs, and also filed an ELA.
Dr. Talian holds both a bachelor’s degree in cell and molecular biology and a doctoral degree in cell biology from Carnegie-Mellon University. His thesis research was conducted in the Department of Anatomy at Northwestern University Medical School. As a post-doctoral/staff fellow at the National Eye Institute of the National Institutes of Health, he performed basic research concerning oncogene expression in the Laboratory of Molecular and Development Biology. He has lectured on regulatory affairs topics at the corporate level and at several medical schools and other institutes of higher education.