Julie Warner

Biography

Dr Julie Warner completed her PhD in 2002 at the University of Newcastle upon Tyne. After spending some time in research at the University of Cambridge and the biotech company AdProTech, Dr Warner joined Gregory Fryer Associates (GFA) in 2003. As a Regulatory Consultant at GFA, Dr Warner co-ordinated and managed projects on behalf of clients, ranging from EU and US orphan drug designation applications, to Protocol Assistance/Scientific Advice, multinational clinical trial applications and marketing authorisation applications. During this time, Dr Warner provided strategic and operational regulatory support for the programmes and managed interactions and negotiations with regulatory authorities in both the EU and US. In 2008, Dr Warner joined Genzyme Europe Research in Cambridge where she was responsible for their cardiovascular portfolio, taking a novel therapy from mid-stage clinical development through to marketing authorisation application. From there, Dr Warner moved to Clovis Oncology UK and was responsible for preparing and maintaining regulatory submissions for the product portfolio. In 2013, Dr Warner was appointed Senior Regulatory Programme Manager at Roche Products, working on an oncology development project. Dr Warner joined Boyds in August 2014 to strengthen the existing regulatory affairs team and in 2016, she became Director of Regulatory Affairs. Bringing over 10 years experience in EU and US regulatory affairs, Dr Warner has a special interest in orphan drugs. Dr Warner has been a member of the Editorial Panel for the professional journal of The Organisation for Professionals in Regulatory Affairs (TOPRA), the Regulatory Rapporteur, for over 10 years, and in 2015 became a Fellow of TOPRA.

Research Interest

orphan drug designation applications, to Protocol Assistance/Scientific Advice, multinational clinical trial applications and marketing authorisation applications.