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DNA

Dr Lesley Reeve

Lesley obtained her PhD in Genetics from Leeds University, UK in January 1997 and started work as a Study Director in the Genetic and Molecular Toxicology Department at Covance Laboratories Ltd, Harrogate, UK. After 2 years in Genetic and Molecular Toxicology, Lesley moved to Regulatory Affairs and is now part of the Global Regulatory Strategy Group at Covance. She has over 20 years experience in nonclinical development of regulated healthcare products, during which time she has authored a range of nonclinical regulatory documentation, on behalf of Clients, including: Investigator’s Brochures, Clinical Trial Applications (including first time in man with higher risk molecules), Section 2.6 of Common Technical Document format Marketing Authorisation Applications, Special Protocol Assessment requests, Nonclinical Overviews, position papers and literature based safety reviews, covering pharmacology, pharmacokinetic and toxicology data. Her current role, as Director of Nonclinical Strategy, involves the provision of expert scientific and regulatory advice on nonclinical data/issues for a range of product types including medical devices, pharmaceutical products, excipients and impurities and providing support to clients with regulatory agency interactions. Outside of Covance, Lesley is a keen supporter of training and development, being an annual guest lecturer on Drug Development at the Universities of Surrey, UK (2006-2015) and Lincoln, UK (2016-present) and involved with teaching and assessment in the Biopharmaceutical Development MSc at the University of Leeds (2016-present). Lesley was awarded an MSc in Regulatory Affairs in 2008 from the University of Cardiff, UK and has been Module Leader for the nonclinical module of the MSc course since 2010. She is a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA) and an Industrial Fellow of the University of Hertfordshire, UK. Lesley has authored and co-authored publications on a range of topics including genotoxicity, carcinogenicity, biocompatibility, risk management plans and post-marketing commitments. She is a manuscript reviewer for, and inaugural member of the Editorial Board of, Toxicology Reports.