Marianne Cunnington

Dr. Cunnington specializes in regulatory epidemiology, including the design and execution of real-world post-marketing safety and effectiveness studies, as well as real-world studies to support the approval of new products through innovative regulatory pathways. Her research expertise includes design, negotiation, and execution of real-world components of risk management plans for new product submissions with regulators across multiple geographies (US, UK, Europe, Japan, South Korea); post-approval safety studies in the EU; post-marketing requirement and commitment studies in the US; and pregnancy registries. Prior to joining Analysis Group, Dr. Cunnington spent more than 20 years as a pharmaceutical industry epidemiologist focusing on the generation of real-world evidence (RWE) to support the development and life cycle management of vaccines and pharmacological therapies. Dr. Cunnington held several senior epidemiology positions within Novartis and GlaxoSmithKline (GSK). At GSK, she chaired the peer review forum for all pharmaceutical RWE projects, provided epidemiological expertise for the company’s Global Safety Board, and was a managing board member of the Innovative Medicines Initiative’s public-private partnership, building an integrated European real-world data network to monitor medication safety in pregnancy. Dr. Cunnington serves on the board of the International Society for Pharmacoepidemiology as an elected representative of European industry and service providers.