Marianne Cunnington

Dr. Cunnington has over 20 years of experience as a pharmaceutical industry epidemiologist. She specializes in the generation of real-world evidence (RWE) in support of the development and life cycle management of pharmaceutical and vaccine products, with a particular focus on regulatory risk management strategies and product benefit-risk assessments. Dr. Cunnington’s research expertise includes the design, negotiation, and execution of real-world components of risk management plans for new product submission to regulators in the US, UK, EU, Japan, and South Korea, including studies of post-approval safety in the EU; post-marketing requirements and commitments in the US; and pregnancy registries. Prior to joining Analysis Group, she served in several senior epidemiology positions at pharmaceutical companies, including as the chair of GSK’s peer review forum for all pharmaceutical RWE projects; as a member of GSK’s Global Safety Board; as head of epidemiology at Novartis Vaccines; and as a managing board member of Innovative Medicines’ public-private partnership initiative to build an integrated European real-world data (RWD) network to monitor medication safety in pregnancy.