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 lifecycle management of pharmaceutical and vaccine products, with particular focus on regulatory risk management strategies and product benefit risk assessments. Dr. Cunnington focuses on regulatory epidemiology with design and execution of real-world post-marketing safety studies, as well as real-world studies to support the approval of new products in the context of innovative regulatory pathways. Her research expertise includes design, negotiation, and execution of real-world components of risk management plans for multiple new product submission 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 held several senior epidemiology positions within Novartis and GlaxoSmithKline (GSK). At GSK, she chaired the peer review forum for all pharmaceutical real world evidence projects, provided epidemiological expertise for the GSK’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 is currently an elected board member representing European industry and service providers for the International Society of Pharmacoepidemiology.