Alice Rouleau

Alice is a healthcare professional with more than 15 years’ experience, 10 years of which were spent working for two major pharmaceutical companies, mainly in the areas of pharmacoepidemiology and HEOR/market access. She worked as senior epidemiology research manager and pharmacoepidemiology department manager with global responsibilities in neuropsychiatry (psychosis, bipolar disorder, stroke, autism spectrum disorder) and metabolism (diabetes). Additionally, Alice has regulatory experience having worked over six years as clinical assessor at the French National Security Agency of Medicines and Health Products.

Alice offers demonstrated methodologic expertise across a full array of real-world evidence needs and designs. She has contributed to the development of global real-world evidence plans with strategy and tactics to support products across development and life cycle management. She led real-world evidence studies (burden of disease, treatment patterns, effectiveness, safety and tolerability, unmet needs) with responsibility in terms of design, planning, coordination and reporting. She managed different types of studies such as prospective cohort studies and retrospective cohort studies based on either chart review or on several EU, US or Canadian healthcare databases. Alice was responsible for a PASS program. She has designed, implemented, and reported to the Medicines and Healthcare Products Regulatory Agency (MHRA), and the Pharmacovigilance Risk Assessment Committee (PRAC), a drug utilization study, as well as a chart review to assess the effectiveness of risk minimization measures. Alice has a strong understanding and interest for the impact of non-interventional studies on the HEOR and market access strategy and needs. Her interests include comparative effectiveness research and hybrid studies.

Alice was trained in pharmacy at the University of Paris V (PharmD). She also earned a master’s degree in pharmacoepidemiology from the University of Bordeaux (MScPH). She completed her scientific background with a master’s degree in health law with specialization in biotechnology at the University of Versailles (MHLaw), and an executive Master of Business Administration degree at the Sorbonne Business School (EMBA).