A Model for an Academia-Industry Collaboration for Pharmacovigilance and Pharmacoepidemiology

Purpose: We describe a novel model for collaboration between academia and the pharmaceutical industry, focused on post-marketing pharmacovigilance. Methods: Otsuka Pharmaceutical, a global Japan-based pharmaceutical company, and Columbia University, a major university, have established a collaboration dedicated to working together in pharmacoepidemiology and post-marketing pharmacovigilance. An oversight committee, made up of individuals from each institution, meets on a regular basis to set policy and provide oversight. Results: The primary aim of this novel academia-industry collaboration is to provide expert research guidance for the industry pharmacovigilance group on questions involving pharmacoepidemiology. University epidemiologists may also be consulted by other divisions of industry, such as the clinical trials group. The first aim of the collaboration is to provide epidemiologic input to industry by determining the incidence, prevalence, and outcomes of diseases; drafting the epidemiology components of risk management plans for drugs; and planning retrospective database analyses. A second major aim is to provide educational services to industry by conducting workshops on basic epidemiology and biostatistics; leading a monthly lecture/journal club series; hosting seminars on medical topics; and providing a writing workshop to assist in preparing abstracts and papers for presentation and publication. University epidemiologists provide oversight/evaluation through quarterly presentations and updates to the industry partner’s external advisory committee as well as to University leadership. Conclusions: This unique academia-pharmaceutical industry collaboration enhances understanding of the medical and epidemiologic challenges faced within a pharmacovigilance department of a global pharmaceutical company. We offer it as a model for others performing mandatory regulatory post-marketing pharmacovigilance activities.