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

Collaborations between academia and the pharmaceutical industry are common for drug development and clinical trials, but rare for pharmacovigilance. Here we describe a novel model for collaboration between academia and the pharmaceutical industry, focused on post-marketing pharmacovigilance, that others may wish to emulate. For the past 5 years, Otsuka Pharmaceutical, a global Japan-based pharmaceutical company, has collaborated with faculty at Columbia University, a major university, for epidemiology support. The primary aim of this collaboration is to provide expert research guidance for Otsuka's pharmacovigilance group on questions involving pharmacoepidemiology. University epidemiologists are also consulted by other industry divisions, such as the clinical trials group. University epidemiologists help to determine the incidence, prevalence, and outcomes of diseases; draft the epidemiology components of risk management plans for drugs; and plan retrospective database analyses. A second major aim of this collaboration is to provide educational services to the company 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. This type of epidemiologic collaboration has key advantages for industry over the alternatives of building an in-house epidemiology department or hiring outside consulting firms: lower cost; rapid access to university experts for potentially esoteric medical topics; and, for education, deep university experience in terms of assembling didactic programming and recruiting speakers. We offer this model for collaboration for others performing mandatory regulatory post-marketing pharmacovigilance activities.