Abstracts

Rationale: The recent Institute of Medicine Report on Epilepsy identified gaps in care management and disease knowledge. To bridge these gaps, collaborative efforts involving sharing of clinical and research expertise and data sources lead to the need for partnerships across the epilepsy research community. The research relationship between medical academia and the biopharmaceutical industry has evolved over the past few decades out of necessity to share resources and expertise to achieve common goals. Limited resources, along with potential conflicts of interest, intellectual property concerns and complexities of the bureaucracies of both academia and industry have limited these types of research partnerships. Despite these barriers, in the past decade, joint participation in disease burden/manifestation research and drug development by biopharmaceutical companies and academia has expanded. Based upon this model, Emory University and UCB have combined expertise and resources to perform translational outcomes research in epilepsy. To our knowledge, this is a first in epilepsy and could be a model for effective and appropriate collaborations for the future.Methods: Preliminary discussions surrounding common research goals and identification of each partner s expertise and resource contributions to the collaboration took place. Emory University had the clinical insight, translational expertise and biostatistical capabilities. UCB had expertise in health economics and outcomes research and access to large administrative data sets containing de-identified patient data. A legal agreement was executed between both entities allowing for ongoing research projects to be conducted over time. A steering committee (SC) was created with equal representation from Emory and UCB, which establishes priorities for research projects, assesses resources, needs, and how to optimally align for each project.Results: The first project, a descriptive analysis of incidence, prevalence, characteristics, and treatment patterns of epilepsy patients in the U.S. was outlined and initiated. The analysis will take place using 2 large administrative claims datasets. A specific contract for the first project was vetted by both institutions, with benchmarks of activity agreed upon. To date, the process has included a comprehensive literature search, establishing case definitions for epilepsy, identifying variables, organizing the data dictionaries, and analyzing the data in an iterative fashion. Additional projects will follow, such as exploration of the natural history of new onset epilepsy, sequences of therapy changes, adherence to and outcomes associated with quality indicators, studies of comorbidities, and costs. Conclusions: This is a unique model of expertise and resource collaboration, with the research goal of advancing the understanding of epilepsy burden, management, and outcomes. In addition, our model is a good example of how to develop, manage, and grow academic-industry collaboration, and will act as an incubator for innovative approaches in future epilepsy research. Funded by UCB, Inc.