Combination Products 2016

Part of the National Cancer Moonshot Initiative, the recently announced Oncology Center of Excellence (OCE) calls on the FDA to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices, and to formalize an innovative, yet seamless cross-center regulatory approach to enhance the coordination of clinical review across oncology-related drugs, biologics, and medical devices. While OCE is focused on a single therapeutic area, this approach may eventually benefit other therapeutic areas, such as cardiovascular, neurodegenerative, and infectious diseases. This session will discuss OCE and the implications and possibilities related to the review of combination products. Our esteemed panel will discuss the reasons behind the formation of OCE, including the perceived benefits of a matrix organizational structure on the development and review of combination products and companion diagnostics. The current status of OCE, including the goals around collaboration with the other Centers, and next steps in the implementation will also be discussed.