DIA 2021 Global Annual Meeting

Since 2018, FDA’s Oncology Center of Excellence (OCE) has led the way in transforming the oncology drug review process by piloting several initiatives. The first pilots were the Real Time Oncology Review (RTOR) and Assessment Aid. RTOR focuses on a more efficient review through data and analysis standardization, and presubmission of datasets allowing for early iterative engagement with the applicant aiming to bring treatments to patients earlier. The Assessment Aid presents the sponsor’s position and the FDA assessment in one document allowing the review team to focus on a critical evaluation of the data as well as increasing review efficiency and consistency. Project Orbis, introduced in 2019, provides a framework for concurrent submission and review of products by FDA and international regulators providing for potential earlier access to oncology drugs in other countries. The RTOR and Assessment Aid Pilots have already demonstrated success by shortening the review time and expanding from supplements to original applications. This has created an interest in expanding these pilots across other FDA Centers/Divisions to accelerate the review of products that address unmet medical needs. Project Orbis, although only a little over a year old, began as a pilot with FDA, TGA and Health Canada and due to the success of that first experience quickly expanded to include Swissmedic, Singapore HSA, ANVISA, and MHRA as international collaborators. This session will review each FDA OCE pilot program and present the industry and FDA views highlighting lessons learned and adjustments made by both sponsor and review teams to enable their effective use and suggested modifications for future improvements. Additionally, expansion of the pilots within FDA to other divisions and thoughts from an international regulator’s perspective on their involvement in Project Orbis will be discussed.