Executive Director Gilead Sciences Inc. - ENTERPRISE
Real-time Review of supplemental NDA (sNDA) applications submitted to the Oncology Center of Excellence (OCE) became a reality in 2018 with the submission and review of the sNDA for Kisqali (ribociclib) to the OCE’s RTR pilot program. RTR enables early iterative FDA-Sponsor dialogue, including a process for sharing clinical data shortly after database lock but in advance of the formal submission. The pilot aims to increase the efficiency of the review and to ensure safe and efficacious medicines are available to patients as soon as possible. RTR has been used successfully in combination with FDA expedited pathways including Breakthrough Designation, and Priority Review, has been expanded to include an NME approval, and has been used in combination with the PROJECT ORBIS pilot. The RTR pilot has been a great success and has become a foundation for further innovation in the OCE.
RTR is a catalyst that can reach far beyond oncology with potential synergistic opportunities linked to FDA’s Drug Safety Pilots, FDA’s IT Modernization Plan, Cloud submissions and more. Further, there is the opportunity to strategically increase the reach of RTR in a step-wise manner beyond oncology, as well as the potential for RTR-like approaches beyond the US.
This session will provide an overview of the FDA OCE RTOR pilot, and experience to date. It will then leverage this foundation to explore future potential synergies, and steps that FDA and Sponsors can take in partnership to further advance the benefits of RTR. Lastly, the session will share an example of how RTR principles are already being applied beyond oncology.
Apply a foundational understanding of Real-time Oncology Review, what it is, the general process, and experience to date, including challenges and key success factors.
Gain a practical understanding of strategic implications of possible future direction and synergistic expansion of RTR, and how to proactively prepare and incorporate that reality into your regulatory strategies.
Recognize the incredible potential benefit of expanding RTOR via a non-oncology case study.