Oncology Center of Excellence Benefits Risk Professional Services

"As part of the 21st Century Cures-Act, the Oncology Center of Excellence (OCE) was established to enhance and modernize the regulation of oncology medical products to achieve patient-centered regulatory decision-making through innovation and collaboration. The FDA Oncology Center of Excellence has a clear role in advancing the emerging and evolving fields of precision oncology, patient-focused drug development, immuno-oncology, pediatric oncology, real-world evidence, the application of big data analytics, oncology devices and diagnostics by coordinating and enhancing the substantial expertise that resides in the individual product centers within FDA. The OCE addresses these mandates by conducting scientific investigation of optimal intermediate endpoints, qualified biomarkers, patient reported outcomes, real world data and best practices for medical product development as well as providing guidance and educational resources that help support informed anticancer therapy development to expedite the availability of directed and novel cancer treatments to the public. OCE awarded a Directed 8(A) Aneon Brillient LLC - JV in FY2025 for one year.