Oncology Center of Excellence Benefits Risk Professional Services
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $1,500,000 to $3,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Points of contact
-
- Joshua Holliday joshua.holliday@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Department of Health and Human Services Food and Drug Administration is seeking professional services for the Oncology Center of Excellence (OCE), focused on advancing precision oncology, patient-focused drug development, and regulatory decision-making through scientific investigation. The contract aims to support OCE's mandates under the 21st Century Cures Act, including research on biomarkers, patient-reported outcomes, and real-world data analytics. The estimated solicitation release date is June 1, 2026, with an anticipated contract award date of August 1, 2026.
While specific award value details are not provided, the contract falls under NAICS code 541715 for Research and Development in Physical, Engineering, and Life Sciences, indicating a specialized professional services procurement. The primary point of contact is Joshua Holliday (joshua.holliday@fda.hhs.gov) from the FDA, and the opportunity follows a previous one-year directed 8(a) award to Aneon Brillient LLC in FY2025. The services will likely be performed at FDA facilities or designated research locations supporting the Oncology Center of Excellence's regulatory and scientific objectives.
Forecast text
"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.
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