Forecast to Publish a Notice of Funding Opportunity for The Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratory (U24 Clinical Trial Not Allowed)

The National Cancer Institute (NCI), a division of the U.S. Department of Health and Human Services under the National Institutes of Health (NIH), is forecasting a Notice of Funding Opportunity (NOFO) for the development and operation of a Pharmacokinetic (PK) Resource Laboratory. This laboratory will be an essential support mechanism for the Experimental Therapeutics Clinical Trials Network (ETCTN), focusing on enhancing the clinical development of Investigational New Drug (IND) agents through pharmacokinetic analyses. The funding opportunity, referenced as FOR-CA-25-090, will employ the U24 cooperative agreement mechanism and does not allow clinical trials as part of the award activities. The PK Resource Laboratory is expected to perform core functions including organizing biospecimen collections, conducting pharmacokinetic and related assays, and reporting on various pharmacologic interactions and effects such as drug-drug interactions, cytochrome P450 enzyme activities, pharmacodynamics, and food-related influences. The overall goal is to improve understanding of how investigational agents behave in the human body during early-phase ETCTN trials. The laboratory is intended to support the Division of Cancer Treatment and Diagnosis (DCTD) and the Cancer Therapy Evaluation Program (CTEP) within NCI. Eligible applicants for this opportunity include nonprofits with 501(c)(3) status that are not institutions of higher education, as well as both public and private institutions of higher education. Applications must come from institutions with standing infrastructure to support pharmacokinetic studies throughout the full clinical development lifecycle of NCI-IND agents. Applicants must be able to demonstrate capacity and readiness to perform within three defined functional components: a Technical Services Core, a Scientific Leadership and Project Development Core, and a Biospecimen Collection, Tracking, Processing and Data Reporting Core. The anticipated Notice of Funding Opportunity is expected to be published on July 31, 2025, with an application due date of October 30, 2025. The forecasted award date and project start date are both set for July 1, 2026. While the NOFO is currently not accepting applications, this early forecast provides applicants ample time to build collaborations and develop responsive project proposals. The expected total program funding is $850,000, though specific award ceilings and floors are not yet published. Only one award is anticipated to be made under this opportunity. No matching requirement is associated with this forecasted grant. The opportunity falls under the discretionary funding category for health-related activities. The primary point of contact for this grant is Dr. Lori A. Henderson at the National Cancer Institute, reachable at 240-276-5930 or via email at NCIETCTNRFA@mail.nih.gov. Potential applicants are encouraged to review the finalized NOFO upon publication and prepare their applications accordingly.