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 component of the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services, is forecasting a Notice of Funding Opportunity (NOFO) for the Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratory. This initiative is designed to support the ETCTN in its mission to advance early-phase clinical trials of NCI Investigational New Drug (IND) agents by enhancing pharmacokinetic data collection, analysis, and interpretation. The objective of this NOFO is to solicit applications from institutions and organizations capable of establishing or maintaining a Pharmacokinetics (PK) Resource Laboratory. The PK Laboratory will serve as a central hub for the collection and processing of biospecimens, and for performing detailed analyses related to pharmacokinetic endpoints, drug-drug interactions, cytochrome P450 (CYP) interactions, pharmacodynamics, and the effects of food on drug metabolism. This research is essential to understanding how investigational drugs behave in the body, thereby improving the design and success of future cancer therapies. This funding opportunity will use the U24 activity code and is classified as a cooperative agreement. It is anticipated that one award will be made, with estimated total program funding of $850,000. Applications are not currently being accepted, as this is a forecasted opportunity. The official NOFO is expected to be published on or around July 31, 2025, with applications due by October 30, 2025. The award and project start dates are estimated to be July 1, 2026. The NOFO does not allow for clinical trials within the scope of this funding, and applications must be submitted in accordance with NIH cooperative agreement terms. Applicants are expected to include three functional components in their applications: a Technical Services Core, a Scientific Leadership and Project Development Core, and a Biospecimen Collection, Tracking, Processing, and Data Reporting Core. Each core must address specific responsibilities related to the comprehensive pharmacokinetic assessment for ETCTN studies. Eligible applicants include public and private institutions of higher education as well as nonprofits with 501(c)(3) status, excluding higher education institutions. Eligibility is limited to entities that can demonstrate existing infrastructure capable of supporting pharmacokinetic studies from trial initiation to completion. Collaborative, multidisciplinary teams comprising physicians, clinical pharmacologists, nurses, and scientists are encouraged to apply, as these teams must be able to conduct pharmacokinetic evaluations for early drug development studies within the NCI’s Cancer Therapy Evaluation Program (CTEP). Interested applicants are encouraged to use the forecast period to develop partnerships and responsive projects. Additional information can be obtained from the designated grantor contact, Dr. Lori A. Henderson at the National Cancer Institute. She can be reached by email at NCIETCTNRFA@mail.nih.gov or by phone at 240-276-5930. The opportunity falls under Assistance Listing 93.395 for Cancer Treatment Research and is discretionary in nature. While no cost sharing or matching is required, applicants must be prepared to meet all programmatic requirements detailed in the full NOFO when it is released.