The Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratory (U24 Clinical Trial Not Allowed)

The National Cancer Institute (NCI), part of the U.S. Department of Health and Human Services through the National Institutes of Health (NIH), is offering a funding opportunity to support the Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratory. This cooperative agreement mechanism (U24) is intended to fund a single institution or organization to serve as a centralized pharmacokinetics (PK) laboratory resource supporting early phase oncology clinical trials conducted under the ETCTN. The ETCTN is a national network focused on accelerating the development of novel anticancer agents through coordinated clinical trials and translational research. The primary purpose of this funding opportunity is to establish or maintain a PK laboratory that will manage biospecimen collection and conduct comprehensive pharmacokinetic and pharmacodynamic analyses for investigational new drug (IND) agents studied within the ETCTN. These analyses include drug absorption, distribution, metabolism, and excretion, as well as drug-drug interactions and biomarker evaluation. The laboratory is expected to support the safe and effective development of cancer therapeutics by generating high-quality data on drug behavior in human subjects, thereby informing dosing strategies and treatment decisions. Funding will support a wide range of activities necessary to operate the PK laboratory, including specimen handling and analysis, data management, statistical modeling, and coordination with ETCTN sites. Applicants must demonstrate the capability to process approximately 25,000 biospecimens annually and maintain robust infrastructure, including technical services, scientific leadership, and biospecimen management systems. While application budgets are not capped, they must reflect actual project needs, and the anticipated total funding is approximately $850,000 to support one award over a project period of up to six years. Cost sharing is not required. Eligible applicants include a broad range of U.S.-based organizations such as public and private higher education institutions, nonprofit organizations, and for-profit entities including small businesses. Foreign organizations and non-U.S. components are not eligible. Applicants must have appropriate registrations, including SAM, Grants.gov, and eRA Commons, and ensure that principal investigators possess the expertise and credentials necessary to lead complex pharmacokinetic research programs. Applications must be submitted electronically through approved NIH systems such as ASSIST or Grants.gov. Required components include a detailed research strategy, organizational structure, communication plans, timelines, and compliance documentation related to Good Laboratory Practice. Evaluation criteria include scientific merit, investigator qualifications, innovation, approach, and institutional environment. Applications will undergo peer review followed by advisory council review before funding decisions are made. Key dates for this opportunity include an opening date of May 30, 2026, and a submission deadline of June 30, 2026. Applications must be submitted by 5:00 PM local time, and no late submissions will be accepted. Peer review is expected in November 2026, with advisory council review in January 2027 and an earliest project start date of April 2027. This funding opportunity is a one-time solicitation with no indication of recurring cycles, and applicants are encouraged to prepare early to ensure compliance with all submission requirements.

Ensure strong demonstration of pharmacokinetic expertise, infrastructure capacity for 25000 biospecimens annually, and robust data analysis and quality control systems; align proposal with ETCTN collaborative framework