Opportunity Information: Apply for RFA CA 27 017
The National Cancer Institute (NCI) is offering a cooperative agreement (U24) to support a centralized Pharmacokinetic Resource Laboratory for the Experimental Therapeutics Clinical Trials Network (ETCTN). The purpose of this award is to maintain or create a lab resource that can reliably handle the pharmacokinetic (PK) work needed across ETCTN early-phase cancer trials that are conducted under NCI-held Investigational New Drug (IND) applications managed within the Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP). In practical terms, the funded group is expected to function as the network's PK backbone, providing consistent, high-quality specimen handling logistics and analytical testing so that drug development decisions for NCI investigational agents can be based on clear, comparable PK and related translational data.
A central feature of this opportunity is the expectation that the PK Laboratory will coordinate biospecimen collection activities and then perform downstream analyses tied to how investigational agents behave in humans during ETCTN trials. The NOFO highlights several major categories of work: traditional pharmacokinetic endpoints (such as concentration-time profiles and exposure metrics), assessment of drug-drug interactions, evaluation of cytochrome P450 (CYP) interactions that may affect metabolism, pharmacodynamic measurements that connect drug exposure to biologic effects, and food-effect assessments that determine whether dosing with or without food meaningfully changes absorption or exposure. The overarching goal is to build a comprehensive understanding of each agent's PK behavior in the actual clinical contexts where it is being tested, so that dosing, scheduling, safety monitoring, and future study design can be optimized and advanced more efficiently.
Because this is a U24 cooperative agreement, the work is framed as a partnership with NCI rather than a stand-alone investigator-initiated project. The award is intended to support an integrated, multidisciplinary operation capable of serving the needs of multiple early-phase trials, not just one study. The NOFO also emphasizes that the PK Laboratory should bring together the right mix of expertise for early drug development and translational research, specifically calling out physicians, clinical pharmacologists, nurses, and scientists as key participants. That mix reflects the real-world workflow required for PK in trials: coordinating clinical sites for timed collections, ensuring proper processing and shipment, maintaining chain-of-custody and sample integrity, executing validated analytical assays, and interpreting results in ways that are useful to trial teams and NCI program leadership.
The scope is explicitly tied to ETCTN studies of NCI IND agents, meaning the laboratory is meant to support clinical development activities already flowing through NCI's investigational pipeline and the ETCTN infrastructure. The funded laboratory would be positioned to deliver standardized and comparable PK-related outputs across the network, which helps reduce variability that can arise when different trials use different labs, different assays, or different collection and processing practices. Ultimately, the value proposition is speed and clarity in decision-making for early-phase oncology agents: better understanding of exposure, metabolism, interaction risks, and biologic activity can directly inform dose selection, combination strategies, labeling-relevant interaction concerns, and whether and how to move an agent forward.
Key administrative details in the source information include the Funding Opportunity Number RFA-CA-27-017 and that it is categorized as discretionary funding through the National Institutes of Health (NIH), specifically NCI, with an activity category in health (CFDA 93.395). The closing date listed is 2026-06-30, and NCI anticipates making a single award (Expected Awards: 1), which signals a strong preference for one centralized resource serving the ETCTN rather than multiple competing laboratories. The listing does not state an award ceiling amount in the provided text (the AwardCeiling field is blank), so applicants would need to consult the full NOFO budget guidance and any referenced policy limits.
Eligibility is broad across U.S.-based organizational types, including public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including those without 501(c)(3) status), for-profit organizations other than small businesses, small businesses, and other eligible entities as defined in the NOFO. At the same time, the opportunity is strict about foreign involvement: non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed. That means the core laboratory work and funded project structure must be domestic, and applicants should be prepared to keep the funded activities fully within allowable U.S.-based organizational boundaries.
Finally, the title includes "Clinical Trial Not Allowed," which indicates the award itself is not intended to run an independent clinical trial as the primary activity. Instead, the laboratory's role is to support ETCTN clinical trials already being conducted by the network, by providing PK and related analyses and the operational infrastructure needed to execute those analyses consistently across multiple studies.Apply for RFA CA 27 017
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "The Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratory (U24 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395.
- This funding opportunity was created on 2026-05-08.
- Applicants must submit their applications by 2026-06-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is an NCI funding opportunity to support a centralized Pharmacokinetic (PK) Resource Laboratory for the Experimental Therapeutics Clinical Trials Network (ETCTN) through a cooperative agreement (U24). The goal is to provide a reliable, high-quality PK backbone for ETCTN early-phase cancer trials conducted under NCI-held Investigational New Drug (IND) applications managed within DCTD/CTEP.
What is the Funding Opportunity Number?
The Funding Opportunity Number is RFA-CA-27-017.
Which agency is offering this award?
The award is offered by the National Institutes of Health (NIH), specifically the National Cancer Institute (NCI).
What type of award mechanism is being used?
The mechanism is a cooperative agreement (U24), which is designed as a partnership with NCI rather than a purely investigator-initiated project.
What does a U24 cooperative agreement imply for how the work will be conducted?
Because it is a U24 cooperative agreement, the PK Laboratory is expected to operate in a collaborative partnership with NCI. The work is framed as a network-serving, integrated resource rather than a stand-alone project focused on a single study.
What is the main purpose of the centralized PK Resource Laboratory?
The main purpose is to maintain or create a lab resource that can reliably handle the pharmacokinetic work needed across ETCTN early-phase cancer trials under NCI-held INDs. The laboratory is expected to provide consistent specimen handling logistics and analytical testing so drug development decisions for NCI investigational agents are supported by clear, comparable PK and related translational data.
Who will the PK Laboratory serve?
The PK Laboratory is intended to serve the ETCTN and support ETCTN studies of NCI IND agents moving through NCI's investigational pipeline and ETCTN infrastructure.
What kinds of studies does this PK Laboratory support?
It supports early-phase cancer trials conducted within ETCTN that are run under NCI-held IND applications managed within DCTD/CTEP.
Is the award intended to support one trial or multiple trials?
The award is intended to support an integrated, multidisciplinary operation capable of serving the needs of multiple early-phase trials, not just one.
What are the major work categories or analyses described in the opportunity?
The NOFO highlights work across traditional PK endpoints (including concentration-time profiles and exposure metrics), assessment of drug-drug interactions, evaluation of cytochrome P450 (CYP) interactions that may affect metabolism, pharmacodynamic measurements linking drug exposure to biologic effects, and food-effect assessments evaluating whether dosing with or without food changes absorption or exposure.
What are "traditional pharmacokinetic endpoints" in the context of this opportunity?
The opportunity explicitly references traditional PK endpoints such as concentration-time profiles and exposure metrics, which describe how investigational agents behave in humans over time during ETCTN trials.
Why are drug-drug interaction and CYP interaction assessments included in the scope?
They are included to help evaluate interaction risks and metabolism-related considerations that can affect dosing, safety monitoring, and future study design for investigational agents.
What is meant by pharmacodynamic measurements in this opportunity?
Pharmacodynamic measurements are described as analyses that connect drug exposure to biologic effects, helping build a more complete understanding of how an agent behaves in the clinical context where it is being tested.
What is a food-effect assessment and why is it included?
A food-effect assessment evaluates whether dosing with or without food meaningfully changes absorption or exposure. It is included to better characterize the agent's PK behavior in real clinical use contexts.
What is the overarching goal of the PK work supported by this award?
The overarching goal is to build a comprehensive understanding of each agent's PK behavior in the clinical contexts where it is being tested, so dosing, scheduling, safety monitoring, and future study design can be optimized and advanced more efficiently.
What operational responsibilities are expected of the PK Laboratory besides running assays?
The PK Laboratory is expected to coordinate biospecimen collection activities and provide downstream analyses. The described real-world workflow includes coordinating clinical sites for timed collections, ensuring proper processing and shipment, maintaining chain-of-custody and sample integrity, executing validated analytical assays, and interpreting results in ways that are useful to trial teams and NCI program leadership.
Why does NCI want a centralized PK Laboratory rather than multiple labs?
The opportunity emphasizes standardized and comparable PK-related outputs across the network and reducing variability that can arise when different trials use different labs, assays, or collection/processing practices. Also, NCI anticipates making a single award, indicating a preference for one centralized resource for ETCTN.
How many awards does NCI expect to make?
NCI anticipates making one award (Expected Awards: 1).
What is the application or closing date listed in the opportunity summary?
The closing date listed is 2026-06-30.
Is there an award ceiling amount stated in the provided information?
No. The provided listing does not state an award ceiling amount (the AwardCeiling field is blank). Applicants would need to consult the full NOFO budget guidance and any referenced policy limits for budget parameters.
What is the CFDA number and program area referenced?
The CFDA listing provided is 93.395, and the activity category is health.
What kinds of organizations are eligible to apply?
Eligibility is broad across U.S.-based organizational types, including public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including those without 501(c)(3) status), for-profit organizations other than small businesses, small businesses, and other eligible entities as defined in the NOFO.
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-U.S. entities are not eligible to apply.
Can a U.S. organization include a non-U.S. component on this award?
No. Non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed.
What does the restriction on foreign components mean in practical terms?
Based on the provided information, it means the core laboratory work and the funded project structure must be domestic and kept within allowable U.S.-based organizational boundaries.
Does the funding opportunity allow clinical trials to be run under this award?
No. The title includes "Clinical Trial Not Allowed," which indicates the award itself is not intended to run an independent clinical trial as the primary activity.
If clinical trials are not allowed, what does the award actually fund?
It funds the laboratory resource and operational infrastructure to support ETCTN clinical trials already being conducted by the network, by providing PK and related analyses and the specimen handling logistics needed to execute those analyses consistently across multiple studies.
What kinds of expertise does NCI expect the PK Laboratory team to include?
The NOFO emphasizes an integrated, multidisciplinary operation and specifically calls out physicians, clinical pharmacologists, nurses, and scientists as key participants.
How will this PK resource impact early oncology drug development decisions?
The value described is speed and clarity in decision-making for early-phase oncology agents. Better understanding of exposure, metabolism, interaction risks, and biologic activity can inform dose selection, combination strategies, labeling-relevant interaction concerns, and whether and how to move an agent forward.
Which NCI program areas are referenced as managing the relevant IND applications?
The IND applications are described as NCI-held and managed within the Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP).
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