Date: August 12, 2013
Estimated Publication Date of Announcement: Fall 2013
First Estimated Application Due Date: Winter 2014
Earliest Estimated Award Date: July 2014
Earliest Estimated Start Date: August 2014
National Cancer Institute (NCI)
The National Cancer Institute intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to support the development of cancer-relevant technologies that would be suitable for global health environments with limited resources. Specifically, the FOA will solicit applications for the development of new technologies/devices and/or adaptation of existing technologies/devices for cancer detection/diagnosis and treatment to be tested and ultimately implemented in low- and middle-income countries (LMICs), as listed by World Bank (http://data.worldbank.org/about/country-classifications/country-and-lending-groups).
The intent of this Notice is to provide potential applicants
with lead time to start the process of forming teams, building collaborations,
and planning responsive applications.
The FOA is expected to be published in the Fall 2013, with an expected application due date in Winter 2014. This FOA will utilize cooperative agreements with the UH2/UH3 activity code with separate funding for the exploratory phase (UH2) and the demonstration phase (UH3), to be submitted in a single application. Details of the planned FOA are provided below
The FOA will be open to all qualified applicants with the appropriate expertise and capacity to conduct cancer-relevant technology development and/or adaptation and, ultimately, its validation for cancer detection/diagnosis and/or treatment in low resources global health settings.
To be responsive to the upcoming FOA, the projects to be considered will need to address all the main requirements summarized below.
1) Focus on cancer types that are treatable in low resources settings. Projects to be considered for an upcoming FOA must be centered on a technology/device/assay development/adaptation addressing a specific cancer type(s) that is (are) treatable in low-resource settings.
2) Technologies/devices suitable for cancer detection/diagnosis or treatment in low resources settings. Areas of application of technology/device/assay to be developed as new or adapted from existing ones may address diverse aspects of cancer detection/diagnosis (using imaging as well as non-imaging approaches) or cancer treatment. However, all these applications must be suitable for clinical use in low-resource settings.
3) Required and desirable attributes of a technology/device/assay to be developed. Suitable technologies/devices/assays to be proposed for development/adaptation must be based on a working prototype (for new technologies) or an existing device (which will serve as basis for adaptation) demonstrating a general feasibility of the proposed approaches. The demonstration of their usability for a chosen cancer is not a prerequisite for application. After the implementation, the proposed technologies/devices are expected to provide tools that are clinically comparable to existing established technologies/devices/assays in clinical practice. However, they are additionally expected to be of low cost, portable, easy to operate by local workers in targeted LMICs, and fully functional under limited resource conditions at the point-of-care.
4) Clinical validation trials in LMICs. All the projects must include plans for an appropriate trial to validate the use and benefits of the technology/device/assay and establish the device’s potential clinical utility in the targeted low-resource environments. The validation trials required for the second phase of the projects must be conducted in LMICs.
5) Multi-disciplinary teams. To properly address the goals of the upcoming FOA, the investigators will have to assemble a collaborative research program with appropriate multidisciplinary expertise in: oncology, engineering (development of biomedical devices/technologies), and global healthcare delivery. In addition, a business component will be required to address issues of manufacturing, regulatory approvals, dissemination, maintainability and sustainability of the technology/device/assay in the targeted LMIC. These multidisciplinary teams are expected to be organized by institution(s) in the United States but must involve appropriate collaborative partnerships with institutions in LMICs for conducting the validation trials.
6) Two-phase projects. Initial cooperative agreement awards of up to two years will be granted for an exploratory (UH2) phase to demonstrate technical functionality and clinical potential in cancer-specific applications. The most promising projects will be selected for transition to the validation (UH3) phase of the award (for up to three years). The primary focus of the UH3 phase is to conduct appropriate validation trials in LMICs.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Please direct all inquiries to:
Avi Rasooly, Ph.D.
National Cancer Institute