Advanced Development and Validation of Emerging Molecular and Cellular Analysis Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)

Organization
NCI
Type
NIH
Application or LOI Due Date
01-22-2021
Comments
LOI due 1/22/21 for application due date of 2/22/21. Other deadlines: 5/27/21 and 9/29/21 - LOI required and due 30 days prior to app due date.
Brief Description

Purpose

This Funding Opportunity Announcement (FOA) solicits grant applications proposing exploratory research projects focused on further development and validation of emerging technologies offering novel capabilities for targeting, probing, or assessing molecular and cellular features of cancer biology for basic or clinical cancer research. Well-suited applications must offer the potential to accelerate and/or enhance research in the areas of cancer biology, early detection and screening, clinical diagnosis, treatment, control, epidemiology, and/or address issues associated with cancer health disparities. Technologies proposed for development may be intended to have widespread applicability but must be focused on improving molecular and/or cellular characterizations of cancer.

FOA Emphasis. This FOA utilizes the R33 mechanism and is suitable for projects, which have overcome major feasibility gaps for the technology or methodology as demonstrated with supportive preliminary data but still require further development and rigorous validation to encourage adoption by the research community. Proposed projects should offer the potential to produce a molecular or cellular analysis capability with a major impact in a broad area of cancer-relevant research. Projects proposed in response to this FOA may involve further development of a novel technology to address an unmet technical measurement or targeting need in cancer research or clinical care but must include a rigorous validation strategy to establish repeatable, reliable performance of the technology in a cancer-relevant biological context of use. Projects proposing to use existing technologies where the novelty resides in the application of the technology or the biological or clinical question being pursued, and not the technical capabilities being developed, are not responsive to this FOA and will not be reviewed.

This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

The IMAT Program

Since its inception in 1998, the IMAT Program has focused on stimulating and accelerating the development, integration, maturation, and dissemination of the most novel and highly innovative technologies in support of cancer research and medicine. Together with the NCI's other technology-focused programs, the IMAT program continues to support the development of tools and methods that enable cancer researchers to make new discoveries, enhance our understanding of cancer etiology and proliferation, improve detection capabilities, develop diagnostic methods and treatment strategies, conduct population-scale studies, address and reduce disparities in clinical care, and assist in clinical decision-making.

The current issuance of the IMAT Program consists of four separate FOAs that cover the following two areas:

  • Molecular and Cellular Analysis Technology Development for Cancer Research is intended to support the development of technologies that are novel and potentially transformative to the molecular and cellular analysis of cancer, which may, in turn, accelerate basic or clinical cancer research. Applications must offer novel measurement, probing, or targeting of cancer-relevant targets at the molecular or cellular level.
    • RFA-CA-21-003 (R21): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate the core functional capabilities of the proposed technology.
    • RFA-CA-21-004 (this FOA, R33): Assumes completion of the initial phase of development and supports the advanced development and robust validation of the technology.
  • Cancer-Relevant Biospecimen Science Technologies is centered on the development and validation of novel technologies to improve or assess the quality of cancer-relevant biospecimens for research or clinical care. Applications must offer novel approaches for procurement, preservation, and/or isolation of proteins, DNA, RNA and other small molecules from biospecimens or otherwise assess their biological integrity. The emphasis is on reducing the impact of pre-analytical variations in the collection, processing, handling, and preservation of cancer-relevant biospecimens or their derivatives to improve their quality and utility for cancer research or clinical care.
    • RFA-CA-21-005 (R21): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate the core functional capabilities of the proposed technology.
    • RFA-CA-21-006 (R33): Assumes completion of the initial phase of development and supports the advanced development and robust validation of the technology.

Additional information about the IMAT Program and its individual FOAs can be found here.

Specific Research Objectives and Scope of this FOA

The proposed projects must be focused on the development and validation of an emerging molecular or cellular analysis technology in a biologically relevant system. In addition, all projects proposed in response to this FOA must involve all of the following general attributes:

  • Potential for substantial improvements over current approaches and/or adding qualitatively new research capabilities.
  • Offers novel capabilities that may be judged by appropriate experts as potentially transformative to research in laboratory and/or in clinical settings, and beyond providing incremental improvements to existing capabilities.
  • Rigorous study design with a verifiable approach based on well-defined performance measures (see below for a description of performance measures). An application lacking performance measures will not be reviewed.

For details on addressing these requirements, see Section IV. Application and Submission Information.

Responsive Technologies and Scientific Scope

Responsive technologies include relevant novel materials, chemical reagents, instrumentation, devices, and associated methods. These technologies may be intended for molecular and/or cellular analyses in vitroin situ, and/or in vivo (with some exceptions listed below), and may target the needs of basic, diagnostic, translational, epidemiological, and/or clinical cancer research or otherwise address issues associated with cancer health disparities. It must be clear that proposed projects are focused on the development of generally applicable technologies to facilitate research in certain areas (e.g., clinical detection, drug development, biomarker discovery and validation, or epidemiology), NOT on pursuing specific discoveries (e.g., discovery of a novel biomarker or demonstrating efficacy for a novel therapeutic agent) or specific applications (e.g. detection of a known biomarker) in those areas.

Technology development projects in any area of cancer-related research are encouraged provided that the technology proposed meets the requirements stated above, including transformative potential for cancer research. Technologies may target atomic, molecular, sub-cellular, and/or cellular features. At the core of any project must be a novel analysis or targeting capability (encompassing novel devices, materials, or chemical/biochemical approaches). General areas of interest include, but are not limited to, the following:

  • Novel technologies to distinguish, assess, and/or monitor cancer stages and progression;
  • Novel technologies that may aid the elucidation of basic mechanisms underlying cancer initiation and progression;
  • New methods, tools, and procedures that may generally facilitate processes related to early cancer detection, screening and/or cancer risk assessment;
  • Technologies that can facilitate and/or enhance molecular analyses in cancer epidemiology (e.g., by allowing for rigorous and/or expeditious collection of various relevant types of data);
  • Technologies to facilitate/accelerate the processes of drug discovery or development of generic approaches to improve drug delivery;
  • Technologies or tools that may help overcome various barriers in research on the incidence, prevalence, mortality, and burden of cancer among members of underserved populations; and
  • Technologies to facilitate the collection of relevant biological data for examining the factors contributing to cancer health disparities (e.g., for cancer sub-types and differences across individuals with diverse racial/ethnic backgrounds).

Non-Responsive Projects

The following aspects/characteristics remain outside the scope of the IMAT Program and this FOA. Applications proposing projects with any of the following characteristics will not be reviewed:

  • Pursuit of a biological or clinical hypothesis for which the novelty of the project resides in the biological or clinical question (i.e., traditional biological-hypothesis driven research) and NOT in the novel technical capability being developed;
  • Technologies for whole-body or in vivo imaging;
  • Inclusion of clinical trials or toxicology studies beyond those required to demonstrate the capabilities of the technology;
  • Biomarker discovery or biomarker validation;
  • Development of specific contrast agents (though generalizable contrast agents are allowed);
  • Development of drugs or therapies; and/or
  • Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses) with the exception of projects which include software development for embedding in new devices or limited amounts of computational efforts as might be needed to develop new devices or methods.

As there are several unique review considerations for this FOA, applicants must address the requested items outlined for the Research Plan in Section IV.2. Application and Submission Information.

IMPORTANT NOTE: Researchers uncertain as to whether their intended technology development project meets the requirements of this FOA are encouraged to contact the Scientific/Research Contact listed below.

Alternative Opportunities

Related IMAT FOA: Applicants proposing projects that still involve a critical question as to the overall feasibility of the approach should consider applying to the companion FOA (RFA-CA-21-003) which uses the R21 mechanism. NOTE: Applications proposing to merge complementary technologies without a substantial requirement for further development or clear need for analytical validation are beyond the scope of the IMAT program solicitations altogether.

Other technology-related funding opportunities. Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software development solutions should consider one of the Informatics Technologies for Cancer Research (ITCR) opportunities. Researchers who emphasize the assessment of whole-body or in vivo imaging technologies as the primary focus of their projects should contact the Cancer Imaging Program (CIP) for information on appropriate funding opportunities.

Annual Meeting

An annual meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the development of technologies for cancer research and clinical care for cancer patients. All investigators supported through this FOA are required to attend this meeting each year, lasting 2-3 days, unless otherwise notified by NCI program officials.

See Section VIII. Other Information for award authorities and regulations.