HHS SBIR PAR-13-327

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) proposing research for commercial development of novel cancer-relevant technologies. The proposed research projects are expected to focus on the development of highly-innovative technologies that improve molecular and/or cellular analysis of cancer with a significant likelihood for either overcoming persistent challenges or obstacles or opening entirely new fields for cancer research or clinical care. Applications should specify milestones relevant to both the development and commercialization of these technologies. This FOA complements the goals of the NCI's Innovative Molecular Analysis Technologies (IMAT) program by facilitating a path towards technology commercialization. Prior participation in the IMAT Program is not required for eligibility for this FOA. Applications are expected to indicate the significant attributes and advantages of the proposed technology over currently available technologies and conventional approaches. 

Although this FOA is open only to SBCs, it is run in partnership with NCI's IMAT Program. The IMAT Program uses research project grant activity codes (R21, R33) and these FOAs are broadly open to all qualified investigators. Non-SBC affiliated investigators interested in the development of relevant technologies are encouraged to consider submitting grant applications to one of these IMAT FOAs (for information on specific IMAT FOAs, see http://innovation.cancer.gov).

The NCI IMAT program is aimed at supporting the early-stage development of highly innovative technologies relevant to cancer research, prevention, diagnosis and treatment, and epidemiology. Since 1998, the IMAT Program has facilitated the development of various tools and methods benefiting research and, ultimately, clinical oncological practice. The emphasis of the IMAT Program is on supporting the early-stage development and validation of high-risk and high-payoff innovations.

The NCI recognizes the need for support in translating emerging analytical technologies into commercially available products and services. To facilitate commercial development of promising technologies and thereby widespread adoption of enabling new tools for cancer research, this FOA aims to fill a funding gap for those SBCs that need to perform further development and validation of a commercially viable product or service. This FOA complements other initiatives (including those from the IMAT Program), by supporting efforts aimed at the transition of technological conceptual advances toward broadly available products/tools/services.

This FOA will support researchers at SBCs, who wish to develop and validate their innovative technologies in the context of commercial use. These technologies could have been invented, discovered, and/or initially developed with support from any funding source including, but not limited to, the NCI IMAT Program, or may be entirely new invention applications. As mentioned previously, although prior participation in the IMAT Program is not required for this FOA, technologies proposed for this FOA are expected to exhibit a high degree of innovation with transformative potential, or otherwise demonstrate clear advantages over currently available technologies as is required for applications to the IMAT Program. Prospective applicants are advised to visit the IMAT website for more information about the program.

Definition of “Technologies”: In the context of this FOA, the term “technologies” encompasses novel techniques, materials, instrumentation, and devices that offer significant improvements in terms of novel types of cancer-relevant analyses, and/or greater resolution, specificity, and/or throughput relative to the currently available methods/tools. Highly-innovative platforms for sample preparation and/or processing, and for improved downstream analysis are also within the scope of this FOA. This further includes technologies that offer a novel means for assessing general analyte quality to determine sample fitness-for-purpose for a known analytical platform. The proposed technology and application must correspond to an important unmet need relevant to cancer research and/or clinical aspects. Given the FOA's emphasis on commercial development, these technologies (for both Phase I and Phase II applications) must have a strong potential for commercial success.

For Phase I projects, preliminary data are strongly encouraged but not required. If preliminary data are not available, Phase I projects must be based on rigorous scientific rationale. Phase I projects are expected to prove technical feasibility of the technology (and possibly generate a prototype, if appropriate) in a degree that is sufficient to support the use of the proposed technology in a cancer relevant application.

For Phase II projects, the Phase I results should have already demonstrated technical feasibility of the invention. Phase II projects are expected to concentrate on further technology development and improvements, to address intellectual property protection (including work towards filing patent application if not done already) and preparation for regulatory steps, as applicable, that might be needed for a commercial application of the technology.

Both Phase I and Phase II projects proposed in response to this FOA must be designed to accelerate the development of these technologies and achieve specific benchmarks that are relevant to commercial feasibility. The overall goal is to facilitate technology development to the point that it would warrant a full commercialization effort and would have the potential to attract external investments, as needed. Given the strong emphasis on the commercial development of emerging analysis technologies beyond the prototype stages, project goals must be supplemented with specific key technical and commercially-relevant milestones. Quantitative milestones are required for both Phase I and Phase II projects as well as for both phases of Fast-Track applications.

Projects in any area of cancer-related molecular or cellular analysis are encouraged, provided that the technology proposed meets the requirement for potential as a commercial product or service. Technologies may target atomic, molecular, sub-cellular, and cellular levels of detection and analyses. Beyond the scope of this FOA, it is anticipated (and encouraged) that the outcomes of successful SBIR projects will help attract strategic partners or investors to support the ultimate commercialization of the technology as a publicly available product or service. 

Technology areas of interest include, but are not limited to, the following:

• Technologies capable of deciphering basic mechanisms underlying cancer initiation and progression;
• Technologies that enable substantially-improved early cancer detection and/or cancer risk assessment;
• Technologies capable of distinguishing, assessing, and/or monitoring cancer stage, and progression;
• Technologies to facilitate/accelerate the processes of drug discovery or development of generic approaches to improve drug delivery;
• 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 for sample preparation and/or processing for improved downstream analysis;
• Technologies that offer a novel means for assessing general analyte quality to determine sample fitness-for-purpose for a known analytical platform; and
• 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.

Technologies that are generally not appropriate for this FOA include the following:

• Projects describing milestones that do not indicate advanced capabilities or offer progress towards commercialization;
• Projects proposing software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses);
• Projects in which the main thrust of effort is on exploring biological or clinical hypotheses (i.e., traditional hypothesis-driven projects) rather than on technology development;
• Projects proposing whole-body or in vivo imaging methods, or specific contrast agents; and
• Projects centered on development of specific drugs or therapies.

Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider:

• one of the Informatics Technologies for Cancer Research FOAs (ITCR; http://itcr.nci.nih.gov) opportunities; or
• one of the Biomedical Information Science and Technology Initiative (BISTI; http://bisti.nih.gov) 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; http://imaging.cancer.gov/) for information on appropriate funding opportunities.