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Related Announcements

PA-21-259 - PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA-21-260 - PHS 2021-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

PA-21-261 - PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

PA-21-262 - PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

Issued by

National Cancer Institute (NCI)

Purpose

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs at the National Cancer Institute (NCI) are issuing this Notice of Special Interest (NOSI) to encourage SBIR/STTR grant applications from small business concerns (SBCs) in response to SBIR/STTR Omnibus Solicitations proposing commercially-directed research for the development of cancer prevention, diagnosis, or treatment technologies to improve cancer outcomes in low- and middle-income countries (LMICs), and low-resource settings in the US.

Specifically, the NCI through this NOSI encourages grant applications from SBCs to develop or adapt, apply, and validate existing or emerging technologies into user-friendly products for cancer prevention, diagnosis, or treatment in low-resource settings. These technologies should be practical and affordable in low-resource settings, including remote or underserved populations within or outside the US. The technologies may include but are not limited to tools for vaccine dissemination/delivery, imaging, in vitro diagnosis, or treatment of pre-cancerous (pre-neoplastic) or cancerous lesions that are preventable or treatable within low-resource settings. Strong emphasis is placed on technologies that directly provide or immediately lead to prevention, diagnosis, or treatment options available in the local health system. This funding opportunity is part of a broader NCI-sponsored AffordableCancer Technologies (ACTs) Program.

Note: LMIC is defined according to the World Bank Country and Lending Groups and is inclusive of low- and middle-income countries, not including upper-middle income countries, for the purposes of this NOSI.

Background

It is estimated that more than two-thirds of the 9.5 million annual cancer deaths in the world occur in LMICs. Furthermore, the incidence rate of cancer is on the rise in populations of many LMICs, with substantial inequalities in cancer survival rates across the world. Access to cancer prevention, screening, detection, diagnosis, and treatment is a significant challenge in many LMICs, especially in areas with limited infrastructure.

Prevention, early detection, and treatment are vital to successful cancer control. Unfortunately, many established cancer control technologies are not suitable for use in low-resource settings globally due to expenses, dependency on extensive medical infrastructure, or both. The same cost-effective cancer technologies that can be beneficial in global low-resource settings may also be beneficial in underserved US populations. Although diagnosis and treatment approaches exist in the US for most cancers, many examples of disparities in cancer outcomes exist for certain underserved populations in both rural and urban settings. There are many factors thought to contribute to these disparate outcomes. However, there is confidence that novel products that are affordable, portable, and whose use does not require extensive training and expertise to be deployed, can improve cancer outcomes in underserved US populations.

Research Objectives

Through this NOSI, the NCI encourages grant applications from SBCs to develop or adapt, apply, and validate existing or emerging technologies into user-friendly, low-resource setting-appropriate technologies for cancer prevention, diagnosis, or treatment.

Projects proposed in response to this NOSI will require multidisciplinary efforts to succeed, and, therefore, all applicant teams must include expertise in oncology, engineering, global health, and healthcare delivery in low-resource settings. Applicants are encouraged to collaborate with academic institutions, local hospitals, community groups, non-governmental organizations, or charities for the conduct of the proposed cancer global health product development activities.

Gaps in access to cancer prevention, screening, diagnosis, and treatment present significant challenges in many global health settings. Though this NOSI will not restrict applications focused on any specific cancer type, four cancer types (based on histology) are highlighted that are particularly amenable to prevention, diagnosis, or treatment in LMICs. They are: cancers of the cervix, colon/rectum, esophagus, and oral cavity. These four cancer types are given a high priority because the introduction of low-cost technologies to prevent, diagnose, or treat them is likely to have a strong impact on reducing the burden of these cancers in low-resource settings.

Cancers, including those caused by oncogenic viruses, remain an important comorbidity for HIV-infected populations even in the current era of worldwide access to antiretroviral therapy. Therefore, NCI encourages applications proposing research on HIV-associated cancers.

Responsiveness

Applications submitted in response to this NOSI must propose to develop or adapt technologies into user-friendly, affordable products for the prevention, diagnosis, or treatment of cancers that are preventable or treatable in a low-resource setting. The proposed project must focus on a specific cancer type (based on histology) and must show promise to deliver medical utility for improved cancer outcomes. Products addressing cancers of the cervix, colon/rectum, esophagus, and oral cavity are particularly encouraged for this NOSI. However, applications may address any single cancer type. The proposed products should have a quantitative milestone with the documentation of clinical utility to the specific low-resource primary healthcare delivery system. The proposed product must comply with the regulations and international standards/guidelines applicable to investigational medical products in the low-resource setting where the product will be used (examples are World Health Organization guidelines and local regulations in LMICs, and Good Laboratory Practice, Good Manufacturing Practice, FDA Investigational New Drug, and Investigational Device Exemption for US settings). All applicants should demonstrate familiarity with applicable regulatory requirements, while Phase II applications require a commercialization plan with a detailed regulatory strategy matched to the low-resource setting of the study.

Projects in response to this solicitation may include, but are not limited to:

• Development of new assay or device or modification of an existing one such that it can be used for/is more appropriate for the detection, diagnosis or treatment of specific cancers in low-resource settings;
• Simplifying or adding new features to a device or assay to enable the device to operate outside a laboratory in low-resource settings (e.g., areas in which the people have limited access to electricity or where other environmental conditions, such as dust, heat, humidity, etc. must be considered);
• Adapting existing or emerging technologies that have not been previously used for cancer detection, diagnosis, or treatment in low-resource settings; and/or
• Performing statistically rigorous validation of the analytical and clinical performance of the device or assay to detect or treat a specific cancer in low-resource settings.

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

• Smartphone-based technologies for cancer detection and diagnostic;
• Portable radiation equipment for therapy, diagnosis, and assisting surgery;
• Portable imaging devices for cancer diagnosis based for examples on optical imaging, spectroscopy, diffuse optical tomography, endoscopy, or ultrasound;
• Devices for cancer treatment such as tools that may facilitate standard minimally invasive cancer treatment modalities, tools for cryotherapy, radiofrequency ablation, laser therapy, low-power-density sonication, high-intensity focused ultrasound or photodynamic therapy in a remote setting;
• Machine learning algorithms to identify precancer and cancer in optical images captured with simple medical devices (e.g., smartphone);
• Machine learning approaches to enhance POC imaging, telemedicine, or digital pathology.
• Software tools for cancer prevention, such as tools for screening, vaccine dissemination, or tools to improve vaccine supply chains;
• Delivery technologies to improve reliability, effectiveness, and/or safety of vaccines at the point of use (e.g., needle-free delivery methods, intradermal delivery that could reduce the quantity of vaccine required for an effective dose, or oral delivery);
• In vitro diagnostic assays such as Point-of-Care analytical tools for blood, saliva, or urine (e.g. lab-on-a-chip biosensors that allow remote performance of chemical and/or biological assays outside of a laboratory environment);
• Devices to aid in the delivery of cancer drug;
• Devices for treatment monitoring;
• Tools for information and communications technologies to enhance cancer data collection, sharing, or analysis.

General Technology Characteristics and Attributes: The proposed technology should represent the state-of-the-art in terms of comparable technologies available in the local health setting. Investigators must explicitly consider the potential for adoption and scale-up in the local LMIC context as design criteria for technologies proposed in applications responding to this NOSI:

• Where there are existing technologies supported by public and private health centers. non-governmental organizations, charities, and development agencies for similar or related applications, the proposed technologies should be comparable in price;
• Considerations of availability, cost, and affordability should include disposables;
• Consideration around dissemination should stress achieving high uptake in the community;
• Technologies should be sustainable and affordable by local providers (either low enough in cost to easily replace, easily replaceable parts/ease of repair, or durability).

Additionally, design-thinking around usability at the point-of-need should be explicitly addressed for all proposed technologies. Such device characteristics may include the following:

• Ease of use: the device, technology, or assay must be suitable for use in the chosen setting by caregivers receiving local training in its operation and maintenance;
• Operable in locations with limited clinical infrastructure (e.g., limited access to electricity, landline communication, refrigeration, or central water supply);
• Designed for use at the community level and/or in non-traditional healthcare settings.

Specific Desirable Attributes:

• Simple to operate by locally trained healthcare staff or client (i.e., self-collection approaches);
• Rapid results (for diagnostic technologies);
• Risk stratified approaches for early detection or screening technologies;
• Connectivity to the internet or telephone network (e.g., to allow for telemedicine);
• Modular design to increase reliability ease-of-use, and to simplify maintenance;
• Incorporation of internal checks of device/assay performance, self-calibration, and error diagnosis;
• Open-source hardware or software;
• Standard readily available off-the-shelf components, such as power supplies, software, or approved imaging probes.

Device Pre-requisites and Preliminary Data: The applicants may have a working prototype or an existing assay/device (not necessarily already used for cancer applications) and preliminary data to demonstrate its potential for preventing, detecting, diagnosing, and/or treating cancer in people in LMIC settings.

Non-responsive Applications

The following aspects/characteristics remain outside the scope of this NOSI. Applications proposing projects with any of the following characteristics will not be responsive to this NOSI:

• Projects lacking LMIC key personnel with substantial involvement in the research activities if the projects target LMICs;
• Pursuit of a biological or clinical hypothesis for which the innovation of the project resides in the biological question (i.e., traditional biological-hypothesis driven research) and NOT in the clinical/public health utility and technical capability being developed;
• Use of technologies for which an initial proof-of-concept has not already been demonstrated in a cancer-relevant biological system/ technology not ready for advanced development and validation without substantial further developmental efforts;
• Biomarker discovery or biomarker validation;
• Development of drugs, biologics, or cancer vaccines.
• Technologies that are generally not appropriate for this NOSI include the following:

• • Technologies not affordable or can’t be maintained in low resource settings Devices that involve highly invasive interventions;
  • Devices that require extensive user training before they can be used;
  • Tools or devices that are exclusively focused on telemedicine;
  • Drug screening;
  • Companion diagnostics for high-cost drugs that are not affordable in low-resource settings.

Application and Submission Information

This notice applies to due dates on or after September 7, 2021 and subsequent receipt dates through September 7, 2024. 

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice.

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. Prospective applicants are asked to submit a letter of intent one month before the due date that includes the following information:

Descriptive title of the proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity

The letter of intent should be sent to:
Ming Zhao, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5225
Fax: 240-276-5236
Email: zhaoming3@mail.nih.gov
 

Two-Phase Projects

For Phase I projects, grantees are expected to develop a working prototype based on adaptation of existing technology, or development of new technology. They will demonstrate the feasibility of the technological innovation for use in a low-resource setting (real or modeled), using a small number of biological samples or animals, where appropriate. Phase I applicants will briefly describe in their applications their business plans, which is likely to require partnering with healthcare staff local to the low-resource setting of interest. It should be noted that LMICs have limited healthcare budgets and often struggle to prioritize healthcare needs. Because of the variation in healthcare systems among LMICs and US regions with underserved populations, applicants will need to consult with local partners (beginning before they submit their application) to develop plans for product design and testing that are suitable to the low-resource setting, including strategies for regulatory approval and reimbursement (if applicable) for the proposed product.

For Phase II projects, applicants will require extensive advance consultation with local healthcare delivery experts in the low-resource setting of the study, and these collaborative relationships should continue throughout the duration of the project. Examples of suitable consulting organizations are local hospitals, medical schools, charities, community groups, non-governmental organizations, and local government offices with expertise in the setting. A portion of grant fund can go to these organizations, standard SBIR outsourcing requirements apply. In Phase II, grantees will adapt the prototype device developed in Phase I to the targeted low-resource setting and will validate the device there with a statistically significant number of animal and/or human samples, live animals, or human subjects (if animal work or human subjects are involved) for the proposed product in the low-resource setting of interest. Animal studies are optional and may not be needed for many products supported by this NOSI. Animal studies need only be proposed for products where intermediate testing in animals is thought to be necessary for regulatory approval, or necessary before an IRB will approve a follow-on human study. For software/IT tool development, applicants are required to validate the product with a large-scale validation/usability study. To the extent possible, the product should be benchmarked against existing commercial products used to address the same healthcare need in developed countries.

First-time applicants may submit a Phase I, Direct-to-Phase II, or Fast-Track application. Quantitative milestones are required for both Phase I and Phase II projects, regardless of whether they are combined in a Fast-Track application.

Beyond the scope of this NOSI, 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.

Projects funded by this NOSI may include patient enrollment in foreign countries. Per SBIR policy, when there are special circumstances justifying the conduct of the proposed research outside the US within time and budget constraints (e.g. a high disease incidence that makes clinical validation more feasible and timely), agencies may approve performance of a portion of the SBIR R&D work outside of the US. In this case, applicants are required to include a statement in their applications on why these resources are not available in the US (see Section III.1, Foreign components in the SBIR/STTR Omnibus Solicitation above).

For funding consideration, applicants must include “NOT-CA-21-062” (without quotation marks) in the Agency Routing Identifier field (box 4b) of the SF424 R&R form. Applications without this information in box 4b will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Ming Zhao, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5225
Email: zhaoming3@mail.nih.gov