Cancer Prevention, Diagnosis, and Treatment Technologies for Low-Resource Settings (R43/R44 - Clinical Trial Optional)

This Funding Opportunity Announcement (FOA) 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 for this FOA 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 conduct of the proposed cancer global health product development activities.

Cancer is a leading cause of premature death in LMICs, with nearly two-thirds of the 7.6 million cancer deaths worldwide in 2011 occurring in that setting, more than the combined burden of HIV/AIDS, tuberculosis, and malaria. Gaps in access to cancer prevention, screening, diagnosis and treatment present significant challenges in many global health settings, especially in rural areas with limited infrastructure, where most of the LMIC population lives. Though this FOA will not restrict applications to any specific cancer type, four cancer types (histologies) 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 an especially strong impact to reduce the burden of these cancers in low-resource settings.

The same cost-effective cancer technologies that can be beneficial in global low-resource settings can also be beneficial in underserved US populations. Although prevention, 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.

Applications submitted to this FOA must propose to develop or adapt technologies into user-friendly, affordable products for 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 (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 FOA. However, applications may address any single cancer type. The proposed products should have as a quantitative milestone the documentation of clinical utility to the specific low-resource healthcare primary 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 study.

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 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 governmental 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 FOA. 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 studies. 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 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 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.

Projects funded by this FOA 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).

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

• Machine learning algorithms to identify precancer and cancer in optical images captured with simple medical devices (e.g., smart phone);
• Machine learning approaches to enhance POC imaging, telemedicine, or digital pathology;
• Software tools for cancer prevention, such as tools for 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);
• Portable imaging devices for cancer diagnosis based for examples on optical imaging, spectroscopy, 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;
• Devices to aid in delivery of cancer drugs;
• Devices for treatment monitoring;
• Tools for information and communications technologies to enhance cancer data collection, sharing, or analysis.

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

• 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.

General Technology Characteristics and Attributes

The proposed products should be non- or minimally-invasive, and must be validated with clinical testing in the low-resource setting of interest. Applicants are encouraged to propose products that are:

a) Highly portable;

b) Operable in locations with limited or no medical infrastructure, electricity, landline telephone communication, internet, refrigeration, or central water supply;

c) Connectable to the Internet as an option;

d) Low-cost; and

e) Simple to operate by locally trained healthcare staff with minimal training.

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