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Fast-Track Proposal will be accepted Direct-to-Phase II proposal will be accepted Number of Anticipated Awards: 3-5 Budget (total costs, per award): Phase I: up to $400,000 for 12 months Phase II: up to $2,000,000 for 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary Cancer is a leading cause of premature death in low-resource settings globally. Nearly two-thirds of the 7.6 million cancer deaths worldwide occur in low- and middle-income countries (LMICs). Gaps in access to cancer treatment present significant challenges in many global health settings, especially in rural areas with limited infrastructure, where most of the LMIC population lives. Most of current cancer treatment technologies are not affordable in global low resource settings, and there is a need to develop cost-effective cancer treatment technologies. In addition, although 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. We believe that novel treatment products that are affordable can improve cancer outcomes in LMICs and in underserved US populations. This solicitation will provide funding opportunities for small business concerns (SBCs) to develop cost-effective and affordable cancer treatment technologies that target low-resource settings, both internationally and within the US. It will allow applications to focus on any specific cancer type, however four cancer types (histologies) are highlighted that are of particular interest because they are highly amenable to cancer treatment in low-resource settings. The four cancer types of interest 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 for cancer treatment is likely to have an especially strong impact to reduce the burden of these cancers in low-resource settings. Project Goals The goal of this solicitation is to encourages applications from SBCs to develop or adapt, apply, and validate existing or emerging technologies into low-resource setting-appropriate technologies for cancer treatment. Page 69 Projects proposed for this contract topic 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. Products addressing cancers of the cervix, colon/rectum, esophagus, and oral cavity are particularly encouraged for this solicitation. However, applications may address any cancer type and may benefit from LMICs collaborators. When appropriate, the proposed project may focus on a specific cancer type (histology). Scientific/Technical Scope Applications submitted to this solicitation must propose to develop or adapt technologies into user-friendly, affordable products for treatment of cancers in a low-resource setting. The proposed project must focus on a specific cancer type (histology) and must show preliminary evidence 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 solicitation. However, applications may address any single cancer type. The proposals must include quantitative milestones and a way to document the clinical utility of the propose product within the specific low-resource healthcare system of interest. 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 in the commercialization plan to include a detailed regulatory strategy matched to the low-resource setting of the study. Beyond the scope of this solicitation, 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 solicitation 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. Technology areas of interest include, but are not limited to, the following: • Affordable guided surgery • Affordable immunotherapy • Affordable tumor-infiltrating lymphocytes or adaptive cell cancer therapies • Affordable photodynamic therapies • Affordable technology for eradication of H. pylori infection • Affordable and preferably mobile devices for cancer treatment such as tools that may facilitate standard minimally invasive cancer treatment modalities tools for cryotherapy, thermal ablation, radiofrequency ablation, laser therapy, low-power-density sonication, high-intensity focused ultrasound (HIFU) therapy that are appropriate to low-resource settings • Devices to aid in delivery of cancer drugs • Mobile "pop-up" cancer therapy lab • Oncolytic viruses’ therapies • Mobile radiotherapy treatments • Portable radiation equipment for therapy and assisting surgery • Tools for information and communications technologies to enhance cancer data collection, sharing, or analysis for treatment of cancer Technologies that are generally not appropriate for this solicitation include the following: • Devices that require extensive user training before they can be used • Drug screening • Experimental therapeutics modalities which are not approved in the US • Technologies not affordable or can’t be maintained in low resource settings Expected Activities and Deliverables Quantitative milestones are required for both Phase I and Phase II projects, regardless of whether they are combined in a Fast-Track application. It should be noted that LMICs have limited healthcare budgets and often struggle to prioritize healthcare needs. Because of Page 70 the variation in healthcare systems among LMICs and US regions with underserved populations, applicants will need to consult with local partners and organizations (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. Examples of suitable consulting organizations are local hospitals, medical schools, charities, community groups, nongovernmental organizations, and local governmental offices with expertise in the setting. A portion of contract fund can go to these organizations, standard SBIR outsourcing requirements apply. Phase I Activities and Deliverables • Develop a working prototype based on adaptation of existing technology, or development of new technology. • 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. • Deliver to NCI the SOPs of the system for cancer treatment • Develop a regulatory strategy/plan and timeline for seeking approval from the appropriate regulatory agency to market the product • Provide a brief business plan, which is likely to require partnering with healthcare staff local to the low-resource setting of interest Phase II Activities and Deliverables • Continue the consultation with local healthcare delivery experts in the low-resource setting of study • Adapt the prototype device or treatment technology developed in Phase I to the targeted low-resource setting • Validate the device or treatment technology in the low-resource setting 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 solicitation. 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. • To the extent possible, benchmark the product against existing commercial products used to address the same healthcare need in developed countries and include a description of competitive landscape in the commercialization plan. • Engage with FDA or the local state regulatory agency to refine the regulatory strategy • In the first year of the contract, provide the Program and Contract officers with a letter(s) of commercial interest. • In the second year of the contract, provide the Program and Contract officers with a letter(s) of commercial commitment, where appropriate. • By the end of Phase II, engage with the appropriate regulatory agency (e.g., US Food and Drug Administration, World Health Organization) to seek and/or obtain marketing approval for the product that was developed.
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