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Fast-Track Proposal will be accepted Direct-to-Phase II proposal will be accepted Number of Anticipated Awards: 4-6 (3 for HPV diagnostics) Budget (total costs, per award): Phase I: up $400,000 for 12 months Phase II: up $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, where gaps in access to cancer prevention, screening, early detection, and diagnosis present significant challenges. For example, cervical cancer is the fourth most common cancer in women. When pre-cancer or early-stage cancer is diagnosed, it is one of the most preventable or treatable forms of cancer, respectively. As a result of complex and expensive cytology-based programs in high-income countries, cervical cancer has become a cancer that defines health disparity populations and one that is still a major cause of morbidity and mortality in low-resource settings globally, where building out a cytology-based screening program may not be realizable. Realization of that goal given the current commercially available human papillomavirus (HPV) tests is unlikely without newer, lower-cost tests coming to market. The purpose of this solicitation is to provide funding opportunities for small business concerns (SBCs) to develop cost effective and affordable technologies for cancer prevention, early detection and/or diagnosis that target low-resource settings, both internationally and within the US. It will allow applications to any specific cancer type, however four cancer types (tissues) are of particularly interest because they are highly amenable to prevention, early detection, and diagnosis 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 affordable and cost-effective technologies for cancer prevention early detection and diagnosis is likely to have an especially strong impact to reduce the burden of these cancers in low-resource settings. For cervical cancer, one of the goals for this initiative is to support the development of new alternatives to standard labbased HPV testing to the market that are both in a form factor as well as price point that will enable primary screening paradigms based on self-collected cervicovaginal specimens to be established globally. Specifically, at- or near-patient nucleic acid amplification approaches are needed that enable rapid detection and genotyping for HPV. Project Goals The goal of this solicitation is to encourages applications from SBCs to develop or adapt, apply, and validate existing or Page 85 emerging technologies into low-resource setting-appropriate technologies for cancer prevention early detection and/or diagnosis. Investigators must explicitly consider potential for adoption and scale-up in the local context as design criteria for technologies proposed in applications responding to this solicitation. 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 highly encouraged for this solicitation. However, applications may address any single cancer type. For cervical cancer, this solicitation is particularly focused on the development of rapid HPV diagnostics at the point-ofneed suitable for taking to scale (e.g., a portable loop-mediated isothermal amplification (LAMP) based assays). Scientific/Technical Scope Applications submitted to this solicitation must propose to develop or adapt technologies into user-friendly, affordable products for prevention, early detection, and diagnosis 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 for cancer prevention, early detection and diagnosis include, but are not limited to, the following: • Delivery technologies to improve reliability, effectiveness, and/or safety of vaccines at the point of use (e.g., needle-free delivery methods, intradermal delivery, or oral delivery) • Diagnostic microarrays • High-throughput cancer screening, cytology, or imaging-based screening • In vitro diagnostic assays such as point-of-care (POC) analytical tools for exfoliated epithelial specimens (e.g., cervical Pap specimens), 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) • Machine learning algorithms to identify precancer and cancer in optical images captured with simple devices (e.g., smart phones) • Portable imaging devices for cancer diagnosis (e.g., optical imaging, diffuse optical tomography, endoscopy, or ultrasound) • "pop-up" labs for cancer screening and diagnosis • Smartphone-based technologies for cancer prevention, detection and/or diagnosis • Software tools for cancer prevention, such as tools for screening, vaccine dissemination, or tools to improve vaccine supply chains • Tele-oncology (e.g., tele-diagnosis, tele-screening, tele-cytology, or tele-colonoscopy) • Tests to predict the potential effectiveness of chemotherapy • Tools for information and communications technologies to enhance cancer data collection, sharing, or analysis Technologies that are generally not appropriate for this solicitation include the following: • Companion diagnostics for high-cost drugs that are not affordable in low-resource settings Page 86 • Devices that involve highly invasive interventions • Devices that require extensive user training before they can be used (e.g., FDA definitions moderate and high complexity devices) • Experimental diagnosis modalities that are not approved in the US • Technologies not affordable or cannot be maintained in lower-resource settings (e.g., World Bank definitions of low-income and lower middle-income countries) 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 low-resource settings 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 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 • For software/IT tool development, applicants are required to conduct a pilot usability study with at least 25 users • Deliver to NCI the SOPs of the system for cancer prevention, and/or diagnosis. • 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 Specific activities and deliverables for applications focused on HPV diagnostics: o Using end-user design principles, develop the prototype diagnostic device with the following characteristics:  Ease of use: the device must be suitable for use by local caregivers with minimal training in its operation and maintenance  Operable in locations with limited clinical infrastructure (i.e., design for use outside of laboratory settings)  Designed for use at the community level and in non-traditional healthcare settings.  Intended for use with self-collected cervicovaginal specimens obtained with one of the current commercially available kits o Demonstrate a working relationship with the site(s) where the clinical validation study will take place. o Conduct studies to establish analytical performance (analytical sensitivity, specificity) and other performance characteristics (e.g., limit of detection, consistency, reproducibility) with self-collected samples. o Conduct studies to evaluate and test user acceptability and feasibility in both average-risk and high-risk (e.g., women living with HIV) populations. o Conduct initial cross-validation with at least one of the current FDA-approved HPV testing assays to determine the clinical performance measures. Phase II Activities and Deliverables • Continue the consultation with local healthcare delivery experts in the low-resource setting of study • Adapt the prototype device developed in Phase I to the targeted low-resource setting • Validate the device in the low-resource setting(s) 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. 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 • Validate the product with a large-scale validation/usability study with at least 100 users if a software/IT tool is developed • 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 Page 87 commercialization plan • Engage with 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. Specific activities and deliverables for applications focused on HPV diagnostics: o Develop a well-defined diagnostic device under good laboratory practices (GLP) and/or good manufacturing practices (GMP) o Perform manufacturing scale-up and production for multi-site and multi-test evaluations, including sites both in the U.S. and at a site in a resource-limited setting o Demonstrate the clinical sensitivity and specificity of the device for self-sampling by performing multi-site and multi-test evaluations o Develop a training plan for healthcare delivery users, to help assure progression toward clinical utility and benefit from the validated technology. o Report on the sustainability/durability of the device/assay
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