Fast track proposals will be accepted. Direct-to-Phase II proposals will not be accepted. Number of anticipated awards: 3-5 Budget (total costs, per award): Phase I: up to $252,131 for up to 9 months; Phase II: up to $1,680,879 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary The cancer research field has become intensely focused on the generation of high-throughput datasets to better understand cancer and ultimately to inform the development of better treatment and prevention tools. NIH and NCI have supported numerous programs including The Cancer Genome Atlas (TCGA), Therapeutically Applicable Research to Generate Effective Treatment (TARGET), and Clinical Proteomic Tumor Atlas Consortium (CPTAC) to generate a wealth of data to be leveraged by the cancer research community. However, we are still limited in our ability to draw insights and meaningful interpretations from these datasets, which include multi-omics, imaging, population, and clinical data, by challenges in integration across disparate datasets. To address these challenges, NCI has created the Cancer Research Data Commons (CRDC) as part of the National Cancer Data Ecosystem recommended by the Cancer Moonshot Blue Ribbon Panel (BRP). The CRDC brings together data with cloud computing infrastructure to provide secure access to various data types across scientific domains, allowing users to analyze, share, and store results by leveraging the storage and elastic compute of the cloud. The primary goal of this contract topic is to solicit commercial sector participation in the CRDC to develop strong commercial analytic tools that can be disseminated and sustained within the cancer research community. The SBIR contract funding mechanism will offer small businesses the opportunity to contribute solutions to address unmet challenges of big data analysis that are not currently provided by the existing tools in the CRDC by developing and extending tools and resources to integrate into the rapidly evolving CRDC. Through this contract topic, NCI seeks to enable wider engagement of the CRDC community by offering enhanced data analysis capabilities, visualization tools, and data access and sharing platforms. This topic is relevant to the BRP recommendation to develop a national cancer data ecosystem for sharing and analysis. Project Goals The goal of this contract topic is to provide support for development and implementation of innovative solutions for continued advancement and evolution of cloud-based informatics tools to integrate with the CRDC for broader user community engagement. Unmet challenges that should be addressed through this solicitation include but are not limited to: 1) Integration of existing tools widely utilized by the cancer research community with the CRDC through adoption of the Data Commons Framework (DCF), and extension of these tools to support unique data analysis opportunities of this platform; 2) Development of novel tools that operate across the CRDC and other data commons such as Gabriella Miller’s Kids First for multi-domain analysis; 3) Collaboration with academic developers of popular tools to integrate them with the CRDC and support commercialization. Development and adaptation of tools that support innovative, integrative data analysis across the CRDC are of particular interest. The activities that fall within the scope of this contract topic include delivery of design specification for the development/extension of informatics tools and demonstration of early phase prototype that shows successful integration with CRDC. Examples of effective integration with CRDC through DCF include execution of the offeror’s pre-existing or new informatics tools on datasets stored in CRDC such as TCGA and performing co-analysis with user-provided data. Successful offerors are expected to develop and implement a business process for broad adoption of their tools and resources by actively engaging with the user communities and conducting outreach and training activities as well as providing appropriate system documentation. The business process should also include business plans for marketing and long-term sustainability, such as sustained hosting of tools, training, and associated resources. Activities outside the scope of this Topic: Proposals for the development of big data analysis tools without consideration for integration with the CRDC will not be considered for award under this Topic. Phase I Activities and Deliverables The proposed Phase I research is expected to clearly demonstrate at minimum a ‘proof of concept’ feasibility of adaption of the offeror’s informatics tool(s) to the CRDC through the Data Commons Framework. The proposal should identify potential barriers for commercial translation and plans to overcome those barriers. Phase I work should include software system specifications of cloud-based platforms for Phase II deployment of the proposed tools and resources. Key activities and deliverables include: • Establish a project team composed of experts in software development, cloud infrastructure, big data informatics, project management, team communication, and user-centered design. • Design the specifications for the development/extension of cloud-based informatics tools to operate in the Cancer Research Data Commons. • Develop an early software prototype. • Demonstrate the feasibility of CRDC integration through the DCF. Examples of feasibility qualification include, but are not limited to, user authentication using Fence to access datasets stored in at least one CRDC node such as the Genomic Data Commons (which exists now) and providing authorization to datasets the user has access to. More nodes, such as the Proteomic Data Commons, are expected to be available for feasibility testing by the end of 2019. • Conduct a pilot software usability study with the participation of at least 25 users. • Provide a report on the results of the first round of usability testing and the approach to modify the prototype based on this user feedback. • Present Phase I results and a future system development plan to NCI staff. Phase II Activities and Deliverables Phase II projects will be expected to implement requirements identified in all Phase I deliverables and launch a prototype that demonstrates successful integration with CRDC and, as appropriate, other data commons. The system design process should encourage interactions between users and developers for evaluation and further advancement of the tools and resources. Key activities and deliverables include: • Enhance, beta test, and finalize prototype development. • Provide detailed plans for implementation of technical assistance and delivery of tool(s) within CRDC. • Demonstrate CRDC integration through DCF by successfully providing access to data within CRDC and performing large-scale data analysis using the offeror’s tools or resources. Examples of large-scale data analysis include, but are not limited to, demonstration of integration of user-provided data with available datasets such as TCGA from CRDC to perform comparative analyses. • Conduct usability testing with the participation of at least 100 users. • Provide a report that synthesizes feedback from all relevant categories of end-users (minimum of 100 users and end users include biomedical researchers and computational scientists) and summarizes the modifications made to the platform after each round of usability testing. • Develop systems documentation and user guides to facilitate commercialization. • Develop and implement a business process for broader adoption of their tools and resources by actively engaging with the user communities. • Develop business process that includes business plans for marketing and long-term sustainability, such as sustained hosting of tools, training and associated resources. • Conduct outreach and training activities. • Present Phase II findings and demonstrate the system to NCI program staff. • In the first year of the contract, provide the Program and Contracting 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.