ARPA-H Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) - Full Proposal
ID: ARPA-H-SOL-24-101Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNIH ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H)Bethesda, MD, 208920004, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; EXPERIMENTAL DEVELOPMENT (AN13)
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health and the Advanced Research Projects Agency for Health (ARPA-H), seeks innovative solutions for its Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program. ARPA-H aims to award multiple contracts for groundbreaking research to develop tools and technologies for bioprinting patient-matched organs, specifically focusing on the kidney, heart, and liver, to address a global organ shortage.

    Proposers should submit comprehensive solutions for developing a sustainable organ supply chain, covering cell generation, large-scale manufacturing, and organ biofabrication. The agency emphasizes the importance of technical merit, innovation, and healthcare impact alongside cost and schedule considerations. Cost proposals should provide a detailed financial breakdown for each phase of the project.

    Key dates include a Proposers' Day and solution summary deadline in May 2024, followed by a full proposal deadline in August 2024. Contact the PRINT Team at PRINT@ARPA-H.gov for further information.

    Point(s) of Contact
    Files
    Title
    Posted
    The focus of this amendment is to refine the Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program's procurement goals. It emphasizes the requirement for GMP grade cell manufacturing and specifies Phase II objectives related to large animal models. The amendment clarifies that proposers can include ARMI | BioFabUSA as a collaborator and outlines the elimination of independent verification and validation (IV&V) from the PRINT program. Instead, the emphasis shifts to early engagement with the FDA. Additionally, it mandates biographical sketches for key personnel. The amendment also provides a detailed outline of expectations and deliverables, including the establishment of GMP manufacturing and validation, along with specific milestones related to cell production and animal studies. This information is crucial for potential contractors to demonstrate their ability to meet the outlined goals.
    The primary objective of this procurement is to acquire administrative and national policy requirements for the ARPA-H Print Program Solicitation. ARPA-H seeks to engage organizations and individuals to provide comprehensive support in various roles. This includes prime organizations, subawardees, and consultants for specialized tasks. The focus is on ensuring compliance with national security directives, managing intellectual property, and addressing potential conflicts of interest. Teams must provide detailed information about their membership, including any non-US affiliations, to ensure security and mitigate organizational conflicts of interest. The proposal should also outline how novel the proposed work is and provide a comprehensive overview of intellectual property rights, especially regarding technical data, computer software, and patents. Moreover, it mandates the disclosure of any human subjects research or animal use protocols, along with the necessary ethical approvals. Critical dates include the proposal preparation date and a valid period of at least 120 days. The solicitation number is ARPA-H-SOL-24-101, and proposers must submit a completed Administrative and National Policy Requirements document as part of their application.
    The government agency seeks to procure expert engineering services, specialized equipment, and supplies for a renewable energy project. The primary objective is to develop and enhance solar power technologies. This is evident in the detailed breakdown of personnel, fringe benefits, travel, equipment, supplies, and contractual costs incurred in the project. The procurement aims to engage multiple engineering firms and vendors for specialized tasks. These include designing receiver systems, developing optimal Fresnel lenses, and creating custom robotics for lens inspection and alignment. The scope of work involves multiple tasks over a multi-year period, with a focus on research, development, and commercialization. Engineers and technicians will work on receiver design, prototype development, and reliability testing. Travel costs are included for essential project-related trips, and the budget also covers the necessary construction preparation for building a wind turbine platform. Key dates and timelines are spread across multiple years, with year-wise breakdowns of costs for personnel, equipment, supplies, and various types of contracts. The evaluation criteria are not explicitly mentioned but likely include technical expertise, project feasibility, and cost-effectiveness. The procurement process appears thorough, requiring detailed justifications, resumes, and competitive quotes for vendor selection. Overall, this RFP outlines a comprehensive, carefully planned procurement for renewable energy research and development, reflecting the government's commitment to advancing sustainable energy solutions.
    The government agency seeks to award a contract for research and development of solar energy technologies. The primary objective is to advance photovoltaic (PV) module manufacturing and performance. This multi-year procurement aims to fund personnel, materials, and contractual support for achieving technical milestones and deliverables related to PV cell and module development. The scope involves multiple tasks, including receiver design, reliability testing, and optimization of fresnel lenses. The agency requires detailed justifications for personnel costs, fringe benefits, travel expenses, equipment, supplies, and contractual arrangements. Vendors, contractors, and research partners contributing over 10% of the total project costs must provide separate budget justifications. Key procurement specifics include: a cap of $221,900 per year for individual salaries; detailed breakdown of travel purposes and costs; equipment items priced over $5,000; and supplies costing under $5,000. The agency emphasizes the need for justification and documentation supporting all proposed costs. The contractual arrangements section requires vendors and partners to outline their roles and associated costs. Construction activities are also outlined, primarily focusing on site preparation for a wind turbine platform. Other direct costs, such as technology transfer and outreach, and indirect costs are included, with strict guidelines for eligibility and justification. Cost share arrangements are considered, with partners contributing resources towards the project objectives. The agency seeks a comprehensive budget justification, ensuring alignment with the proposed research objectives. Critical dates include the submission deadline and expected project timeline, both spanning multiple years. Evaluating proposals will consider the technical merit and cost effectiveness of the proposed work, with cost sharing being a positive factor.
    The primary objective of this procurement is to acquire comprehensive cost proposals from vendors for a government project. The focus is on detailing the financial breakdown of the proposed costs, encompassing multiple categories. These include direct labor, fringe benefits, labor overhead, subcontractor expenses, other direct costs like materials and travel, and overhead costs such as material handling and general and administrative rates. The government seeks a clear cost structure for each phase of the project, with labor rates and associated costs listed for each labor category. Vendors are expected to provide a detailed cost proposal spreadsheet, outlining expenses for each phase of the project. The spreadsheet has specific tabs for different phases, with instructions to fill in yellow fields and provide supporting data. The government emphasizes the importance of submitting well-structured cost proposals, making it easier for evaluation and potential award negotiations. The evaluation criteria will likely place significant emphasis on the cost-effectiveness and reasonableness of the proposed costs. Key dates are not explicitly mentioned within the files, indicating that they may be outlined elsewhere in the procurement process. Similarly, contract details are not present, suggesting they will be established if an award is made.
    The focus of this RFP is the procurement of specialized cells, specifically GMP grade cells, which are a crucial element for the PRINT program's success. Proposers seek to clarify various aspects of the cell manufacturing and testing requirements. The ability to produce GMP-grade cells for transplant is a key objective in the program's second phase, with GLP-grade cells being acceptable for certain studies. Advanced Regenerative Manufacturing Institute's potential role as a collaborator is now permissible, following changes to the validation process. While Institutional Review Board approval isn't mandatory for application submission, it is a condition that must be met post-award. The RFP also seeks to engage proposers in developing humanized large animal models for research, but accessibility challenges lead to a revised requirement to use severe combined immunodeficiency (SCID) pigs or equivalent species. With a projected start date in Q2 2025, proposers are instructed to include annual meeting costs in their submissions, and the location can be estimated as Washington, D.C.
    The Advanced Research Projects Agency for Health (ARPA-H) seeks innovative solutions for its Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program. The goal is to develop tools and technologies for bioprinting patient-matched organs to address the global shortage of transplant organs. ARPA-H aims to award multiple contracts for groundbreaking research. The focus is on creating a process to biofabricate kidney, heart, and liver tissues using advanced cell manufacturing and 3D bioprinting techniques. The agency seeks end-to-end solutions to produce functional organs for transplantation without immune rejection, including: 1. Patient cell source identification and differentiation protocols. 2. Large-scale manufacturing processes for cell types, ensuring quality and scalability. 3. Biofabrication technologies, including software, bioreactors, and bioinks, for in vivo testing. Proposers must address all three technical areas for one target organ. The evaluation criteria emphasize the technical merit and innovation of the proposed solution, its potential impact on healthcare, and the qualifications of the team. Key dates include a Proposers' Day in May 2024 and a solution summary deadline in late May, with full proposals due in August 2024.
    The Advanced Research Projects Agency for Health (ARPA-H) seeks innovative solutions for its Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program. The goal is to develop tools and technologies to biofabricate patient-matched kidney, heart, and liver organs, restoring normal function without immune rejection. ARPA-H aims to award multiple contracts for groundbreaking research. Proposals should address three technical areas: generating necessary organ cells, large-scale manufacturing, and organ biofabrication for in vivo testing. The focus is on revolutionary approaches to create a sustainable organ supply chain. Offerings must include a data sharing plan, address equity requirements, and adhere to OCI guidelines. Key dates include a Proposers' Day in May and a solution summary submission deadline in late May 2024, with full proposals due in August 2024. Evaluation criteria prioritize the technical merit and potential impact on health outcomes, with cost and schedule considerations also factored in. This solicitation encourages collaboration across disciplines to revolutionize organ biofabrication and significantly impact the global organ shortage.
    The Advanced Research Projects Agency for Health (ARPA-H) seeks innovative solutions to develop a process for biofabricating patient-matched kidney, heart, and liver organs. The goal is to restore normal function using 3D bioprinting and advanced cell manufacturing. The request for proposals (RFP) outlines a five-year program divided into two phases. Phase 1 focuses on research and development, including identifying cell sources, developing differentiation protocols, and enhancing bioprinting methods. Phase 2 aims to establish Good Manufacturing Practice protocols, perform large animal studies, and prepare for Investigational New Drug filings. The RFP emphasizes the need for approaches that go beyond the current state of the art in organ biofabrication, emphasizing revolutionary, immunocompetent solutions. Offerors must address all three technical areas: cell generation, large-scale manufacturing, and organ biofabrication. Proposed solutions will be evaluated based on their potential to achieve program objectives, with an emphasis on technical merit and innovation. Multiple awards are anticipated, with selections leading to Cooperative Agreements or Other Transaction Agreements. Key dates include a Proposers' Day in May 2024 and solution summary and full proposal deadlines in May and July 2024, respectively.
    The Advanced Research Projects Agency for Health (ARPA-H) seeks innovative solutions for its Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program. The objective is to revolutionize organ biofabrication using 3D printing, advanced cell manufacturing, and tissue engineering. ARPA-H aims to develop a process to biofabricate patient-matched organs, specifically the kidney, heart, and liver, to restore normal function. This would address the global organ shortage and eliminate the need for immune-suppressing drugs. The agency seeks proposals covering three technical areas. TA1 focuses on generating necessary organ cell types from efficient cell sources, while TA2 involves large-scale manufacturing of these cells for in vivo testing. TA3 addresses organ biofabrication, including bioprinting methods, software, and bioreactors, with the goal of demonstrating organ function restoration in animal models. The desired end product is a scalable and accessible organ biofabrication process. Proposers must demonstrate capabilities across all technical areas and include commercialization plans. The evaluation criteria emphasize the technical merit and innovation of the proposed solution, its potential impact on ARPA-H's mission, and the qualifications of the team. Solution Summaries are due by May 28, 2024, with full proposals invited thereafter. The anticipated contract type is Cooperative Agreements or Other Transaction Agreements, with multiple awards expected.
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