Treating Hereditary Rare Diseases With In Vivo Precision Genetic Medicines (THRIVE)
ID: ARPA-H-SOL-25-122Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H)Washington, DC, 20005, USA

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

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

Set Aside

No Set aside used (NONE)

Original Source

https://sam.gov/workspace/contract/opp/c35d47c1cc4d40b0b496d2d62d894495/view
Timeline
    Description

    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the "Treating Hereditary Rare Diseases With In Vivo Precision Genetic Medicines (THRIVE)" program. This initiative aims to accelerate the development of innovative precision genetic medicines (PGMs) to treat hereditary rare diseases, focusing on creating integrated platforms that address technical and real-world challenges in genetic medicine. Proposals must include a solution summary, a PowerPoint presentation, and a detailed Gantt chart, with key deadlines set for October 31, 2025, for solution summaries and December 22, 2025, for PowerPoint submissions. Interested parties can contact the THRIVE Program at THRIVE@arpa-h.gov for further information.

    Point(s) of Contact
    THRIVE PROGRAM
    THRIVE@arpa-h.gov
    Files
    Title
    Posted
    THRIVE FAQ - OCT092025.pdf
    The THRIVE program is a government initiative seeking innovative Precision Genetic Medicines (PGMs) that are disease, age, organ, and technology agnostic. It encourages solutions for rare diseases, aiming to create one-time interventions addressing genetic root causes. Proposers must submit a Solution Summary and address all three modules of the program, including clinical trial readiness and community deployment. Teams are expected to include diverse expertise, including patient advocacy groups, and collaborate to establish a viable, sustainable, and scalable ecosystem for PGMs. The program utilizes Other Transaction (OT) Agreements and requires a cost-sharing strategy that increases performer contributions over five years. THRIVE aims to accelerate regulatory innovation and make data publicly available to advance genetic medicine development, with a focus on affordable cures for all patients.
    THRIVE ISO_Amendment 4.docx
    ARPA-H-SOL-25-122, titled "THRIVE," is an Innovative Solutions Opening (ISO) seeking groundbreaking genetic medicine platforms to treat hereditary rare diseases. The program aims to accelerate the design, development, regulatory approval, and real-world deployment of precision genetic medicines (PGMs). THRIVE is structured into three modules: PGM design and development, investigational medicine, and real-world viability pilots and scaling. It emphasizes addressing technical and real-world limitations of current approaches, such as the need for precise delivery tools and streamlined regulatory pathways. The initiative encourages cost-sharing, diverse multidisciplinary teams, and a focus on affordability and accessibility. A key component is the establishment of a publicly accessible data platform to leverage AI/ML for future PGM development. The submission process involves a solution summary, PowerPoint presentation, and a full proposal, with specific deadlines and evaluation criteria focusing on technical merit, ARPA-H mission relevance, proposer capabilities, and cost realism. Proposals must outline comprehensive IP strategies and post-THRIVE commercialization terms to ensure broad patient access and a sustainable PGM industry.
    THRIVE ISO_Amendment 4.pdf
    ARPA-H-SOL-25-122, titled "THRIVE," is an Innovative Solutions Opening (ISO) seeking groundbreaking genetic medicine platforms to treat hereditary rare diseases. The program aims to accelerate the design, development, regulatory approval, and real-world deployment of precision genetic medicines (PGMs). THRIVE is structured into three modules: PGM design and development, investigational medicine, and real-world viability pilots and scaling. It emphasizes addressing technical and real-world limitations of current approaches, such as the need for precise delivery tools and streamlined regulatory pathways. The initiative encourages cost-sharing, diverse multidisciplinary teams, and a focus on affordability and accessibility. A key component is the establishment of a publicly accessible data platform to leverage AI/ML for future PGM development. The submission process involves a solution summary, PowerPoint presentation, and a full proposal, with specific deadlines and evaluation criteria focusing on technical merit, ARPA-H mission relevance, proposer capabilities, and cost realism. Proposals must outline comprehensive IP strategies and post-THRIVE commercialization terms to ensure broad patient access and a sustainable PGM industry.
    THRIVE ISO_Amendment_No_1_Tracked_Changes.docx
    ARPA-H-SOL-25-122, titled "THRIVE," is an Innovative Solutions Opening (ISO) from the Advanced Research Projects Agency for Health (ARPA-H) focused on treating hereditary rare diseases with in vivo precision genetic medicines. The program seeks to accelerate the development of precision genetic medicines (PGMs) by fostering innovative platforms that combine therapeutic cargo with targeted delivery tools. THRIVE addresses the urgent need for therapies for over 10,000 rare diseases, aiming to shift the paradigm from chronic medication to one-time curative interventions. The program is structured into three modules: PGM design and development, investigational medicine, and real-world viability pilots and scaling. It emphasizes regulatory facilitation, data sharing, and a team-based approach involving diverse expertise, including patient advocacy groups. Cost-sharing is strongly encouraged, with ARPA-H providing declining funding over five years. Proposals are evaluated based on technical merit, relevance to ARPA-H's mission, proposer capabilities, and cost realism. The goal is to develop affordable, accessible, and scalable PGM solutions, ensuring equitable healthcare outcomes.
    THRIVE ISO_Amendment_No_1.pdf
    The Advanced Research Projects Agency for Health (ARPA-H) has issued an Innovative Solutions Opening (ISO) for the "Treating Hereditary Rare diseases with In Vivo precision genetic mEdicines (THRIVE)" program. This initiative seeks to accelerate the development of one-time therapeutic interventions for hereditary rare diseases (RDs) by addressing technical and real-world limitations of current genetic medicines. THRIVE focuses on creating integrated platforms of genetic technologies (cargo and delivery tools) to rapidly design and develop multiple precision genetic medicines (PGMs). The five-year program is structured into three parallel modules: PGM design and development, investigational medicine, and real-world viability pilots and scaling. It emphasizes regulatory facilitation, data platform creation for AI/ML-assisted development, team requirements including patient advocacy groups, and post-THRIVE commercialization strategies that prioritize affordability and accessibility for small patient populations. The program encourages cost-sharing and outlines a two-step proposal review process based on technical merit, relevance to ARPA-H's mission, proposer capabilities, and cost realism.
    THRIVE ISO_Final_16092025.docx
    ARPA-H-SOL-25-122, titled "THRIVE," is an Innovative Solutions Opening (ISO) seeking groundbreaking genetic medicine solutions for rare diseases. The program aims to accelerate the design and development of precision genetic medicines (PGMs) through integrated platforms, streamline regulatory pathways, pilot real-world viability, and establish a publicly accessible data platform. THRIVE requires multidisciplinary teams to address three modules: PGM design and development, investigational medicine, and real-world viability/scaling. Proposals must demonstrate cost-share and address post-THRIVE commercialization, including IP licensing and PGM pricing, with an emphasis on affordability and accessibility for rare disease patients. The program explicitly excludes incremental improvements, the use of human embryos/fetal tissue/human-animal chimeras, and certain gene therapy approaches. The review process involves a solution summary and a full proposal evaluation based on technical merit, relevance to ARPA-H's mission, proposer capabilities, and cost realism.
    THRIVE ISO_Final_16092025.pdf
    ARPA-H-SOL-25-122, titled "THRIVE," is an Innovative Solutions Opening (ISO) from the Advanced Research Projects Agency for Health (ARPA-H) focused on treating hereditary rare diseases with in vivo precision genetic medicines. The program aims to develop one-time therapeutic interventions to slow, reverse, or cure rare diseases by accelerating the design and development of precision genetic medicine (PGM) platforms. THRIVE is structured into three parallel modules: PGM design and development, investigational medicine, and real-world viability pilots and scaling. It emphasizes rapid regulatory innovation, patient access, and the establishment of a publicly accessible data platform. The program requires cost-sharing, collaborative team structures, and a comprehensive IP strategy for post-THRIVE commercialization. Proposals are evaluated on technical merit, relevance to the ARPA-H mission, proposer capabilities, and cost realism. Non-U.S. entities are encouraged to collaborate with U.S. entities, and all proposers must be registered in SAM.gov.
    THRIVE ISO_Final_20250925.docx
    ARPA-H-SOL-25-122, titled "Treating Hereditary Rare diseases with In Vivo precision genetic mEdicines (THRIVE)," is an Innovative Solutions Opening (ISO) seeking groundbreaking solutions for rare diseases (RDs). The program aims to accelerate the development of precision genetic medicines (PGMs) through integrated platforms, regulatory innovation, and real-world viability pilots. THRIVE is structured into three modules: PGM design and development, investigational medicine, and real-world viability and scaling. It emphasizes age- and organ-agnostic solutions, excluding gene supplementation gene therapy and ex vivo CRISPR-Cas9 approaches. The program requires cost-sharing and proposes a unique approach to intellectual property licensing and PGM pricing to ensure affordability and accessibility, especially for small patient populations. The submission process involves a solution summary and a full proposal, evaluated on technical merit, relevance to the ARPA-H mission, proposer capabilities, and cost realism. Non-U.S. entities can participate, and teams must have active SAM.gov registration.
    THRIVE ISO_Final_20250925.pdf
    ARPA-H-SOL-25-122, titled "Treating Hereditary Rare diseases with In Vivo precision genetic mEdicines (THRIVE)," is an Innovative Solutions Opening (ISO) seeking groundbreaking solutions for rare diseases (RDs). The program aims to accelerate the development of precision genetic medicines (PGMs) through integrated platforms, regulatory innovation, and real-world viability pilots. THRIVE is structured into three modules: PGM design and development, investigational medicine, and real-world viability and scaling. It emphasizes age- and organ-agnostic solutions, excluding gene supplementation gene therapy and ex vivo CRISPR-Cas9 approaches. The program requires cost-sharing and proposes a unique approach to intellectual property licensing and PGM pricing to ensure affordability and accessibility, especially for small patient populations. The submission process involves a solution summary and a full proposal, evaluated on technical merit, relevance to the ARPA-H mission, proposer capabilities, and cost realism. Non-U.S. entities can participate, and teams must have active SAM.gov registration.
    THRIVE_PPT_Presentation_Template.pptx
    The Advanced Research Projects Agency for Health (ARPA-H) Program THRIVE is soliciting proposals for platform technologies aimed at treating various diseases. Proposers are required to submit a PowerPoint presentation (maximum 18 slides) and a detailed Gantt chart (preferably Excel) by December 22, 2025, 3 PM ET, to THRIVE@arpa-h.gov. Optional Appendix PDFs are allowed. Virtual presentations will be scheduled between January 5th and 16th, 2026, consisting of a 15-minute pitch and 20 minutes for Q&A. The presentation should cover proposed diseases, technologies, detailed regulatory strategy (5-8 slides), a sustainable deployment model (2-4 slides), intellectual property strategy (maximum 2 slides), cost of goods per patient (maximum 1 slide), a high-level Gantt chart (maximum 1 slide), and a budget slide (not presented). Key focus areas include demonstrating regulatory competency, sustainable deployment beyond THRIVE, and a clear understanding of economics and IP. Encouraged teams will receive feedback for submitting full proposals, which will be the final stage for award decisions.
    Similar Opportunities
    GENETIC MEDICINES AND INDIVIDUALIZED MANUFACTURING FOR EVERYONE (GIVE)
    Buyer not available
    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program. This initiative aims to revolutionize the biomanufacturing of RNA-based genetic medicines by fostering innovations in automated RNA manufacturing and integrated quality control, ultimately enabling rapid, cost-effective, and localized production in non-GMP environments. Interested parties must submit solution summaries by December 19, 2025, with full proposals due by February 27, 2026, and are encouraged to participate in a Proposers’ Day on November 13, 2025, for further insights. For additional information, please refer to the program's website or contact the designated email address.
    Proactive Health Office (PHO) Mission Office Innovative Solutions Opening (ISO)
    Buyer not available
    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is soliciting innovative solutions aimed at enhancing the healthspan and health outcomes of Americans by focusing on proactive health measures. The Proactive Health Office (PHO) seeks proposals that address population-level improvements in disease prevention, early detection methods, and system-level innovations for effective health delivery, emphasizing revolutionary advances rather than incremental improvements. This opportunity is critical for fostering advancements in public health and requires adherence to specific administrative and national policy guidelines, including intellectual property rights and research security measures. Interested parties must submit a Solution Summary by March 5, 2029, and can find further details and submission links at https://solutions.arpa-h.gov, with inquiries directed to the same site.
    Health Science Futures (HSF) Mission Office Innovative Solutions Opening (ISO)
    Buyer not available
    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the Health Science Futures (HSF) Mission Office Innovative Solutions Opening (ISO). This initiative aims to gather innovative solutions that address future healthcare challenges, focusing on groundbreaking research in areas such as maternal/fetal medicine, genetic therapies, chronic diseases, and mental health, while excluding proposals for incremental advances or clinical trials. Proposers are required to submit a Solution Summary for initial feedback, followed by a detailed proposal that adheres to updated administrative and national policy requirements, including compliance with ethical research guidelines and research security disclosures. Interested parties should submit their proposals via the designated ARPA-H portal, with specific deadlines and further details available through the provided links.
    Resilient Systems Office (RSO) Mission Office Innovative Solutions Opening (ISO)
    Buyer not available
    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the Resilient Systems Office (RSO) Mission Office Innovative Solutions Opening (ISO). This opportunity invites submissions that address systemic challenges in healthcare and public health by leveraging innovative technologies to improve care quality, efficacy, and accessibility. Proposals will be evaluated based on scientific merit, alignment with ARPA-H's mission, proposer capabilities, and cost, with a focus on open-source intellectual property and compliance with research regulations. Interested parties must submit solution summaries and proposals via the designated ARPA-H portal, with the closing date for submissions set for March 5, 2029. For further inquiries, proposers can reach out through the same portal.
    Scalable Solutions Office (SSO) Mission Office Innovative Solutions Opening (ISO)
    Buyer not available
    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the Innovative Solutions Opening (ISO) under the Scalable Solutions Office (SSO). This initiative aims to develop innovative solutions that enhance healthcare access, affordability, and distribution, particularly in underserved communities, while addressing challenges in biomanufacturing and health technology distribution. The solicitation is open until March 5, 2029, and encourages submissions from academia, non-profits, and for-profit entities, with multiple awards anticipated as Other Transactions. Interested parties must submit a Solution Summary for initial feedback before proceeding with a full proposal, adhering to strict guidelines on intellectual property, research security, and cost proposal requirements. For further details, proposers can reach out through the designated submission portals and must ensure compliance with the updated administrative and national policy requirements outlined in the solicitation documents.
    EVIDENT (Evidence-Based Validation & Innovation for Rapid Therapeutics)
    Buyer not available
    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is initiating the Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT) initiative to fund innovative solutions that align with HHS and ARPA-H objectives. This initiative aims to efficiently support research and development in the field of behavioral health, particularly focusing on rapid therapeutic innovations. The Proposers’ Day, scheduled for December 10, 2025, will provide an opportunity for interested parties to learn more about the technical areas of the EVIDENT initiative and to engage with ARPA-H and Advanced Technology International (ATI). For additional information and registration details, interested parties are encouraged to refer to the provided links.
    Independent Validation and Verification (IV&V) Services for the REACT Program
    Buyer not available
    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is seeking independent validation and verification (IV&V) services for its Resilient Extended Automatic Cell Therapies (REACT) program. The primary objective is to ensure the standardization and reproducibility of engineered cell lines used in developing wireless implantable medical devices, specifically the "Living Pharmacy" for therapeutic delivery and the "Living Sentinel" for disease tracking. These services are crucial for scaling manufacturing capabilities and aligning with regulatory standards, ultimately facilitating the commercialization of these health care devices. Proposals are due by January 5, 2026, with the contract covering a period from February 23, 2026, to August 22, 2028, and interested parties can contact Larin Harris at larim.harris@arpa-h.gov or Clare Sanchez at clare.sanchez@arpa-h.gov for further information.
    BioStabilization Systems (BoSS)
    Buyer not available
    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is seeking proposals for the BioStabilization Systems (BoSS) program aimed at revolutionizing the stabilization, manufacturing, and distribution of live cell-based therapies. The program addresses the critical challenge of ultra-cold storage requirements for advanced cell and gene therapies by developing bioprocessing systems that enable the production of thermally stable cells, thereby enhancing the efficiency and resilience of biologics distribution. Interested parties can submit Solution Summaries for consideration as either Performer teams or Independent Verification and Validation (IV&V) partners, with deadlines set for February 19, 2026, and April 17, 2026, respectively. For more information, including submission guidelines and program details, please visit the ARPA-H website or refer to the attached documents.
    Autonomous Interventions and Robotics (AIR) Advanced Research Projects Agency for Health (ARPA-H)
    Buyer not available
    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the Autonomous Interventions and Robotics (AIR) program, aimed at advancing autonomous robotic surgery technologies. This initiative focuses on two key technical areas: autonomous endovascular robotics, which includes developing systems for procedures such as thrombectomy and embolization, and the creation of untethered microbots for various clinical applications. The program is critical for enhancing medical interventions and is structured over a five-year timeline, with specific milestones for development and testing phases. Interested parties, including universities, non-profits, and businesses, must submit their proposals by March 30, 2026, with a preliminary Solution Summary due by January 26, 2026. For further inquiries, contact the AIR Program at AIR@ARPA-H.GOV.
    Autonomous Interventions and Robotics (AIR) Advanced Research Projects Agency for Health (ARPA-H)
    Buyer not available
    The Department of Health and Human Services, through the Advanced Research Projects Agency for Health (ARPA-H), is seeking proposals for its Autonomous Interventions and Robotics (AIR) program, which aims to advance autonomous robotic surgery technologies. This initiative focuses on two technical areas: Autonomous Endovascular Robotics, which includes developing robotic systems for endovascular procedures and creating a simulation environment, and Microbots, which targets the development of untethered, autonomous microbots for various interventional procedures. The program is structured over a five-year timeline with specific phases and milestones, emphasizing collaboration with the FDA for regulatory approval. Interested parties are encouraged to attend a Proposers’ Day on December 16, 2025, in Washington, DC, to learn more about the program and network with potential collaborators. For further inquiries, contact the AIR Program at AIR@ARPA-H.GOV.