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/23f0ea200c4d4899bac5652b02f09e2e/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.
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