Genetic Medicines And Individualized Manufacturing For Everyone (GIVE)

The Advanced Research Projects Agency for Health (ARPA-H), operating under the U.S. Department of Health and Human Services, has released an Innovative Solutions Opening (ISO) titled Genetic Medicines and Individualized Manufacturing for Everyone (GIVE). This program is administered by ARPA-H’s Scalable Solutions Office and is intended to transform the biomanufacturing landscape in the United States by enabling distributed, on-demand access to genetic medicines. ARPA-H was established to accelerate the pace of biomedical innovation, drawing on the Defense Advanced Research Projects Agency (DARPA) model of high-risk, high-reward research. Through GIVE, the agency seeks to bring advanced RNA-based therapies and other genetic medicines closer to patients by replacing the traditional centralized model with a distributed, localized one. The GIVE program was created in recognition of the pressing challenges facing genetic medicine manufacturing. Currently, gene therapies, vaccines, and RNA-based treatments require costly facilities, long regulatory pathways, and complex logistics, including ultra-cold shipping. These barriers delay treatment access and raise costs beyond the reach of many patients. GIVE proposes an entirely new model for biomanufacturing—leveraging automation, artificial intelligence, robotics, and integrated quality systems to allow hospitals and clinics to directly produce individualized or personalized medicines in days rather than years. The goal is to enable nationwide access to cutting-edge therapies for cancer, rare diseases, and chronic conditions. The solicitation outlines three overarching program goals. First, performers are asked to create a fully cell-free RNA manufacturing and formulation system that is GMP-capable, modular, and automated, with minimal operator input. Second, the program seeks the development of an integrated quality control platform capable of performing rapid, automated lot release testing in distributed environments. Third, GIVE aims to demonstrate the feasibility of a multi-site, multi-product, and multi-scale biomanufacturing network that can meet regulatory standards outside traditional GMP facilities. The program requires technical solutions to be compliant with FDA standards, CFR Part 11 electronic records requirements, and interoperability expectations for data and process management. The program structure spans 54 months over three phases. Phase 1, lasting six months, focuses on design and engineering plans. Phase 2 runs for 24 months and requires demonstration of three RNA products across different therapeutic categories in a non-GMP setting. Phase 3, also 24 months, requires GMP-compliant demonstrations of two RNA products. Both technical areas—TA1 (Automated RNA Manufacturing) and TA2 (Integrated Quality Control)—must demonstrate their capabilities individually or in tandem. Independent Verification and Validation (IV&V) may be required at various points to assess cybersecurity, biosecurity, and technical performance. Eligibility for GIVE is broad, including nonprofit organizations, universities, for-profit companies, small businesses, and other non-government entities. Federally Funded Research and Development Centers (FFRDCs) and U.S. government entities are prohibited from direct participation, except in narrowly defined circumstances. Non-U.S. entities may apply if they comply with U.S. export control laws, are not considered foreign entities of concern, and meet security disclosure requirements. Applicants must also be registered in SAM.gov with a Unique Entity ID at the time of submission. Applications follow a two-step process: first, submission of a solution summary by December 19, 2025, followed by a full proposal due February 27, 2026. Proposers must use ARPA-H’s online submission portals for both steps. Cost sharing is not required but is encouraged, especially for later phases. Proposals will be reviewed based on scientific merit, proposer capabilities, contribution to ARPA-H’s mission, and cost realism. Evaluation will consider innovation, feasibility, end-user impact, commercialization potential, and adherence to quality and regulatory standards. ARPA-H anticipates making multiple awards under Other Transaction (OT) agreements. Award notifications will be provided after proposal review and negotiations. The program does not specify an award ceiling or total funding pool, but emphasizes technical readiness, multi-product scalability, and potential for nationwide deployment. Through GIVE, ARPA-H intends to lay the foundation for a distributed biomanufacturing network capable of transforming access to genetic medicine across the United States.

Proposals evaluated on scientific merit, proposer capabilities, ARPA-H mission contribution, and cost realism. Bold, innovative approaches prioritized over low-risk ideas.