Last Updated: November 17, 2025
Important Update to Timeline and Submission Requirements (Step 2: PowerPoint Presentation Submission Requirements)
Transforming Genetic Medicine for Rare Diseases: ARPA-H’s THRIVE Initiative
The Advanced Research Projects Agency for Health (ARPA-H), through its Health Science Futures Office, has announced the Treating Hereditary Rare diseases with In Vivo precision genetic mEdicines (THRIVE) Innovative Solutions Opening (ISO) (ARPA-H-SOL-25-122). The initiative represents a bold step toward curative genetic medicines that could transform treatment for millions. Collectively, rare diseases affect one in ten people (most of them children), and 95% of rare diseases lack approved therapies. ARPA-H seeks to catalyze breakthroughs that replace chronic, lifelong management with one-time precision genetic interventions.
Program Overview
THRIVE aims to create a future where patients can opt for single-dose treatments designed to slow, reverse, or cure their conditions. Unlike traditional models that rely on daily medications, THRIVE will invest in platforms that pair therapeutic cargo with precision delivery. These platforms will serve as engines for rapidly designing and deploying multiple precision genetic medicines (PGMs).
The program is structured into three parallel modules:
- Platform Design & Development (Module 1) – Performer teams must design at least two platforms, each demonstrating two or more PGMs. Proposals should include non-clinical testing for safety, toxicity, and efficacy.
- Investigational Medicine (Module 2) – Once a PGM shows safety and potential efficacy, patients may opt to access it under a streamlined process, enabling real-world treatments much faster than traditional pathways.
- Real-world Pilots & Scaling (Module 3) – Teams must prove scalability by onboarding satellite clinics more than 250 miles from expert hubs, ensuring patients can be treated where they live.
In addition, THRIVE will support regulatory innovation and build a federated data platform to integrate program outputs with national and international rare disease resources, enabling AI/ML-driven acceleration of PGM development.
Step 2: PowerPoint Presentation Submission Requirements
As teams advance in the ARPA-H review process, Step 2 marks a significant escalation in both expectations and required detail. After receiving Step 1 feedback letters, each designed to help proposers make an informed decision on whether to continue, eligible teams will be encouraged to submit a PowerPoint presentation and accompanying Gantt chart. This stage is intentionally rigorous, ensuring that teams can articulate a credible development strategy, operational plan, regulatory pathway, and long-term deployment model before progressing to full proposal submission.
Required Submission Materials
Proposers must submit three elements: (1) a presentation following the ARPA H template, limited to one title slide, one cover slide, and up to 18 content slides; (2) a full project Gantt chart in an editable format, with Excel preferred; and (3) an optional PDF appendix containing supporting materials. The Gantt chart will be evaluated for its granularity and clarity, particularly regarding the assignment of tasks and responsibilities across partner organizations. Appendix slides within the PowerPoint deck are not permitted, and any supplemental information must be placed exclusively in the PDF document.
PowerPoint Presentation Focus Areas
The Step 2 presentation must emphasize two primary themes:
- Regulatory and Development Pathway (5 to 8 slides). Proposers must outline a detailed regulatory strategy covering nonclinical development, clinical planning, and chemistry, manufacturing, and controls (CMC). This should include multiple potential regulatory pathways, approaches to platformization, and mechanisms for leveraging existing guidance or international experience. Teams must also demonstrate competency in patient engagement, provide timeline visualizations, describe learnings that will accelerate follow on products, and articulate early thinking on payer relevant evidence.
- Sustainable Deployment Model During and After THRIVE (2 to 4 slides). Teams must propose a viable model for nationwide deployment, spanning licensure through long term commercial sustainability. Submissions should address incentives for knowledge and IP transfer, long term clinical operations across geographically distinct sites, and strategies to maintain patient involvement for at least five years, grounded in realistic assumptions about today’s policy, IP, and healthcare environment.
Additional Required Slides
Proposers must also include sections covering disease and platform selection (1 to 2 slides), intellectual property strategy (up to 2 slides), economics and cost of goods (up to 2 slides), a high-level Gantt chart (1 slide, not presented), and a preliminary rough order of magnitude budget (1 slide, not presented). These elements are intended to demonstrate feasibility, cost awareness, freedom to operate considerations, and team wide project management capability.
Important Dates
Applicants should note the following deadlines:
- October 2, 2025 – Lightning Talks & Sidebars (virtual)
- October 24, 2025 – Q&A deadline
- October 31, 2025 (11:59PM ET) – Solution Summaries due
- December 22, 2025 (3:00PM ET) – PowerPoint Presentations due
- January 5th to January 16th, 2026 – Virtual PowerPoint presentations
- February 5, 2026 (3:00PM ET) – Full Proposals due
Funding Information
- Awards Anticipated: Multiple
- Award Instrument: Other Transaction Agreements (OTs)
- Period of Performance: 5 years
- Cost Share: ARPA-H will cover 100% of project costs in Year 1, with its contribution decreasing annually to 20% in Year 5. Performers must provide the balance through cash or in-kind contributions.
Post-THRIVE, teams are expected to establish commercialization strategies including licensing and pricing models that ensure PGMs remain affordable and accessible to small patient populations.
Why It Matters
Rare diseases cost U.S. taxpayers an estimated $1 trillion annually in direct and indirect burdens. By accelerating curative PGMs, THRIVE aims to relieve families of devastating health challenges and redefine the future of medicine.
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