Complement-ARIE NAMs Reduction to Practice Challenge

The Complement-ARIE (Complement Animal Research in Experimentation) New Approach Methodologies (NAMs) Reduction to Practice (RTP) Challenge is a major scientific innovation initiative administered by the National Institutes of Health (NIH) Office of the Director. Through the NIH Common Fund, this program seeks to catalyze the development, validation, and widespread adoption of combinatorial NAMs as human-relevant alternatives to traditional animal-based research methods. Launched in collaboration with the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA), the challenge addresses an urgent scientific and regulatory need to modernize biomedical research and toxicity testing through integrated technological approaches that improve human clinical relevance. The RTP Challenge unfolds across three distinct phases over a three-year period. Each phase introduces progressively complex deliverables and award tiers, beginning with proof-of-concept proposals in Phase 1, followed by prototype development and milestone validations in Phase 2, and culminating in full prototype delivery for independent validation and qualification in Phase 3. In Phase 1, participants are required to submit proposals demonstrating the feasibility of their combinatorial NAMs with reproducible preliminary data, a clear context of use, and a credible development plan. Up to 20 winners will be awarded $80,000 each and will advance to Phase 2. This next phase involves both prototype construction and internal validation steps, with milestone-based awards of $150,000 and $200,000 respectively for up to 10 and 7 teams. In the final phase, solvers who successfully deliver and document a comprehensive NAMs platform for independent evaluation may be awarded one of three $500,000 runner-up prizes or a $1,000,000 grand prize. Combinatorial NAMs, by definition, integrate multiple non-animal testing strategies—such as in vitro organoids, in silico computational models, and in chemico biochemical techniques—to produce synergistic platforms that enhance predictability of human outcomes. The RTP Challenge is open to solvers across academia, industry, nonprofits, and advocacy communities. Participants may apply as independent teams or as legally incorporated U.S.-based entities. Teams must designate a U.S. citizen or permanent resident as their leader to be eligible for monetary prizes. While international collaborators may join, they are not eligible for cash awards. Submissions must be entered through the designated HeroX challenge platform. Each team may submit only one entry, though entities may submit multiple distinct proposals. Applicants are required to follow a strict submission format in Phase 1, including a cover page, executive and plain-language summaries, team bios, and a ten-page project narrative with detailed data and developmental plans. These documents must demonstrate a viable path through Phase 2 milestones and ultimately toward validation readiness in Phase 3. Judging criteria for Phase 1 include five weighted categories: significance and impact, innovation, team composition, feasibility and preliminary data, and overall scientific approach. Winners will be publicly announced, and key elements of their proposals (titles, summaries, and descriptions) may be shared for broader public engagement. The timeline for the RTP Challenge is structured with clarity. Phase 1 officially launches on September 25, 2025, with registration opening on September 30, 2025. Submissions are due by March 1, 2026. Winners for Phase 1 will be announced by July 1, 2026. Estimated dates for future phases include Phase 2 launch in July 2026, milestone deadlines in March and August 2027, and final Phase 3 results in August 2028. All timeline dates are subject to change at the NIH's discretion. If fewer awards are made in earlier phases, unallocated funds may be redistributed in later rounds. This Challenge is conducted under the authority of the COMPETES Reauthorization Act [15 U.S.C. § 3719], consistent with NIH's mission to drive innovations that enhance human health. By encouraging the adoption of NAMs and supporting human-relevant biomedical technologies, the NIH seeks to reduce reliance on animal models, streamline translational research, and facilitate more accurate assessments of safety and efficacy. The RTP Challenge ultimately promotes development of high-impact tools that align with principles of reproducibility, data transparency, and ethical research. This multi-agency effort reinforces the federal commitment to modernize biomedical science while engaging a broad, multidisciplinary community in solving complex human health challenges.

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