Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS)

The Advanced Research Projects Agency for Health (ARPA-H) seeks proposals for the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) Program through an Innovative Solutions Opening, with Solution Summaries due November 30, 2026. ARPA-H intends to award multiple Other Transaction Agreements and will not use a set-aside category. An informational webinar is scheduled for October 15, 2026, and a two-day Proposers' Day for November 6 and 9, 2026.

The program establishes persistent, multi-arm platform trials integrating three technical areas: TA1 (Phaseless Design Engine with simulation-based design and in silico models), TA2 (Continuous Inference supporting adaptive decisions with statistical validity), and TA3 (Agentic Operations with AI-enabled clinical operations systems). Core Platform Teams must select a disease area demonstrating substantial unmet patient need, propose at least three drug or biologic intervention arms with at least two unapproved interventions, establish a multi-site clinical network with minimum six sites, and demonstrate economic sustainability for approximately a decade post-program. The five-year program consists of Stage I (24 months) for platform buildout and Stage II (36 months) for capability validation.

ARPA-H will fund the first three intervention arms in full and may partially fund arms four and five; cost sharing is strongly encouraged. Eligible proposers include commercial entities, academia, and nonprofits. Federally Funded Research and Development Centers (FFRDCs) and government entities are prohibited as prime or sub-performers. All proposers must maintain active System for Award Management (SAM) registration and complete human subjects research approvals before funding begins. Solution Pitch packages are estimated due January 22, 2027, with virtual presentations scheduled for February 1–5, 2027. Questions should be directed to SURPASS@ARPA-H.GOV. The NAICS code is 541714, Research and Development in Biotechnology (except Nanobiotechnology); PSC is AN13.