2–2B cost to bring a new antibiotic to market is the single biggest deterrent to entry — and most of that cost is regulatory risk, not science. ADAPT-RX is a multi-stakeholder regulatory innovation programme that tackles this root cause directly.

Three interlocking mechanisms: (1) Master Protocol Framework — a pre-approved adaptive trial architecture shared across antibiotic developers, with shared placebo/comparator arms across multiple compounds. This eliminates duplicate Phase II placebo cohorts, cutting per-compound Phase II costs by ~45%.

(2) Rolling Regulatory Review — FDA/EMA pre-submission meetings from Phase I, with real-time review of data packages so that approval decisions come within 90 days of Phase III completion rather than 12–18 months.

(3) Surrogate Endpoint Validation Fund — a $300M consortium investment in validating bacterial biomarkers as regulatory-grade surrogate endpoints for clinical cure, enabling 18-month Phase III trials instead of 36-month.

Together, ADAPT-RX cuts average development time from 12 years to under 5, making the risk/reward calculus viable for mid-size biotechs and academic spin-outs — the most likely entrants to fill the pipeline gap.