for the next 18-24 mo., the biggest bottleneck in AI drug discovery is experimental validation and verification however it is increasingly clear that in 36 mo., the biggest bottleneck in AI drug discovery will be clinical trial scarcity the challenge with US clinical trial infrastructure goes far beyond simply regulatory reform in fact, outside of Australia, US FDA is the fastest in the world in getting INDs reviewed (30 day response time vs 60 in UK and Western Europe, and 60 working days in China) Yet, median time to site activation after trial regulatory approval for oncology trials is: US (academic oncology site) - 171 days (~6 mo) Australia Phase 1 - 63 days (~1.5 mo) China - as quick as 4 weeks It gets worse. Based on July 2026 analysis, US sites not only take median 124 days to get sites activated, it takes *another* 93 days to get FPI (first patient in). Australia sites can usually get from site activation to FPI in 2 weeks. To top it off, it takes *309 days* on average for US trials to get 75% of sites in a trial activated what's going on? the challenge is multifactorial - in the US, drawn out budget negotiations at every clinical site, significant overlapping local ethics and protocol reviews (esp at high profile academic research centers), and extensive site contract negotiations lead to months / quarters / years of delays. There is no magic bullet solution - no fell swoop of regulatory or policy change will address this - wholesale revamp is needed. simultaneously, US and western biotechs (and frontier labs) can't just wait around for systemic change to unfold. They need to play the game on the ground in order to establish a human data edge a new clinical execution paradigm + AI-native translational layer is sorely needed