This is making the rounds, and it's great - but we need to go much further to stay competitive with China: They key is to let states do it, the FDA just needs to create acceptance for state-led programs. - New Hampshire's HB1734 creates the option for private/non-profit/independent scientific review boards (like IRBs) to apply regulatory frameworks for phase-1s or equivalent (like Australia CTN). Federal rules would prohibit actual phase-1/INDs to be conducted this way, but if the FDA just issues guidance to accept such trials this would unleash state innovation. Everyone wins: the FDA already accepts Australia's trials, and this way those can just be brought into the US territory. By doing it through states, no federal law needs change. - Montana's SB 535 and New Hampshire HB 1734 allow for post-phase-1 "right-to-try 2.0" access. The key is that they're a) very broad, any patient qualifies instead of required proof they die in 6 months, and b) the provider has better monetization options. Again, we're already doing that: a) off-label drugs have just passed a phase-1 but not proven efficacy, b) right-to-try is federal policy and the moral case for patients is obvious. This creates a whole alternative pathway post-phase-1 that gives biotechs many more options to innovate. Montana & New Hampshire are creating oversight mechanisms that ensure safety but are administered more efficiently through scientific review boards (which again have oversight by state health departments, i.e. if there are bad actors their licenses can be revoked). Again, everyone wins: through these official state pathways there is less grey market for stem cell clinics and these programs could collect outcome data that improves official INDs for approval by the FDA. These state frameworks, including also e.g. Utah, Florida, Texas are genuinely innovative. @FDA @DrMakaryFDA need to create recognition for state frameworks, so there is clarity about federal-state legal conflicts - otherwise these programs will attract grey markets (larger, credible players need clarity). This is much simpler than federal-level changes, and unleashes decentralized regulatory innovation. @sytses @RuxandraTeslo @cremieuxrecueil @ATabarrok @dr4liberty @zachweinberg @patricksmalone @GraniteBio

🚨 Major boost for US biotech: @WhiteHouse backed @US_FDA proposal for an **optional risk-based Expedited IND pathway** — slashing Phase 1 timelines to first-in-human trials using validated preclinical data. Reduces duplicative requirements that drive longer/higher-burden US timelines vs. China/Australia (where early trials can be 50-60% cheaper & start in weeks, vs. US delays of months to a year). Saves significant time & money for smaller firms. #Biotech #FDA

To put it a different way, while I see the vision of a fully self-driving lab, even a human-driven lab with a meaningful autopilot (or even lane-following cruise control) mode would be enormously empowering to a wide range of scientists