Biotech Federalism, Montana SB535 & Regulatory Entrepreneurship w/ Special Guest Bradley Tusk

Every founder building in a regulated market eventually hits the same wall: the regulatory system was designed for a different era, and moving it takes more than better technology. It takes political and institutional strategy. Bradley Tusk has built a career solving exactly this problem. As Uber's first political advisor, he pioneered the playbook for how a tech company could overcome entrenched regulatory opposition city by city, state by state. He later founded Tusk Ventures, the first venture capital firm dedicated to startups operating in highly regulated industries, and authored The Fixer: My Adventures Saving Startups from Death by Politics. He will be joining us in NYC for a converdation about whether that same Uber playbook can be applied to biotech — alongside leaders of an emerging movement around "Biotech Federalism". Biotech is stuck in a catch-22: trial costs keep rising in line with Eroom's Law (doubling every 9 years), small biotechs run out of runway before generating the evidence FDA needs, and 90+% of patients are excluded from trials in the first place.

Federal reform is too slow. Biotech Federalism aims to prove a new model in states first, to then make federal reform easier. Montana SB535 is the first US law that authorizes state-licensed Experimental Treatment Centers to provide unapproved drugs (post-Phase-1) to patients with flexible payment arrangements, under state-regulated ethics oversight. Infinita formed and operates the first Experimental Treatment Review Board under the law. The first company review decision came down in July, coverage has run in The Information, MIT Tech Review  and elsewhere, and New Hampshire, and other states are drafting similar legislation.

State-level pathways like SB535 give AI-native biotech, cell and gene therapy, rare disease, and longevity companies a complementary route: bring treatments to patients now while generating real-world evidence to overcome the catch-22. The Tusk question: can we run the…