In this episode, Niklas Anzinger sits down with Stephen Martin, U.S. Lead at Infinita and Operations Lead of the Montana Experimental Treatment Review Board (ETRB), to explore what could become a new model for biotech development and patient access in the United States.
Montana SB 535, is a new framework allowing eligible post-Phase 1 experimental treatments to reach patients under regulated oversight with special clinic licenses and an expert review board. Stephen explains why traditional Right-to-Try and expanded access programs have struggled to scale, and how Montana could change the economics by allowing biotechs to generate real-world evidence, treat patients, and create revenue earlier in the development process.
They discuss how the pathway works in practice, who qualifies, opportunities for biotech companies and physicians, the relationship between state and federal regulation, the FDA’s role, and whether Montana could ultimately provide a blueprint for accelerating drug development across the United States.
