Montana Senate Bill 535: New Opportunities for Biopharma in Montana
Montana has taken a bold step to expand access to experimental treatments through the passage of Senate Bill 535 (SB535) in May 2025. This first-of-its-kind legislation builds on the state’s earlier right-to-try laws and creates an entirely new framework for licensed experimental treatment centers.
What SB535 Does
Allows healthcare providers, through licensed treatment centers, to administer experimental treatments that have successfully completed Phase I clinical trials but are not yet fully approved by the FDA.
Establishes a regulatory structure for experimental treatment centers, including licensing, provider eligibility, informed consent requirements, safety oversight, and reporting.
Requires centers to dedicate 2% of annual net profits toward improving access to experimental treatments for Montana residents.
Why It Matters
SB535 makes Montana the only state in the nation where firms can move more quickly from a successful Phase I trial into limited commercialization. This positions Montana as a highly attractive location for biopharma, biotherapeutics, and other life sciences companies that want to accelerate time-to-market while continuing the federal FDA approval process.
Implications for the Innovation Corridor Gateway
With SB535 in place, demand is expected to grow for high-quality facilities that can support experimental treatment activity. The planned Montana Innovation Corridor Gateway Phase One building will include a 20,000 SF GMP-ready floor — a flexible shell equipped with essential infrastructure for pilot manufacturing and commercialization.
By co-locating with complementary tenants such as contract research organizations (CROs), regulatory consultants, and professional service providers, biopharma firms entering Montana under SB535 will have access to a supportive ecosystem. The presence of the Montana World Trade Center (MWTC) on-site will also ensure global connectivity and catalytic programming.
Opportunity for Bio Firms
For companies in the biopharma space, SB535 represents a unique competitive advantage available only in Montana. The Gateway project, with its GMP-ready capacity and innovation ecosystem, is designed to make it easier for firms to establish a presence, launch pilot manufacturing, and connect to global markets.
Senate Bill 535: Revise laws related to experimental treatments | 2025 MTFP Capitol Tracker