We help biotechs navigate emerging clinical access pathways.
From Phase 1 Straight to Patients: The Montana SB535 Pathway
A casual meetup for biotech founders, clinicians, researchers and investors in Singapore.
Feel free to forward the invitation to peers.
Light snacks and drinks will be provided.
Most promising therapies clear Phase 1 and then wait years before a patient outside a trial can access them.
Biotech is stuck in a catch-22: small companies run out of runway before they can generate the evidence they need to reach patients.
But, Montana created another route.
In May 2025, Montana passed SB535, the first US law that authorizes state-licensed Experimental Treatment Centers to provide therapies that have completed Phase 1 to patients, under independent ethics and safety review.
In July 2026, the state adopted rules creating Experimental Treatment Review Boards (ETRBs). The first, the Montana ETRB, is now operational, with scientists and physicians including Matt Kaeberlein, Felipe Sierra, Jamie Justice, Jessica Flanigan and James Burke. It issued its first company review decision in July.
What this means for biotechs building in Asia:
A US route to reach patients after Phase 1, alongside your existing trials
Clinical evidence from treated patients
Patient access that doesn’t depend on trial funding alone
We’ll cover how the pathway works, which therapies qualify, and what it takes for a Singapore-based company to use it.
Agenda
4:00 - 4:30pm Walk-in & Networking
4:30 - 5:30pm The Montana SB535 Pathway + Q&A
5:30 - 6:00pm Open Networking
Who’s coming
Biotech founders and operators, clinicians, researchers and investors.
We help biotechs navigate emerging clinical access pathways.