Hi community!
September went by fast, and most of it happened in Montana.
Two foundations are now covering the license fee for the first clinics that join Montana’s experimental treatment pathway, and in October we’re taking the conversation to Billings and New York.
We also have two new podcast episodes on why healthcare is built the way it is, and what it could look like instead.
So follow along to learn more about ↓
$50,000 in Grants for Montana’s First Treatment Centers
Under Montana’s SB535, clinics and hospitals can become Experimental Treatment Centers (ETCs). That means they can offer patients treatments that have completed Phase 1 trials but aren’t FDA-approved yet.
To get licensed, a clinic has to pay a $10,000 application fee to the state. For a small clinic or community hospital, that may be a lot to pay before the program has proven itself.
So the Sijbrandij Foundation and the Musella Foundation are helping these biotechs to cover it. Together they committed $50,000 to pay the full fee for the first five approved clinics!
Are you a doctor or do you run a clinic? Write to stephen@infinita.co to apply.
How Does Montana’s Pathway Actually Work?
We get this question a lot, so we put together a 3-minute explainer.
What’s new in Montana is that all patients are eligible, not only the terminally ill, and biotechs can now charge for treatments instead of only covering costs. But it’s not a free-for-all. Every treatment follows the same path:
The treatment has to be eligible, which includes completing Phase 1.
An independent Experimental Treatment Review Board (ETRB) reviews the protocol, the safety evidence, and informed consent.
A clinic licensed by the state handles the actual care and monitoring.
The patient and their doctor make the final decision together.
Infinita helps biotechs through the process, the ETRB reviews independently, and the clinics take care of patients.
The Montana ETRB Issues Its First Guidance
Can a safety study conducted outside the U.S. qualify a treatment for Montana, even if it was never called “Phase 1”?
The Montana ETRB’s first Guidance Letter says yes. The Board will evaluate studies by their design, oversight, and safety evidence, not their label. A qualifying study needs systematic safety monitoring and appropriate oversight, but not randomization, placebo controls, proof of efficacy, or a minimum number of participants.
Highlights From This Month’s Podcast Episode
In Episode 117, John Cochrane, economist at Stanford and the Hoover Institution, joins Niklas to take apart the three arguments usually used to justify heavy regulation: that the poor need protection, that patients can’t make informed choices, and that nobody can shop around in a health crisis. His answer is that private certifiers, insurance, and competition could keep patients safe while giving them better options, the same way they already do in airlines and retail.
In Episode 116, cardiologist Dr. Anish Koka and neurosurgeon Dr. Anthony DiGiorgio, co-hosts of The Doctor’s Lounge, explain why the US system keeps favoring large hospitals over independent doctors. They get into rules like Stark Law, and Certificate of Need laws, which in more than 35 states require government approval to open a new facility. They also look at Montana’s rollback of Certificate of Need as a possible blueprint for other states.
And that’s all for September!
Before you go, here’s what’s coming up.
Your next best chance to meet us:
Montana SB535 for Biotech & Healthcare, Billings Meetup, Thursday, October 8, with Rep. Curtis Schomer. A casual evening on what SB535 means for Montana’s biotech and healthcare scene.
Biotech Federalism, Montana SB535 & Regulatory Entrepreneurship, Tuesday, October 20, with Bradley Tusk, Uber’s first political advisor.
Both require approval, so request your spot early!
Also worth your time:
Future Neuro Founders Program, October 9, 16, and 23. A free, virtual program by PsyMed Ventures and KdT Ventures for scientists ready to go from academia to building companies in neuro.
Must reads this month:
Follow along
See you in Billings or New York,
Nelsi ;)