Founder & CEO of Infinita | Montana ETRB | Stranded Technologies Podcast
Montana & Roatan
Joined July 2009
- Tweets8.7K
- Following6.4K
- Followers6.1K
- Likes8.6K
Pinned Tweet
Announcing Montana ETRB
Montana opens up for biotech acceleration.
Infinita has formed the first-ever ETRB (experimental treatment review board) under Montana law.
The review board’s role is oversight for access to treatments before FDA approval.
For a $12.5k fee, you can submit a post-phase-1 therapy to our review board (submission link below).
What is a Montana ETRB?
Montana’s model is a major regulatory innovation. National regulators typically review treatments one by one, which causes years-long bottlenecks.
In Montana, registered ETRBs do treatment reviews, licensed specialized clinics (ETCs) provide treatments. The state receives reporting and can take away licenses.
That’s smart regulation. Competitive, efficient, with oversight. That’s what American biotech needs.
First Montana ETRB Members
We are honored to welcome highly esteemed scientists, physicians and bioethicists on the first Montana ETRB:
- Matt Kaeberlein, PhD (@mkaeberlein) - a biologist internationally recognized for research on the basic mechanisms of aging and translational interventions to extend healthspan
- Felipe Sierra, PhD - a biochemist that served as Director of the Division of Aging Biology, NIA/NIH, where he developed the concept of Geroscience.
- Jessica Flanigan, PhD - a bioethicist who is is the Richard L. Morrill Chair in Ethics and Democratic Values at the University of Richmond, where she teaches leadership and healthcare ethics
- Jamie Justice, PhD (@j_n_justice) - is Executive Vice President of the Health Domain at XPRIZE and Executive Director of the XPRIZE Healthspan Prize
- James M. Burke, MD - is a hematologist and oncologist with more than three decades of experience in cancer drug development and patient care
Each review submitted will have to pass their judgement on adequate safety characterization.
What will the ETRB look for?
An ETRB’s legal mandate is safety-only.
Risks need to be disclosed to patients for informed consent properly, and treatments need to have a safety profile equivalent to a successful phase-1 trial.
After that it’s up to the doctor and patient to decide.
ETRB will compete for reputation.
They are free to approve or not approve according to their assessment. If they wanted, they could even ask for efficacy data as a basis for approval.
Our Montana ETRB has a set of governance principles that guide its decisions beyond the legally required minimum floor, as a guide for its decisionsmaking.
Congratulations to Montana
Thanks to the leadership of Sen. Kenneth Bogner (@KennethBogner), Montana now has the most forward looking medical access law in the country in SB 535.
Montana’s department of health and human services (DPHHS) provided a tight and comprehensive set of rules for clinic licenses and review boards.
Montana is becoming a biotech frontier.
Towards Clinical Trial Abundance
The FDA has led the world for decades, gating the largest and most innovative biopharma market in the world. But the US’ competitive advantage is evaporating. Regulators in Australia and China have made clinical trials far more cost- and time-competitive. Patients are going to offshore clinics in Mexico and the Caribbean. High-agency patients like Sid Sijbrandij (@sytses) take matters into their own hands, and use multiple available jurisdictions.
The FDA needs to modernize, and lots of federal efforts to this end are underway. We support federal reforms, however these efforts often fall short or are slow.
Let US states innovate. The states can be as a source of regulatory innovation. In states important learnings can take place, and inform better federal policy.
Montana is leading the charge in biotech. New Hampshire is following suit. Utah, Texas and Florida have opened up to stem cells and many states are improving conditions for individualized treatments.
FDA / HHS should give explicit safe harbor to such responsible state medical access programs, to encourage a regulated market forming vs. gray markets.
How to Get Involved
We’re looking for state and federal policymakers to advance this regulatory innovation, clinicians to be the patient-facing stewards for responsible access, scientific reviewers to partake in ETRB oversight, biotechs to provide their novel treatments to these programs to collect valuable data, and ultimately for patients to benefit from potentially life-saving access.
Get in touch! Mine and @righttotryguys DMs are open
Niklas Anzinger retweeted
The Montana Experimental Treatment Review Board (ETRB) held its monthly meeting and reviewed two submissions under SB 535. The Board issued two Review Decision Letters:
• RDL-2026-002: WinSanTor, Inc., WST-057 (topical pirenzepine 4%). Approved with conditions.
• RDL-2026-003: MuseCell Innovations Pte. Ltd., Dezawa MuseCells (allogeneic cell therapy). Deferred pending additional information. This is not a disapproval.
All Review Decision Letters issued by the Board are now available in a public repository ↓
Niklas Anzinger retweeted
I'm happy to announce that in October the ETRB reviewed two treatments, and approved @WinSanTor's topical pirenzepine for peripheral neuropathy!
Now that we've got two treatments approved for use in Montana, the last step is to get an ETC (experimental treatment center) up and running. We are hoping to be able to announce this late November or early December!
The Montana Experimental Treatment Review Board (ETRB) held its monthly meeting and reviewed two submissions under SB 535. The Board issued two Review Decision Letters:
• RDL-2026-002: WinSanTor, Inc., WST-057 (topical pirenzepine 4%). Approved with conditions.
• RDL-2026-003: MuseCell Innovations Pte. Ltd., Dezawa MuseCells (allogeneic cell therapy). Deferred pending additional information. This is not a disapproval.
All Review Decision Letters issued by the Board are now available in a public repository ↓
This is such a testament to the culture in medicine.
What would that paper even talk about? Just pre-meditate what will happen? Artificial lab conditions?
I'm all for scientific rigor, but real data is generated in-market.
Deploy, disclose risks, and open up to third-party monitoring.
Niklas Anzinger retweeted
Hosting a private dinner with the @CellinoBio team this Friday in West Palm
@nabihasaklayen & I are bringing together some brilliant minds to chat about where medical science is headed, from regenerative medicine & cellular therapies to the breakthroughs that will change how we live & age \
Good food, good company, good chats
Event link in comments xx
Niklas Anzinger retweeted
A biologist in Ohio is living with a rare form of cystic fibrosis. His particular mutation is not amenable to existing drugs for the disease.
And that’s why, for the last 10+ years, he has been trying to make a gene therapy to cure it. New essay today in @AsimovPress.
Most people living with cystic fibrosis still make copies of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. These proteins are often defective, but modern drugs can help them fold or function properly.
And these drugs have been enormously successful. For decades, treatments like antibiotics and mechanical vibration vests have helped clear bacteria from the airways and raise life expectancy for people with cystic fibrosis from about 10 years to 40. Newer drugs that restore CFTR function have pushed life expectancy even higher; many patients today can live relatively normal lives.
But about 5–10% of people with cystic fibrosis have mutations that prevent them from making essentially any CFTR protein at all. These are often called nonsense or frameshift mutations. And because these patients don't make the protein, the existing CFTR-modulating drugs have nothing to act upon.
@jacobwitten1, the author of today's essay, is one of these patients. His laboratory at Case Western Reserve University is developing lipid nanoparticles that can deliver RNA into lung cells, with the ultimate goal of restoring CFTR function. These particles could carry RNA strands encoding the missing protein, or gene-editing tools that fix the mutation directly.
This is a deeply personal essay about the last 30 years of cystic fibrosis research, the extraordinary difficulty of delivering gene therapies into the lungs, and what it’s like to try to cure your own disease. We’re extremely honored that Jacob decided to write this! The piece is charming and irreverent and, I think, a reflection of his personality.
press.asimov.com/articles/cy…
Niklas Anzinger retweeted
Practicing physician here. Have thought about this a lot and would to love to hear how we end up in such different spots.
I'm a dermatologist, I do a lot of teaching to other dermatologists and consulting for pharma. Was in charge of teaching dermatology at The Ohio State University for 10 years. My specialty is figuring out the diagnosis on cases other dermatologists haven't been able to figure out. Been doing it for 20 years.
Until about a year ago, AI was completely useless for me professionally.
Then I saw a commercial for @doctronic, thought it sounded like such a cheesy name that it might a parity, but obviously would be terrible. So I went to their website to get a laugh, maybe something I could joke about on my podcast.
Chatbot interface. Great, I'll pretend to be a patient, show it what it's really like - that the patients don't read the textbook.
I pick a diagnosis. My area of expertise, adult onset atopic dermatitis, that is very similar to several other forms of dermatitis that are difficult to tell apart. Pretend to be a patient and give vague, incomplete, misleading answers.
Damn thing gives me a perfect differential diagnosis and plan.
Holy fuck.
I try it with a bunch of esoteric dermatologic diseases - autoimmune, malignant, infectious - pretend to be a real patient, give vague and incomplete answers.
Time after time it gives differential diagnoses and plans that I'd have been satisfied with from someone who just finished residency.
I have other academic derm friends try it. Same goal - pretending to be a real patient seeing how it does.
Same result as me - gets it about as right as you'd expect from a graduating resident.
This thing can do IT. I'm pretending to be the most challenging patients I see, the poor historians, answering the way I believe they'd answer. And it gets the right answer.
Have spent the last year building harnesses via project instructions, doing lots of pushing to see where Claude's limits are. It was good in early 2026 and has gotten dramatically better by late 2027.
In all honesty, given the choice between a Claude Ultra subscription with some instructions on how to use it and a reasonable harness to start vs. having to get answers from the traditional healthcare system through normal channels - making appointments, calling and messaging normal offices, etc?
I'd recommend the vast majority of people go with Claude. Sure, it's going to make some mistakes, but it'll be fewer mistakes that are more likely to be caught and rectified than will happen in the existing system.
That's why I think AI should be given prescribing authority now. Establish the equivalent of board certification and systems that can meet the requirements for that certification can prescribe and write orders like a human doctor doing telemedicine visits.
Build in oversight, of course: some percentage of cases get randomly selected for review by humans, all cases are reviewed by multiple adversarial AIs based on different lab's frontier models and if the AIs can't agree on a plan, they escalate to a human.
Niklas Anzinger retweeted
Stage 4 lung cancer used to mean a countdown to death.
Now there are 40+ clinical trials for ALK alone, a mutation in ~5% of lung cancers.
Fuck you, cancer. We're not done. Not me, not the thousands of us still fighting!
Niklas Anzinger retweeted
Every parent wants a happy child. So we built MDD-PGT, the first genetic predictor of depression for embryo screening.
Kids with a lower MDD-PGT tend to sleep better, fight less and enjoy jokes more. With 10 embryos, picking the lowest-risk one cuts depression risk by over 40%.
Niklas Anzinger retweeted
Can confirm from the patient side. Designing a personalized vaccine for my own tumor turned out to be the doable part. Manufacturing, sign-offs and paying for it are the real wall, and that's exactly where the next wave of builders should be looking.
nitter.cf/kevinace/status/211047…
Niklas Anzinger retweeted
The n-of-1 biotech era has arrived.
With @FDA’s rare disease framework, n=1 patient receiving a custom medicine?
With AI + @Prof_Oak_, n=1 employee?
n-of-1 can mean your target patient population or your entire org chart.
Niklas Anzinger retweeted
How much does the world actually spend on science?
1. US government research funding: ~$99 billion
In FY2024, federal agencies obligated about $47.5B for basic research and $51B for applied research. That's the pool most scientists mean when they say "grants": NIH, NSF, DOE, NASA and others.
2. Add philanthropy: ~$126 billion
Foundations and donors add about $27B on top of federal grants, supporting research at US universities and nonprofit institutes in 2024. That's roughly a fifth of all support for that work.
3. All US R&D: ~$1 trillion
Total US R&D hit $937B in 2023 and an estimated $993B in 2024. Most of it is industry funding product development. Government research and philanthropy together make up only about one-eighth of the total.
4. Global R&D: ~$3.8 trillion
The world spent an estimated $3.8T on R&D in 2024. The US and China each crossed $1T
What this means
The money that funds open, curiosity-driven science is a fraction of total R&D, and it flows through slow, centralized channels. Even modest improvements in how that ~$126B is allocated would compound across every field.
That $126B is the segment ResearchHub is currently starting with. Moving just 1% of it, about $1.3B a year, through preregistered proposals with incentivized peer review would change how a meaningful share of American science gets funded, reviewed, and shared.
Listen to the man open.spotify.com/episode/1I9…
Niklas Anzinger retweeted
Having started a biotech co in the past two years, the recent Mithril Medicine news felt pretty unsurprising.
When people ask me what surprised me most about being a biotech founder, I always say that I dramatically overestimated the number of people I would need to hire. AI has been transformational here, but so has the excessive build-out of CRO capabilities in the COVID ZIRP era making CRO prices dramatically cheaper than they would be otherwise. Operations, chemistry, tox, and most preclinical work can all be outsourced for 20-60% of the price of building the same capabilities in house. The core platform still needs hands-on internal work, but if you're building a very traditional asset-flip biotech startup, then there is no core platform to begin with.
There is some sacrifice in terms of speed over the long-term, but the combo of AI+automation+CROs suddenly allows biotech startups to create value on previously-challenging VC fund timelines. My prediction is that a biotech startup model consisting of a tiny team of 1-5 people is going to become fairly standard in the near-term future.
Niklas Anzinger retweeted
Every treatment the Montana Experimental Treatment Review Board approves must generate evidence on its safety and outcomes.
The Board’s Guidance on Continuing Evidence Generation requires each submission to include a framework for collecting, reviewing, and reporting safety and outcome data while the treatment is offered.
The requirement scales with existing oversight. Treatments under an active FDA IND or IDE, or an equivalent WHO Listed Authority approval, generally meet it through existing reporting. Others require IRB-reviewed research or an ETRB-approved monitoring framework.
The Board will not approve products under an FDA clinical hold, withdrawn for safety reasons, or shown in well-controlled trials to lack meaningful benefit or cause net harm.
Niklas Anzinger retweeted
That's Tullock's Paradox:
There's so much money to be gained through politics, yet firms spend comparatively little on it.
It's mysterious why there's *so little* money in politics.
Niklas Anzinger retweeted
The most underrated AI health feature right now is ChatGPT's Health connector.
Not the dashboard. The dashboard is whatever.
The magic is that it's connected to my actual medical records. So when I ask about a new medication, it already knows I have high cholesterol and works that into the answer. Ask about a scan, it pulls the actual report. Ask about an appointment, it knows which one. Want to map my BP trends against a med change? EZ PZ
No re-explaining my history every chat. No copy-pasting lab results.
I know the reflex is "never give AI your medical records." I think that's backwards. My records are already sitting in a dozen portals and insurance databases. The only one not using them to help me was me.
If you're managing a chronic illness, connect your records and ask it something hard.
Niklas Anzinger retweeted
Fascinated to see if drugs developed this way successfully make the mouse-to-human jump more often.
Top drug hunters running multiple programs in parallel, with real cross-pollination, should push a LOT of candidates into phase 1 and 2.
That'll be great for clinical trialists like me. But we'll be the bottleneck - existing trial infrastructure can't absorb that many candidates and buildout is slow, so we'll need a filter for what goes into phase 2.
I could see Montana's ETRB (@NiklasAnzinger) playing that role - finish phase 1, then get an early human efficacy signal without the 3 years and $50M a phase 2 takes.
Niklas Anzinger retweeted
Unpopular opinion: the hardest part of cancer isn't the cancer. It's the unpaid admin job the healthcare system hands you.
Here's all the shit I did across 27 months so far:
64 "please fill out your history" questionnaires
80 calls just to get pills delivered
150+ appointments and calls
79 days in a waiting room
23 CT, MRI and PET scans
209 scheduling messages
5 radiation treatments
34 full blood panels
5,500+ cancer pills
1,360 lab results
1 thoracentesis
2 biopsies
The phone trees, the endless redundant forms, the reschedules and the "we never received that order" are what grind you down.
And I'm someone who's good at this stuff. Imagine doing it sick, alone, or without the time.
If someone you love is in treatment, "let me know if you need anything" is nice. "I'll make the pharmacy call this week" is better.
