Founder & CEO of Infinita | Montana ETRB | Stranded Technologies Podcast
Montana & Roatan
Joined July 2009
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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
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.
Niklas Anzinger retweeted
Despite staggering advances in basic science, drug development research is only getting slower. The main culprit? Increasing clinical trial timelines. The median clinical development pathway has increased from 8.4 years to 9.3 years and pipeline creation has slowed 32% even as R&D spend has gone up.
This is the point I keep making about the main bottleneck to drug discovery and why AI on its own won't be enough. These timelines aren't going anywhere (ofc AI can be used creatively to ease such bottlenecks -- eg via better endpoints that allow smaller cohorts for trials, followed up for shorter periods of time).
Niklas Anzinger retweeted
26 boxes of cancer pills. Carried home from Shanghai.
Debbie Doppelt, 60, had lung cancer with 10 tiny tumours in her brain. The drug that could help, sunvozertinib, is made by Dizal in Shanghai.
Approved in China in 2023.
FDA approval July 2025.
Still not on sale in the US as of mid October.
So her son Max flew to China and bought a supply for about $10,000.
One doctor told the family: "Too bad she's not Chinese ... She could go to a pharmacy in China and buy it."
At least 30 Americans have made similar trips, KFF Health News reports. China accounted for up to 46% of new drugs tested worldwide last year.
Honestly I find this one hard to read. Western media still frames Chinese biotech as a "threat". Patients see it differently, they just need the medicine.
Niklas Anzinger retweeted
The FDA APPROVED this lung cancer pill in July 2025.
You couldn't buy it in America until THIS WEEK.
Not a safety issue. Not a science issue. The drugmaker just had no US sales setup. So an approved cancer drug sat in limbo for 15 MONTHS while the business side figured out who gets to sell it.
Meanwhile this woman's cancer was metastasizing in her brain.
So her son said screw it, flew to Shanghai, and came home with 26 boxes of cancer pills in his luggage.
I take a targeted lung cancer pill every day. If mine was stuck in paperwork hell, I'd be on the next flight too.
Would you fly? Or wait politely for the paperwork?
26 boxes of cancer pills. Carried home from Shanghai.
Debbie Doppelt, 60, had lung cancer with 10 tiny tumours in her brain. The drug that could help, sunvozertinib, is made by Dizal in Shanghai.
Approved in China in 2023.
FDA approval July 2025.
Still not on sale in the US as of mid October.
So her son Max flew to China and bought a supply for about $10,000.
One doctor told the family: "Too bad she's not Chinese ... She could go to a pharmacy in China and buy it."
At least 30 Americans have made similar trips, KFF Health News reports. China accounted for up to 46% of new drugs tested worldwide last year.
Honestly I find this one hard to read. Western media still frames Chinese biotech as a "threat". Patients see it differently, they just need the medicine.
Niklas Anzinger retweeted
PopVax's first vaccine entered a Phase I clinical trial on August 31. We're following this up with an ambitious pipeline of vaccines (HCV, TB, Strep A, rabies) and cancer therapeutics (liver & pancreatic cancer). Come help us develop new medicines to save 1 million lives each year! Here are some key open positions:
Principal Scientist - Analytical Method Development (jobs.popvax.com/30208) and Senior Scientist - HPLC Method Development (jobs.popvax.com/41508): We design millions of new molecules – proteins, RNA, LNPs, and more. Your job is to figure out how to characterize them at high-throughput without sacrificing rigour, repeatability, and robustness, as well as to help make those methods GMP-grade as part of the handover to QC. We intend to take new medicines into clinical trials in weeks, not years, so we need to build adaptable analytical platforms, not bespoke methods that work for only one molecule. We strongly prefer candidates with the ability to write code to build automated data analysis pipelines for their methods – LLM-generated code is fine as long as you are able to comprehensively validate the logic and output of the pipelines.
Head of Quality Control (jobs.popvax.com/41525) – We manufacture our own clinical doses at the RNA Foundry, and every analytical method we develop for a new molecule eventually has to become a validated QC method. You’ll lead the team that tests every batch to international GMP standards, take on method transfers from analytical development, and build a QC function that can keep pace with a pipeline aiming to reach the clinic in weeks, not years.
Junior Scientist - Vaccine Immunology (jobs.popvax.com/37003) – Our vaccine programs halt or advance on the immunogenicity data that comes back from animal and organoid studies. You’ll run the assays that produce that data – ELISAs, pseudovirus neutralization, and bacterial growth-inhibition assays – and coordinate animal studies with our internal teams and CROs, following each study from plan to samples to result. We prefer candidates who can write code for routine data analysis.
Head of Legal (jobs.popvax.com/41524) – Our first vaccine was manufactured in India, was filled into vials in the US, and has now entered a clinical trial in Australia. We work with dozens of counterparties – funders, governments, universities, CROs, and suppliers – with more added each week. You’ll own the day-to-day of our Indian legal work, from contracts to compliance to labour law, work with the legal teams supporting our UK and Australian operations, and make sure paperwork is never the bottleneck between our new medicines and the clinic.
Chief of Staff to the Chief Science Officer: Our CSO needs a partner who can take experimental planning and coordination off his plate so that he can spend more time thinking hard about our thorniest problems. You will turn complex scientific hypotheses into clear executable plans, coordinate with scientists to see each experiment through, and analyze the data to help plan the next round of iteration. You’ll need a strong scientific background, a sharp eye for detail, and boundless energy to keep ambitious scientific work moving. To apply, email dhruv [at] popvax [dot] com with a human-written explanation of why you’re the best person for the job.
If none of these are a good fit, take a look popvax.com/jobs or email us at work [at] popvax [dot] com.
On August 31, the first two participants were injected with @PopVaxIndia’s first fridge-stable RNA vaccine candidate in a Phase I clinical trial in Australia. We built this vaccine at our RNA Foundry in Hyderabad – from computational design to GMP manufacturing. Here's how:
Niklas Anzinger retweeted
🚨 Can we predict clinical trial success?
Introducing inClinico Agent by Insilico Medicine. 🧬
⚡ Months of analysis → minutes
🧠 100,000+ clinical trials
🎯 AI-powered outcome predictions
Clinical development is going agentic. 🧵
Niklas Anzinger retweeted
Phase 1: We gave it to like 20 healthy people and they didn't die. Can't really be compelling.
Phase 2: We gave it to like 100 people with the disease and it looked like it did something. That can be compelling and after that is when the funding and acquisition talks start happening.
But Phase 2 costs $10M and 3 years of background run rate for the company that eats up another $30M, with a 30% chance the results are compelling enough to attract more more capital or an acquisition that will allow phase 3 to happen.
Having 10 or 20 patients who got it in Montana and showed any positive benefit would massively derisk phase 2.
Niklas Anzinger retweeted
Cool new report from @CatoInstitute with an updated methodology on freedom for US states. Only two states get an overall "A" grade: Arizona and Montana (both gets A's in personal freedom, B's in econ freedom)
Only governor with an "A" grade overall: @GovGianforte!
My latest for @PostOpinions is a first look at the new & improved "Freedom in the 50 States" report from @CatoInstitute, discussing how common partisan breakdowns of economic & personal freedom in the US are mostly wrong:
wapo.st/4igStdq (🎁)
Niklas Anzinger retweeted
Biotech is a venture market unlike any other.
The acquisition as the primary endpoint of building a company - unusual, in other tech long founder duration is encouraged, and not selling too early if at all.
Boards have much more power over the founder than in other markets, reducing the ability of founders to pursue less popular pathways to success.
And most importantly: biotechs are mostly a pure R&D effort.
In almost all other industries (except some highly specific deeptech), you interact with customers on a daily basis. Not so in biotech.
This unfortunately means biotech is not built around the ultimate beneficiary: the patient. The customers it's built for are the regulator and the acquirer.
Niklas Anzinger retweeted
I don't know if @CaribouBio is a case in point, but if "Eroom's Law" is doubling the cost of drug approval every 9 years then of course promising drug programs get abandoned because the funding dries up.
Funding dries up because the returns are bad.
Credit: @cremieuxrecueil
Niklas Anzinger retweeted
A watershed for FDA regulation. Every patient on the vaccine arm got a different product, with neoantigens chosen from sequencing of each person's own tumor. So FDA had no single active sequence to review. The IND pre-specified how the product would change for each patient.
#ESMO26 embargo lifted following breach.
Detailed data confirm Moderna $MRNA and Merck $MRK cancer vaccine met key endpoints in melanoma trial
Personalized mRNA therapy reduced disease recurrence by 42% compared to standard treatment
statnews.com/2026/10/22/esmo…
Niklas Anzinger retweeted
1Day Sooner supports the "Faster Clinical Trials Act," which you can read more about here: cnbc.com/2026/10/22/bipartis…
The 🧵 below explains what we hope this bill can accomplish!
Niklas Anzinger retweeted
PSA for biotech entrepreneurs:
Do not take FDA feedback as gospel. Cross-check it against FDA guidance documents and regulations. If you find inconsistencies, ask the FDA for clarification, citing the relevant guidance documents and regulations.
Quite often, FDA review teams, especially more junior reviewers, are not fully familiar with the agency's own regulations and guidance documents.
Niklas Anzinger retweeted
I was wrong. AI will be curing lots of diseases and way sooner than I thought.
Here’s where I blew it: I was thinking about AI curing disease the way we’ve always thought of cures. Use this treatment and the disease is permanently controlled.
But @Preventive_Onc pointed out a better way to think about it.
Apply escape velocity to disease, not just aging.
If you haven’t heard of escape velocity: we just have to make longevity progress fast enough that each year’s breakthroughs extend lifespan by 366 days.
Applied to disease, we just have to control it long enough that when the treatment stops working or the side effects show up, the next thing is ready to switch to.
So the bottleneck isn’t a human lifespan anymore.
It’s whether the next treatment is ready before the current one wears out.
That’s not an intelligence problem. It’s a regulatory problem.
And @NiklasAnzinger and Montana have already solved it, as long as the FDA doesn't block it.
Disease escape velocity.
You heard it here first.
Another way to explain why AI won’t be curing all disease soon is that it doesn’t remove the bottleneck.
No, it’s not that it won’t be smart enough. Hell, it’s smart enough now, let alone in a year or 5 years.
But no matter how smart it is, it just moves the bottleneck downstream.
The perfect virtual cell and virtual tissue and virtual human will generate hypotheses, insanely good hypotheses that we’d never come up with on our own.
Then AI will design the experiments to validate the hypotheses and run them in parallel and that’ll get us incredible drugs.
But once we have the drugs we won’t know if they’re cures until we give them to real, live humans and watch them for the rest of their lives.
So amazing treatments, which we already have, are going to start dropping faster than Millennium Prize problems.
(I actually heard Anthropic is dropping 816 drug candidates the weekend before their IPO, BTW. You heard it here first.)
But the point is that you can check a math proof by reading it.
To check a cure you have to observe lots of humans for their entire lives.
So how long does it take to find out if a treatment is a cure?
An entire human lifespan.
That’s the bottleneck.
@AlexanderKalian
Niklas Anzinger retweeted
Last month, we demonstrated high-rate alchemy: turning mercury into real, stable gold, beating CERN’s record by a factor of 10.
Last week, we enriched isotopes in the world’s most powerful plasma centrifuge, beating the Soviet record that stood for 40 years.
Now, we’re building a fusion reactor in San Francisco to achieve record power density.