Niklas Anzinger

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

You know @robinhanson’s idea of combining life insurance with healthcare to fix incentives?

Actually wouldn’t that fix legal too, and it’s much easier to do?

Combine legal liability insurance with legal services. Incentive to not need the lawyer or enter adversarial litigation.

The idea is free. Someone please do it.

This is such a pointed insight 💡

This theory seems wrong to me that what explains low spending for politics is explained by coordination problems

slatestarcodex.com/2019/09/18/too…

The reason is that concentrated interests exist, and they can overcome coordination problems because they receive large benefits

The reason is something different, and not discussed: you can't buy political outcomes.

There are laws in all but 6 US states, and at the federal level - you can't buy a political outcome (e.g. "pass this bill and I pay you a bonus")

This means DC politics works by hefty monthly retainers, and the lobbying firm budgets its political capital to keep the client engaged enough to not cancel them (continue giving hope, new angles etc.) - but not enough to actually succeed and reach the goal because you then you stop earning money.

You can't buy the product, you can only buy the typically empty hope of buying the product.

Curious about your take @slatestarcodex @DavidDFriedman @cremieuxrecueil

P.S.: doesn't that mean the 6 US states without limits should have more functioning markets? It's some evidence against the theory, but not conclusive because these states are small - so the value isn't high enough.

Infinita is proudly declaring its support for the "Faster Clinical Trials Act", a bipartisan bill introduced by Reps.
@JakeAuch (D-MA) and @RepMGriffith (R-VA).

Clinical trial reform at the federal level has suffered from a lack of ambition.

This is the first bill that I've seen that is not lacking ambition whatsoever.

"The bill also sets targets to reduce the cost per patient for the clinical trials conducted by these networks by 30 to 50 percent and speed participant enrollment in those trials by 30 percent."

The mechanisms how to reduce costs are a distillation best policy research that I've seen over the years, incl. by @IFP, @RuxandraTeslo, @sytses & many more

The things I am most excited about:

- Bringing evidence generation closer into the clinic; proving real-world effectiveness has been an afterthought in FDA approvals, leading to lack of safety & efficacy

- Streamlined trial site networks that can be accessed via a "multi-site, single-IRB", overcoming the IRB fragmentation that is a major source of delay in early research

- Governance sandboxes - critically, the bill does not make the mistake of trying to fix everything at once. Its mandate is to support sandboxes, innovative trial models

With this, the US has a real shot at retaining its competitive advantage in biotech, and could do right by millions of patients to access trials in the US instead of abroad.