Andrés Grases

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