The ETRB reviews investigational treatment submissions under Montana SB535 from biotechnology companies, treatment sponsors, and clinical partners. The board evaluates submitted safety data, treatment protocols, and supporting materials for compliance with applicable Montana requirements.
Evaluate Safety & Monitoring Protocols
The ETRB evaluates whether submitted protocols include appropriate safety monitoring, informed consent materials, adverse event procedures, and operational safeguards. Review focuses on safety standards, disclosure practices, and patient protections associated with investigational treatment use.
Support Structured Clinical Access
The ETRB provides a structured review pathway for investigational treatments that have completed Phase 1 clinical trials or equivalent safety studies. The board operates through independent expert review and documented submission procedures under Montana law.
2 — Administrative Screening Applications are reviewed for completeness, eligibility requirements, and required supporting documentation under Montana SB535.
3 — Expert Review ETRB members evaluate:safety evidencemonitoring planstreatment protocolsinformed consent procedurespharmacovigilance plansmanufacturing and quality documentation
4 — Determination Sponsors receive a formal determination along with any required conditions, clarifications, or additional documentation requests.
Matt Kaeberlein, PhD, is a biologist focused on the biology of aging and translational longevity science. He is co-founder of the Dog Aging Project and founding director of the University of Washington Healthy Aging and Longevity Research Institute.
Jessica Flanigan is the Richard L. Morrill Chair in Ethics and Democratic Values at the University of Richmond. Her work focuses on medical ethics, patient autonomy, and public policy.
Jamie Justice, PhD, is Executive Vice President of Health at XPRIZE and Executive Director of the XPRIZE Healthspan Prize. Her research focuses on aging biology, clinical trials, and gerotherapeutic interventions.
James M. Burke, MD, is a Montana-based medical oncologist with more than 30 years of clinical and biotechnology experience, including leadership roles in immuno-oncology and experimental therapeutics.
Felipe Sierra, PhD, is a scientist focused on the biology of aging and translational geroscience, with extensive leadership experience in aging research initiatives.
Required Materials Applicants may be asked to provide: • Phase 1 clinical trial data or equivalent safety evidence • Treatment overview and mechanism of action • Proposed treatment protocol • Safety monitoring and adverse event procedures • Draft informed consent materials • Manufacturing and quality documentation • Regulatory status information • Sponsor and contact information
An Experimental Treatment Review Board (ETRB) is an independent review body authorized under Montana SB535 to evaluate investigational treatment submissions and associated safety protocols.
Does the ETRB provide medical treatment directly?
No. The ETRB does not administer treatments or provide patient care directly. Treatment administration occurs through participating clinical providers and facilities.
What does the ETRB evaluate?
The ETRB evaluates submitted safety evidence, treatment protocols, informed consent procedures, monitoring plans, and related materials under applicable Montana law.
Are all submissions approved?
No. Applications are evaluated individually based on submitted materials, safety information, protocol quality, and compliance with applicable requirements.
Who can submit a treatment?
Biotechnology companies, treatment sponsors, and authorized partners with investigational treatments that have completed Phase 1 clinical trials or equivalent safety studies may apply for review.
Does ETRB review constitute FDA approval?
No. Investigational treatments reviewed by the ETRB are not approved by the U.S. Food and Drug Administration for general use unless separately authorized by the FDA.
What materials are required for submission?
Submission materials generally include safety evidence, treatment protocols, informed consent materials, manufacturing information, and sponsor documentation. Additional materials may be requested during review.
steve@infinita.city, niklas@infinita.city Infinita City, Inc. (a Delaware Corporation) 251 Little Falls Drive, Wilmington, DE, 19808 Operating under applicable Montana law including SB535. Investigational treatment review activities conducted pursuant to applicable Montana law.
The ETRB does not provide medical advice or direct patient care. Review determinations do not constitute approval by the U.S. Food and Drug Administration.
