Early Clinical Access

Bridging the Gap
from Biotech to Clinic.

Infinita helps biotechs navigate emerging clinical access pathways.
Supporting clinical access through Montana's SB535 Experimental Treatment Center Law and other emerging pathways.
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Emerging clinical access pathways are creating new routes from breakthrough science to patient care.
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Infinita helps treatment developers navigate those pathways responsibly.
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Explore Options
Every treatment is different.
Explore the pathway that's right for yours.
The Bottleneck


Promising Therapies Get Stuck.

+68%

of Phase 1 therapies fail for commercial,
not scientific reasons.
The Consequence

Patients Die While Waiting.

~0.02%

of eligible patients gain access
to experimental treatments.
Toward Clinical Trial Abundance.
02 Pathways

Clinical Early
Access Pathways.

Navigate, and implement clinical early access strategies across emerging pathways.
Infinita helps biotechs evaluate, navigate, and implement clinical early access strategies across emerging pathways.


Right-to-try, compassionate use / expanded access, special jurisdictions are real options for clinical access

Montana

New Hampshire

Prospera

Montana, US.

Pathway Overview.

Montana established one of the first state-level frameworks allowing eligible patients to access certain experimental treatments following early safety evidence and independent expert review.

Technical Profile.

LOCATION:
Montana, US.
STATUS:
Live.
FRAMEWORK:
SB535.
ACCESS:
Early Clinical Access.
APPLICABILITY:
Pre- and post-Phase 1 therapies.
03 Featured Pathway

Montana SB535.

A pathway for eligible post-Phase 1 experimental treatments.

01—

Independent Review.

Treatment submissions are independently reviewed by the Montana ETRB under the requirements of SB535.

02—

Clinical Administration.

Connect with participating clinics and physicians prepared to administer eligible treatments within Montana's framework.

03—

Evidence Generation.

Coordinat, manufacturing logistics, and clinical outcomes data collection throughout the access program.
03 Featured Pathway

Montana ETRB.

Independent scientific and ethical review under the requirements of SB535.