Absentia Labs' AI 'Digital Liver' Becomes First AI Drug-Development Tool Accepted Into the FDA's ISTAND Program
Absentia Labs says its AI-driven Digital Liver Model is the first AI drug-development tool accepted into the FDA's ISTAND qualification pathway, at the Letter of Intent stage, to predict drug-induced liver injury.
Overview
Absentia Labs, a Boston biotech startup, said its AI-driven Digital Liver Model has become the first AI Drug Development Tool accepted into the U.S. Food and Drug Administration’s Innovative Science and Technology Approaches for New Drugs (ISTAND) qualification pathway, according to a company announcement carried by BioSpace. The model, which is designed to predict drug-induced liver injury (DILI), has been accepted at the Letter of Intent stage of the FDA’s three-stage ISTAND Drug Development Tool Qualification Program, the company said.
What We Know
- The tool is intended to flag liver-safety risks before a drug candidate reaches human testing. According to the FDA, as quoted in the announcement, DILI is “one of the most significant safety concerns in drug development and a leading cause of clinical trial termination and drug attrition during the Investigational New Drug process, yet current modeling does not accurately identify DILI risk in humans,” per BioSpace.
- Absentia said the prediction gap persists because human liver response varies widely based on metabolism, genetics, immune response, dose and exposure history, according to the announcement.
- The Digital Liver Model “addresses these complexities by combining mechanistic biology with AI trained on drug-response data, helping developers assess liver injury risk earlier and make more informed decisions before candidates advance into human trials,” the company said.
- Absentia framed the acceptance as a step toward regulatory recognition of “a new category of AI-based DDTs and New Approach Methodologies (NAMs) that improve the prediction of human safety and reduce reliance on animal testing,” BioSpace reported.
“Much of the conversation around AI in pharmaceuticals has focused on drug discovery and finding promising new molecules faster,” said Farhan Khodaee, PhD, CEO and co-founder of Absentia Labs, in the announcement. “We’re focused on drug development and the harder question: whether those discoveries are safe and effective enough to advance toward clinical trials at all.”
“Our goal is to make human biology more predictive, so drug developers can better understand how medicines may behave in the human body before patients are exposed to unnecessary risk,” Khodaee added, according to BioSpace.
The Company
Founded in Boston in 2024, Absentia Labs was co-founded by Farhan Khodaee, PhD; chief technology officer Rohola Zandie, PhD; and chief operating officer Robert Betancort, MBA, according to the announcement. The Digital Liver Model is the first application of the company’s broader AI platform, BioSpace reported.
What We Don’t Know
Acceptance at the Letter of Intent stage is the first step of the three-stage qualification program, and the model is not yet a fully qualified FDA drug-development tool, per BioSpace. The company’s announcement did not disclose clinical validation data or performance benchmarks for the model, and it did not detail the specific context of use for which the tool would ultimately be qualified.