ISTAND Pilot Expands Drug Development Tools
The FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) program is broadening the kinds of drug development tools (DDTs) it will formally qualify, accepting novel approaches that fall outside the agency's existing qualification pathways. Launched as a pilot in November 2020, ISTAND has accepted eight submissions, including three AI-based tools, two animal-free preclinical safety methods, two tissue-based methods, and one novel statistical approach, and has engaged technologies such as organ-on-a-chip models and digital health trackers. Citing that uptake, the FDA announced that ISTAND has transitioned from a pilot to a permanent DDT Qualification Program. For drug developers, a qualified tool can be reused across programs for a defined context of use, potentially speeding trials and regulatory decisions.
What ISTAND does
The FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) program offers a pathway to qualify novel drug development tools (DDTs) that do not fit the agency's existing qualification programs. DDTs are methods, materials, or measures used in drug development, and can include biomarkers (biological signals of a condition or disease) and clinical outcome assessments that capture how a patient feels, functions, or survives. Once a tool is qualified, developers can reuse it across drug programs for a defined context of use, such as a biomarker that identifies eligible patients for a clinical trial.
From pilot to permanent
The FDA launched ISTAND as a pilot in November 2020. According to an FDA Voices article from the Center for Drug Evaluation and Research (CDER), the agency has transitioned ISTAND from a pilot to a permanent DDT Qualification Program, citing the volume of submissions it attracted. The article was authored by ShaAvhree Buckman-Garner, Director of CDER's Office of Translational Sciences, and Mary Thanh Hai, Acting Director of CDER's Office of New Drugs. The permanent program keeps ISTAND focused on tools outside the FDA's other qualification pathways.
What has been qualified
Since its inception, ISTAND has accepted eight submissions: three AI-based tools, two tools that assess preclinical safety without using animals, two novel methods involving tissues, and one novel statistical approach, with the FDA now providing feedback on them. During the pilot, the program engaged with technologies including organ-on-a-chip models (devices that mimic the structure and function of a human organ), AI-enabled tools, digital health technologies such as a fitness tracker, and complex in vitro models. The FDA maintains a searchable database of DDT qualification projects across CDER and the Center for Biologics Evaluation and Research. The agency said the high number of acceptances during the pilot is what justified making the program permanent.
Why it matters
Making ISTAND permanent signals that the FDA intends to keep a standing door open for tools that previously had no qualification route. As a general industry pattern, a qualified DDT reduces duplicate validation work because multiple sponsors can rely on the same tool for the same context of use, which can shorten timelines and lower cost. The emphasis on AI-enabled tools and animal-free safety methods also reflects broader regulatory interest in modern, non-traditional evidence. These are structural effects; whether any specific tool advances still depends on FDA review against its safety and effectiveness standards. For patients, the stated aim is faster access to therapies that address unmet needs, though qualification is a means rather than a guarantee of approval.
How it fits FDA's wider push
The FDA frames ISTAND as complementary to other modernization efforts, including its Roadmap to reduce, replace, and refine animal testing, the Rare Disease Endpoint Advancement Pilot Program, Model-Informed Drug Development, Complex Innovative Trial Design, and the CDER Center for Clinical Trial Innovation. Tool developers can engage ISTAND for regulatory feedback and potential qualification, and the agency directs interested parties to the ISTAND webpage or to contact the program directly.
Key Points
- 1WHAT: The FDA's ISTAND program qualifies novel drug development tools that fall outside existing pathways, and has now become a permanent qualification program.
- 2WHY: ISTAND accepted eight submissions, including AI tools, animal-free safety methods, and organ-on-a-chip models, prompting the shift from pilot to permanent.
- 3SO WHAT: Qualified tools can be reused across drug programs for a set context of use, potentially speeding clinical trials and FDA decisions.
Scoring Rationale
A regulatory pilot to expand qualification pathways for drug development tools is notable for drug developers and regulatory science, with moderate relevance to AI/ML practitioners.
Sources
Public references used for this report.
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