FDA ISTAND program for new drug development tools
Drug development tools are methods, materials, or measures that have the potential to facilitate drug development. FDA established the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program in 2020 to encourage innovation of drug development tools that are out-of-scope for existing qualification programs but may still be useful for drug development. Approaches that could be considered under the pilot program include:
- Using microphysiological systems to assess safety or efficacy questions.
- Developing novel nonclinical pharmacology or toxicology assays.
- Using artificial intelligence-based algorithms to evaluate patients, develop novel endpoints, or inform study design.
In the pilot phase, FDA anticipates accepting two to four submissions into the ISTAND program each year with a triage and selection process that focuses on public health impact and feasibility of implementation. There were three projects accepted into ISTAND during 2022 and 2023, including one representing both the first artificial intelligence-based and digital health technology-based project and the first project in neuroscience to be accepted into the program. The Drug Development Tools Research Grant Cycle will be open through May 13, 2024 for Fiscal Year 2024, and through May 13, 2025 for Fiscal Year 2025.