Today, the U.S. Food and Drug Administration launched the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for developers of novel drug development tools (DDTs). This pilot creates a pathway for developers to submit proposals for novel approaches that do not have an existing regulatory path.
ISTAND encourages development of DDTs that fall outside of the existing DDT qualification programs: biomarkers, clinical outcome assessments, and animal models for use under the Animal Rule. ISTAND’s goal is to provide scientific and logistical support to DDT developers and to FDA’s clinical divisions for timely incorporation of novel technologies and scientific approaches in drug development and regulatory review, and ultimately, for accelerating new therapeutics to patients.
Key benefits of ISTAND program:
• Access to FDA feedback at an early stage of tool development – building developer’s and FDA’s confidence in emerging technologies for first time use under the DDT pathway;
• Potential for qualification under the DDT Qualification process, with the flexibility to offer other outcomes if qualification is not the best path; and
• New platforms to efficiently collaborate and share knowledge of new tools across FDA divisions and with external stakeholders including international regulatory bodies, creating more consensus and consistent views from the agency.
During the pilot phase, FDA anticipates accepting 2-4 applications into the ISTAND program each year through a triage and selection process focusing on impact to public health and possibility of implementation.