CDER And CBER Accept First Submission To ISTAND Pilot Program

FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have accepted the agency’s first submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program.

FDA launched ISTAND in 2020 to support development of drug development tools (DDTs) that are considered novel to be used in regulatory applications for new medical products.

DDTs are methods, materials or measures that can facilitate drug development. Certain DDTs, such as biomarkers and clinical outcome assessments, have clearly established pathways for evaluation and application. ISTAND opens additional opportunities for unconventional approaches to be reviewed and accepted by FDA. If qualified, these tools can help optimize drug development and evaluation, potentially expediting the availability of safe and effective drug and biologic products.

ISTAND’s first accepted Letter of Intent (LOI) submission is for a tool that proposes to evaluate off-target protein binding for a variety of biotherapeutic modalities, potentially reducing or eliminating the need to conduct some of the more standard nonclinical toxicology tests. The tool’s developers hope it will improve the accuracy, sensitivity and overall utility of specificity testing of biotherapeutics to support investigational new drug applications.

The LOI acceptance is the first step of the three-step qualification process in the DDT qualification programs, and it is based on several factors, including the scientific merit of the submission, the ability of the DDT to address a specified drug development need, the availability of information and resources that support the proposed qualification effort and demonstration that the DDT is feasible and practical within the proposed context of use. FDA will now work with the applicant to provide feedback on the next qualification step—a qualification plan.

CDER and CBER are excited to kickstart the future of novel DDT development with the first ISTAND LOI acceptance. We look forward to ISTAND’s continued support of innovative approaches to drug development and to the program’s contributions to bringing effective therapies to patients faster.

For more information:

• CDER Conversation: CDER Focuses on Novel Drug Development Tools to Help Speed Creation of New Therapies (https://www.fda.gov/drugs/news-events-human-drugs/cder-focuses-novel-drug-development-tools-help-speed-creation-new-therapies)
• ISTAND Pilot Program Submission Process (https://www.fda.gov/drugs/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program-submission-process)
• DDT Qualification Programs (https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tool-ddt-qualification-programs)
• CDER & CBER Drug Development Tool Qualification Project Search (https://fda.force.com/ddt/s/)