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 In this section:

        Drug Development Tool (DDT) Qualification Programs

Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program

                        
                Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program Submission Process Home
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          Development & Approval Process | Drugs
          Drug Development Tool (DDT) Qualification Programs
          Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot ProgramDrug Development Tool (DDT) Qualification Programs Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program
  	
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    PrintDDT Funding Announcement (PDF)
FY2023 DDT Grant cycle is now accepting applications through May 3, 2023


With a significant delay in our DDT qualification reviews at CDER due to an overall increase in the DDT Qualification Program workloads, we will accept your grant applications as long as your DDT submission (LOI or QP) is deemed reviewable by the grant deadline (May 3, 2023). If your grant application is reviewed favorability by the grant review panel with an above acceptable total score, your grant award will be deferred until  your LOI (or QP) is fully accepted by the program (with the issuance of the determination letter). Contingent upon availability of the funds to the DDT grant program and the priority of your project at that time, the grant award may be made shortly after the acceptance of your LOI (or QP). If you have a question regarding this change, please reach out to CDER-DDT Grants Contracts CDER-DDTGrantsContracts@fda.hhs.gov.


Drug Development Tools (DDTs) are methods, materials, or measures that have the potential to facilitate drug development. As described in the 21st Century Cures legislation, DDTs include biomarkers, clinical outcome assessments, and other methods, materials, or measures that aid drug development and regulatory review. To support DDT development efforts, FDA has established qualification programs for biomarkers, clinical outcome assessments, and for animal models for use under the Animal Rule.

The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program is designed to expand DDT types by encouraging development of DDTs that are out of scope for existing DDT qualification programs but may still be beneficial for drug development.

**Examples of submissions that might be considered for ISTAND include, but are not limited to:**

Tools that may help enable remote or decentralized trials

Application of patient-performed digital photography in dermatology trials

​Tools that may advance our understanding of drugs

Use of tissue chips (i.e., microphysiological systems) to assess safety or efficacy questions
	Development of novel nonclinical pharmacology/toxicology assays

Tools that leverage digital health technologies

Use of artificial intelligence (AI)-based algorithms to evaluate patients, develop novel endpoints, or inform study design
	Use of novel digital health technologies (e.g., wearables) for patient assessment

Development programs needed for evaluation of adherence sensors​

What outcomes are available under the ISTAND Pilot Program?

ISTAND’s goal is to support the development of novel approaches to drug development that may be acceptable for regulatory use. Some novel programs may be considered as DDTs eligible for qualification independent of a specific drug program and will go through the qualification process.

A qualified DDT can be relied upon to have a specific interpretation and application in drug development and regulatory review within its stated context of use. Once qualified, DDTs will be available to use in any drug development program for the qualified context of use. Additionally, the qualified DDT can generally be included in IND, NDA, or BLA applications without needing FDA to reconsider and reconfirm its suitability.Other programs may not optimally fit into the existing DDT qualification paradigms but still represent potential value to drug development. In such cases, ISTAND will work with the sponsor to find the best outcome, which may involve:

a series of meetings with appropriate FDA staff to gain input to the sponsor,
	a public meeting to gain input on the novel approach,
	a “white paper” to raise considerations for implementation of the novel DDT,
	development of a guidance that states FDA’s position on how the novel tool might be used in drug development; or
	other means of FDA input and advice to support the DDT’s furtherance.ISTAND Pathways Process Flow Chart: ISTAND (Submission or Referral) to 3 step Qualification Process to Qualified DDT or ISTAND (Submission or Referral) to ISTAND Continuous Engagement to Public Meeting, White Paper, Guidance
What information about submissions will be made public?

Submissions to the ISTAND Pilot Program that are admitted for review and deemed appropriate for qualification as an outcome are subject to the transparency provisions of the 21st Century Cures Act. More information on these provisions can be found on the Drug Development Tool Qualification Process: Transparency Provisions page. Submissions that do not proceed towards DDT qualification are not subject to those provisions.

What is the nature of the pilot?

In the pilot phase, FDA anticipates accepting 2-4 submissions into the ISTAND program each year with a triage and selection process that focuses on public health impact and feasibility of implementation.

For information on how to apply, see ISTAND Pilot Program Submission Process.

                                                                                  Content current as of:
      04/06/2023
                  
                   
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                        Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program Submission Process
 
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