NIH Novel Drug (DDT) and Medical Device Development Tools (MDDT)

This Funding Opportunity Announcement (FOA) encourages Small Business Technology Transfer (STTR) grant applications proposing research projects, directed towards commercialization, for the development of new drug development tools (DDT) and medical device development tools (MDDT) in the field of substance use disorder (SUD) research.

Donor Name: National Institutes of Health

State: All States

County: All Counties

Type of Grant: Grant

Deadline: 11/14/2022

Size of the Grant: $320,000

Grant Duration: 1 year

Details:

The scope and complexity of the current drug crisis are staggering, and there is an urgent need for a comprehensive effort to offer new medical products to affected individuals, families, and communities. Scientific advances and product development based on those advances can provide solutions to help overcome the crisis. Medical products regulated by the U.S. Food and Drug Administration (FDA), including pharmacotherapeutics and therapeutic or diagnostic medical devices, offer promising means to monitor, diagnose, and treat patients suffering from substance use disorders (SUD). However, there are currently limited therapeutic and diagnostic options available, leaving a significant gap between existing therapies and meeting the needs of patients and clinicians. Part of the bottleneck with medical product approvals stems from the lack of appropriate regulatory guidance and associated tools available to support research, development, clinical study, and subsequent approval of therapeutics and diagnostics for patients with SUD. Additional factors include stigma surrounding SUD patients and treatment options, lack of broadly accepted clinical endpoints, lengthy and expensive product development timelines, and overall reluctance from industry to engage in the SUD space for these reasons.

Specific Areas of Research Interest

Area 1: Drug Development Tools (DDT): The information below comes from the guidance document and provides an overview of the types of tools that will be considered for the DDT program. Details about the three types of DDTs (Biomarkers, clinical outcome assessments, and non-clinical assessment methods) are described below.
- Biomarkers are defined as biological characteristics objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention. Examples of biomarkers can include:
  - molecular biomarker
  - histologic biomarkereduca
  - radiographic (imaging) biomarker
  - physiologic characteristics
- Clinical outcome assessments (COAs) are a measurement of a patient’s symptoms, a patient’s overall and mental state, or the effects of a disease or condition on how the patient functions. A COA may be used to determine whether a drug has demonstrated a clinical benefit. Examples of COAs include:
  - patient-reported outcome measures (PRO)
  - clinician-reported outcome measures (CRO)
  - observer-reported outcome measures (ObsRO)
  - performance outcome measures (PerfO)
- Animal models developed and intended for use in the adequate and well-controlled animal efficacy studies that serve as substantial evidence of effectiveness for drugs developed under the regulations commonly referred to as the Animal Rule.
Area 2. Medical Device Development Tools (MDDT): The information below comes from the guidance document and provides an overview of the types of tools that will be considered for the MDDT program. Details about the three types of MDDTs are described below.
- Clinical outcome assessments (COAs) that produce a score, in addition to clearly defined methods and instructions for administering the tool, a standard form for data collection, and well-documented methods for scoring, analysis, and interpretation of results in the targeted patient population. Examples of COAs include:
  - patient-reported outcome measures (PRO)
  - clinician-reported outcome measures (CRO)
  - observer-reported outcome measures (ObsRO)
  - performance outcome measures (PerfO)
- Biomarker tests are a test or instrument used to detect or measure a biomarker. It is a defined characteristic that is objectively measured and evaluated as an indicator of normal biological process, pathogenic process, or response to therapeutic intervention. Examples of biomarkers can include:
  - susceptibility/risk biomarker
  - diagnostic biomarker
  - monitoring biomarker
  - prognostic biomarker
  - predictive biomarker
  - pharmacodynamic/response biomarker
  - safety biomarker
- Non-clinical assessment models developed to measure or predict a parameter of interest which can include the following:
  - in vitro (bench) model
  - ex vivo model
  - animal model
  - computational model

The STTR program is a phased program

An overall objective of the STTR program is to increase private sector commercialization of innovations derived from federally supported research and development.

The main objective in STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts. In contrast, the STTR Phase II objective is to continue the R&D efforts to advance the technology toward ultimate commercialization.

Beyond the scope of this FOA, it is anticipated and encouraged that the outcomes of successful STTR projects will help attract strategic partners or investors to support the ultimate commercialization of the technology as a publicly available product or service.

This FOA invites three types of applications:

Phase I. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and determine the quality of performance of the small business awardee organization before proceeding to Phase II.
Phase II. The objective of Phase II is to continue the R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II. Therefore, NIDA evaluates that investigators have established technical and commercial feasibility in Phase I before deciding on Phase II support.
Fast Track. In an NIH SBIR fast-track both Phase I and Phase II are submitted and reviewed as one application to reduce or eliminate the funding gap between phases. Fast-Track (Phase I/ Phase II) applications should include a clear rationale of the technical and commercial feasibility of the proposed approach and technology in the SUD area; demonstrate a high probability of commercialization; include clear, appropriate, measurable, clinically meaningful milestones to be achieved before initiating Phase II; and indicate potential Phase III support/interest (non-SBIR) from future commercialization partners. The objective of Phase II (as a part of Fast Track applications) is to continue the R&D efforts initiated in Phase I to advance technologies to potential commercialization. Projects proposed for Phase II are based on the results achieved in Phase I (or equivalent) and aim to demonstrate scientific and technical merit and commercial potential. Therefore, NIDA evaluates that investigators have established technical and commercial feasibility in Phase I and that proposed milestones are met before deciding on Phase II support.

First-time applicants may submit a Phase I, or a Fast-Track application.

Funding Information

NIDA intends to commit $3,000,000 in FY 2023 to fund 3-5 awards.
Total funding support (direct costs, indirect costs, fees) may not exceed $320,000 for Phase I awards and $2,500,000 for Phase II awards.
Award periods may not exceed 1 year for Phase I and 3 years for Phase II.

Eligibility Criteria