Notice Number: NOT-DA-17-013

Key Dates
Release Date: March 29, 2017

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this Notice is to alert the field to program priorities relevant to the SBIR and STTR program of the National Institute on Drug Abuse (NIDA).

The SBIR/STTR program is intended to meet, among others, the following goals: strengthen the role of small business in meeting Federal research or research and development (R/R&D) needs; increase the commercial application of Federally-supported research results; and improve the return on investment from Federally-funded research.

In this Notice, NIDA emphasizes its need to discover, develop and clinically evaluate medications to treat substance use disorders (SUDs).

Specifically, this Notice underscores the high programmatic priority given to research that seeks to achieve this goal in the following ways:

1. Drug (Medication) discovery and development-enabling activities for SUDs.

Development of innovative technologies, methods or tools, including but not limited to:

• Innovative in vitro, in situ, or in vivo tools for the analysis of the central nervous system, normal and/or diseased.
• Technologies, including molecular imaging, gene expression profiling, and genotyping and sequencing approaches designed to better inform SUD diagnosis and treatment.
• Assay development (e.g., biochemical, functional) and validation, especially, hiPSC-based assays, human organoid, or 3-D culture systems with the intention of developing medium to high-throughput assays.
• Tools to simplify the design and preclinical development of medications for SUDs.
• Discovery of SUD-related biomarkers (BMs) (e.g., BMs of chronic drug exposure, pharmacodynamic, toxicological/safety; BM assay development and validation), and BM-associated device development.
• Development of BM known to be associated with a health (salutary) outcome, which are quantitatively affected by reduction in drug use are particularly welcome.
• Predictors of clinical outcomes in SUDs, e.g. physiological, electroencephalographic, cognitive tests, and biochemical, epigenetic, and genetic assays.
• Point of care monitoring systems  to improve quantitative assessment of  subject adherence to clinical trial protocols 
• Tools that could be used as quantitative direct (e.g. plasma, saliva, or urine) measures or indirect (e.g. physiological, facial, motor, pupillometry) BMs of drug intoxication

2. Drug (Medication) discovery and development activities.

Application of emerging and existing technologies and platforms for SUD medication development with the focus on products with the potential to minimize drug seeking, compulsive behavior:

• Early therapeutic discovery activities ranging from Target ID and validation through lead development.
• Preclinical and/or clinical drug development.
• Technologies or formulations to improve medication delivery.

NIDA SBIR funding decisions are based on combination of factors. In addition to 1) programmatic priorities described in this Notice, NIDA considers 2) the potential for commercialization, 3) portfolio balance (to determine whether the similar projects have already be funded, search NIH Reporter http://projectreporter.nih.gov/reporter.cfm), 4) for Phase II applications, the results of Phase I and the commercial potential and scientific/technical merit of the Phase II application, 5) the quality of the previous performance of the applicant in SBIR program, including evidence of Phase III activities, 6) the peer review scores and critiques, 7) availability of funds.

Meritorious applications outside of the areas of current strategic interest could be funded at the levels of statutory guidelines (not to exceed $150,000 for Phase I and $1,000,000 for Phase II in total costs, including direct costs, indirect costs and fee). Applicants are strongly encouraged to contact NIDA Program Officials prior to submitting any award budget in excess of these amounts. Approval from NIDA Program Officials must be obtained for applications which exceed the levels of statutory guidelines. NIDA reserves the right not to fund otherwise meritorious applications, or reduce the budget of such applications, when the proposed budgets exceed statutory guidelines.

Inquiries

Please direct all inquiries to:

Elena Koustova, PhD, MBA
National Institute on Drug Abuse (NIDA)
Telephone: 301-496-8768
Email: [email protected]