The National Institutes of Health (NIH) encourages Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) proposing research projects, directed towards commercialization, for the development of novel, evidence-based, FDA-regulated medical products addressing the needs of patients suffering from opioid use disorders (OUD) and/or stimulant use disorders (StUD).
Donor Name: National Institutes of Health (NIH)
State: All States
County: All Counties
Type of Grant: Grant
Deadline: 07/15/2023
Size of the Grant: $300,000
Grant Duration: 1 year
Details:
Applications received under this NOFO may fall within two scientific areas, namely:
- pharmacotherapeutics (small molecules and biologics) and
- medical therapeutic and diagnostic devices, including software as a medical device. This NOFO strives to contribute to the effort against the national opioid and psychostimulant emergency and offer new medical products for individuals, families, and communities affected by this devastating crisis. Small business companies that developed currently marketed technologies or are developing technologies for different indications and are interested in demonstrating that their FDA-regulated product has a potential application in the OUD/StUD space are encouraged to apply.
Area 1: OUD/StUD pharmacotherapeutics
Projects proposed under Area 1 may include, but are not limited to, developing the following categories of pharmacotherapeutics for OUD/StUD:
- Small or large molecule agents.
- Biologics, including antibodies and therapeutic vaccines.
- Natural products.
- Longer-acting formulations of existing addiction medications.
- Longer-acting formulations of agonists or antagonists, e.g., longer-lasting naloxone formulations and new medications.
- Advanced drug delivery systems.
- Development and characterization of biomarkers.
Applications may include the following activities and steps in the R&D process:
- Target identification or validation.
- Assay development, confirmation of hits, and hit-to-lead studies.
- Lead optimization of compound(s) or biologic(s).
- In vivo pharmacokinetic, pharmacodynamic, and toxicology studies.
- In vivo preclinical efficacy studies.
- Formulation development studies.
- Process development to support clinical manufacturing (e.g., scale-up feasibility).
- Other activities leading to the selection of a development candidate.
Area 2: Medical therapeutic and diagnostic devices, including software as a medical device
Projects proposed under Area 2 may include, but are not necessarily limited to, research and development of the following categories of medical devices:
- Imaging technologies for investigating brain function and enhancing the diagnosis of OUD/StUD.
- Devices that directly diagnose and reduce craving and withdrawal symptoms or increase retention in outpatient therapies.
- Therapeutic devices (e.g., neuromodulation) intended to improve OUD/StUD treatment outcomes and prevent a recurrence.
- Devices, including digital therapeutics, intended to identify and treat newborns exposed to opioids, stimulants, and other drugs, to improve both short- and long-term developmental outcomes; novel approaches to managing neonatal abstinence syndrome.
- Devices intended for the treatment of pediatric patients (e.g., neonates, infants, adolescents) including use of extrapolation methods to treat pediatric patients following FDA’s pediatric extrapolation guidance
- Devices, including digital therapeutics, with treatment indications for pregnant persons suffering from OUD/StUD.
- In vitro diagnostic assays such as Point-of-Care analytical tools for blood, saliva, or urine (e.g., lab-on-a-chip biosensors that allow remote performance of chemical or biological assays outside a laboratory environment).
- Stand-alone or adjunctive digital therapeutics (e.g., Software as a Medical Device, Software in Medical Device) focused on behavioral health interventions to diagnose, treat, prevent, and mitigate OUD/StUD.
- Devices, including wearables and connected digital therapeutics at point-of-care, intended to detect, diagnose, and treat opioid-induced respiratory depression.
- Data science and cloud-based technologies empowered by artificial intelligence intended to collect, integrate, analyze, and visualize multimodal data related to the diagnosis/treatment of OUD/StUD, including disorder progression and risk of recurrence.
- Technologies that integrate sensors, wearables, and environmental and social factors to analyze behavior patterns, social interactions, ecological momentary assessment of triggers, and identifying stress responses to personalize just-in-time treatment interventions.
This NOFO 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.
Funding Information
Award Ceiling: $300,000
Project Period
Award periods normally may not exceed 1 year for Phase I and 3 years for Phase II. Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project.
Eligible Applicants
Small businesses
Additional Information on Eligibility
Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
For more information, visit Grants.gov.
