Funding Opportunity Purpose:
The overall goal of The Step Up for SUD initiative is to advance fundamental discoveries into medicines to treat substance use disorders (SUD) for the benefit of society. The purpose of this funding opportunity is to enhance and accelerate research on drug targets for SUD aiming to expand the range of targets and mechanisms in development for SUD therapies. The initiative will provide both funding and the in-kind access to biomedical product development experts. It will be administered as a unique, short-term and nimble funding opportunity to support the confirmatory research in robust drug target validation/invalidation to allow for early decision to either proceed to a next step or stop the projects. At this point, only research projects on potential drug/biologic therapeutics, not diagnostics or devices, will be supported.
NOT or Funding Opportunity Number:
- RFA-DA-20-025 - Step Up for Substance Use Disorders (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research (U18 - Clinical Trial Not Allowed)
- NOT-DA-20-024 - Webinar announcement
Application Due Date
- February 13, 2020, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
An informational webinar will be given on:
- Thursday December 12th, 2019
- Time: 11:00am-12:00pm EST
- Completed: View Presentation (PDF, 2.1 MB)
- Q&A from Webinar
- Tuesday January 7th, 2020
- Time: 11:00am-12:00pm EST
The main focus of research activities funded through this FOA is drug target validation. For the purpose of this FOA, target is defined as molecular entity present in living systems that, upon interaction with therapeutic agents of their byproduct, result in modified biological responses that lead to therapeutic outcomes. The interaction between a drug and its target leads directly or indirectly to observable clinical outcomes. While the main focus of this initiative is on target validation, the applications could be submitted to explore any early discovery stage (e.g. assay development, hit identification/ confirmation) up to the lead optimization stage. More advanced drug discovery and development efforts are not appropriate for this FOA and are supported by NIDA through multiple available FOAs.
The proposed studies could include, but not limited to, the following:
- Validation of targets for SUD treatment;
- Experiments to assure data robustness (e.g., reproducing the key (including published) in vitro and in vivo finding in at least 2 duplicate studies using same material, doses, readouts);
- Determination of biological criteria for hit designation;
- Determination of approach for hit-to-lead discovery;
- Developing the target-specific screening paradigms and decision trees;
- Development and validation of in vitro and in vivo assays;
- General mechanism of action (MOA) and selectivity testing;
- Composing drug product concepts (e.g., Target Product Profile (TPP));
- Compound screening (including FDA-approved drugs for other indications, drugs approved outside of US, etc.) to yield hits and leads;
- Business case preparation work;
- Experiments to strengthen the intellectual property (IP) position.
Applications to test new therapeutic ideas (a new mechanism/ target class for SUD or a new SUD indication for a validated mechanism/ target class), especially the ones enabled by the growing availability of the broader armamentarium of treatment modalities are encouraged. Monoclonal antibodies, recombinant proteins, nucleus acid-based therapeutics and viral vectors have expanded the druggable target space compared with traditional small-molecule drugs alone.
Through this FOA, the development of pharmacotherapeutics, not diagnostics or devices, will be supported. Applications focusing solely on generation of new animal models, development of new human laboratory models or mechanistic studies of the neurobiology of addiction are considered non-responsive for this FOA and maybe withdrawn.