Notice of Intent to Publish a Funding Opportunity Announcement for Step Up for Substance Use Disorders (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research (U18 - Clinical Trial Not Allowed)

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Notice Number: NOT-DA-19-076

Key Dates

Release Date: September 16, 2019
Estimated Publication Date of Funding Opportunity Announcement: October 30, 2019
First Estimated Application Due Date: February 13, 2020
Earliest Estimated Award Date: September 01, 2020
Earliest Estimated Start Date: September 01, 2020

Related Announcements
None

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

The National Institute on Drug Abuse (NIDA) intends to publish a Funding Opportunity Announcement (FOA) to establish 50 new awards for the “Step Up for Substance Use Disorders (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research” program to provide short-term funding to conduct experiments aiming to expand the range of drug targets and mechanisms for SUD therapies. In addition, the FOA will allow for in-kind access to biomedical product development expertise, business strategy and commercialization support, and assistance in the company/startup formation, as needed. 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 the next step or stop the project. At this point, only research projects on potential drug/biologic therapeutics, not diagnostics or devices, will be supported.

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 for cocaine, methamphetamine, or cannabis use disorders are encouraged. For each project funded under this FOA, the NIDA will assemble an NIH expert panel called a Project Development Team (PDT) comprising of Program Official (PO), Science Officer (SO), the PI/PD and appropriate NIH expert consultants. Together, the team will create a credible thesis for how the PI/PD will address an important SUD issue in a transformative way, differentiate from other approaches, and create a path for progressively de-risking that opportunity. The PDT will help the PD/PI establish an overall strategy for the project, including identifying the critical value inflection point to determine what needs to be done in the preceding stage to make the technology attractive to potential partners.

The FOA will utilize the U18 funding mechanism, which is a cooperative agreement, a support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Research Initiative Details

The 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 alternative, available FOAs.

The proposed studies could include, but are 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.

The applicants are expected to take deliberative measures to publicize the outcomes, including negative, of this funding in the Project Outcomes Section of all Final and Interim Research Performance Progress Reports (RPPRs) and making them available to the general public via the NIH RePORTER in accordance to NOT-OD-18-103.

Funding Information

Estimated Total Funding Application budget are limited to $150,00 direct coast per year
Expected Number of Awards TBD
Estimated Award Ceiling $150,000 per year direct costs for no more than 1 year
Primary CFDA Numbers 93.279

Anticipated Eligible Organizations

Applications are not being solicited at this time.

 

Inquiries

Please direct all inquiries to:

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Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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