Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01)

Funding Opportunity Announcement (FOA) Number	PAR-13-334
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279
Funding Opportunity Purpose	NIDA grant-funded research programs aiming to develop medications for the treatment of Substance Use Disorders (SUDs) are often hindered by a lack of both human and financial resources.  Drug development is a lengthy process that requires a wide range of skill sets.  Consequently, individual grantees with the necessary expertise in one area of medications development are often unable to advance a project through the next stage because of a lack of real world experience in the development process and/or the financial resources to advance a medication through the development pipeline in an acceptable timeframe. The purpose of this Funding Opportunity Announcement (FOA) is to support research that advances compounds towards FDA approval by leveraging NIDA funds with the strengths and resources of outside  organizations, such as for-profit and not-for-profit entities, including academic institutions, pharmaceutical and biotechnology companies, private and public foundations, and small businesses.  Applications from single entities that possess considerable resources for medications development will also be considered, provided the entity demonstrates a significant resource commitment to the proposed project. A resource commitment from a single entity could, for example, consist of salary support for key personnel or production and formulation of clinical trial material. It is anticipated that in comparison with traditional grant-funded research, strategic alliances will increase the pace at which medications to treat SUDs move through the drug development process.  Both the term (up to three years) and budget (up to $2,000,000/year in direct costs) of the grant are consistent with the objective of accelerating the pace of medications development compared to traditional research project grant funding.  Project aims can range from the development of a new molecular entity to the expansion of an existing medication’s clinical indication(s). Each project must have a defined entry and exit point in the medications development pathway, with the objective of advancement in the FDA approval process.  It is hoped that support for these collaborations will accelerate the rate of medications development for Substance Use Disorders.

Key Dates

Posted Date	August 19, 2013
Open Date (Earliest Submission Date)	February 27, 2014
Letter of Intent Due Date(s)	30 days prior to receipt date
Application Due Date(s)	March 27, 2014, July 28, 2014, March 27, 2015, July28, 2015, March 28, 2016, July 28, 2016, by 5:00 PM local time of applicant organization.