OSP FO# 11-224

AGENCY: Department of Health and Human Services (DHHS)/National Institutes of Health (NIH)/National Institute of Neurological Disorders and Stroke (NINDS)

PROGRAM: NINDS Exploratory/Developmental Projects in Translational Research (R21)

OBJECTIVES: This program provides funding to support preliminary steps in the preclinical development of therapeutics for neurological disorders. Such projects, if successful, should lead directly to a subsequent project that will include all remaining activities for submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA). The scope includes only therapy development activities, so development of diagnostics, biomarkers, or rehabilitation strategies cannot be supported. Clinical research, basic research, and studies of disease mechanism are outside program scope.

The primary purpose of the NINDS Exploratory/Developmental Projects in Translational Research is to support preliminary therapy development goals that are outside the scope of cooperative agreement projects.

These include:

  • Creation and validation of screening assays for therapy development. The assays may be intended for primary or secondary screening efforts at any level of throughput.
  • Creation of animal models of neurological disorders for therapy development. Animal models that will be used for basic research are outside the scope of the program.
  • Identification of candidate therapeutics, including primary or secondary screening efforts at any level of throughput. Primary screening efforts are not supported by the cooperative agreement mechanisms in the NINDS Translational Research Program.
  • Development of preliminary in vivo efficacy data for identified candidate therapeutics. If a NINDS Exploratory/Developmental Project in Transitional Research includes in vivo proof of concept on efficacy, the project will be eligible for transition to cooperative agreement funding in the NINDS Translational Research Program.

There is increasing awareness among neurological disease communities that to assess the predictive value of preclinical research, sufficient information must be available about study design, execution, analysis, and interpretation. Examples of the critical elements of a well-designed study are summarized on the NINDS web site (http://www.ninds.nih.gov/funding/grant_policy.htm). NINDS urges applicants to the program to consider these elements when describing supporting data and designing the proposed studies.

DEADLINE: October 16, February 16 and June 16 annually until September 8, 2012.

FUNDING INFORMATION: This program will utilize the NIH exploratory/developmental (R21) grant. A maximum of $275,000 in direct costs over a two-year project period may be requested. Direct costs are limited to $200,000 per year with a project duration of up to two years.

AGENCY CONTACT:
Thomas Miller, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Neuroscience Center, Room 2139
6001 Executive Blvd MSC 9527
Bethesda, Maryland 20892
Telephone: (301) 496-1779
Email: tm208y@nih.gov
Web: http://grants.nih.gov/grants/guide/pa-files/PAR-11-293.html

REMARKS: NIH requires that applications to this program be submitted electronically through Grants.gov (http://www.grants.gov). After submission via Grants.gov, applications will be retrieved and processed by the NIH Commons system (https://commons.era.nih.gov/commons/index.jsp). In order to prepare a responsive application, PIs should download both the complete program guidelines (PAR-11-293) and the corresponding application package from Grants.gov as well as the NIH Grants.gov Application Guide (http://grants.nih.gov/grants/funding/424/index.htm). PIs must also be registered Commons users.

For more information about Grants.gov and the NIH Commons, or to register as a Commons user, please contact either India Adams (adamsi@bu.edu) or A. B. Effgen (abeffgen@bu.edu) in the Office of Sponsored Programs (OSP) at x3-4365. In addition, please contact the OSP Assistant Director assigned to your school or department as soon as possible to coordinate submission through the Grants.gov system.

Complete program guidelines and application material may be obtained from the web site listed above or from the Office of Sponsored Programs (OSP). Please distribute this notice to any faculty or staff members who might be interested in the information. For more information, please contact the OSP at X3-4365 or ospinfo@bu.edu, or visit the OSP web site at http://www.bu.edu/osp.