The NINDS intends to launch a second biomarker initiative by publishing a Funding Opportunity Announcement (FOA) focused on the analytical and clinical validation of candidate biomarkers for neurological disorders and conditions.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in April 2018 with an expected application due date in June 2018

This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

Biomarkers have become recognized as critical to the successful development of effective therapeutics. Despite the active pace of discovery of novel biomarker candidates, few biomarkers progress through the essential steps of analytical and clinical validation, and robust, well-validated biomarkers for use in Phase II and Phase III clinical trials remain scant. Thus, there is a critical need to support the clinical validation of candidate biomarkers to improve public health, particularly for disorders of the nervous system where failures to advance therapeutics from discovery to the market are notorious.

The NINDS biomarker initiative consists of four primary components: 1) Leverage existing NIH-funded tissue and data repositories, 2) Efforts to better understand gaps in biomarker discovery through scientific workshops, 3) Milestone-driven funding opportunities focused on analytical and clinical validation of candidate biomarkers, and 4) The development of an online website that will provide a one-stop shop for investigators with an interest in using resources and applying for funding for biomarker research.

The funding opportunity announcement will be milestone driven. The FOA will support clinical validation or evaluation of clinical utility of candidate biomarkers. The degree of validation will depend upon the context of use for the biomarker, using the standards and guidelines provided by the FDA.
Applicants are strongly encouraged to consult with NINDS program staff (below) as plans for an application are being developed.

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization

Applications are not being solicited at this time.

Mary Ann Pelleymounter, Ph.D.

National Institute of Neurological Disorders and Stroke

301-451-4551