Notice Number: NOT-NS-18-020
Release Date: December 4, 2017
Estimated Publication Date of Funding Opportunity Announcement: 11/29/2017
First Estimated Application Due Date: 06/10/2018
Earliest Estimated Award Date: 02/10/2019
Earliest Estimated Start Date: 02/11/2019
National Institute of Neurological Disorders and Stroke (NINDS)
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.
Please direct all inquiries to: