Notice of Intent to Publish a Funding Opportunity Announcement for Biomarker Discovery through the Use of Data and Resources Developed by the NINDS Parkinson's Disease Biomarker Program (PDBP) (U01)

Notice Number: NOT-NS-14-027

Key Dates
Release Date: Release Date:   May 8, 2014
Estimated Publication Date of Announcement:  June, 2014 
First Estimated Application Due Date:  October, 2014 
Earliest Estimated Award Date:  March, 2015 
Earliest Estimated Start Date:  March, 2015 

Related Announcements
NOT-NS-12-003
NOT-NS-13-020

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research to support the discovery, assay optimization, and replication stages required for the development of biological biomarkers for Parkinson’s disease (PD).  It is expected that studies funded under this FOA will integrate with and enhance the NINDS Parkinson's Disease Biomarker Program (PDBP). Discovery or pilot projects may use samples from either the PDBP or other extant collections of biospecimens and data, as long as consent for the extant biospecimens and data enables deposition of all data into the PDBP Data Management Resource (DMR).  For examples of extant biospecimen collections, summary and contact information is available at https://pdbp.ninds.nih.gov/jsp/funding.jsp. It is expected that the replication stage study will use PDBP biospecimens and data.
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 the summer of 2014 with an expected application due date in September 2014.

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

Research Initiative Details

The National Institute of Neurological Disorders and Stroke NINDS Parkinson's Disease Biomarkers Program (PDBP) was established to advance discovery of biomarkers that will improve the efficiency and outcome of Phase II clinical trials for Parkinson's Disease (PD) and advance therapeutic development for PD. The PDBP covers the spectrum of Parkinson's disease from first diagnosis to more advance stages of the disease and includes the longitudinal collection of clinical data and biospecimens.  Since the program began in November of 2012, six clinical sites have enrolled more than 900 participants in the study, and over 12,000 clinical forms are available through the PDBP data management resource (DMR).  Each participating clinical site follows a standardized schedule for patient visits and clinical data collection.  Also, through a standardized set of procedures, biospecimens are collected and stored at the NINDS Repository.  There are currently over 250 cerebrospinal fluid samples (CSF) and collectively more than 3800 RNA, DNA, plasma and serum samples available for analysis.  These biospecimens and associated quality control data on the biospecimens are available through the NINDS Repository catalog in the PDBP DMR and requests for biospecimens are handled through the PDBP Biospecimen Resource Access Committee (BRAC).  Investigators who are interested in Parkinson's Disease Biomarker development may request access to PDBP biospecimens and data at any time. To learn more about the NINDS Parkinson's Disease Biomarker Program (PDBP) and the PDBP Data Management Resource please visit the PDBP website.

To view the data and biospecimens available through the PDBP, researchers must first gain access to the PDBP DMR by requesting an account (Request a PDBP DMR account). Once your signed Data Use Certification (DUC) is received, access will be available to the PDBP data Query tool, NINDS Biorepository catalog and Order Manager.  Investigators who are given access to either PDBP data or both data and biospecimens are expected to acknowledge the PDBP Consortium in all resulting publications according to the PDBP publication policy.  As outlined in NOT-NS-13-020, all NINDS funded PD biomarker projects will follow the data and resource sharing guidelines and standards established for the NINDS PDBP including deposition of clinical and biospecimen assessment data with the PDBP DMR.

This Notice encourages investigators with expertise and insights into areas of Parkinson's Disease basic and translational research, target validation, biomarker platform development and biomarker discovery to begin to consider applying for this new FOA.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Katrina Gwinn, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5745
Email: gwinnk@ninds.nih.gov

Margaret Sutherland, Ph. D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: sutherlandm@ninds.nih.gov

 

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