NINDS Parkinson's Disease Biomarkers Program Strategy

Notice Number: NOT-NS-11-020

Update: The following update relating to this announcement has been issued:

• September 1, 2011 - See Notice NOT-NS-11-027. NINDS Request for Information (RFI) on Creating a Data Management Resource for the Parkinson's Disease Biomarkers Program.

Release Date: July 15, 2011

National Institute of Neurological Disorders and Stroke (NINDS)

Recently, there has been considerable progress in our understanding of the biology of Parkinson’s disease. However, inadequate measures of disease progression, the limited ability to detect neurodegeneration prior to the onset of motor signs, and the lack of assays that measure target engagement by potential therapeutics all currently impede therapy development. To overcome these obstacles, the NINDS intends to establish a Parkinson s Disease Biomarkers Program (PDBP). The goal of this program is to facilitate the development of neuroprotective agents that slow or halt the progression of Parkinson’s disease. By providing shared, high quality resources, the PDBP program will coordinate the efforts of multiple stakeholders. It will serve as a multi-faceted platform for: 1) integrating existing biomarker efforts, 2) standardizing data collection and management across these efforts, 3) accelerating the discovery and validation of new biomarkers, and 4) fostering and expanding collaborative opportunities for all stakeholders. It will facilitate both clinical and laboratory-based discovery projects designed to lead to the validation of candidate markers for pre-symptomatic diagnosis and monitoring of disease progression. These markers will ultimately be critical for designing effective Phase II and III clinical trials.

Initially, the PDBP will have three major components:

1) Funding for discovery projects designed to identify promising biomarkers. Examples of such projects include the development or validation of assays for candidate analytes or the use of well-defined cohort studies to identify clinical, pathological, or imaging biomarkers. All studies must include consent language that allows broad public sharing of biological samples and deposition of data into the resources described below.

2) A contract-based resource for the banking and sharing of existing and prospective biological samples that meet stringent inclusion criteria to be described in the funding announcements.

3) A Data Management Resource (DMR). This resource will receive, process, and distribute all standardized clinical, imaging, biological, and molecular data from the discovery and other Parkinson s biomarkers projects. Both positive and negative data will be included in the DMR.

To accelerate the pace of discovery, sharing of data and biological samples will be a core feature of the PDBP. The program will have clear sharing requirements for data and biological samples that will promote sharing in as close to "real time" as possible. In collaboration with the Parkinson's disease research community, NINDS will integrate all its PD biomarker projects within this program.

Please direct all inquiries to:
Program Contact: Katrina Gwinn MD
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Blvd Room 2143
Bethesda, MD 20892
EXPRESS/COURIER: Rockville, MD 20852
Phone: (301); 496-5745 Fax: (301) 401-5301
Email: [email protected]