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Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U44
PAR-21-057

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U01
PAR-21-056

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U01
PAR-21-058

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U44
PAR-21-059

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

Research Supplements to Promote Diversity in Health-Related Research (Admin Supp Clinical Trial Not Allowed)

PA
Monday, November 16, 2020
Monday, May 8, 2023
333
PA-21-071

Funding Opportunity Purpose

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to enhance the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Treatments for Lewy Body Dementias--Exploratory Clinical Trial (U01 Clinical Trial Required)

RFA
Wednesday, October 28, 2020
Wednesday, March 3, 2021
U01
RFA-NS-21-008

Funding Opportunity Purpose

This Funding Opportunity Announcement invites applications from experienced investigators seeking to conduct exploratory clinical trials designed to test new treatments for patients with Lewy Body Dementia (LBD). Applicants may propose to conduct either Phase I or Phase II clinical trials depending on the developmental stage of the potential therapeutic, but all trials must include patients with LBD. Proposed therapies may include novel medications or devices, or existing treatments that are potentially beneficial but not currently approved for use in patients with LBD. Treatments intended to prevent or delay disease progression in LBD patients, as well as therapies to alleviate existing motor or non-motor clinical symptoms, are of interest.

Notice of Special Interest: Administrative Supplements for Connecting Pre-mortem Clinical Information with Post-Mortem Brain Analysis

Notice of Special Interest
Wednesday, August 26, 2020
Tuesday, June 29, 2021
333
NOT-NS-21-001

Funding Opportunity Purpose

The Lewy Body Dementias (LBD) are frequently misdiagnosed or underdiagnosed during life, and despite the development of diagnostic criteria at multiple expert consensus conferences, the gold standard for diagnosis remains post-mortem brain analysis. Improvement in diagnostic accuracy during life, and the development of good quality diagnostic biomarkers, would be greatly facilitated if comprehensive, longitudinal clinical and biological data obtained on patients during life were regularly linked with detailed post-mortem brain examination. In response to recommendations from the Alzheimer's Disease Related Dementias (ADRD) Summits convened by the NINDS in 2013, 2016, and 2019, longitudinal clinical data and biospecimens are being collected from patients with LBD and shared with the research community through the Parkinsons Disease Biomarker Program (PDBP). The PDBP is an NINDS-funded resource that collects standardized clinical data and biospecimens longitudinally on patients with Parkinson's Disease (PD) and PD-related disorders (including LBD) with the goal of accelerating the pace of biomarkers research. The PDBP currently has data and biospecimens on about 1900 subjects, some of whom have gone to autopsy, though relatively little post-mortem data on these subjects is available in PDBP at this time. This NOSI encourages researchers with extensive pre- and post-mortem data on patients with LBD to apply for supplemental funds to be used for the purpose of adding this data to the existing NINDSPDBP repository. Supplements may be requested by: Researchers who have previously contributed clinical and biospecimen data to the PDBP on patients with LBD while alive, and who wish to add the post-mortem autopsy data they have collected on the same patient(s) after their death.

BRAIN Initiative: Tools for Germline Gene Editing in Marmosets (U01 - Clinical Trial Not Allowed)

RFA
Friday, July 17, 2020
Saturday, October 15, 2022
U01
RFA-DA-21-006

Funding Opportunity Purpose

The purpose of this FOA isto develop tools and technologies to conduct cientifically rigorous, ethical, efficient, and cost-effective research infrastructure that supports germline and somatic transgenic and gene editing studies in the common marmoset (Callithrix jacchus). These studies should to answer crucial scientific questions that require genetic perturbation in a non-human primate model organism with the aim of supporting BRAIN goals of understanding the brain in health an disease.

NINDS Morris K. Udall Centers of Excellence for Parkinson's Disease Research (P50 Clinical Trial Optional)

RFA
Wednesday, July 15, 2020
Tuesday, September 27, 2022
P50
RFA-NS-21-001

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for the Morris K. Udall Centers of Excellence for Parkinsons Disease Research program. The overarching goal of the specialized Udall Centers program is to establish a network of Centers that work collaboratively as well as independently to define the causes of and discover improved treatments for Parkinsons disease (PD). A more immediate goal for each Center is to rapidly advance synergistic, interdisciplinary research programs while serving as national leaders in PD research. Udall Centers also serve as local resources by organizing research career enhancement activities for Center investigators and periodic outreach to the PD patient/advocacy community. Applicants are expected to identify and address an overall research theme that defines a critical challenge in PD research. The stated theme, proposed research projects, and associated cores will inform the etiology, pathogenesis or treatment of PD; investigations on related synucleinopathies may be included if such studies directly address the identified PD research challenge. Requirements include 1) a minimum of three research projects; 2) research cores that are each essential to accomplish the aims of at least two proposed research projects, plus an Administrative Core; 3) a mission statement and plan for career enhancement of Center trainees and investigators; and 4) a plan for effective outreach, including dissemination of Udall Center research results, to the local patient and advocacy community. The NINDS Udall Centers program prioritizes innovative and integrative research with significant potential for discovery. A considerable degree of synergy must be evident among Center research projects and cores, such that successful completion of the aims could not be accomplished without the Center structure. The Udall Center Director (PD/PI) must be an established leader in scientific research with visionary leadership skills and proven expertise.

PHS 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA
Tuesday, July 14, 2020
Tuesday, April 6, 2021
R43/R44
PA-20-260

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH, CDC, and FDA awarding components identified in this FOA are encouraged to submit SBIR grant applications in response to identified topics (see PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. This Parent Funding Opportunity Announcement does not accept clinical trials.

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