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Validated biomarkers that detect risk, stage the disease, and predict its rate of progression in the at-risk setting for T1D are required to conduct more efficient clinical trials. These biomarkers may include markers of beta cell stress, dysfunction, and damage, functional beta cell mass,  autoimmune/inflammatory biomarkers, and/or biomarkers of impaired glucose and metabolic control. While progress has been made in identifying predictive markers for risk of T1D, there may be alternative molecular biomarkers (metabolites, proteomics, gene expression patterns, additional autoantibodies, etc.) that may prove to be expressed earlier, be more highly predictive, and/or more cost effective for detecting risk. Biomarkers that detect activation of innate immunity  or of T cells specific for beta cells, islet inflammation or beta cell stress, dysfunction or damage may be demonstrated to serve this role.

The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery of strong candidate biomarkers and endpoints for pain that can be used to facilitate the development of non-opioid pain therapeutics from discovery through Phase II clinical trials.  Specifically, the focus of this FOA is on the identification and initial biological, analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints. Although research supported by this FOA can include animal studies, it must also include preliminary human validation using carefully standardized human samples or human clinical studies. The goal of this initiative is to deliver candidate biomarkers, biomarker signatures, and/or endpoints that are ready for advanced clinical and analytical validation research.

Grants of up to $300,000 over two years will be awarded in support of projects focused on the development of biomarkers previously identified in samples from well-characterized human subjects. Validated methods should be used in quantifying and qualifying biomarkers, with less enthusiasm for the development of novel technologies. Priority biomarker areas include companion biomarkers, neuroimaging, CSF and blood-based biomarkers, and functional activity measures.

The purpose of this Funding Opportunity Announcement (FOA) is to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of neurological disease for use in multi-site clinical trials and clinical practice.

The purpose of this Funding Opportunity Announcement (FOA) is to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond).

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-driven research to discover human biomarkers in Parkinsons disease and other Parkinsonian syndromes, as a component of the NINDS Parkinsons Disease Biomarkers Program (PDBP). This FOA encourages biomarkers discovery projects in 1) genetically causal Parkinson's disease, especially for particular sub-types of Parkinson's Disease (PD), including genetic cohorts, biologically defined cohorts of idiopathic PD, or ethnic subgroups of idiopathic PD; 2) The differentiation of synucleinopathies (such as PD and Multiple System Atrophy (MSA) from tauopathies (such asProgressive Supranuclear Palsy and Corticobasal degeneration); or 3) to improve diagnostic differentiation between idiopathic/subtypes of PD and these disorders, as well as from Essential tremor. In order to further advance research in this area, broad sharing of biospecimens and associated data is a critical feature of the PDBP generally and of this FOA specifically.A timeline including milestones, which will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years, is required for all studies.

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-driven research to discover human biomarkers in Parkinsons disease and other Parkinsonian syndromes, as a component of the NINDS Parkinsons Disease Biomarkers Program (PDBP). This FOA encourages biomarkers discovery projects in 1) genetically causal Parkinson's disease, especially for particular sub-types of Parkinson's Disease (PD), including genetic cohorts, biologically defined cohorts of idiopathic PD, or ethnic subgroups of idiopathic PD; 2) The differentiation of synucleinopathies (such as PD and Multiple System Atrophy (MSA) from tauopathies (such asProgressive Supranuclear Palsy and Corticobasal degeneration); or 3) to improve diagnostic differentiation between idiopathic/subtypes of PD and these disorders, as well as from Essential tremor. In order to further advance research in this area, broad sharing of biospecimens and associated data is a critical feature of the PDBP generally and of this FOA specifically.A timeline including milestones, which will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years, is required for all studies.

The purpose of this Funding Opportunity Announcement (FOA) is to support the discovery of promising candidate biomarkers that will facilitate the development of non-opioid therapeutic options for the treatment of pain conditions. The goal of this FOA is to encourage a biomarker discovery process that will result in the development of pain biomarkers that can withstand rigorous clinical and analytical validation. It is hoped that an increased availability of rigorous biomarkers for pain will facilitate the discovery and development of transformational non-opioid therapeutics for pain.

JDRF requests proposals from qualified laboratories to serve as a Biomarker Analysis Centers. One Center will focus on mass cytometry analysis, and one Center on transcriptome analysis. Applicants may submit a proposal to serve as the Center for Mass Cytometry Analysis, the Center for Transcriptome Analysis, or both. The successful applicant(s) will receive access to TrialNet samples and conduct the project in close collaboration with TrialNet's Coordinating Center. Mass cytometric and transcriptomic approaches will be used to address the following Research Questions: Do biomarkers or signatures exist that can differentiate risk of progression in multiple AAb+ subjects to clinical diagnosis of T1D (prognostic biomarkers for Stage 1 to Stage 3)? Are there changes in biomarkers over time in multiple AAb+ subjects (Stage 1) that predict progression to clinical diagnosis of T1D (Stage 3)?

The purpose of this Funding Opportunity Announcement (FOA) is to solicit organ-specific applications for Biomarker Developmental Laboratories (BDLs), one of the four scientific units of the recently funded Early Detection Research Network (EDRN). The EDRN is a national infrastructure funded to discover, develop, and validate biomarkers for risk assessment, detection, and molecular diagnosis and prognosis of early cancer. BDLs are responsible for the discovery, development, characterization, and testing of new, or the refinement of existing, biomarkers and biomarker assays for risk assessment, detection, and molecular diagnosis and prognosis of cancers. The existing BDLs are primarily focused on ovary and gastrointestinal cancers. The proposed BDLs (to be supported under this FOA) must be focused on cancers of the breast, prostate and other genitourinary organs, and lung. In addition, cancers with rapidly rising incidenc

In May of 2013 the National Institute of Neurological Disorders and Stroke (NINDS), with input from the National Institute on Aging (NIA), held an Alzheimer's Disease-Related Dementias Conference in response to the National Plan to Address Alzheimer's Disease. The Conference brought together national and international experts and members of the public to develop research priorities for accelerating the development of therapies for the Alzheimer's disease-related dementias (ADRDs). The ADRD 2013 research recommendations that resulted are part of the National Plan to Address Alzheimer's Disease. This FOA addresses the National Plan's highest priority for human-based research on vascular contributions to cognitive impairment and dementia (VCID): to develop noninvasive markers of key vascular processes related to VCID in Alzheimer's and related dementias. The research program initiated here underscores the need to facilitate the development of biomarkers to improve the efficiency and outcome of Phase II and III clinical trials and advance therapeutic development. These companion FOAs (RFA-NS-16-019, i.e. this FOA; and RFA-NS-16-020 for the Biomarkers Development Projects) establish the Small Vessel VCID Biomarkers Consortium, and are focused on small vessel (i.e. arterioles, capillaries, and venules) VCID in vascular cognitive impairment (VCI), vascular dementia, and all mixed and pure cognitive impairment and dementias with contributing small vessel vascular disease, including such as commonly occurs in sporadic Alzheimer's disease. Awards funded under these two FOAs create a consortium and infrastructure to complete development projects as well as planning that will enable follow-up activities (to be carried out under future separate funding; for example large scale multi-site validation studies and other activities, for future FDA qualification of small vessel VCID biomarkers and use in clinical trials).

The FY20 GWIRP Therapeutic/Biomarker Trial Award supports large-scale, pivotal (e.g., Phase IIb-III) clinical trials that will revolutionize the clinical management of GWI. The Therapeutic/Biomarker Trial Award targets the "Confirmation" phase of the research pipeline as outlined in Section II.A.2. The proposed research should lead to an approach that is fundamentally better than interventions already approved or in clinical development. Objective biomarkers to measure the biological effect of an investigational therapeutic or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual Gulf War Veteran or Gulf War Veteran subgroup must be included in the trial design. Development of markers for the purposes of diagnosis, prognosis, or measurement of disease progression without consideration of the therapeutic development process will not be supported.

This Funding Opportunity Announcement (FOA) will support extramural research to investigate and mitigate challenges facing clinical assay development due to biopsy biospecimen preanalytical variability. The program will tie in with current efforts to optimize clinical biomarker assays utilized in NCI-sponsored clinical trials. Results from this research program will improve the understanding of how biopsy collection, processing, and storage procedures may affect all aspects of analytical performance for current and emerging clinical biomarkers, as well as expedite clinical biomarker assay development through the evidence-based standardization of biopsy handling practices. Critical information gained through these research awards may increase the reliability of clinical biomarker assays, reduce time requirements for assay development, and decrease assay failure during late-stage testing.

Clinical trials for Alzheimer's disease and related dementias have been hindered, in part, by the limited number of biomarkers available to (1) accurately diagnose these diseases; (2) enrich and stratify patient cohorts; (3) demonstrate target engagement for novel therapeutics; and (4) reliably monitor disease progression and response to treatment. While currently available biomarkers have helped to accelerate clinical trials, most are either expensive, invasive, or both, and only provide information on a small number of disease targets. Therefore, additional biomarkers are needed to provide a more complete picture of the disease.

Clinical trials for Alzheimer's disease and related dementias have been hindered, in part, by the limited number of biomarkers available to (1) accurately diagnose these diseases, (2) enrich and stratify patient cohorts, (3) demonstrate target engagement for novel therapeutics, and (4) reliably monitor disease progression and response to treatment. While currently available biomarkers have helped to accelerate clinical trials, most are either expensive, invasive, or both, and provide information on a small number of disease targets. Thus, additional biomarkers are needed to provide a more complete picture of the disease.

The aim of this RFP is to develop biomarkers for which there is a clear clinical need in Alzheimer's disease and related dementias. Specifically, this RFP focuses on: - developing novel PET ligands for clinical use - supporting novel CSF biomarkers - validating established MRI approaches in larger cohorts Novel biomarkers of neuroinflammation and synaptic integrity are considered high priority. Other target areas of interest include: - Neuronal loss - Vascular injury and blood-brain barrier integrity - Mitochondria and metabolic function - Protein misfolding/proteostasis - Oxidative stress - White matter changes - Other novel targets supported by compelling biological rationale and connection to disease The ADDF has limited interest in CSF measures of amyloid and tau.

The purpose of this funding opportunity announcement (FOA) is to 1) expand the collection of clinical data and biological specimens in the NINDS Parkinsons Disease Biomarkers Program (PDBP), a community research resource, to include data from patients with Lewy Body Dementias (including Dementia with Lewy Bodies and Parkinson's Disease with Dementia), and 2) to support hypothesis-driven clinical research to discover biomarkers that will improve the efficiency and outcome of Phase II clinical trials for the Lewy Body dementias and to provide an expansion of this existing research resource center for dissemination of information and access by the scientific community for further advancing research in this field. Applications may include both of these goals if justified.

The purpose of this funding opportunity announcement (FOA) is to 1) expand the collection of clinical data and biological specimens in the NINDS Parkinsons Disease Biomarkers Program (PDBP), a community research resource, to include data from patients with Lewy Body Dementias (including Dementia with Lewy Bodies and Parkinson's Disease with Dementia), and 2) to support hypothesis-driven clinical research to discover biomarkers that will improve the efficiency and outcome of Phase II clinical trials for the Lewy Body dementias and to provide an expansion of this existing research resource center for dissemination of information and access by the scientific community for further advancing research in this field. Applications may include both of these goals if justified.

The Chronic Kidney Disease Biomarkers Consortium [CKD BioCon] was established in September 2009 as a result of RFA-DK-08-015 [Chronic Kidney Disease Biomarker Discovery and Validation Consortium (U01)] to develop, validate and qualify biomarkers based on existing biosamples from well-characterized CKD patients with longitudinal follow-up. The second phase of the CKD BioCon was funded in September 2014, pursuant to RFA-DK-14-011.  Two additional Centers were brought into the Consortium in 2015.  The CKD BioCon currently consists of eight Participating Clinical Centers (PCCs) and is actively engaged in multiple research protocols.

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-driven research to discover human biomarkers in Parkinsons disease and other Parkinsonian syndromes, as a component of the NINDS Parkinsons Disease Biomarkers Program (PDBP). This FOA encourages biomarkers discovery projects in 1) genetically causal Parkinson's disease, especially for particular sub-types of Parkinson's Disease (PD), including genetic cohorts, biologically defined cohorts of idiopathic PD, or ethnic subgroups of idiopathic PD; 2) The differentiation of synucleinopathies (such as PD and Multiple System Atrophy (MSA) from tauopathies (such as Progressive Supranuclear Palsy and Corticobasal degeneration); or 3) to improve diagnostic differentiation between idiopathic/subtypes of PD and these disorders, as well as from Essential tremor. In order to further advance research in this area, broad sharing of biospecimens and associated data is a critical feature of the PDBP generally and of this FOA specifically. A timeline including milestones, which will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years, is required for all studies.

his Funding Opportunity Announcement (FOA) invites research project (R01) applications that combine imaging and biomarkers. The overall objective of this FOA is to facilitate collaborative imaging and biomarker research to improve cancer screening, early cancer detection and diagnosis by integrating multi modality imaging strategies and multiplexed biomarker methodologies.

This Request for Proposal (RFP) seeks to support the development and validation of novel and existing biomarkers that will enhance the design and performance of clinical trials for Alzheimer's disease, related dementias, and cognitive aging. More accurate and comprehensive biomarkers will improve patient selection and pharmacodynamic measurements, and provide additional tools for early detection and accurate diagnosis.