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The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers (ICs). Specifically, the program seeks to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs outside the NIH), and by providing support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting clinical research projects in collaboration with NIH intramural investigators.

The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers (ICs). Specifically, the program seeks to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs outside the NIH), and by providing support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting clinical research projects in collaboration with NIH intramural investigators.

Through this I-Corps at NIH program Funding Opportunity Announcement (FOA), NIH and CDC provide administrative supplement awards to active SBIR (NIH and CDC) and STTR Phase I (NIH only) grantees/awardees. The I-Corps at NIH mission is to empower entrepreneurs in developing and validating a strategic business model through diverse customer discovery in order to meet unmet clinical needs. I-Corps enables and accelerates the transformation of invention to impact SBIR and STTR Phase I awardees in a no-cost extension are eligible as long as, if selected, their no cost extension covers the entire duration of I-Corps at NIH cohort. The program provides three-member project teams with access to instruction and mentoring to accelerate the translation of technologies currently being developed with NIH and CDC SBIR and STTR funding. It is anticipated that outcomes for the I-Corps teams participating in this program will include significantly refined commercialization plans and well-informed pivots in their overall commercialization strategies. Prospective applicants are strongly encouraged to contact Scientific/Research staff for more information about the program before applying.

This FOA invites applications from multidisciplinary teams to perform secondary data analysis, using existing datasets from two or more multi-site clinical research projects, to address scientific and clinical hypotheses relevant to neurological disorders and conditions within the NINDS mission. In this phased funding mechanism, applications are required to systematically and comprehensively perform cross-project data harmonization and curation, assessed using Go/No-go data-quality metrics, prior to funding of the second phase of data analyses. Consistent with the FAIR (findable, accessible, interoperable and reusable) data principles, this funding opportunity expects open-source cataloging of the processes and tools used for harmonization, curation, and analysis, as well as controlled access to the curated datasets.

The purpose of this FOA is to provide investigators with a mechanism to access contract research/medical organizations (CROs/CMOs) and subject matter experts (SMEs) within the NINDS Ultra-Rare Gene-based Therapy (URGenT) Network to support planning, manufacturing, and limited nonclinical therapeutic development efforts.

The Ultra-Rare Gene-Based Therapy (URGenT) network supports Investigational New Drug (IND)-enabling studies and planning activities for First-in-Human (FIH) clinical testing of gene-based or transcript-directed therapeutics, such as oligonucleotides and viral-based gene therapies, for ultra-rare neurological or neuromuscular disorders. The goal of this funding opportunity announcement (FOA) is to accelerate the development of a promising clinical candidate with robust biological rationale and demonstrated proof of concept (POC) data for the intended approach in a model system relevant to a specified patient population towards an IND filing and the initiation of a clinical trial.

Functional Neurological Disorders (FNDs) are characterized by symptoms of altered voluntary motor or sensory function with clinical findings providing evidence of incompatibility between the symptoms and recognized neurological or medical conditions. FNDs are highly prevalent and associated with significant morbidity, health care costs, and even mortality. In some respects, this group of conditions sits at the intersection of neurology and psychiatry, but the majority of cases first come to the attention of neurologists. Management is complex and requires interdisciplinary approaches. Given the disability caused by the symptoms, and the high cost in healthcare utilization and loss of productivity, FNDs amount to a significant missed opportunity for therapeutic intervention and therefore, a healthcare crisis. Diagnosis and management of FNDs remain very challenging. Diagnostic criteria have been proposed but they are not universally agreed upon. Diagnosis is based on positive clinical findings, and can be supported by laboratory or ancillary investigation findings. Certain FND subtypes are more difficult to correctly diagnose than others. More importantly, laboratory-supported diagnosis is possible, and biomarkers can be developed, but significantly more research is needed in these areas to advance clinical management of FNDs. Therapies exist and have been studied in select populations but gathering high-level evidence through clinical trials is hampered by limitations in available outcome measures. Differential responses to treatments have been recorded, and thus, prediction of aggregate treatment response has been difficult. This FOA invites researchers to submit prospective clinical projects that address critical needs for clinical trial readiness in FNDs. Projects appropriate for this FOA include the validation of biomarkers, endpoints and clinical outcome assessments (COA) that are fit-for-purpose and have a defined context of use for clinical trials.

This funding opportunity announcement (FOA) invites research projects that seek to explain the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in human health, illness, recovery, and overall wellbeing. Types of projects submitted under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical and/or behavioral outcomes in humans to understand fundamental aspects of phenomena related to social connectedness and isolatedness. NIH considers such studies as prospective basic science studies involving human participants that meet the NIH definition of basic research and fall within the NIH definition of clinical trials (see, e.g., NOT-OD-19-024) Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Applications proposing studies that include but not limited to model animal research or observational studies involving humans should submit under the companion Clinical Trials Not Allowed version of this FOA.

This funding opportunity announcement (FOA) invites research projects that seek to model the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in health, illness, recovery, and overall wellbeing. Both animal and human subjects research projects are welcome. Researchers proposing basic science experimental studies involving human participants should consider the companion FOA TEMP-14931 "Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Basic Experimental Studies with Humans Required)".

The purpose of this FOA is to provide support for institutional research training programs in Alzheimers Disease/Alzheimers Disease-Related Dementias (AD/ADRD). These institutional research training programs should produce well-trained neuroscientists who leave the program with the research skills and scientific knowledge to make a significant contribution to research on AD/ADRD cognitive impairment and dementia. Programs should be designed to enhance the breadth and depth of training across the spectrum AD/ADRD research areas (e.g. AD, Vascular Contributions to Cognitive Impairment and Dementia (VCID), Lewy Body Dementia (LBD), Fronto-temporal Dementia (FTD) and mixed dementias) by incorporating didactic, research and career development components within this theme into a program that fosters exceptional research skills and knowledge. Programs may support basic, clinical and/or translational research. Programs supported by this FOA must include formal components to ensure a thorough understanding of experimental design, statistical principles and methodological approaches, analytical skills, and skills for communicating science, both orally and in writing, to a wide variety of audiences. All programs are expected to design and/or provide opportunities and activities that will foster the development of quantitative literacy and the application of quantitative approaches to the trainees' research. These training programs are intended to be 2 years in duration and support training of one or more of the following groups: dissertation stage predoctoral students in their 3rd and/or 4th year of graduate school, postdoctoral fellows and fellowship-stage clinicians. (NINDS does not support first or second year graduate students under this FOA).