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Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)

3 weeks 1 day ago
Funding Opportunity RFA-TR-24-023 from the NIH Guide for Grants and Contracts. This notice of funding opportunity (NOFO) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning.

Kidney Technology Development Research Education Program (R25 - Independent Clinical Trial Not Allowed)

3 weeks 1 day ago
Funding Opportunity RFA-DK-25-009 from the NIH Guide for Grants and Contracts. This NOFO encourages applications from institutions that propose to establish research experiences in kidney technology development. Successful programs should include a collaborative capstone research or design project(s), innovative and/or ground-breaking technology development, multidisciplinary/interdisciplinary teamwork, education in entrepreneurship, product development and navigating regulatory pathways, and clinical immersion. The intent of this NOFO is to recruit undergraduate students as participants and to engage students from engineering and technical domains, but applicants may also propose the inclusion of medical students, graduate students and/or dual-degree students (e.g., M.D./Ph.D.; Pharm.D./Ph.D.) prior to their qualifying exams and selection of Ph.D. mentor.

Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional)

3 weeks 2 days ago
Funding Opportunity RFA-MH-25-190 from the NIH Guide for Grants and Contracts. The purpose of this phased Notice of Funding Opportunity (NOFO) is to create a pipeline to accelerate the development and early validation of predictive tools and/or biomarkers to inform individual-level treatment selection among two or more existing therapeutics for depression. This phased inter-agency program will be milestone-based and provide support from multi-disciplinary teams to address scientific, technical, clinical, regulatory, and commercialization requirements. In the first phase (UG3), investigators are expected to identify potential tools and/or biomarker(s) that can predict whether a patient will differentially respond to one well-established depression treatment versus another. This could be accomplished using secondary analysis of data from completed clinical trials or using real-world clinical data, or by conducting small, efficient pilot feasibility studies to assess promising new tools or biomarkers to predict individual treatment response to a specific therapeutic for depression. In the second phase (UH3), investigators will conduct independent, prospective clinical trials to initially validate the utility of the tool/biomarker for predicting differential response to established treatments for depression. The overall goal of this NOFO is to support the testing of various tools/biomarkers as predictors of response to well-established depression treatments and halt the development of those tools that do not meet sufficient performance characteristics to justify further testing. Ultimately, tools that are successful in early-stage studies could be further evaluated for future use in decision-making in clinical practice settings.

Medical Rehabilitation Research Resource (P50 Clinical Trial Optional)

3 weeks 2 days ago
Funding Opportunity RFA-HD-25-001 from the NIH Guide for Grants and Contracts. This Notice of Funding Opportunity (NOFO) invites grant applications from institutions/organizations that propose to build a Medical Rehabilitation Research Center. The centers will have a specific rehabilitation research theme and be comprised of a research project supported by 3 cores. The 3 cores will have functions within the center as well as functions nationwide. Together, the cores will support: administrative functions (including an optional pilot program), resource sharing, and community engagement and outreach. The Medical Rehabilitation Research Centers will contribute tomedical rehabilitation research infrastructure by developing and disseminating techniques, data, theories, research programs, and expertise with the goal of enhancing the capability of medical rehabilitation investigators to understand mechanisms of functional recovery, develop therapeutic strategies, identify clinical care gaps, and improve the lives of people with disabilities. Applications must include a plan for inclusion of People with Lived Experience (as a required other attachment) that is relevant to the research theme of the center and increases the potential impact of the center.

NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)

3 weeks 2 days ago
Funding Opportunity PAR-24-173 from the NIH Guide for Grants and Contracts. The objective of this funding opportunity is to support investigator-initiated, Phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training.

Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional)

3 weeks 2 days ago
Funding Opportunity PAR-24-206 from the NIH Guide for Grants and Contracts. The objective of this Notice of Funding Opportunity (NOFO) is to invite new and renewal applications for the Rare Diseases Clinical Research Consortia (RDCRC) that comprise the Rare Diseases Clinical Research Network (RDCRN). The RDCRCs are intended to advance and improve diagnosis, management, and treatment of numerous, diverse rare diseases through highly collaborative, multi-site, patient-centric, translational and clinical research. Special emphasis will be placed on the early and timely identification of individuals with rare diseases and clinical trial readiness.

Immunobiology of Xenotransplantation (U19 Clinical Trial Not Allowed)

3 weeks 3 days ago
Funding Opportunity RFA-AI-24-020 from the NIH Guide for Grants and Contracts. The purpose of this notice of funding opportunity (NOFO) is to solicit applications to participate in the Immunobiology of Xenotransplantation Cooperative Research Program (IXCRP), a multi-center program dedicated to resolving immunologic and physiologic barriers to safe and efficacious xenotransplantation using preclinical pig to nonhuman primate (NHP) or human decedent models of pancreatic islet, kidney, heart, lung, or liver xenotransplantation.

Immunobiology of Xenotransplantation (U01 Clinical Trial Not Allowed)

3 weeks 3 days ago
Funding Opportunity RFA-AI-24-019 from the NIH Guide for Grants and Contracts. The purpose of this notice of funding opportunity (NOFO) is to solicit applications to participate in the Immunobiology of Xenotransplantation Cooperative Research Program (IXCRP), a multi-center program dedicated to resolving immunologic and physiologic barriers to safe and efficacious xenotransplantation using preclinical pig to nonhuman primate (NHP) or human decedent models of pancreatic islet, kidney, heart, lung, or liver xenotransplantation.

Diabetes Research Centers (P30 Clinical Trial Optional)

3 weeks 3 days ago
Funding Opportunity RFA-DK-25-008 from the NIH Guide for Grants and Contracts. This Notice of Funding Opportunity (NOFO) invites applications for Diabetes Research Centers (DRCs) that are designed to support and enhance the national research effort in diabetes, its complications, and related endocrine and metabolic diseases. The purpose of this Centers program is to bring together basic and clinical investigators to enhance communication, multidisciplinary collaboration, and effectiveness of ongoing research in Diabetes Research Center topic areas. By providing shared access to specialized technical resources (research cores) and supporting a Pilot and Feasibility Program (P and F), DRCs are intended to create an environment that provides the capability for accomplishments greater than those that would be possible by individual research project grant support alone. New Center programs that bring in diverse perspectives, propose unique scientific themes, or provide innovative resources are encouraged. Emphasis will be placed on Center programs that propose enhanced synergies with other NIDDK-funded programs as well as providing a rich mentoring environment for future diabetes researchers. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

Discovery of Early Type 1 Diabetes Disease Processes in the Human Pancreas [HIRN Consortium on Beta Cell Death and Survival (CBDS)] (U01 Clinical Trial Not Allowed)

3 weeks 3 days ago
Funding Opportunity RFA-DK-23-007 from the NIH Guide for Grants and Contracts. This Notice of Funding Opportunity (NOFO) requests applications to explore human pancreatic tissues and the immune compartment for the discovery of specific signaling or processing pathways that may contribute to the asymptomatic phase of T1D, the discovery of early biomarkers of T1D pathogenesis, the development of diagnostic tools for the detection and staging of early T1D in at-risk or recently-diagnosed individuals, and/or the identification and biological validation of therapeutic targets for the development of preventative or early treatment strategies. Successful applicants will join the Consortium on Beta Cell Death and Survival (CBDS), whose mission is to better define and detect the mechanisms of beta cell stress and destruction central to the development of T1D in humans, with the long-term goal of protecting the residual beta cell mass in T1D patients as early as possible in the disease process, and of preventing the progression to autoimmunity. The CBDS is part of a collaborative research framework, the Human Islet Research Network (HIRN, https://hirnetwork.org/), whose overall mission is to support innovative and collaborative translational research to understand how human beta cells are lost in T1D, and to find innovative strategies to protect and replace functional beta cell mass in humans. This NOFO will only support studies with a primary focus on increasing our understanding of human disease biology (as opposed to rodent or other animal models). This NOFO will not accept applications proposing a clinical trial.