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The National Eye Institute (NEI) announces the reissue of PAR-10-281, "Translational Research Program (TRP) on Therapy for Visual Disorders". This program focuses on the development of novel therapies to treat visual diseases and disorders. In the context of this program, an expert develops a multi-disciplinary research team that applies an integrative approach to develop rapid and efficient translation of innovative laboratory research findings into clinical therapeutic development. It involves collaborative teams of scientists and clinicians with expertise in multiple disciplines, operating according to a clear leadership plan. Such a collaborative approach is particularly appropriate for research focused on pathways that will likely be targeted by biological intervention, such as gene therapy, cell-based therapy, and pharmacological approaches. The intention of this program is to make resources available to scientists from several disciplines to address scientific and technical questions that would be beyond the capabilities of any one research group.

In recent years, somatic cells as therapeutic agents have provided new treatment approaches for a number of pathological conditions that were deemed untreatable, or difficult to treat. Several successful cell therapies using T cells have been demonstrated for cancer and autoimmune diseases, while stem cell therapies have given relief for heart disease and stroke. Hundreds of clinical trials are ongoing to examine efficacy of cell therapies for a variety of other diseases including diabetes, Alzheimer's, Parkinson's, and Crohn's disease. Production of therapeutic cells is currently expensive and, therefore, cost prohibitive for the large number of people who might benefit from these treatments. The overarching goal of this Advanced Biomanufacturing of Therapeutic Cells (ABTC) solicitation is to catalyze well-integrated interdisciplinary research to understand, design, and control cell manufacturing systems and processes that will enable reproducible, cost-effective, and high-quality production of cells with predictable performance for the identified therapeutic function.

In recent years, somatic cells as therapeutic agents have provided new treatment approaches for a number of pathological conditions that were deemed untreatable, or difficult to treat. Several successful cell therapies using T cells have been demonstrated for cancer and autoimmune diseases, while stem cell therapies have given relief for heart disease and stroke. Hundreds of clinical trials are ongoing to examine efficacy of cell therapies for a variety of other diseases including diabetes, Alzheimer's, Parkinson's, and Crohn's disease. Production of therapeutic cells is currently expensive and, therefore, cost prohibitive for the large number of people who might benefit from these treatments. The overarching goal of this Advanced Biomanufacturing of Therapeutic Cells (ABTC) solicitation is to catalyze well-integrated interdisciplinary research to understand, design, and control cell manufacturing systems and processes that will enable reproducible, cost-effective, and high-quality production of cells with predictable performance for the identified therapeutic function.

The purpose of this FOA is to stimulate development of translation-enabling models for evaluating survival and integration of regenerated photoreceptors (PRCs) and retinal ganglion cells (RGCs) in model systems that are closer to human visual anatomy, function and/or disease than current models. The development of these models, tools, devices, novel therapies and/or other resources is expected to provide a resource to vision researchers developing cell-replacement therapies for visual system diseases and disorders. This FOA seeks to develop models that emulate critical aspects of a human blinding disease that might be amenable to regenerative therapy. The model system might involve specific defects generated by transgenic gene insertion and/or deletion, gene editing, chemical/physical means, and/or other approaches to emulate characteristics of human disease or create defects amenable to cell-replacement therapy. Model systems using non-human primates or other cone-dominant species that are more representative of the anatomy and physiology of the human retina are highly encouraged. Other biological models are acceptable provided they meet the overall objectives of the FOA.

The purpose of this FOA is the rapid and efficient translation of innovative laboratory research findings into therapies, devices or other resources for use by clinicians to treat visual system diseases or disorders. Multidisciplinary teams of scientists and clinicians will focus on generating preclinical data that will lead to the development of biological interventions, such as gene therapy, cell-based therapy, pharmacological approaches, and/or medical devices. The ultimate goal of this program is to make technological, biological and pharmacological resources available to clinicians and their patients.

The purpose of this FOA is the rapid and efficient translation of innovative laboratory research findings into therapies, devices or other resources for use by clinicians to treat visual system diseases or disorders. Multidisciplinary teams of scientists and clinicians must focus on generating preclinical data that will lead to the development of biological interventions, such as gene therapy, cell-based therapy, pharmacological approaches, and/or medical devices. The ultimate goal of this program is to make technological, biological and pharmacological resources available to clinicians and their patients. Each project should have a well-defined end-point, achievable within a five-year time frame, of developing a device or treatment for a specific ocular disease.

This Funding Opportunity Announcement (FOA) encourages research project applications under the cooperative agreement (UG3/UH3) mechanism to address the development, optimization and validation of quantitative imaging (QI) software tools and methods for prediction and/or measurement of response to cancer therapies or for planning and validating radiation therapy treatment strategies in clinical trials. The scientific scope of this FOA includes: · Development and optimization of QI tools and/or methods for treatment planning, predicting or measuring response to therapy as open source tools that will translate into clinical trial decision support; · Validation of the optimized tools in clinical settings to demonstrate their value for decision support in ongoing single-site or multi-site clinical trials. A phased approach that emphasizes each of these activities must be proposed. Investigators must apply for both the UG3 and UH3 phases together in the single application. The UG3 effort is to be used for the development and optimization of QI tools and methods chosen for study by the investigating team, while the UH3 phase is for the validation of the tools/methods developed in the UG3 phase. The UG3 phase can be no more than 2 years in duration, and the total project cannot exceed 5 years. At completion, UG3 projects will be reviewed by program staff. Those that have met their milestones may be administratively considered by NCI program staff for transition to the UH3 validation phase.

The goal of the Biophotonics program is to explore the research frontiers in photonics principles, engineering and technology that are relevant for critical problems in fields of medicine, biology and biotechnology.  Fundamental engineering research and innovation in photonics is required to lay the foundations for new technologies beyond those that are mature and ready for application in medical diagnostics and therapies.  Advances are needed in nanophotonics, optogenetics, contrast and targeting agents, ultra-thin probes, wide field imaging, and rapid biomarker screening. Low cost and minimally invasive medical diagnostics and therapies are key motivating application goals.

The goal of the Biophotonics program is to explore the research frontiers in photonics principles, engineering and technology that are relevant for critical problems in fields of medicine, biology and biotechnology.  Fundamental engineering research and innovation in photonics is required to lay the foundations for new technologies beyond those that are mature and ready for application in medical diagnostics and therapies.  Advances are needed in nanophotonics, optogenetics, contrast and targeting agents, ultra-thin probes, wide field imaging, and rapid biomarker screening. Low cost and minimally invasive medical diagnostics and therapies are key motivating application goals. 

Morton Cure Paralysis Fund (MCPF) is committed to developing effective therapies (cures) for paralysis associated with spinal cord injury and other disorders of the central nervous system (CNS).  MCPF funds activities that hold promise of identifying therapies (cures) for paralysis in humans. MCPF has particular focus of placing projects in the research pipeline that is, enabling scientists to develop the proof concept data necessary to apply for larger NIH grants. MCPF has particular focus of placing projects in the research pipeline that is, enabling scientists to develop the proof concept data necessary to apply for larger NIH grants. The development of effective therapies for chronic injury is a high priority for the organization. Basic research will be supported if it has clear potential to accelerate progress at the applied end of the continuum and/or if it reflects innovative research or a 'change of direction.

The goal of the Biophotonics program is to explore the research frontiers in photonics principles, engineering and technology that are relevant for critical problems in fields of medicine, biology and biotechnology.  Fundamental engineering research and innovation in photonics is required to lay the foundations for new technologies beyond those that are mature and ready for application in medical diagnostics and therapies.  Advances are needed in nanophotonics, optogenetics, contrast and targeting agents, ultra-thin probes, wide field imaging, and rapid biomarker screening. Low cost and minimally invasive medical diagnostics and therapies are key motivating application goals.

The goal of the Biophotonics program is to explore the research frontiers in photonics principles, engineering and technology that are relevant for critical problems in fields of medicine, biology and biotechnology.  Fundamental engineering research and innovation in photonics is required to lay the foundations for new technologies beyond those that are mature and ready for application in medical diagnostics and therapies.  Advances are needed in nanophotonics, optogenetics, contrast and targeting agents, ultra-thin probes, wide field imaging, and rapid biomarker screening. Low cost and minimally invasive medical diagnostics and therapies are key motivating application goals.

The purpose of this Funding Opportunity Announcement (FOA) is to invite cooperative agreement (U01) applications that propose studies to enhance pre-clinical in vitro and in vivo testing of NCI-prioritized molecularly targeted anti-cancer agents for use with radiation therapy combined with systemic chemotherapy. These studies should generate validated high-quality preclinical data on the effects of molecular therapeutics when added to standard-of-care therapies for solid tumors. The specific purpose is to provide a more rational basis for prioritizing those NCI-supported investigational new drugs or agents (INDs) most likely to have clinical activity with chemo-radiotherapy. The overall goal is to accelerate the pace at which combined modality treatments with greater efficacy are identified and incorporated into standard practices for treatments of patients with solid tumors.

The purpose of this Funding Opportunity Announcement (FOA) is to invite cooperative agreement (U01) applications that propose studies to enhance pre-clinical in vitro and in vivo testing of NCI-prioritized molecularly targeted anti-cancer agents for use with radiation therapy combined with systemic chemotherapy. These studies should generate validated high-quality preclinical data on the effects of molecular therapeutics when added to standard-of-care therapies for solid tumors. The specific purpose is to provide a more rational basis for prioritizing those NCI-supported investigational new drugs or agents (INDs) most likely to have clinical activity with chemo-radiotherapy. The overall goal is to accelerate the pace at which combined modality treatments with greater efficacy are identified and incorporated into standard practices for treatments of patients with solid tumors.

Cell-based therapies, especially immune cells, have the potential to revolutionize human healthcare in various different contexts, including cancer and personalized medicine. For example, CAR (Chimeric antigen receptor) T-cell therapy for cancer requires modification, in vitro culture and expansion of human T-cells.   Manufacturing of therapeutic cells as the end product presents major engineering challenges.  New therapies and cell-based products depend critically on the development of robust, reliable and reproducible biomanufacturing technologies.

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

The Foundation Fighting Blindness, the world's leading organization searching for treatments and cures for inherited retinal diseases, is launching a new Translational Research Acceleration Program (TRAP) to help advance vision-saving research toward the clinical usage. The Foundation is accepting applications for retinal degeneration treatment approaches, including but not limited to: genetic therapies, regenerative treatments, and novel medical therapies. There are a variety of TRAP grant mechanisms that can provide up to $1.5 million in funding over three years.

The purpose of this FOA is to solicit applications for an Epilepsy Center without Walls (CWOW) focused on collaborative preclinical and clinical research to prepare for translational and clinical development of disease modifying or prevention therapies for epilepsy. An additional goal is to develop community partnerships and community resources to advance development of such therapies.   

The ALS Therapy Alliance was established in 2000 to facilitate ALS research projects and collaborations among a diverse group of scientists and clinicians at multiple institutions working to cure amyotrophic lateral sclerosis. The alliance represents a unique collaborative enterprise that spans multiple laboratories, universities, and disciplines.   Today, the ATA partners with corporations, biotech and pharmaceutical firms, manufacturers, and the media to create awareness and raise funds for ALS research through its annual Breakthrough ALS campaign. To date, more than $30 million has been raised to fund research for finding a cure for this devastating disease.   The ALS Therapy Alliance is accepting applications from investigators for ALS research projects. Grants ranging from $100,000 to $1 million over one to three years will be awarded to projects -- including but not limited to basic, clinical, and translational research and clinical trials - aimed at developing a better understanding of, or treatments for, ALS.   National and international nonprofit organizations and for-profit companies are eligible to apply.

The purpose of this funding opportunity announcement (FOA) is to promote the discovery of novel small molecules that may enhance the ability of the immune system to selectively recognize and attack cancer cells. These small molecules could be further developed into stand-alone immunotherapeutics or synergistic partners for existing therapies, or as chemical probes for the discovery and validation of novel targets involved in anti-tumor immunity. Investigators from multiple scientific disciplines (immuno-oncology, tumor biology, screening technology, medicinal chemistry, and pharmacology) are encouraged to establish collaborative teams to discover and develop novel small molecule immunomodulators for cancer therapy. This FOA encourages the design of research projects that utilize the following phases of discovery research: 1) assay development specifically designed for immuno-oncology targets with the intent to screen for novel small molecule compounds that show potential as either probes or drugs, or as pre-therapeutic leads; 2) screen implementation for immunomodulatory targets to identify initial screening hits (from high throughput target-focused approaches or moderate throughput phenotypic- and fragment-based approaches); 3) hit validation through secondary orthogonal and counter screening assays, and hit prioritization; and 4) hit-to-lead optimization.

The purpose of this funding opportunity announcement (FOA) is to promote the discovery of novel small molecules that may enhance the ability of the immune system to selectively recognize and attack cancer cells. These small molecules could be further developed into stand-alone immunotherapeutics or synergistic partners for existing therapies, or as chemical probes for the discovery and validation of novel targets involved in anti-tumor immunity. Investigators from multiple scientific disciplines (immuno-oncology, tumor biology, screening technology, medicinal chemistry, and pharmacology) are encouraged to establish collaborative teams to discover and develop novel small molecule immunomodulators for cancer therapy. This FOA encourages the design of research projects that utilize the following phases of discovery research: 1) assay development specifically designed for immuno-oncology targets with the intent to screen for novel small molecule compounds that show potential as either probes or drugs, or as pre-therapeutic leads; 2) screen implementation for immunomodulatory targets to identify initial screening hits (from high throughput target-focused approaches or moderate throughput phenotypic- and fragment-based approaches); 3) hit validation through secondary orthogonal and counter screening assays, and hit prioritization; and 4) hit-to-lead optimization.

Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) seeks research project (R01) grant applications describing projects that integrate imaging and fluid-based tumor monitoring (liquid biopsy) assays during cancer therapy in patients to determine the optimal use of those modalities in the characterization of therapy response and/or emergence of resistance.

The purpose of this Funding Opportunity Announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The projects must focus on products related to the mission and goals of the NIDDK and may evaluate drugs, biologics, or devices, as well as surgical, behavioral or rehabilitation therapies. The purpose of this Funding Opportunity Announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The projects must focus on products related to the mission and goals of the NIDDK and may evaluate drugs, biologics, or devices, as well as surgical, behavioral or rehabilitation therapies.

The objective of FDA's Orphan Products Natural History Grants Program is to support studies that characterize the natural history of rare diseases/conditions, identify genotypic and phenotypic subpopulations, and develop and/or validate clinical outcome measures, biomarkers and/or companion diagnostics. The ultimate goal of these natural history studies is to support clinical development of products for use in serious rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products. Applicants must include in the application's Background and Significance section documentation to support that the estimated prevalence of the orphan disease or condition in the US is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the US per year), and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.  Additional information may be required upon request, for example, regarding population estimate and rationale.