Group items tagged

The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the validation 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 advanced analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints using retrospective and/or prospective methods. It is assumed that: 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding Context of Use is in place. Research supported by this FOA will ultimately demonstrate that biomarker or endpoint change is reliably correlated with variables such as clinical outcome, pathophysiologic subsets of pain, therapeutic target engagement or response to a pain therapeutic; in addition, biomarker response will demonstrate specificity to the pain condition or therapeutic as demonstrated at multiple clinical sites. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers, biomarker signatures and endpoints of pain to application in clinical trials (Phase II clinical trials and beyond) and in the spectrum of clinical practice.

The purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and validation of novel therapeutic targets to facilitate the development of pain therapeutics. Specifically, the focus of this FOA is on the basic science discovery of targets in the peripheral nervous system, central nervous system, immune system or other tissues in the body that can be used to develop treatments that have minimal side effects and little to no abuse/addiction liability. Research supported by this FOA must include rigorous validation studies to demonstrate the robustness of the target as a pain treatment target. This will lower the risk of adopting the target in translational projects to develop small molecules, biologics, natural substances, or devices that interact with this target for new pain treatments. Translational research to develop new medical devices are not the focus of this FOA. Basic science studies of pain and related systems in the body are responsive to this FOA and are encouraged in the context of novel pain therapeutic target discovery. This FOA is not specific for any one or group of pain conditions. Projects to identify novel targets for acute pain, chronic pain, migraine, other headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, sickle-cell pain, post stroke pain, etc. will be considered. Projects to identify novel targets for a combination of chronic overlapping pain conditions or for specific pathological conditions will be considered. Projects that seek to identify novel targets in specific populations such as women, children, older adults or other underrepresented groups will also be responsive to this FOA.

The Therapeutic Development Award supports research ranging from validation of therapeutic leads through U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)- enabling studies. The proposed studies are expected to be empirical in nature and product- driven. Applicants with limited ALS experience are strongly encouraged to collaborate with those having substantial expertise in ALS research and/or ALS model systems. Examples of activities that will be supported by this award include: Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds Validation of early pilot studies, including the use of multiple ALS model systems and/or replicating preliminary data with more time points or additional doses Studies on formulation and stability leading to Good Manufacturing Practice (GMP) production methods IND-enabling studies, to include compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies in relevant model system

The Therapeutic Development Award supports research ranging from validation of therapeutic leads to U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited ALS experience are strongly encouraged to collaborate with those having substantial expertise in ALS research and/or ALS model systems. Examples of activities that will be supported by this award include: * Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds * Validation of early pilot studies, including the use of multiple ALS model systems and/or replicating preliminary data with more time points or additional doses * Studies on formulation and stability leading to Good Manufacturing Practice (GMP) production methods * IND-enabling studies, to include compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies in relevant model systems Validation of treatment approaches in appropriately powered and controlled studies using biological correlates of disease activity and progression in pre-existing, de-identified human specimens from well-characterized patient cohorts is encouraged. Examples of acceptable cohorts for study include controlled clinical trials, observational studies, and registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://wwwn.cdc.gov/als/).

The focus of this Funding Opportunity Announcement (FOA) is on in vivo human studies, and in vitro studies on human cells or tissues, aimed at potential identification of therapeutic targets or and/or testing of interventions for healthy aging. Potential therapeutic targets include FOXO3 itself and upstream and downstream regulators in pathways mediated by FOXO3. The range of research areas of interest in this FOA includes studies that: 1) examine in vivo phenotypic effects of human FOXO3 variants, and/or 2) elucidate effects of these variants on cellular functions and the pathways that mediate them, and/or 3) identify and evaluate candidate therapeutic targets (e.g., target validation studies, testing of candidate compounds) for potential interventions based on FOXO3 functional pathways. Projects involving whole genome sequencing of new or existing cohorts are outside the scope of this FOA. However, targeted resequencing on a limited sample set in an existing cohort could be supported by this FOA.

Significant advances in the understanding of the pathophysiology and molecular biology of multiple myeloma have identified numerous molecular targets for therapeutic intervention. Immunotherapeutic approaches (e.g., Daratumumab and Elotuzumab) have established themselves in the armamentarium for multiple myeloma, and ongoing adoptive cell therapy trials provide encouraging signs of clinical activity. As immune-based therapeutic agents continue to advance their way through the clinic, there is a critical need for increased understanding of the role that the immune system plays in myeloma disease biology, disease progression, and therapeutic response and resistance. The knowledge developed through this RFP will be critical to fully developing precision immunotherapy for the treatment of myeloma.

Significant advances in the understanding of the pathophysiology and molecular biology of multiple myeloma have identified numerous molecular targets for therapeutic intervention. Immunotherapeutic approaches (e.g., Daratumumab and Elotuzumab) have established themselves in the armamentarium for multiple myeloma, and ongoing adoptive cell therapy trials provide encouraging signs of clinical activity. As immune-based therapeutic agents continue to advance their way through the clinic, there is a critical need for increased understanding of the role that the immune system plays in myeloma disease biology, disease progression, and therapeutic response and resistance. The knowledge developed through this RFP will be critical to fully developing precision immunotherapy for the treatment of myeloma. To that end, MMRF is seeking applications for its MMRF Research Fellows Awards. Through the program, the foundation will support research projects focused on the immune biology of multiple myeloma and precursor disease; rational immune therapy and the immunological basis of response and resistance; next generation adoptive cell therapies; and next generation liquid biopsies and diagnostics.

This Funding Opportunity Announcement (FOA) is dedicated to the discovery of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, and cell therapies) for disorders that fall under the NINDS mission.  It supports the optimization of therapeutic lead(s) showing convincing proof-of-concept.   At the end of the funding period, projects that successfully advance through support from this program will have identified a optimized candidate, which has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, and will be ready for entry into the CREATE Bio Development track for further development to enable filing for an Investigational New Drug (IND).   

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.

(RFA-NS-19-025 is being reissued to accommodate an additional receipt date). The purpose of this funding opportunity announcement (FOA) is to invite applications for the Specialized Clinical Centers (hubs) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIHs Helping to End Addiction Long-term (HEAL) Initiative. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs. EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (hubs). The purpose of this funding opportunity announcement (FOA) is to invite applications for the hubs within EPPIC-Net. A hub will typically be a regional medical center that will actively enroll subjects into clinical trials and studies performed in EPPIC-Net. Each hub should have ready access to patient populations with specific pain conditions and have expertise in characterization of that pain condition. A hub will additionally provide scientific leadership and administrative oversight to its multiple (2-10) satellite sites (spokes). This FOA solicits applications EPPIC-Net Specialized Clinical Centers. Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-18-036) and Data Coordinating Center (RFA-NS-18-035). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL Partnership, as described above, or from separate NIH funding announcements.

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Specialized Clinical Centers ("hubs") of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIH's Helping to End Addiction Long-term (HEAL) Initiative. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in-depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs.

The Orphan Disease Center works with closely with community organizations, the biotech community, and researchers to improve therapeutic treatment options for those afflicted with orphan diseases. Oftentimes genetic, orphan diseases are conditions that affect fewer than two hundred thousand individuals nationwide. Due to their relative rarity, research and funding for these conditions is largely unmet. In support of this mission, the center has partnered with the LouLou Foundation, a pioneer in CDKL5 research, and is accepting applications for the CDKL5 Program of Excellence Pilot Grant Program. Through the program, grants of up to $150,000 will be awarded in support of research focused on treatments for CDKL5 Deficiency Disorder. Those with CDD suffer from treatment-resistant seizures, severe cognitive and motor disability, as well as sensory problems. Because there are many knowledge gaps in CDKL5 research, the foundation is interested in any basic research with the potential to contribute to future treatment options. Priority areas established by the foundation include innovative therapeutic approaches for CDD, systems biology and computational modeling approaches, novel applications of functional techniques, and discovery and validation of CDKL5 biomarkers.

The overall goal of this initiative is to identify neurophysiological measures potential assays for treatment development research. The funding opportunity announcement (FOA) will support efforts to optimize and evaluate measures of neurophysiological processes that are disrupted within or across mental disorders in both healthy humans and in another species relevant to the therapeutic development pipeline. The initiative will support initial proof of concept studies aimed at identifying measures for potential development as preclinical assays for evaluating potential new drug and device therapies and their targets. Data will also reveal assay measures where the performance between preclinical animal species and humans is dissimilar, thus establishing a firm basis for limiting speculative extrapolations of preclinical animal findings to humans. The ultimate practical goal of this FOA is to improve the efficiency of the therapeutic development process by identifying coherence of measures and inconsistencies between the preclinical screening pipeline and clinical evaluation of new treatment candidates and thereby hasten the development of more effective treatments for mental disorders.

This FOA provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological disorders that fall under the NINDS mission. Therapeutic agents may include but are not limited to small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the NINDS Cooperative Research to Enable and Advance Translational Enterprises for Biologics program (CREATE Bio) program for biologics, biotechnology products, Blueprint Neurotherapeutics Network for small molecules, or other translational programs.

This Funding Opportunity Announcement (FOA) encourages Small Business Technology Transfer (STTR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for disorders that fall under the mission of NIAAA.  An identified candidate, having 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 prior to application. The FOA supports Investigational New Drug (IND)-enabling studies for the therapeutic candidate. At the end of the funding period, a successful project should have, at a minimum, an IND application submitted to the U.S. Food and Drug Administration (FDA). The program supports early-phase clinical trials, although these are not required. Also listed under U44

This Catalyze Product Definition Funding Opportunity Announcement (FOA) will provide the early stage translational support needed to identify and characterize potential therapeutic candidates to treat heart, lung, blood, and sleep diseases and disorders. This FOA is part of a suite of Catalyze innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical program or attract independent development support from other federal or private partners for preclinical optimization and development of therapeutic agents.

This Funding Opportunity Announcement (FOA) will provide the early stage translational support needed to identify a lead compound series toward development of potential therapeutic agents to treat heart, lung, blood, and sleep diseases and disorders. This FOA is part of a suite of Catalyze innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical program or attract independent development support from other federal or private partners for preclinical optimization and development of therapeutic agents.

Program Description: In recent years, the National Endowment for the Arts' research agenda has focused on yielding new knowledge about the value and impact of the arts. Through the National Endowment for the Arts Research Labs (NEA Research Labs), we seek to extend this agenda and its impact by cultivating a series of transdisciplinary research partnerships, grounded in the social and behavioral sciences, to produce and report empirical insights about the arts for the benefit of arts and non-arts sectors alike. Each NEA Research Lab will define its own research agenda, conduct a research program to implement that agenda, and prepare reports that will contribute substantively to a wider understanding of one of three areas of special interest to the National Endowment for the Arts: 1. The Arts, Health, and Social/Emotional Well-Being a. Therapeutic Approaches and Benefits b. Non-Therapeutic Approaches and Benefits 2. The Arts, Creativity, Cognition, and Learning 3. The Arts, Entrepreneurship, and Innovation We anticipate that a sustained engagement with these topic areas, and with the corresponding research questions we frame below, will have distinctive benefits not only for the arts community, but also for sectors such as healthcare, education, and business or management.

NIMH seeks applications for research projects to evaluate the effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions affecting youth, adults, and older adults. This FOA encourages clinical trials to establish the effectiveness and test hypotheses regarding moderators, mediators, and mechanisms of action of post-acute phase therapeutic and services interventions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden for promoting optimal longer-term outcomes.

NIDDK requests applications to join a new research consortium "Microphysiological Systems (MPS) for Modeling Diabetes (MPS-MOD)". NIDDK will support the development and validation of human tissue chips that closely mimic the normal physiology of key metabolic tissues, including the pancreatic islet, liver, skeletal muscle, and white adipose tissue (WAT). Experimental designs for the MPS-MOD platforms should incorporate strategies to measure pathophysiological changes associated with metabolic disease, including the impact of immune cells on metabolic dysfunction. Once developed, these multi-dimensional MPS-MOD platforms will serve as the foundation for NIDDK's advanced strategy to identify new and novel therapeutics for diabetes. The utility and validity of model systems developed under this initiative will be measured, in part, through the ability of known diabetes therapeutic agents and biomarkers to influence biology of the system, using best practices and rigorous study design. The need for high-quality, well-characterized isogenic/patient derived iPSC (induced pluripotent stem cell) lines and standardized differentiation procedures is a critical step in turning disease-specific lines into tools for discovery. In the future, iPSC-based human tissue chips could play a central role in drug development, testing, screening, drug repurposing and toxicity testing.