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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.

The Investigator-Initiated Translational Research Award (IITRA) supports translational research that will develop promising ideas in lung cancer into clinical applications. Translational research may be defined as an integration of basic science and clinical observations. Observations that drive a research idea may originate from a laboratory discovery, population-based studies, or a clinician's firsthand knowledge of patient care. The ultimate goal of translational research is to move a concept or observation forward into clinical application. However, Principal Investigators (PIs) should not view translational research as a one-way continuum from bench to bedside. The research plan must involve a reciprocal flow of ideas and information between basic and clinical science. This mechanism is intended to fund a broad range of translational studies, including, but not limited to, the following: * Studies advancing/translating in vitro and/or animal studies to applications with human samples/cohorts. * Late-stage preclinical work leading to/preparing for a clinical trial, e.g., Investigational New Drug (IND) application submission. * Correlative studies that are associated with an ongoing or completed clinical trial and projects that develop endpoints for clinical trials. Preliminary data to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of lung cancer.

This announcement encourages exploratory research applications aimed at investigating the role environmental exposures play in the development and/or the exacerbation of autoimmune disease. Applicants may propose to use in vitro studies or animal models to explore possible mechanisms in which environmental exposures associated with human autoimmune endpoints are involved in the induction of an autoimmune response or an autoimmune disease. Of particular interest are projects that will identify and characterize critical windows of exposure susceptibility, projects that explore mechanisms responsible for gender differences in response and development of autoimmune disease, and studies that can produce potential biomarkers for use in subsequent human surveillance studies.

The goal of the Pancreatic Cancer Action Network-AACR Research Acceleration Network (RAN) Grants is to provide funding and strategic assistance to research projects with the potential to double survival for pancreatic cancer by the year 2020. These projects must be implemented by a multi-institutional team and include a clinical component with an endpoint relevant to improving the detection or treatment of pancreatic cancer. The RAN Grants will provide $1,000,000 in funding for direct and indirect expenses related to the research project over a one- to three-year time frame. In addition to the grant, the Pancreatic Cancer Action Network will provide strategic project management support to help optimize project implementation and progress during the grant term.

The goal of a Bioengineering Research Partnership (BRP) is to drive the development and speed the adoption of promising tools and technologies that can address important biomedical problems for which insufficient or no solutions exist.  The use of engineering principles is encouraged to establish these tools and technologies as robust, well-characterized solutions that fulfill an unmet need. A synergistic partnership between engineering and the life, physical, and computational sciences is also encouraged, where the unique skills of each discipline combine to enhance our understanding of life science processes or the practice of medicine. The purpose of this FOA is to encourage BRP applications that: 1) establish a robust engineering solution to a problem in biomedical research or the practice of medicine; 2) develop a strategic alliance of multidisciplinary partners based on a well-defined leadership plan; and 3) realize a specific endpoint within 5-10 years based on a detailed plan with a timeline and quantitative milestones.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research to advance the understanding of natural history of infection for three sexually transmitted infections (STIs): gonorrhea, syphilis, and chlamydia. This research opportunity encourages studies that address the natural history of infection in the context of either: 1) correlates of protection, 2) host response to infection, 3) clinical endpoints of disease, or 4) biological and clinical factors that influence clearance rather than persistence of infection.

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers.  The purpose of this FOA is to develop Immuno-engineering to Improve Immunotherapy (i3) Centers, as new components of the Immuno-Oncology Translation Network (IOTN). The i3 Centers will be comprised of multi-disciplinary teams focused on developing and employing engineered immunotherapy approaches to design more durable, widely accessible, and less toxic immunoprevention and immunotherapy strategies. The overarching goals of the IOTN are to accelerate translational research of innate and adaptive immune mechanisms that contribute to tumor progression, and evaluate new or improved immunotherapeutic strategies (including combinations with standard or other therapies) resulting in durable anti-cancer responses. Studies should be largely pre-clinical involving clinically-relevant models and endpoints. 

The NIEHS is establishing an infrastructure, the Human Health Exposure Analysis Resource (HHEAR) as a continuation of the Children's Health Exposure Analysis Resource (CHEAR). The goal of this consortium is to provide the research community access to laboratory and statistical analyses to add or expand the inclusion of environmental exposures in their research and to make that data publicly available as a means to improve our knowledge of the comprehensive effects of environmental exposures on human health throughout the life course. This FOA solicits Laboratories (Lab Hubs) providing a comprehensive suite of analysis of environmental exposures in samples such as dust, soil, and drinking water related to the immediate environment of individuals and linked to health endpoints. Each Hub will incorporate a developmental core to develop novel measures for environmental samples, expanding the number of current, commonly measured analytes, and developing new methods for detecting analytes in other environmental samples and providing additional insight into the sources of exposures that influence human health. The Environmental Monitoring Lab will also serve as a 'clearinghouse for evaluation and provision of emerging tools and technologies for personal exposure assessment to the client community.

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

The Clinical Translational Research Award supports studies that will move promising, well-founded preclinical and/or clinical research findings closer to clinical application, including diagnosis, prognosis, or treatment of TSC. Projects supported by this award mechanism may include studies moving from preclinical to clinical research (including a pilot clinical trial) and/or the reverse, analyzing human anatomical substances and/or data associated with clinical trials (such as correlative studies). Studies advancing clinical trial readiness through development of biomarkers, clinical endpoints, and validation of PK/PD are of particular interest to the FY19 TSCRP. Preference will be given to studies that involve human samples, patients, or leverage existing clinical data and/or ongoing clinical studies. Preclinical studies may be appropriate but must include a clinical component. Projects that are exploratory and/or strictly animal research will not be considered for funding. Developmental pathways for translational research that may be useful for designing translational research studies for support under this mechanism can be found in the report of the National Cancer Institute Translational Research Working Group (http://clincancerres.aacrjournals.org/ content/14/18/5664.full). These pathways are comprehensive and span the entire translational research continuum from bench to bedside to bench.

 Current product-specific bioequivalence (BE) guidance published by the Office of Generic Drugs for dry powder inhalers (DPIs) include in vitro testing recommendations for single actuation content and aerodynamic particle size distribution, as well as recommendations for a pharmacokinetic study and a pharmacodynamic or clinical endpoint study.  Given the extensive nature of current DPI BE guidance, it is desirable that current in vitro testing for DPIs be more reflective of in vivo performance.  Computational fluid dynamics (CFD) and discrete element modeling (DEM) have been used to predict dry powder aerosol behavior, including the effects of agglomeration and deagglomeration.  The purpose of the study will be to develop a CFD-DEM model which can be used to evaluate the impact of various physicochemical properties and device performance properties on regional deposition, to identify potentially biorelevant ranges for these properties that may be useful for future BE recommendations.   

The American Association for Cancer Research-Johnson & Johnson Lung Cancer Innovation Science Grants program is a joint effort to address the need for promoting and supporting collaborative cancer research in areas that include digital therapeutics and smoking cessation, as well as biomarkers/behavioral phenotyping that bolster  understanding of how lung cancer can be successfully intercepted.  To that end, a grant of $1 million over three years will be awarded to a multi-institutional team in support of a new idea and/or innovative approach that has direct application and relevance to lung cancer prevention and interception. The proposed research should be translational in nature and include a clinical component with an endpoint relevant to improving the detection or treatment of lung cancer.

A rare disease is defined by the Orphan Drug Act as a disease that affects less than 200,000 people in the US. As described in FDA draft Guidance, "Rare Diseases: Common Issues in Drug Development Guidance for Industry" (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm458485.pdf ), fit-for-purpose clinical endpoints for many rare diseases are not available. Selection or development of clinical outcome assessments for use to support efficacy of a treatment in a rare disease can be challenging due to the small sample size of possible participants for participation in instrument development and clinical trials and heterogeneity of the target patient population (e.g., phenotypic or genotypic variations, age, clinical manifestations, variations in patient experience, and rate of disease progression). However, many rare diseases share similar clinical characteristics such as decline in cognition and physical function, which offers an opportunity to explore clinical outcome assessments that may cover a spectrum of rare diseases.

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The goal of the network is to foster collaborative team science approaches to accelerate the discover of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur. The purpose of this FOA is to establish a Cancer Immunotherapy Consortium (CIC) composed of organ site-specific Cancer Immunotherapy Research Projects as a component of the Immuno-Oncology Translation Network (IOTN). The CIC will form an integrated network of multi-disciplinary, collaborative teams with the overarching goals of accelerating translational research of innate and adaptive immune mechanisms that contribute to tumor progression, and evaluating new or improved immunotherapeutic strategies (including combinations with standard or other therapies) resulting in durable anti-cancer responses. Studies should be largely pre-clinical involving clinically-relevant models and endpoints.

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The goal of the network is to foster collaborative team science approaches to accelerate the discover of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur. The purpose of this specific FOA is to establish Cancer Immunoprevention Research Projects that will function as components of a Cancer Immunotherapy Consortium (CIC), which will also include Cancer Immunotherapy Research Projects. The CIC will form an integrated network of multi-disciplinary, collaborative teams with the overarching goals of accelerating translational research of innate and adaptive immune mechanisms that contribute to tumor initiation and progression, and evaluating new or improved immunopreventive and immunotherapeutic strategies (including combinations with standard or other therapies). Studies should be largely pre-clinical involving clinically-relevant models and endpoints, and have the potential for rapid translation into early-phase clinical applications.

This funding opportunity announcement (FOA) invites applications for P50 Research Center Grants for Specialized Programs of Research Excellence (SPOREs). The program will fund P50 SPORE grants to support state-of-the-art investigator-initiated translational research that will contribute to improved prevention, early detection, diagnosis, and treatment of an organ-specific cancer or a related group of cancers. For the purpose of this FOA, cancers derived from the same organ system (i.e., a group of organs that perform a common function) are considered related. Examples of such organ systems include gastrointestinal, endocrine and other biological systems. Other programmatically appropriate groups of cancers may include those centered around a common biological mechanism critical for promoting tumorigenesis and/or cancer progression in organ sites that belong to different organ systems. For example, a SPORE may focus on cancers caused by the same infectious agent or cancers sustained and promoted by dysregulation of a common signaling pathway. In addition, a SPORE may focus on cross-cutting themes such as pediatric cancers or cancer health disparities. The research supported through this program must be translational and must stem from research on human biology using cellular, molecular, structural, biochemical, and/or genetic experimental approaches. SPORE projects must have the goal of reaching a translational human endpoint within the project period of the grant.

This could include, but is not limited to: (a) alternative and clean energy sources; (b) environmental and social issues as related to specific or broader energy and resource management issues; (c) economic, environmental, and social costs/benefits of energy development (alternative and fossil fuel); (d) hazard and risk assessment of different methods of energy production on various endpoints/receptors; (e) development of frameworks for managing energy development; and (f) restoration/reclamation of lands damaged by energy extraction

Applications will be accepted for a broad range of melanoma research projects involving basic science, clinical trials, etc. 1. An adequate discussion of biostatistics is required, including but not limited to specification of numbers of cell lines, laboratory animals, or patients to be treated in the studies. 2. Plans for adjustment for multiple looks should be presented, particularly in regards to clinical endpoints and evaluation of multiple biomarkers.

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.