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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.

TRANSLATIONAL MEDICINE AND THERAPEUTICS: The goal of the PhRMA Foundation's Translational Medicine and Therapeutics Program is to promote the development and use of experimental and computational methods in an integrative approach towards clinical needs in diagnosis, treatment and prevention. This can involve enhanced understanding of human biological and disease processes but requires a strong translational component. This program will support the concepts of Translational Medicine and Therapeutics as defined by the Foundation: "Translational medicine and therapeutics is a discipline focused on bridging experimental and computational technologies and discoveries in the research laboratory to their application in clinical practice. Examples of research components include activities in molecular and cellular biology, pathophysiology, systems biology, bioinformatics, modeling and simulation, and other quantitative sciences to connect basic biological concepts and entities to directly address unmet medical needs. The goals are to use clinical observation as the basis for hypothesis generation to further basic research and to efficiently advance the product of basic research to patients." Translational Medicine and Therapeutics awards will advance training and support career development of scientists engaged in research that significantly integrates cutting-edge technologies with advanced biological, chemical, and pharmacological sciences and engineering methodologies in such areas as (but not restricted to): * Genetics (Molecular, Pharmaco-, Population, Medical) * Genomics (Functional, Structural, Toxico-, Pharmaco-, Comparative) * Systems (Biology and Pharmacology) * Pathways and networks * Integrative biology * Modeling and simulation * Target Identification and Validation * Biomarker Discovery and Validation * Vaccine Development * Molecular Epidimiology * Imaging * Disease Modeling

 This Funding Opportunity Announcement (FOA) invites applications for Cystic Fibrosis (CF) Research and Translation Core Centers.  CF Research and Translation Core Centers are designed to support both basic and clinical research on Cystic Fibrosis.  CF Research and Translation Core Centers support three primary research-related activities: Research Core services; a Pilot and Feasibility program; and an Administrative Core with an enrichment program.  Core Centers provide shared resources to support research to develop and test new therapies for CF and to foster collaborations among institutions with a strong existing research base in CF.  The NIDDK currently supports seven CF Research and Translation Centers located at institutions with documented programs of research excellence in basic and clinical CF Research.  Information about the currently funded CF Research and Translation Centers may be found at:

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.

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for projects to expand, improve, or transform the utility of mammalian cancer and tumor models for translational research. With this FOA, the NCI intends to encourage submission of projects devoted to demonstrating that mammalian models or their derivatives used for translational research are robust representations of human biology, are appropriate to test questions of clinical importance, and provide reliable information for patients' benefit. These practical goals contrast with the goals of many mechanistic, NCI-supported R01 projects that employ mammals, or develop and use mammalian cancer models, transplantation tumor models, or models derived from mammalian or human tissues or cells for hypothesis-testing, non-clinical research. Among many other possible endeavors, applicants in response to this FOA could propose demonstrations of how to overcome translational deficiencies of mammalian oncology models, define new uses of mammalian models or their genetics for unexplored translational challenges, advance standard practices for use of translational models, test approaches to validate and credential models, or challenge current practices for how models are used translationally

The DMDRP Investigator-Initiated Research Award (IIRA) supports translational research that will accelerate the movement of promising ideas in Duchenne research into clinical applications. Translational research may be defined as an integration of basic science and clinical observations with the specific goal of developing new therapies. 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 should involve a reciprocal flow of ideas and information between basic and clinical science. Within this continuum, the IIRA supports later-stage translational research projects, including early-phase, proof-of-principle clinical trials and correlative studies to better inform development of drugs, devices, and other interventions. Research projects may also include preclinical studies utilizing animal models, human subjects, or human anatomical substances.

The B2B was launched by NHLBI in 2009 as a novel approach to break through the major barriers of translational research, identify the causes of human congenital heart disease, and ultimately improve outcomes for individuals with congenital heart disease. The B2B strategy is to accelerate translation of scientific discovery into clinical practice through collaborations among basic, translational, and clinical researchers. The CDDRC and PCGC interact with each other, and with the NHLBI Pediatric Heart Network (PHN) to encourage translation of results from basic science to clinical research, and to provide clinical input on pressing needs for basic and translational research. The goal of the CDDRC is to accelerate discovery of the genetic etiology and biologic pathways associated with cardiovascular development and congenital heart disease by facilitating access to and querying of annotated data from cardiovascular development studies. The CDDRC will facilitate analysis of candidate genes and variants associated with CHD by assembling the data output from previous funding cycles of the Cardiovascular Development Consortium (CvDC), plus external datasets, into a queryable data repository complete with computational tools. The product of the CDDRC would, by the end of the project period, be a coordinated and interoperable suite of harmonized datasets, computational tools, and links to model organism databases that could be inserted as a functional module into the NHLBI DataSTAGE platform.

The ARP Clinical Translational Research Award is intended to support early-phase, proof-of-principle translational studies that will examine hypothesis-based, innovative interventions that have the potential to address current clinical deficits for ASD. Applications are strongly encouraged to address one of the ARP Clinical Translational Research Award Areas of Interest. If the proposed project does not address any of the FY19 ARP Clinical Translational Research Award Areas of Interest, the application should describe how the project will nevertheless address a critical need of the ASD community. Outcomes from studies funded by this award are anticipated to provide scientific rationale for subsequent development of larger, efficacy-based clinical trials of interventions that will transform ASD clinical care. Projects are required to involve human subjects. Projects that are strictly animal research aimed at developing or refining new technology and research to establish the efficacy/ effectiveness of diagnostic agents are not allowed under this funding opportunity. The proposed studies should include early-phase, proof-of-principle studies using human subjects. The proposed studies may be interventional, including Phase 0 clinical trials or single-group intervention studies, and may involve some retrospective data analysis; however, purely retrospective or database-related research is not allowed.

The John Merck Fund has had a longstanding interest in people with intellectual and developmental disorders since its inception in 1970.  In 2012, JMF launched the Developmental Disabilities Translational Research Program, which supports researchers in developing treatments and improving outcomes for individuals with developmental disabilities, particularly Down syndrome and Fragile X syndrome (and FX associated disorders).  The awards are made to the most highly innovative translational research projects that have the greatest potential of investigating rational and effective treatments and interventions for the particular condition being addressed.  The program emphasizes interdisciplinary collaborative grant applications focused primarily on FXS and DS, but the program supports studies focused on other developmental disabilities under special circumstances.  The Fund is particularly interested in translational research that is designed to improve the lives of people with developmental disabilities and their families.  Investigators from a range of disciplines are encouraged to apply.

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. 

NCATS plans to support the research, development and testing of up to three biomedical reasoning tool prototypes for the Biomedical Data Translator for an estimated $1,000,000 total costs each. NCATS is utilizing a three-step application process (challenge-concept-proposal) for this expedited program. The duration of each award will be less than one year. All awardees will be expected to collaborate and cooperate with NCATS staff, one another and potentially other contributors to the overall program to maximize the exploration of the potential capabilities of Translator and to understand technical feasibility and challenges of having multiple groups build a single resource. All U.S. and foreign organizations and U.S. citizens are eligible to apply. This funding opportunity is open to U.S. and foreign organizations, including academic institutions and commercial entities; subcontracts are allowed. U.S. citizens may also apply as individuals and may be direct recipients of an award. Non-citizen individuals residing in the U.S. or foreign country not affiliated with either a U.S. or foreign organization are not eligible to be direct recipients of an award. Successful completion of the application process will require applicants to have specific skills related to translational research and software development. Applicants need to demonstrate technical skills, including familiarity with web communication protocols, a variety of programming languages and software stack, and general algorithmic techniques in the areas of artificial intelligence, machine learning, and knowledge engineering, as well as problem solving skills, especially creativity and persistence. Applicants familiar with languages and packages most useful for solving different tasks, the entire challenge process may take between 2 and 8 hours to complete.

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 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.

The involvement of small businesses in translational aging research could substantially hasten the pace at which scientific advances are transformed into commercial products to improve or maintain the health and functional independence of older adults. Therefore, this funding opportunity announcement (FOA) is intended to encourage a greater involvement by small businesses through the SBIR mechanism in transforming scientific advances in aging research into novel devices, products, health care practices and programs that will benefit the lives of older adults. For the purposes of this FOA, T1 translational research on aging is defined as the application of basic and clinical biomedical or basic behavioral and social research findings towards the development of new strategies for prevention and treatment of age-related pathologies. T1 translational research approaches could include the development of new research tools or improving existing technologies to diagnose, prevent or treat age-related conditions, functional decline and disability.

The FY17 HRRP TRA mechanism is being offered in this first year of the program to support preclinical translational research that will accelerate the movement of promising initiatives relevant to hearing restoration into clinical applications. The ultimate goal of translational research is to move an observation forward into clinical application and accelerate the clinical introduction of healthcare products, technologies, or practice guidelines. Observations that drive a research idea may be derived from a laboratory discovery, population-based studies, or a clinician's first-hand knowledge of patients and anecdotal data. However, Principal Investigators (PIs) should not view translational research as a one-way continuum from bench to bedside. The research plan should involve a reciprocal flow of ideas and information between basic and clinical science.

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 FOA invites applications for the Microphysiological Systems (MPS) for Disease Modeling and Efficacy Testing Program to develop highly reproducible and translatable in vitro models for preclinical efficacy studies through discovery and validation of translatable biomarkers, development of standardized methods for preclinical efficacy testing and definitive efficacy testing of candidate therapeutics using best practices and rigorous study design. An essential feature will be a multidisciplinary approach that brings together experts in bioengineering, microfluidics, material science, "omic" sciences, computational biology, disease biology, pathology, electrophysiology, pharmacology, biostatistics and clinical science.

This FOA invites applications for the Microphysiological Systems (MPS) for Disease Modeling and Efficacy Testing Program to develop highly reproducible and translatable in vitro models for preclinical efficacy studies through discovery and validation of translatable biomarkers, development of standardized methods for preclinical efficacy testing and definitive efficacy testing of candidate therapeutics using best practices and rigorous study design. An essential feature will be a multidisciplinary approach that brings together experts in bioengineering, microfluidics, material science, "omic" sciences, computational biology, disease biology, pathology, electrophysiology, pharmacology, biostatistics and clinical science.

Objectives: The grant groundbreaking or unconventional methodologies, whose risky outlook is justified by the possibility of a major breakthrough. Basic Science: If a proposal is rooted in basic science, applicants are encouraged to collaborate with investigators who can further the potential for translation of ideas and findings. Translational Science: If a proposal is translational by nature, applicants are encouraged to identify industry and clinical partners to assist in propelling their research toward clinical study. Clinical Science: For those looking to submit a clinical research proposal, applicants are encouraged to collaborate with individuals who could facilitate potential clinical implementation.

The purpose of this funding opportunity announcement is to encourage collaborations between the life and physical sciences that: 1) apply a multidisciplinary bioengineering approach to the solution of a biomedical problem; and 2) integrate, optimize, validate, translate or otherwise accelerate the adoption of promising tools, methods and techniques for a specific research or clinical problem in basic, translational, or clinical science and practice. An application may propose design-directed, developmental, discovery-driven, or hypothesis-driven research and is appropriate for small teams applying an integrative approach to increase our understanding of and solve problems in biological, clinical or translational science.