Government Bioscience Grant (GBG) Report February 2015

Transcription

1 Government Bioscience Grant (GBG) Report February 2015 Title (Agency) Opp. Number Description Deadline Funding Level Eligibility Link NEURAL SYSTEMS National Institutes of Health (UO1) BRAIN Initiative: Development, Optimization, and Validation of Novel Tools and Technologies for Neuroscience Research (STTR) (R41/R42) RFA-DA- 015 DA- 015.html 090.html PAR- 090 The objective of the consortium is to establish a national, multisite, longitudinal cohort study to prospectively examine the neurodevelopmental and behavioral effects of substance use from early adolescence (approximately age 9-10) through the period of risk for substance use and substance use disorders. The purpose of this funding opportunity announcement (FOA) is to support the development of novel tools and technologies through the through the Small Business Technology Transfer (STTR) program to advance the field of neuroscience research, including 1) tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function, 2) proof-of-concept testing and development of new technologies and novel approaches for large scale recording and manipulation of neural activity, at or near cellular resolution, at multiple spatial and/or temporal scales, in any region and throughout the entire depth of the brain, and 3) iterative refinement of such tools and technologies with the end-user community with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience practice. 4/14/15 Est. Total $25,000,000 1/5/18 N/A Small Businesses 1

2 BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH2/UH3) BRAIN Initiative: Clinical Studies to Advance Next- Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3) Exploratory Technologies to Understand the Control of Organ Function by the Peripheral Nervous System for SPARC (U18) RFA-NS- 006 RFA-NS- 008 RFA-RM- 002 The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical study (e.g., Early Feasibility Study). The small clinical study should provide data to answer key questions about the function or final design of a device. This Funding Opportunity Announcement (FOA),, solicits U18 Research Demonstration Cooperative Agreement applications to develop new and/or enhance existing tools and technologies tailored to elucidate the neurobiology and neurophysiology underlying autonomic control of internal organs in health or disease, which will ultimately inform next generation neuromodulation therapies. These awards will establish feasibility for further technology development in any future SPARC initiatives. Additionally, the technologies developed through these awards are expected to lay the groundwork for more systematic facilitation of biological mapping activities in any future SPARC initiatives. 4/15/15 4/14/15 Est. Total $9,000,000 Est. Total $3,000,000 $1,500,000 4/15/15 $200,000 NS- 006.html NS- 008.html RM- 002.html 2

3 CANCER Assay Validation for High Quality Markers for NCI- Supported Clinical Trials (UH2/UH3) Assay Validation for High Quality Markers for NCI- Supported Clinical Trials (UH3) Multilevel Interventions in Cancer Care Delivery: Building from the Problem of Follow-up to Abnormal Screening Tests (U01) PAR- 095 PAR html 108.html PAR- 108 The purpose of this Funding Opportunity Announcement (FOA) is to improve the development and validation of molecular diagnostics for the treatment, control, or prevention of cancer. This FOA includes, but is not limited to, the validation of prognostic, predictive or response markers for treatment and markers for cancer control or prevention trials. Applicants should have an assay that works in human samples and whose importance is well justified for development into a clinical assay. The UH2 phase of this FOA supports analytical validation of assays for these markers that must be achieved within two years before an assay may undergo clinical validation. The UH3 phase of this FOA supports the clinical validation of established assays for up to three years using specimens from retrospective or prospective studies from NCI-supported or other clinical trials. The goals of this FOA are two-fold. First, this FOA seeks to advance the science of multilevel interventions in three ways: a) by establishing a common conceptualization of levels and the associated level-specific factors that affect practice; b) by standardizing metrics of the levels and their main effects on other levels and the individuals needing follow-up care; and c) by developing and standardizing the analysis of the effect of interventions on the individuals, groups, and organizations responsible for intervention implementation. Second, this FOA encourages applications that test interventions to improve the follow-up of abnormal screening in one or more ways, including: a) measuring multilevel effects of single-level interventions; b) comparing single vs. multilevel interventions; and c) testing multilevel interventions. 10/6/17 10/6/17 N/A N/A 9/21/17 $750, html 3

4 GENETICS Identification of Genetic and Genomic Variants by Next-Gen in Sequencing Nonhuman Animal Models (U01) PAR- 120 The goals of this initiative are to identify gene variants of traits associated with addiction and substance abuse in selectively bred, and outbred non-human animal models using methodologies of Next Gen-Sequencing, mapping, and genotyping. This FOA will replace PAR "Identification of Gene Variants for Addiction Related Traits by Next-Gen Sequencing in Model Organisms Selectively Bred for Addiction Traits (UH2/UH3)" 3/1/18 N/A 120.html IMAGING The Human Placenta Project: Developing Paradigm- Shifting Innovations for in vivo Human Placental Assessment (U34) RFA-HD- 032 This funding opportunity announcement in support of the Human Placenta Project (HPP) aims to support the initial stages of development of entirely new or next-generation placental imaging and assessment technologies and methods that will increase our capability to safely assess human placental structure and function in vivo throughout gestation. 3/31/2015 Est. Total $2,500,000 $300,000 HD- 032.html GENERAL Medical Rehabilitation Research Resource (P2C) RFA-HD- 010 This Funding Opportunity Announcement (FOA) invites grant applications from institutions/organizations that propose to build research infrastructure to promote external collaboration with the medical rehabilitation community. The aim of this FOA is to create a national network of research cores that provide access to collateral expertise in biomedical, behavioral, engineering, and/or psychosocial fields that is particularly relevant to medical rehabilitation research. We are particularly interested in supporting infrastructure programs in clinical trial design, engineering and the environment, individualized medical rehabilitation and dynamic reassessment, and applied behavioral supports for rehabilitation research and healthy outcomes. 3/15/15 Est. Total $7,200,000 $750,000 HD- 010.html 4

5 Materials for Transduction (MATRIX) DARPA- BAA- 19 The Materials for Transduction (MATRIX) program in DARPA s Defense Sciences Office (DSO) is seeking innovative ideas and novel approaches to achieve revolutionary transductional devices and capabilities using materials with energy conversion capabilities and/or strongly correlated properties. 4/2/15 N/A Opportuniti es/solicitati ons/dso_s olicitations. aspx Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R33) RFA-AT The goal of this funding opportunity is to support pilot testing of natural products (i.e., botanicals, dietary supplements, and probiotics), which have sufficient early-stage data to justify further clinical testing of the product. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. The data collected should be used to fill gaps in scientific knowledge and provide the information necessary to develop a competitive full-scale clinical trial. 6/29/15 Est. Total $500,000 $450,000 AT html Phased Innovation for Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R21/R33) RFA-AT Est. Total $1,000,000 AT html Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01) PAR- 115 This Funding Opportunity Announcement (FOA) is to encourage Research Project Grant (R01) applications to pursue clinical observational (CO) studies to obtain data necessary for designing clinical trials for musculoskeletal, rheumatic, or skin diseases or conditions. Research data from observational cohort studies can enhance clinical trial design by providing essential information about disease symptoms, stages and timing of disease progression, comorbid conditions, availability of potential clinical trial participants, and outcomes that are important to patients. CO studies also can facilitate efforts to develop and/or validate objective biomarkers or subjective outcome measures for use in a future trial or trials. 11/1/17 $225, html 5

6 NIAMS Musculoskeletal Biology and Medicine Resource-based Centers (P30) RFA-AR The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) requests applications for the NIAMS Resource-based Centers (P30) for research areas within its mission in musculoskeletal biology and medicine. The Resource-based Centers will provide critical research infrastructure, shared facilities, services, and/or resources to groups of investigators conducting research on musculoskeletal biology and medicine, enabling them to conduct their independently-funded individual and/or collaborative research projects more efficiently and/or more effectively, with the broad overall goal of accelerating, enriching, and enhancing the effectiveness of ongoing basic, translational, and clinical research and promoting new research within the NIAMS mission. 6/11/15 Est. Total $1,500,000 $500,000 AR html NIAMS Rheumatic Diseases Research Resource-based Centers (P30) Metabolomics Core for the Undiagnosed Diseases Network (UDN) (U01) RFA-AR RFA-RM- 001 This Funding Opportunity Announcement (FOA) is to establish a Metabolomics Core to augment clinical and laboratory findings of the Undiagnosed Diseases Network (UDN) and to assist the Network in the diagnosis of patients with undiagnosed diseases. Responsive applications will describe a plan to provide comprehensive analytical methods, analyses, technologies, and metabolomics expertise to the UDN to aid in clinical diagnosis and investigate potential mechanisms underlying phenotypic changes in patients. Due to the rare, even unique, disorders of UDN patients, the application should describe the need to develop specialized, "boutique" assays and methods of measurement in analyses of both normal and abnormal compounds of the diseased metabolome. 10/9/15 Est. Total $2,000,000 $500,000 4/15/15 Est. Total $1,000,000 $1,000,000 AR html RM- 001.html 6

7 Systems Biology and Antibacterial Resistance (U01) RFA-AI This Funding Opportunity Announcement (FOA) solicits applications that use a multi-disciplinary systems biology approach to study the molecular interaction networks of the pathogen and the host in association with antibacterial resistance or in response to treatment of antibacterial resistant infections. The applications focus must be on bacterial pathogens with established antibacterial resistance. This FOA will not support applications focused on drug-resistant tuberculosis. 7/9/2015 Est. Total $8,000,000 $2,000,000 AI html Development and validation of laboratory procedures using next generation sequencing technologies to assess genes causing severe combined immune deficiency (SCID) in state newborn screening laboratories Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01) RFA-EH- 002 This FOA is to develop, improve, and implement laboratory techniques to assess babies born with severe combined immune deficiency (SCID) and other primary immunodeficiencies using next generation sequencing technologies as a second tier test in state newborn screening aboratories. CDC seeks to evaluate the potential of using next generation sequencing technologies in the state newborn screening laboratory setting. Results of this activity will be used to inform other state newborn screening laboratories about the feasibility of using next generation sequencing technologies in the state newborn screening laboratory setting to evaluate babies that screen positive for SCID and other primary mmunodeficiencies. The ultimate goal is to improve treatment outcomes for babies with SCID or other primary immunodeficiencies. 4/6/2015 $350,000 w.acf.hhs.g ov/hhsgrant sforecast/in dex.cfm?s witch=gran t.view&gff _grants_for ecastinfoid = RFA-FD- 006 There is a lack of compendial or biorelevant in vitro drug release assays for long-acting contraceptive intrauterine systems. The objective of this study is to investigate dissolution methods, both real time and accelerated conditions, for levonorgestrel intrauterine system (5-year application) and to analyze their capability of detecting manufacturing differences, predicting in vivo performance, and to evaluate method robustness. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic intrauterine systems. 4/27/15 $125,000 FD- 006.html 7

8 Dissolution Methods for Long-acting Periodontal Drug Products (U01) RFA-FD- 007 There is a lack of compendial or biorelevant in vitro drug release assays for long-acting periodontal dosage forms. These products include biodegradable microspheres, in situ forming implants and matrix tablets. The purpose of this study is to develop a biorelevant dissolution method for a long-acting periodontal dosage form and to identify the drug product's key physicochemical attributes that affect the drug dissolution behavior and bioavailability. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic long-acting periodontal drug products. 4/27/15 $125,000 FD- 007.html Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01) RFA-FD- 008 The purpose of this project is to: Subtopic 1: conduct physiologically-based pharmacokinetic modeling (PBPK) to relate critical quality attributes to in vivo performance for bioequivalence (BE) evaluation; Subtopic 2: perform population pharmacokinetic-pharmacodynamic (PK-PD) modeling and statistical analysis to identify ways to reduce residual variability and identify appropriate PK metrics, enabling BE assessment in parallel BE studies with acceptable sample size. The findings from these studies will help establish scientific and regulatory standards for ensuring therapeutic equivalence of generic LAI products. 4/27/15 $200,000 FD- 008.html Molecular Mechanisms of Combination Adjuvants (MMCA)(U01) RFA-AI- 005 This Funding Opportunity Announcement (FOA) solicits applications that propose studies of the mechanism of action of a combination of two or more vaccine adjuvants (combination adjuvant). Adjuvants that are used in these studies must already have shown immune boosting activity when used individually in licensed or unlicensed vaccines (e.g. experimental or candidate vaccines). The purpose of this FOA is to build upon the investment the NIAID has already made into adjuvant research, by combining previously identified and characterized adjuvants and characterizing their immune stimulating activity. The Cooperative Agreement grant mechanism allows for coordination of these research efforts with NIAIDs overall adjuvant research objectives. The long-term goal is to promote the development of novel adjuvant combinations which will improve the immunogenicity of vaccines while addressing concerns related to reactogenicity. 6/9/15 Est. Total $4,000,000 $350,000 AI- 005.html 8

9 High-End Instrumentation (HEI) Grant (S10) Developing Technologies and Tools to Monitor HIV Brain Reservoirs and How They May be Altered by Exposure to Substances of Abuse (R21/R33) Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R01) NIH Big Data to Knowledge (BD2K) Enhancing Diversity in Biomedical Data Science (R25) PAR- 118 RFA-DA- 018 PA /7/18 N/A files/pa- 105.html RFA-MD- 005 The ORIP High-End Shared Instrument Grant (HEI) program encourages applications from groups of NIH-supported investigators to purchase or upgrade a single item of expensive, specialized, commercially available instruments or integrated systems that cost at least $600,000. The maximum award is $2,000,000. Types of instruments supported include, but are not limited to, X-ray diffraction systems, nuclear magnetic resonance (NMR) and mass spectrometers, DNA sequencers, biosensors, electron and confocal microscopes, cell-sorters, and biomedical Imagers. The purpose of this Funding Opportunity Announcement (FOA) is to support projects developing technologies and tools to detect and quantify HIV brain reservoirs and how they may be altered by exposure to substances of abuse. This Funding Opportunity Announcement (FOA) invites Research Project Grant (R01) applications to support the development of novel biomarkers and improved HIV incidence assays and algorithms with increased specificity for distinguishing incident from chronic HIV infections. The NIH Research Education (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this Big Data to Knowledge (BD2K) R25 program is to support educational activities that enhance the diversity of the biomedical, behavioral, and clinical research workforce. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on research experiences and curriculum development. 5/29/15 Est. Total $20,000,000 $2,000,000 4/10/15 Est. Total $3,000,000 Private, public and state controlled institutions of Higher Edu; Nonprofits 118.html DA- 018.html 4/7/15 Est. Total $1,000,000 $200,000 MD- 005.html 9

10 Shared Instrumentation Grant (SIG) (S10) Reducing the burden of neglected parasitic infections (NPIs) in the United States through evidence-based prevention and control activities PAR- 088 CDC- RFA- GH 1617 The Shared Instrument Grant (SIG) program encourages applications from groups of NIH-supported investigators to purchase or upgrade a single item of expensive, specialized, commercially available instruments or integrated systems that cost at least $50,000. The maximum award is $600,000. Types of instruments supported include, but are not limited to: X-ray diffraction systems, nuclear magnetic resonance (NMR) and mass spectrometers, DNA and protein sequencers, biosensors, electron and confocal microscopes, cell-sorters, and biomedical imagers. The purpose of this FOA is to reduce the overall burden of neglected parasitic infections (NPIs) in the United States through evidence-based prevention and control activities including the development of new strategies, educational tools and materials, and guidelines. NPIs are a group of five parasitic diseases that have been targeted by the CDC as priorities for public health action based on the number of people infected, severity of the illnesses, and the ability to prevent and treat them. 5/29/15 Est. Total $40,000,000 $600,000 3/13/15 Est. Total $1,000,000 $200, html v/hhsgrants forecast/hh s_m/index. cfm?switch =grant.vie w&gff_gra nts_forecas tinfoid=