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The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator-initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.

The purpose of this Funding Opportunity Announcement (FOA) is to support the development of innovative technologies to non-invasively label and monitor genome edited cells in vivo. The ultimate goal for these technologies is to inform on safety and efficacy of in vivo genome editing over time.

The United States Agency for International Development (USAID) is seeking applications for a cooperative agreement from qualified entities to implement the "HIV Services and Systems Strengthening (HS3)" program. USAID/Dominican Republic (DR), under the United States President's Emergency Plan for AIDS Relief (PEPFAR), will continue to assist the Government of the Dominican Republic (GoDR) in achieving HIV epidemic control through the implementation of clinical care activities using a health systems strengthening (HSS) approach under the proposed HIV Services and Systems Strengthening (HS3) Project from 2018-2023. The overall aim of the activity should be to assist the GoDR in reaching HIV epidemic control and preparing the GoDR and key population/priority population (KP/PP) safety-net private providers to transition from donor support.The purpose of the HS3 Project is to implement dynamic, catalytic, scalable, and responsive HIV service delivery packages for KP/PP to accelerate the country's HIV response to achieve 90-90-90 targets while effecting positive change on the health system to remove barriers that prevent the DR from reaching 90- 90-90. Key populations are defined as men who have sex with men (MSM), transgender (TG) individuals, and female sex workers (FSW). Priority populations are defined as migrants of Haitian descent.

The purpose of this funding opportunity announcement (FOA) is twofold: 1. to accelerate translational and clinical Phase I and II a/b safety and efficacy studies for substantiating measurable functional benefits of probiotic/prebiotic components and/or their combinations; and; 2. to understand the underlying mechanisms of their action(s), and variability in responses to these interventions. This FOA calls for interdisciplinary collaborations across scientific disciplines engaged in microbiome and pro/prebiotic research including, but not limited to: nutritional science, microbiology, virology, microecology and microbiome, genomics, immunology, computational biology, chemistry, bioengineering, as well as integration of omics and computational approaches in DNA technologies. This FOA will not support phase III clinical trials.

 The purpose of this Funding Opportunity Announcement (FOA) is to support Large Animal Testing Centers to evaluate in vivo genome editing technologies developed by other investigators in the Somatic Cell Genome Editing Program (SCGE). Each Testing Center will use wild-type pigs or non-human primates, as well as reporter animals developed under RFA-RM-18-013. The Testing Centers will work collaboratively with investigators funded under RFA-RM-18-016 and RFA-RM-18-017 to assess efficacy and safety of in vivo genome editing and delivery technologies. Testing Centers will breed, archive and maintain cohorts of well characterized and genotyped large animals, establish methods and protocols for the evaluation of the delivery systems and editing tools, conduct testing and provide results to the SCGE Dissemination and Coordination Center. Such activities will accelerate the translation of genome editing technologies into treatments for human diseases.  

The intended outcome of this cooperative agreement is to advance the goal of a national food safety system by supporting and enhancing state food laboratories tasked with investigation of foodborne disease outbreaks in activities including: 1. Ensuring microbiological and chemical food analyses performed on behalf of the State manufactured food regulatory programs are conducted within the scope of an International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC) 17025 accredited laboratory; 2. Strengthening the collaboration between the laboratories and State manufactured food regulatory programs; 3. Increasing the number of State samples collected and analyzed for surveillance purposes annually; 4. Developing a stronger international rapid surveillance system for pathogen traceback through the GenomeTrakr network using a minimum set of metadata fields for all food and environmental isolates; and 5. Providing additional support to the State food laboratories through an outside association to offer trainings, workshops, and educational resources to both awardees under this cooperative agreement and to unfunded laboratories seeking ISO/IEC 17025 accreditation.

The objective of this Funding Opportunity Announcement (FOA) is to support the development of new and innovative multipurpose prevention technologies (MPT) with rheological/biophysical properties and product user perceptions compatible with current long-acting reversible contraceptive (LARC) strategies (look, feel, effectiveness, safety and duration of action) for the dual purpose of preventing pregnancy and HIV infection in women. MPTs proposed for development must be dual indication and prevent pregnancy and HIV infection and have drug delivery systems (DDS) capable with sustained/extended release of both drugs. MPTs proposed for development must use a licensed contraceptive. This FOA requires an industry partner, milestones linked to Go/No Go decisions and year 5 funding requires submission of a pre-IND application to the FDA.

The objective of this Funding Opportunity Announcement (FOA) is to support the development of new and innovative multipurpose prevention technologies (MPT) with rheological/biophysical properties and product user perceptions compatible with current long-acting reversible contraceptive (LARC) strategies (look, feel, effectiveness, safety and duration of action) for the dual purpose of preventing pregnancy and HIV infection in women. MPTs proposed for development must be dual indication and prevent pregnancy and HIV infection and have drug delivery systems (DDS) capable with sustained/extended release of both drugs. MPTs proposed for development must use a licensed contraceptive. This FOA requires an industry partner, milestones linked to Go/No Go decisions and year 5 funding requires submission of a pre-IND application to the FDA.

This funding opportunity announcement will supportprojectsto enhance the availability and delivery of safe blood to be used for transfusion in patients from low or lower-middle income countries (LLMICs) in Sub-Saharan Africa (SSA). For example, ensuring that children with malaria or sickle cell disease and pregnant women who suffer from obstetric hemorrhage have access to safe transfusion therapies is of high programmatic interest. BLOODSAFE will support projects that develop and test feasible, effective and sustainable strategies to increase the number of safe blood donors, to improve quality and safety of blood supplies, and to enhance blood delivery to patients in need, especially in remote settings.

The NICHD invites applications from investigators to develop a multi-site project designed to conduct clinical trials to investigate problems in reproductive medicine, female and male infertility, and gynecologic and male reproductive system diseases and disorders that impact fertility. This funding opportunity announcement (FOA) is intended to support multi-site clinical research consortia devoted to evaluating safety and efficacy of new medications, treatments and technologies addressing questions in infertility.  The objective of this program is to advance scientific research that facilitates diagnostic and therapeutic solutions to infertility by using common protocols in large scale human trials to obtain answers more rapidly than individual sites acting alone.

The purpose of this funding opportunity announcement (FOA) is to support clinical studies of products that address unmet needs in rare diseases or conditions or provide highly significant improvements in treatment or diagnosis.  Through the support of efficient and innovative clinical studies evaluating safety and/or effectiveness, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and support studies that will either result in market approval of these products or substantially contribute to the essential data needed for medical product development that will ultimately meet the needs of rare disease patients.

The purpose of this Funding Opportunity Announcement (FOA) is to invite cooperative agreement applications for research that advances promising compounds thorough the drug development pipeline for the treatment of Alcohol Use Disorder (AUD). NIAAA is seeking applications for medications development research projects from both for-profit and not-for-profit entities, including academic institutions, pharmaceutical and biotechnology companies, private and public foundations, small businesses not eligible for the SBIR/STTR program and single entities able to demonstrate significant resource commitment to the proposed project. A resource commitment from a single entity could, for example, consist of salary support for key personnel or production and formulation of clinical trial material. The aim of this FOA is to move candidate compounds through Investigational New Drug (IND) requirements, Phase 1 human safety, tolerability, and dosing studies, and Phase 2 human laboratory and proof-of-concept trials. Within these phases of drug development, each proposed project should have a defined entry and exit point. Finally, this FOA will not support animal studies to prove efficacy of the candidate compound unless required by the Food and Drug Administration or peer review. Applicants are strongly encouraged to contact the NIAAA Division of Medications Development Staff prior to submitting to this FOA.

This Funding Opportunity Announcement (FOA) invites applications that propose transformative engineering solutions to technical challenges associated with new development, substantial optimization of existing technologies and clinical translation of intraoral biodevices. Proposed technologies are expected to advance development of oral biodevices for clinical use, including but not limited to: precision medicine-based detection, diagnosis and treatment of oral and overall health conditions, and measurement of patient functional status and clinical outcome assessment. Areas of interest in this FOA include engineering approaches that allow integration of electronic, physical, and biological systems into functional biodevices that are safe and effective for detection, diagnosis and treatment of oral and systemic disease. Products of this research will be functional biodevices and integrated approaches thoroughly characterized to demonstrate preclinical safety and effective performance in support of specific intended clinical applications. To streamline the development of oral biodevices that advance precision medicine-based approaches in clinical practice, this FOA encourages interdisciplinary collaborations across engineering, multifunctional sensors, pharmacology, chemistry, medicine, and dentistry, as well as between academia and industry.

BARD projects, conducted cooperatively by American and Israeli scientists, cover all phases of agricultural research and development, including integrated projects and strategic or applied research. Cooperative research entails active collaboration between Israeli and American scientists. The following research areas were identified by the Board of Directors as top priorities for the coming years: Increased Efficiency of Agricultural Production Protection of Plants and Animals Against Biotic and Abiotic Stress Food Quality, Safety and Security Water Quality & Quantity Functional Genomics and Proteomics Sensors and Robotics Sustainable Bio-Energy Systems

ABC Wildlife humanely manages urban wildlife and insects in the interest of human health and safety from an environmental sustainability perspective with a love of nature and a deep respect for all living things. ABC Wildlife has offered humane wildlife removal services to the Chicagoland area for over 35 years.  As a woman-owned corporation operating in a largely male field, ABC Wildlife understands the remarkable impact women can have when allowed to break through. We want to pave the way for other women pursuing their dreams in the scientific world, which is why ABC Wildlife is introducing a scholarship designed to increase the number of women studying and influencing the future of science, including technology, engineering and math.

This funding opportunity announcement (FOA) encourages applications from institutions/ organizations addressing preclinical research in model organisms of neurodevelopmental disorders. Applications submitted to this FOA should propose to develop, validate, and/or calibrate outcome measures, surrogate markers, and biomarkers in model organisms that can inform and effectively translate to human clinical trials for individuals with intellectual and developmental disabilities (IDD). In addition, applications may propose to conduct rigorous, controlled and standardized preclinical animal trials designed for safety, toxicity, and efficacy prediction or to perform an independent validation of efficacy in animals prior to human clinical trials. The goal of this FOA is to accelerate and improve the preclinical testing of candidate treatments and therapeutic compounds in order to move promising new drug therapies into clinical trials. Potential applicants may also be interested in the FOA PAR-16-216, Outcome Measures For Use In Treatment Trials of Individuals with Intellectual and Developmental Disabilities.

This Funding Opportunity Announcement (FOA) encourages formative research, intervention development, and pilot-testing of interventions. Primary scientific areas of focus include the feasibility, tolerability, acceptability and safety of novel or adapted interventions that target HIV prevention, treatment or services research. For the purposes of this FOA, "intervention" may include behavioral, social, or structural approaches, as well as combination biomedical and behavioral approaches that prevent the acquisition and transmission of HIV infection, or improve clinical outcomes for persons who are HIV infected.

The purpose of this Funding Opportunity Announcement (FOA) is to support large animal Testing Centers to evaluate in vivo genome editing technologies developed by other investigators in the Somatic Cell Genome Editing Program (SCGE). Testing Centers will use either pigs or non-human primates, including wild-type animals, as well as reporter animals developed by RFA-RM-18-013. The Testing Centers will work collaboratively with investigators funded under RM-18-016 and RFA-RM-18-017 to assess efficacy and safety of in vivo genome editing and delivery technologies. Centers will breed, archive and maintain cohorts of well characterized and genotyped large animals, establish methods and protocols for the evaluation of the delivery systems and editing tools, conduct testing and provide results to the Dissemination and Coordination Center of the SCGE. Such activities will accelerate the translation of genome editing technologies into treatments for human diseases.

The Biosensing program is part of the Engineering Biology and Health cluster, which also includes 1) the Biophotonics program; 2) the Cellular and Biochemical Engineering program; 3) the Disability and Rehabilitation Engineering program; and 4) the Engineering of Biomedical Systems program. The Biosensing program supports fundamental engineering research on devices and methods for measurement and quantification of biological analytes. Examples of biosensors include, but are not limited to, electrochemical/electrical biosensors, optical biosensors, plasmonic biosensors, and paper-based and nanopore-based biosensors. In addition to advancing biosensor technology development, proposals that address critical needs in biomedical research, public health, food safety, agriculture, forensic, environmental protection, and homeland security are highly encouraged. Proposals that incorporate emerging nanotechnology methods are especially encouraged.

This Funding Opportunity Announcement (FOA) seeks grant applications for a Research Coordinating Center (RCC) to support associated "Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB SIMPLe)" UG3/UH3 phased cooperative agreements that propose to optimally and sustainably address late-stage implementation research questions to address the delivery of proven-effective prevention and treatment interventions for heart, lung, blood, and sleep (HLBS) comorbid diseases and disorders in people living with HIV (PLHIV) in World Bank designated low- and middle-income countries (LMICs) and Small Island Developing States (SIDS). For the purposes of this FOA, late-stage implementation research is defined as research to identify strategies to achieve sustainable uptake of proven-effective interventions in routine clinical, public health, and community-based settings and maximize the positive impact on population health. The RCC will coordinate the collaborative efforts of the global alliance of funded UG3/UH3 phased cooperative agreements conducting late-stage implementation research within the following geographical regions: East Asia and the Pacific, Europe and Central Asia, Latin America and the Caribbean, Middle East and North Africa, South Asia, and Sub-Saharan Africa. The HLB SIMPLe RCC will coordinate activities including in-person and virtual Network Steering Committee meetings, subcommittee meetings, and working groups; promote collaboration and communication among investigators and the broader research community; coordinate network outreach activities; coordinate joint research and capacity building efforts conducted across the HLB SIMPLe alliance; and organize, implement, and manage a global implementation research data safety and monitoring board (DSMB). Also listed under UG3/UH3