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The current pipeline of candidate antimicrobial products is insufficient to counter the threat of antimicrobial resistance . A novel collaborative model is needed to spur innovation and investment towards new antimicrobial products to repopulate the early development pipeline. In 2014, the United States Government released the National Strategy for Combating Antimicrobial Resistant Bacteria. A component of the National Strategy is to establish a Biopharmaceutical Accelerator for Combating Antibiotic-Resistant Bacteria [Accelerator] to fund Research and Development (R&D) activities to help progress candidate products from the proof-of-concept stage through pre-clinical development. Candidates that graduate from the Accelerator will be better positioned for R&D investment and clinical development. There are various Accelerator models in the marketplace. The Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) Accelerator will be a non-equity accelerator that provides non-dilutive funding to product developers for R&D activities and enables the product developers to retain full ownership and control of their company. The Accelerator for CARB will be focusing only on antibacterial products. BARDA will provide direct funding and NIAID will provide in-kind services (e.g. preclinical services, technical expertise) to the Accelerator [the cooperative agreement recipient] that will manage a portfolio of investments of early stage antimicrobial product candidates.

The current pipeline of candidate antimicrobial products is insufficient to counter the threat of antimicrobial resistance . A novel collaborative model is needed to spur innovation and investment towards new antimicrobial products to repopulate the early development pipeline. In 2014, the United States Government released the National Strategy for Combating Antimicrobial Resistant Bacteria. A component of the National Strategy is to establish a Biopharmaceutical Accelerator for Combating Antibiotic-Resistant Bacteria [Accelerator] to fund Research and Development (R&D) activities to help progress candidate products from the proof-of-concept stage through pre-clinical development. Candidates that graduate from the Accelerator will be better positioned for R&D investment and clinical development. There are various Accelerator models in the marketplace. The Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) Accelerator will be a non-equity accelerator that provides non-dilutive funding to product developers for R&D activities and enables the product developers to retain full ownership and control of their company. The Accelerator for CARB will be focusing only on antibacterial products. BARDA will provide direct funding and NIAID will provide in-kind services (e.g. preclinical services, technical expertise) to the Accelerator [the cooperative agreement recipient] that will manage a portfolio of investments of early stage antimicrobial product candidates.

The objective of FDA's Orphan Products Natural History Grants Program is to support studies that characterize the natural history of rare diseases/conditions, identify genotypic and phenotypic subpopulations, and develop and/or validate clinical outcome measures, biomarkers and/or companion diagnostics. The ultimate goal of these natural history studies is to support clinical development of products for use in serious rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products. Applicants must include in the application's Background and Significance section documentation to support that the estimated prevalence of the orphan disease or condition in the US is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the US per year), and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.  Additional information may be required upon request, for example, regarding population estimate and rationale.

The DOE Isotope Program (IP), managed by SC Nuclear Physics (NP), hereby announces its interest in receiving applications for Research and Development (R&D) on novel methods to produce or improve production radioactive or enriched stable isotopes needed for a wide variety of research and applications. This announcement is administered under the NP Isotope Development & Production for Research and Applications (IDPRA) Sub-Program. The proposed R&D should generate data relevant to isotope production or lead to new and innovative technologies, or improvements to existing technologies to foster enhanced production of isotopes. Successful proposals will clearly describe how the outcome of the proposed work would support and enhance the production of isotopes used for research and applications in medicine, homeland security, the physical sciences, biological and geological sciences, energy, industry, etc. Applications incorporating effective ways to train personnel with essential knowledge and skills related to the production, processing, purification, and distribution of enriched stable and radioactive isotopes are strongly encouraged. A companion Program Announcement to DOE National Laboratories (LAB-1896) will be posted on the SC Grants and Contracts web site at: https://science.energy.gov/grants. Applications submitted to this FOA will be evaluated by peer review competitively with those submitted to the Laboratory companion announcement.

The purpose of the SCRI program is to address the critical needs of the specialty crop industry by awarding grants to support research and extension that address key challenges of national, regional, and multi-state importance in sustaining all components of food and agriculture, including conventional and organic food production systems. Projects must address at least one of five focus areas: Research in plant breeding, genetics, genomics, and other methods to improve crop characteristics; Efforts to identify and address threats from pests and diseases, including threats to specialty crop pollinators; Efforts to improve production efficiency, handling and processing, productivity, and profitability over the long term (including specialty crop policy and marketing) New innovations and technology, including improved mechanization and technologies that delay or inhibit ripening; and Methods to prevent, detect, monitor, control, and respond to potential food safety hazards in the production efficiency, handling and processing of specialty crops.

The purpose of the SCRI program is to address the critical needs of the specialty crop industry by awarding grants to support research and extension that address key challenges of national, regional, and multi-state importance in sustaining all components of food and agriculture, including conventional and organic food production systems. Projects must address at least one of five focus areas: Research in plant breeding, genetics, genomics, and other methods to improve crop characteristics; Efforts to identify and address threats from pests and diseases, including threats to specialty crop pollinators; Efforts to improve production efficiency, handling and processing, productivity, and profitability over the long term (including specialty crop policy and marketing) New innovations and technology, including improved mechanization and technologies that delay or inhibit ripening; and Methods to prevent, detect, monitor, control, and respond to potential food safety hazards in the production efficiency, handling and processing of specialty crops.

The purpose of this project to develop physiologically based absorption and pharmacokinetic (PK) models for complex drug products, such as locally acting drug products and non-biological complex parenteral drug products. Research should target the general purpose of impacting generic drug product guidance preparation, development of generic formulations by industry, and generic drug product evaluation for the areas described in Section I, Funding Opportunity Description.

To continue making safe and effective topical semisolid drug products available to the American public, it is essential that FDA's regulatory science, as well as best practices in the pharmaceutical industry, are informed by the most current understanding of the product quality attributes that are potentially critical to the therapeutic performance of topical semisolid dosage forms. The scope of this project is to characterize all measurable physical/chemical qualities of different dosage forms of semisolid topical drug products, identify appropriate methodologies for measuring each of these quality attributes, characterize formulation and manufacturing parameters that alter the arrangement of matter in the dosage form as measured by specific quality attributes, and utilize in vitro and/or in vivo measures of product performance to correlate variations in critical quality attributes with a failure mode for a drug product.  

Stem cell technology holds the promise of providing a nearly limitless source of safe, immune-matched cells for clinical use. One of the first areas where this promise can be realized is through cell products that lack a nucleus and thus face fewer regulatory hurdles, such as red blood cells and platelets. Considerable progress has been made but scientific questions remain and improved tools to enhance the production are required if translation to clinical use is to be achieved. To this end, this FOA will support research addressing remaining scientific questions to enable and accelerate the use of stem cell-derived blood products as therapeutics. While production of sufficient numbers of cells such as platelets and red cells has been demonstrated using cellular engineering methods, basic research questions related to cell differentiation and maturation remain, which if elucidated, may allow for the development of new ways to efficiently produce clinically-useful stem cell-derived platelets or red blood cells. In addition to this FOA, two companion FOAs (RFA-HL-15-029 and RFA-HL-15-030) will support small business research to develop improved techniques and tools to enhance the production of clinically-relevant, functional stem cell-derived red blood cells or platelets in a more efficient and cost-effective manner.

The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy.  FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a "rare disease or condition" and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.

The goal of this funding opportunity announcement (FOA) is to support pilot testing of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. 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. This FOA is not intended to support a randomized controlled trial (RCT) to test the efficacy of the natural product on clinical outcomes.  Rather, 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.

The goal of this funding opportunity announcement (FOA) is to support pilot testing of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. 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. This FOA is not intended to support a randomized controlled trial (RCT) to test the efficacy of the natural product on clinical outcomes.  Rather, 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.

The goal of this funding opportunity announcement (FOA) is to support pilot testing of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. 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. This FOA is not intended to support a randomized controlled trial (RCT) to test the efficacy of the natural product on clinical outcomes.  Rather, 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.

The goal of this funding opportunity announcement (FOA) is to support pilot testing of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. 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. This FOA is not intended to support a randomized controlled trial (RCT) to test the efficacy of the natural product on clinical outcomes.  Rather, 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.

Background Generic drug products demonstrate BE to the (brand name) reference listed drug (RLD) and/or reference standard (RS) product by showing that they can deliver the same amount of the same drug to the site(s) of therapeutic action at the same rate and to the same extent as the RLD/RS drug product. For many systemically-acting drug products, BE is evaluated based upon plasma PK studies, which U.S. regulations consider to provide the most accurate, sensitive and reproducible evidence for establishing BE. This PK-based evaluation of BE also has the potential to be relatively efficient, and is well suited to generic drug development. Evaluating the PK of a locally-administered drug in a solid tissue like the skin can be scientifically and technically challenging. An in vitro cutaneous PK-based approach has been developed to support the evaluation of BE using an in vitro permeation test (IVPT) with excised human skin mounted in diffusion cells. In vivo cutaneous PK-based approaches have also been explored over the last several decades, including some using microdialysis/microperfusion probes inserted in the skin, or using non-invasive spectroscopic/imaging technologies. However, there is currently no in vivo cutaneous PK-based method that has been established to evaluate topical BE, and further research is needed.

The PRMRP Technology/Therapeutic Development Award (TTDA) is a product-driven award intended to provide support for the translation of promising preclinical findings into products for clinical applications, including prevention, detection, diagnosis, patient care, and/or quality of life, in at least one of the Congressionally directed FY13 PRMRP Topic Areas. Products in development should be responsive to the health care needs of military service members,Veterans, and/or beneficiaries. The product(s) to be developed may be pharmacologic agents (drugs or biologics), devices, and/or clinical guidance for standard of care. The Principal Investigator (PI) must provide a transitio

This Funding Opportunity Announcement (FOA) invites applications for target discovery and validation, lead discovery and optimization, preclinical and/or clinical development of safe and effective male contraceptive products.  This program aims to support a wide range of research, both basic and applied, with the goal of developing clinically useful male contraceptive products.  There is no safe, effective and reversible male contraceptive drug product in the market.  Thus, this program is critical in support of research with the goal of identifying male contraceptive targets and developing products to alleviate this problematic challenge.  

The U.S. Department of Agriculture (USDA) established the  Agriculture and Food Research Initiative (AFRI) under which the Secretary of Agriculture may make competitive grants for fundamental and applied research, education, and extension to address food and agricultural sciences (as defined under section 1404 of the National  Agricultural Research, Extension, and Teaching Policy Act of 1977 (NARETPA) (7 U.S.C. 3103)), as amended, in six priority areas. The six priority areas include: 1) plant health and production and plant products; 2) animal health and production and animal products; 3) food  safety, nutrition, and health; 4) renewable energy, natural resources, and environment; 5) agriculture systems and technology; and 6) agriculture economics and rural communities. 

The mission of the Crohn's & Colitis Foundation is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life of children and adults affected by these diseases. In order to pursue this mission, the Crohn's & Colitis Foundation seeks to support and accelerate the discovery and development of research-based products with potential for positive impact for patients suffering from inflammatory bowel diseases (IBD). The Foundation hereby solicits proposals from companies and academic investigators seeking support for the discovery and development of such products. Proposals will be reviewed in order to determine whether programs are eligible for Foundation support through the Entrepreneurial Investing (EI) Initiative to fund the discovery and development of products with potential for benefit in the IBD field. Funded programs may be led by investigators at companies or academic institutions. The EI program is not a traditional research grant mechanism. Its objective is to identify and support organizations that will benefit from partnership with the Foundation in pursuit of product discovery and development. This document identifies program policies and terms, funding and resources available for fundees, eligibility, selection criteria and application procedures.

 The purpose of this program is to support research activities that expand the knowledge base related to complex products and formulation development, analysis, and manufacturing control to advance risk-based quality assessment of new and generic drug products. We will also consider biological products relevant to CDER (e.g., monoclonal antibodies and therapeutic proteins) for this announcement.       

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.

Genomic Science program supports basic research aimed at identifying the foundational principles that drive biological systems. These principles govern the translation of the genetic code into integrated networks of proteins, enzymes, regulatory elements, and metabolite pools that are the functional processes of organisms including microbes and multispecies communities relevant to DOE missions in energy and the environment. To address the DOE mission in sustainable Bioenergy development, the Genomic Science program brings omics-driven tools of modern systems biology to bear on the challenges associated with microbial production of advanced Biofuels and Bioproducts.Developing an increased understanding of how biological systems function and translating that knowledge to enhance the production capabilities of microbes and plants forms the basis of DOE's mission in sustainable Bioenergy. To harness the biosynthetic processing power of the microbial world for advanced Biofuels and Bioproducts production, an expanded set of platform organisms with appropriate metabolic capabilities and stress tolerance characteristics with a suite of modification tools will need to be developed. To foster this development, the DOE-BER Genomic Science program supports research aimed at understanding the principles that govern the functional properties of bioenergy relevant organisms at the genomic scale.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage biomedical, behavioral, and social science research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing.  Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. Research results from this FOA are expected to generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.  

The purpose of this Funding Opportunity Announcement (FOA) is to encourage biomedical, behavioral, and social science research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing.  Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. Research results from this FOA are expected to generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.