Grants for Independent school districts - Agriculture

The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetyl galactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereo chemically controlled synthesis and biological activity assessment using in vitro and animal models. The proposed studies will focus on 1) synthesis of each diastereomer of LEQVIO (Inclisiran) in stereo chemically pure form; 2) assessment of the biological activity of each stereo chemically pure diastereomer in inhibiting PCSK9 activity using in vitro assays and in a transgenic mouse model; 3) development of analytical methods to identify and characterize the stereochemical structure of each diastereomer in LEQVIO; and 4) assessment of the individual contribution of each diastereomer to the overall pharmacological activity of LEQVIO. Tools developed in this research can also be applied to other similar GalNAc-conjugated siRNAs specifically, and other siRNAs in general. Knowledge gained from this research will also contribute to the sameness evaluation of generic siRNAs, and to the quality control of oligonucleotide drugs.

Modified release (MR) oral drug products are considered to have a high risk for alcohol dose dumping (ADD) because they contain large quantities of drug(s), designed to release over a prolonged period of time. Accidental exposure of these products to alcohol can result in the relatively rapid release of large quantities of drug with severe side effects, including death. To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in 0%, 5%, 20%, and 40% alcoholic dissolution media for all prospective generic versions of MR oral drug products. To date, ADD assessments have not been harmonized globally. For instance, the U.S. FDA recommends testing up to 40% alcoholic media while the European Medicines Agency recommends testing up to 20% alcoholic media. This type of difference can present a challenge for formulators designing products for multiple markets, as historical data has shown release from MR oral products do not always follow a linear response (either increasing or decreasing) to increasing alcohol concentrations. In addition, interpretation of an ADD assessment may be limited by the inability of the test to predict in vivo behavior. The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs.

The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.

This funding opportunity provides financial support to various organizations, including universities and non-profits, to improve veterinary diagnostic capabilities and address public health issues related to animal food safety and antimicrobial resistance.

The Summer Meals Capacity-Building Mini-Grants program seeks to increase the number of children and youth in the City of Rochester receiving summer meals and the number of days meals are served. Donor Name: Rochester Area Community Foundation State: New York City: Rochester Type of Grant: Grant Deadline: 05/17/2024 Size of the Grant: $10,000 to $100,000 Grant Duration: Grant Duration Not Mentioned Details: The Summer Meals program is federally funded and designed to provide food to youth when the regular school year is not in session. The program serves youth 18 and under who are in programs that serve, or are located near, a school with at least 50% free and reduced meals eligibility rates. The City of Rochester is designated a high-need area, making all youth in the city eligible for summer meals. The Summer Meals program (officially the Summer Food Service Program) is administered by the U.S. Department of Agriculture (USDA) Food and Nutrition Service. Proposals may include requests for one or more of the following: A Summer Meals Volunteer Coordinator or supplemental staff to increase the Summer Meals site’s capacity to serve additional children and/or to extend the number of days of meal service. One-time capital purchases to increase the capacity of the Summer Meals site to serve additional children and/or extend the number of days of meal service. Examples include purchase of tables, chairs, and coolers. Examples can be found here: Refrigeration and dining, Equipment One-time capital purchase of equipment or supplies that will encourage physical activity and fun, thus increasing the capacity of the provider to serve additional summer meals as more youth may be enticed to participate. Categories  Children  Equity  Youth  Funding Information Up to $15,000. Eligibility Criteria All applicants must be an approved partner of one of the three main Summer Meals sponsors in Rochester (the City of Rochester, Rochester City School District, or Foodlink) for meal delivery, or maintains its own LEA status with NYSED for Summer Meal sponsorship; AND An organization, church, or government entity that has previously provided reimbursable Summer Meals through the New York State Department of Education under the Summer Food Service Program in the City of Rochester; OR A 501(c)(3) organization or 509(a)(1) public organization Previous Summer Meals Mini-Grant recipients are eligible to reapply, but priority may be given to organizations that have not received Summer Meals Mini-Grants in the past. For more information, visit RACF.