Food and Nutrition Grants

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.

This grant provides funding to established nonprofit organizations that support community needs such as affordable housing, crisis shelters, and healthcare access for families and individuals in areas where the foundation operates.

The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement. The proposed work directly supports the U.S. FDAs stated goal of protecting public health from unacceptable risks from nitrosamine impurities in human drugs. Although significant experimental and policy/regulatory initiatives have been undertaken in this area, there remains a need for further research into and development and refinement of translational and implementable practices that will protect the public against nitrosamine risks while ensuring continued safe access to critical therapeutic drugs. The aim is to improve the safety of human drugs with potential nitrosamine impurity liabilities. In addition to the work outlined above, the award recipient will assess how best to ensure that this research and practices development continues among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends.

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 program provides financial support and resources to nonprofit organizations across the USA that are dedicated to combating hunger, particularly in high-need rural and underserved minority communities.

This grant provides funding and support to nonprofit organizations and community programs across the USA that address food insecurity, promote diversity and inclusion, and reduce food waste.

The GOODS Program is a grant opportunity provided by Greater Good Charities. It aims to distribute food, essential supplies, clothing, housewares, toys, and more to pets and people in need across the world. The program helps various constituents including pets (homeless and owned), families facing economic hardships, unhoused populations, military veterans, domestic violence survivors, victims of disasters, and displaced persons. The GOODS Program works by sourcing and managing excess, re-branded, and short-dated food and supplies from donors such as manufacturers, distributors, and retailers. These products are then made available to qualified distribution groups called Ambassadors who ensure they reach the organizations in need known as Recipients. The program operates through a sustainable hub and spoke model similar to a food bank where goods are donated but costs are covered by handling fees and donations. To apply as a Recipient organization, interested parties can locate the nearest Ambassador on the program's website and apply directly through their website. For general inquiries or to inquire about grants and services, individuals can contact Greater Good Charities through their website or send checks to their designated address in Seattle, WA.

This grant provides funding to nonprofit organizations and government agencies in South Florida to improve health outcomes for vulnerable and low- to moderate-income communities.

The objective of this research proposal is to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) for two major types of long acting injectables (LAIs) such as crystalline suspensions and polymer-based implants by considering their distinct characteristics. The goal of the project is to develop a bottom-up mechanistic PBPK model for these two LAI categories by accounting for the influence of critical formulation attributes of each LAI drug product type to predict its in vivo release mechanism. The model formulation parameters and relevant physiology should be informed with suitable in vitro and in vivo experiments. A suitable preclinical animal model can be used to validate the PBPK model based IVIVCs for both LAI suspensions and polymer based implants. The use of PBPK modelling provides a unique opportunity to understand how the physicochemical properties of drug molecules/polymer, implant specific properties, critical formulation attributes, and physiology, among other things, influence the in vivo release mechanisms of LAI drug products and their disposition characteristics. Moreover, once developed, a mechanistic PBPK model can help to define the 'safe space' for critical formulation attributes relevant to the reference listed drug (RLD) product, explain sources of PK variability and extrapolate predictions to human subjects by leveraging animal model data and by accounting for species-specific physiological differences.

This grant provides funding to nonprofit organizations that enhance early childhood education and support economic development initiatives for children from birth to age five, particularly those from low- to moderate-income families.

Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clinical endpoint or pharmacodynamic BE studies, as a relatively cost- and time-efficient complement to benchtop and clinical experiments that has been widely used in developing and assessing generic inhaler devices. However, despite the advances in the power of modern computers, there are still some bottlenecks in using CFD due to computational time, limited grid resolution, pre- and post-processing of large simulation data sets, model parameter estimations, and uncertainty quantifications. Machine learning (ML) has been gaining more attention as a potential tool to alleviate such limitations that arise in CFD. The purpose of this grant is to develop a methodology to integrate ML with CFD models of OIDPs to promote alternative BE studies to enhance and accelerate the development and approval of generic OIDPs.

This grant provides funding to nonprofit organizations and local entities in Mississippi to support health promotion and community wellness programs that benefit the state's residents.

This funding opportunity supports youth gardening education programs and educator training initiatives for children in grades K-12 in select Indiana counties, promoting organic gardening and various educational outcomes.

This funding opportunity supports U.S.-based researchers and organizations in developing non-addictive pain relief therapies to combat the opioid crisis, with a focus on advancing preclinical candidates toward clinical trials.

The Silvio O. Conte Digestive Diseases Research Core Centers grant, provided by the NIDDK, supports collaborative research on digestive and liver diseases by offering shared resources to enhance productivity and foster new ideas, centered around a theme within the NIDDK's mission.

This funding opportunity provides financial support for new and underrepresented researchers in the health sciences to conduct projects aligned with the missions of NIAID or NIDDK.

This funding opportunity supports postdoctoral researchers in biomedical and behavioral fields, providing mentorship and resources to help them develop into independent scientists.

This funding opportunity supports predoctoral students in dual-degree programs at institutions without NIH-funded training programs, helping them pursue research and clinical training to become future physician-scientists.

This funding opportunity supports students enrolled in dual-degree medical and research training programs, helping them develop into independent physician-scientists through mentored research and clinical training.

This funding opportunity supports institutions in creating collaborative training networks for early-career researchers focused on advancing studies in kidney, urologic, and hematologic diseases.