Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed
ID: 351805Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $300K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351805

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-007.html
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) is offering a funding opportunity aimed at utilizing real-world data (RWD) and machine learning/artificial intelligence (ML/AI) to enhance post-market surveillance of complex generic drug products. The objective is to develop and test an algorithmic RWD model to assess clinical outcomes for patients switching between complex generic drugs and their reference listed drugs (RLDs), addressing the limitations of current surveillance methods that rely heavily on adverse event reporting. This initiative is crucial for modernizing drug safety surveillance and ensuring therapeutic equivalence in an increasingly complex generic marketplace. The funding amount is up to $300,000 for one award, with applications due by April 8, 2024. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov for further information, and additional details can be found in the funding announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-007.html.

    Point(s) of Contact
    terrin.brown@fda.hhs.gov
    Files
    Title
    Posted
    RFA-FD-24-007.html
    The U.S. Food and Drug Administration (FDA) has issued a Notice of Funding Opportunity (NOFO) aiming to utilize real-world data (RWD) and machine learning/artificial intelligence (ML/AI) to enhance post-market surveillance of complex generic drug products. The funding, under Cooperative Agreement U01, targets the development of an RWD algorithmic model to assess clinical outcomes in patients switching between complex generic drugs and reference listed drugs (RLDs). Given the rising complexity and market share of these generic products, current surveillance methods that heavily rely on adverse event reporting have proven limited. The funding opportunity consists of several key deadlines, including application submissions by March 31, 2024, and emphasizes collaboration between awarded institutions and FDA scientists. Participants are encouraged to share generated data with FDA while meeting specific reporting requirements. Up to $300,000 is allocated for one award, with potential for two additional years depending on fund availability and project performance. Eligible applicants include various educational institutions and organizations, with a keen focus on promoting diversity and inclusion in applications. This initiative represents an important step towards modernizing drug safety surveillance methods through innovative technologies and partnerships.
    Similar Opportunities
    Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a grant opportunity titled "Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed." This grant aims to develop methodologies that integrate machine learning with computational fluid dynamics (CFD) models to enhance bioequivalence studies for generic orally inhaled drug products (OIDPs), addressing existing limitations in CFD applications. The integration of these technologies is crucial for improving the efficiency and effectiveness of developing and approving generic inhalers, which are vital for public health. The estimated total program funding is $600,000, with one award expected, and interested applicants can contact Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further information. The opportunity is set for the fiscal year 2024 and does not require cost sharing or matching.
    Center for Research on Complex Generics (U18) Clinical Trials Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for the establishment of a Center for Research on Complex Generics through a cooperative agreement. This initiative aims to enhance collaboration with the generic drug industry, focusing on identifying scientific challenges in generic product development and facilitating research that supports the FDA's mission to improve patient access to high-quality, safe, and effective generic drugs. The Center will serve as a hub for coordination among FDA, academia, and industry stakeholders, conducting research, hosting workshops, and providing public access to research outcomes. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610. The funding amount is set at $1.5 million, with one award anticipated for the fiscal year 2025.
    Collaborations to Enhance Drug Development and Regulatory Science
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is inviting applications for a federal grant titled "Collaborations to Enhance Drug Development and Regulatory Science." This opportunity aims to establish cooperative agreements that support Public-Private Partnerships and collaborative activities under the Critical Path Initiative, focusing on innovative projects that enhance drug product development, advanced manufacturing, and the translation of scientific discoveries into therapeutics. The initiative is crucial for fostering innovation in drug safety, efficacy, quality, and performance, with a total funding ceiling of $5 million available for six expected awards in fiscal year 2024. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call (240) 402-7610 for further information.
    Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled "Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional." This initiative aims to develop and validate an in vitro mechanistic methodology to assess the performance of amorphous solid dispersion (ASD) drug products under various clinically relevant conditions, ultimately enhancing the understanding of how food and acid-reducing agents affect drug absorption. The funding, which ranges from $250,000 to $500,000, is intended to support research that correlates in vitro observations with in vivo outcomes, thereby informing regulatory decisions for high-risk generic oral drug products. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call (240) 402-7610 for further information, with applications being accepted for the fiscal year 2024.
    Drug Development Tools Research Grants (U01) Clinical Trials Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering Drug Development Tools Research Grants (U01) to support research aimed at advancing drug development tools (DDTs) that have an accepted or reviewable Letter of Intent within the FDA's qualification program. These grants are intended for developers working towards their qualification plan or full qualification package, focusing on tools that can enhance public health by optimizing the drug development process, such as biomarkers or animal models. The funding opportunity provides up to $500,000 for a maximum two-year period, with applications due by May 13, 2024, and May 13, 2025. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov for further information and are encouraged to review the detailed announcement available at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-030.html.
    Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a federal grant opportunity titled "Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required." This grant aims to fund clinical trials that evaluate the efficacy and safety of products intended to address unmet needs in rare neurodegenerative diseases affecting both children and adults, thereby increasing the number of approved treatments in this critical area. The initiative is part of the FDA's broader effort to enhance drug development for rare diseases, which is vital for improving health outcomes in affected populations. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for more information, with funding amounts ranging from $650,000 to $900,000 for the fiscal year 2025.
    Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is announcing a funding opportunity for a Cooperative Agreement titled "Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)." This initiative aims to support research and development of practices that mitigate risks associated with nitrosamine impurities in human drugs, thereby enhancing public health safety while ensuring access to essential therapeutic drugs. The FDA seeks to fund one award with a total funding amount of $350,000, with no cost-sharing or matching requirements. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information. The opportunity is forecasted for fiscal year 2024, and applicants may submit multiple distinct applications, adhering to guidelines regarding overlapping submissions.
    Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for a cooperative agreement aimed at the synthesis and biological activity assessment of different diastereomers in the siRNA drug LEQVIO (Inclisiran). The primary objective of this research is to systematically evaluate the diastereomeric composition of LEQVIO, focusing on the synthesis of each diastereomer in stereo chemically pure form, assessing their biological activity in inhibiting PCSK9, and developing analytical methods for characterization. This research is significant for enhancing the understanding of the pharmacological activity of LEQVIO and contributing to the quality control of oligonucleotide drugs. The funding amount is set at $300,000, with one award expected, and interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further details.
    Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for the identification of drug-related and formulation-related factors that contribute to alcohol dose dumping (ADD) in modified release oral drug products through a cooperative agreement. The objective of this research is to develop tools that facilitate the creation of generic MR drug products with a low potential for ADD, support regulatory decision-making, and provide evidence for the FDA to refine its recommendations regarding ADD assessments. This initiative is crucial as modified release oral drug products pose significant risks when exposed to alcohol, potentially leading to severe side effects, including death. The FDA anticipates awarding one grant with a funding amount of $250,000, and interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information. The opportunity is open to unrestricted applicants, and submissions must be scientifically distinct to avoid duplication.
    Manufactured Foods Flexible Funding Model (MF-FFM)
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Manufactured Foods Flexible Funding Model (MF-FFM)" aimed at advancing a nationally integrated food safety system. This cooperative agreement seeks to support initiatives related to Manufactured Food Regulatory Program Standards (MFRPS), dietary supplement safety, and state compliance and enforcement infrastructure, with a focus on enhancing food safety practices across jurisdictions. The program is critical for ensuring that state regulatory programs maintain high-quality standards and best practices in food safety. Interested applicants, which include state, local, territorial, and tribal agencies, as well as non-profit training entities collaborating with higher education institutions, can reach out to Gordana Zuber at gordana.zuber@fda.hhs.gov or by phone at 301-348-1747 for further details. The estimated project start date is July 1, 2023, with approximately 50 awards expected under this discretionary funding opportunity.