Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
ID: 351804Type: 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/351804

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-006.html
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) has announced a funding opportunity aimed at developing physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectables (LAIs), specifically crystalline suspensions and polymer-based implants. The objective is to create a PBPK model that incorporates critical formulation attributes to better predict in vivo drug release mechanisms, thereby enhancing the understanding of pharmacokinetics and variability in transitioning from animal models to human predictions. This initiative is crucial for addressing gaps in the pharmacokinetic profiles of LAIs and supporting the development of generic products. Interested applicants, including higher education institutions and nonprofits, can apply for up to $600,000 in funding for two awards, with applications due by April 8, 2024. For further details, contact Terrin Brown at terrin.brown@fda.hhs.gov or visit the funding announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-006.html.

    Point(s) of Contact
    terrin.brown@fda.hhs.gov
    Files
    Title
    Posted
    RFA-FD-24-006.html
    The Department of Health and Human Services, through the U.S. Food and Drug Administration (FDA), has issued a Notice of Funding Opportunity (NOFO) focused on developing mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectables (LAIs) like crystalline suspensions and polymer-based implants. The goal is to create a physiologically based pharmacokinetic (PBPK) model that accounts for critical formulation attributes and their effects on in vivo drug release mechanisms. This initiative seeks to enhance understanding of how formulation characteristics influence pharmacokinetics and variability when transitioning from animal models to human predictions. Key dates include the NOFO posting on November 13, 2023, with application deadlines set for March 31, 2024. Eligible applicants include higher education institutions, nonprofits, and various levels of government. Up to $600,000 is allocated for funding two awards over a three-year project period. Each year’s funding is capped, and successful applicants are expected to collaborate closely with FDA staff. The ultimate aim of the research is to generate validated PBPK models to support the creation of generic LAI products, addressing current gaps in the understanding of their complicated pharmacokinetic profiles.
    Similar Opportunities
    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
    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.
    Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography," which requires a clinical trial. This cooperative agreement aims to support research and development of non-invasive technologies to accurately measure the pharmacokinetics of topically applied drugs within the skin, facilitating the demonstration of bioequivalence for topical products. 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 by phone at 240-338-7494 for further information. Applications are expected to be submitted in fiscal year 2024, with specific guidelines regarding submission of distinct applications to avoid overlap.
    Collaborations to Enhance Drug Development and Regulatory Science
    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.
    Center for Research on Complex Generics (U18) Clinical Trials Optional
    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.
    Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
    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.
    Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed
    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.
    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
    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.
    Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed
    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.
    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
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled "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)." This cooperative agreement aims to develop and test an AI- or ML-based algorithmic model utilizing real-world data to enhance post-market surveillance of complex generic drug products, which are increasingly prevalent in the marketplace and may exhibit distinct differences from their reference listed counterparts. The initiative is critical for ensuring therapeutic equivalence and facilitating timely regulatory actions based on identified post-market signals. Interested applicants can apply for a funding amount of $300,000, with the opportunity being forecasted for fiscal year 2024. For further inquiries, applicants may contact Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-338-7494.
    Laboratory Flexible Funding Model (LFFM)
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled the Laboratory Flexible Funding Model (LFFM) aimed at enhancing the capacities of state human and animal food testing laboratories to support an integrated food safety system. This cooperative agreement focuses on prioritized sample testing and method development in microbiology, chemistry, and radiochemistry, with the goal of improving food safety and defense capabilities. The program is crucial for preventing foodborne illnesses and ensuring the safety of food in the U.S., with approximately $25 million in funding anticipated for fiscal year 2025 and a total of 75 awards expected. Eligible applicants include accredited private institutions of higher education and government entities, with key deadlines starting with letters of intent due on January 17, 2025. For further details, interested parties can contact Lisa Pendleton at lisa.pendleton@fda.hhs.gov or refer to the funding announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-007.html.