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
ID: 351807Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $250K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
  1. 1
    Forecast Posted Not available
  2. 2
    Forecast Due Not available
  3. 3
    Posted Jan 15, 2024 12:00 AM
  4. 4
    Due Apr 8, 2024 12:00 AM
Description

The Food and Drug Administration (FDA) is offering a federal grant 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 funding opportunity aims to examine the utility of an in vitro simulated gastrointestinal (GI) dissolution model for the assessment of in vitro performance of amorphous solid dispersion (ASD) drug products under different clinically relevant conditions.

The purpose of this grant is to develop and validate an in vitro mechanistic methodology that can provide an improved understanding of the impact of food and acid reducing agents on the absorption of test and reference listed drug (RLD) drug products. This methodology will take into consideration the potentially different formulations and manufacturing processes of these products. The goal is to correlate the in vitro observations to in vivo outcomes, help define types of in vivo bioequivalence (BE) studies needed for ASD drug products, and inform regulatory decision-making related to mitigating the risk of potential failure modes for therapeutic equivalence for high-risk generic oral drug products.

The funding opportunity does not require cost sharing or matching requirements. It falls under the category of Food and Nutrition and is a discretionary grant. The estimated total program funding is $250,000, with an award ceiling of $250,000. The FDA expects to make two awards through this grant opportunity.

For more information and to access the funding opportunity announcement, please visit the following link: RFA-FD-24-009 Funding Opportunity Announcement. If you have any questions or need further assistance, you can contact Terrin Brown at terrin.brown@fda.hhs.gov.

Point(s) of Contact
Files
No associated files provided.
Similar Opportunities
Drug Development Tools Research Grants (U01) Clinical Trials Optional
Food and Drug Administration
The Food and Drug Administration (FDA) is offering Drug Development Tools Research Grants (U01) through a Cooperative Agreement funding instrument. This opportunity falls under the category of Food and Nutrition and is currently open for applications. The grants aim to support the development of drug development tools that have an accepted or reviewable Letter of Intent (LOI) within the FDA's Drug Development Tool Qualification Program. These tools are intended to fill unmet needs in drug development and will be made publicly available once qualified. The grants do not require cost sharing or matching requirements. The estimated total program funding is $6 million, with an expected number of 6 awards to be granted. The award ceiling and floor are both set at $500,000. The closing date for applications is May 13, 2025, and the archive date is June 12, 2025. Eligible applicants include developers of drug development tools who have an accepted or reviewable LOI within the FDA's Drug Development Tool Qualification Program and are working towards their qualification plan or full qualification package. Previous recipients of DDT research grant support from FDA-CDER/CBER are also eligible to apply if they have successfully progressed to the next submission milestone and are requesting additional funding for new DDT project needs addressing different aspects of the project. For more information and to apply, please visit the following link: [RFA-FD-24-030 Funding Opportunity Announcement](https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-030.html). If you have any questions, you can contact Terrin Brown, the grantor, at terrin.brown@fda.hhs.gov.
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 offering a federal grant opportunity titled "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". This grant aims to support research in developing tools that facilitate the development of modified release (MR) generic drug products with a low potential for alcohol dose dumping (ADD). Modified release oral drug products are designed to release drugs over a prolonged period of time and are at high risk for ADD when exposed to alcohol. Accidental exposure to alcohol can result in the rapid release of large quantities of drugs, leading to severe side effects and even death. To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in various alcoholic dissolution media for prospective generic versions of MR oral drug products. Currently, there is a lack of global harmonization in ADD assessments. For example, the FDA recommends testing up to 40% alcoholic media, while the European Medicines Agency recommends testing up to 20% alcoholic media. This difference poses challenges for formulators designing products for multiple markets, as historical data has shown that release from MR oral products does not always follow a linear response to increasing alcohol concentrations. The purpose of this research is to develop tools that facilitate the development of MR generic drug products with a low potential for ADD. These tools will support regulatory decision making during the assessment of such products and provide evidence for the FDA to develop more specific recommendations for demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high-risk drugs. The grant has a funding ceiling and floor of $250,000 and is expected to result in one award. It falls under the category of funding activity for consumer protection. The grant is forecasted for the fiscal year 2024 and does not require cost sharing or matching. The opportunity is a cooperative agreement and is open to unrestricted eligible applicants. For more information, interested parties can contact Terrin Brown, the grantor, at terrin.brown@fda.hhs.gov or (240) 402-7610.
Collaborations to Enhance Drug Development and Regulatory Science
Food and Drug Administration
The Food and Drug Administration (FDA) is offering a grant opportunity titled "Collaborations to Enhance Drug Development and Regulatory Science". This grant aims to support, manage, and facilitate Public-Private Partnerships and Collaborative activities as part of the Critical Path Initiative and to support regulatory science efforts. The FDA and grantees will work together to develop innovative, collaborative projects in research, education, and outreach. These projects can help foster drug product innovation by supporting efforts to accelerate drug product development, approaches to advanced manufacturing, translation of basic science discoveries into therapeutics, and approaches to enhance the safety, efficacy, quality, and performance of drug products. The grant has an award ceiling and floor of $5,000,000 and expects to fund 6 awards. The grant is forecasted and falls under the category of funding activity for Consumer Protection. The grant is open to unrestricted eligible applicants. The deadline for application submission is in the fiscal year 2024. For more information, you can contact Terrin Brown, the grantor, at terrin.brown@fda.hhs.gov or (240) 402-7610.
Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
Food and Drug Administration
The Food and Drug Administration (FDA) is offering a federal grant opportunity titled "Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional". This grant aims to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) for long-acting injectables (LAIs) such as crystalline suspensions and polymer-based implants. The objective of this research proposal is to create a bottom-up mechanistic PBPK model for these two categories of LAIs by considering their distinct characteristics and the influence of critical formulation attributes. The goal is to predict the in vivo release mechanism of each LAI drug product type by incorporating relevant physiology and suitable in vitro and in vivo experiments. The PBPK model can be validated using a suitable preclinical animal model. This research will provide insights into how the physicochemical properties of drug molecules/polymer, implant-specific properties, critical formulation attributes, and physiology influence the in vivo release mechanisms and disposition characteristics of LAI drug products. The developed PBPK model will help define the "safe space" for critical formulation attributes, explain sources of pharmacokinetic variability, and extrapolate predictions to human subjects by leveraging animal model data and accounting for species-specific physiological differences. The grant has an estimated total program funding of $600,000, with an award ceiling of $300,000. It is a cooperative agreement and falls under the category of funding activity related to health. The grant is forecasted for the fiscal year 2024, and it is open to eligible applicants, including independent school districts, public housing authorities, Native American tribal organizations, and non-domestic entities. For more information, interested parties can contact Terrin Brown, a Grants Management Specialist at the FDA, via email at Terrin.Brown@fda.hhs.gov or by phone at 240-402-7610.