The Food and Drug Administration (FDA) has announced a new funding opportunity titled “Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional,” under the opportunity number FOR-FD-24-002. This program aims to advance research in the development of physiologically based pharmacokinetic (PBPK) models for long-acting injectables (LAIs), including crystalline suspensions and polymer-based implants. With an estimated total program funding of $600,000 and an award ceiling of $300,000, the program seeks to fund two awards.
The primary objective of this research is to create a mechanistic PBPK model for these LAI categories, considering the influence of critical formulation attributes and in vivo release mechanisms. This project is crucial for understanding how various factors, including drug and polymer physicochemical properties, formulation attributes, and physiological aspects, influence the release and disposition of LAI drug products. The program is open to a wide range of applicants, including educational institutions, government bodies, nonprofits, and for-profit organizations. This initiative represents an essential step towards enhancing drug delivery systems and improving patient outcomes in the field of pharmacokinetics and pharmacodynamics.
Opportunity ID: 351078
General Information
| Document Type: | Grants Notice |
| Opportunity Number: | FOR-FD-24-002 |
| Opportunity Title: | Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Food and Nutrition Health Science and Technology and other Research and Development |
| Category Explanation: | |
| Expected Number of Awards: | 2 |
| CFDA Number(s): | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Forecast 1 |
| Forecasted Date: | Nov 21, 2023 |
| Last Updated Date: | Nov 21, 2023 |
| Estimated Post Date: | |
| Estimated Application Due Date: | |
| Estimated Award Date: | |
| Estimated Project Start Date: | |
| Fiscal Year: | 2024 |
| Archive Date: | |
| Estimated Total Program Funding: | $ 600,000 |
| Award Ceiling: | $ 300,000 |
| Award Floor: |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Public housing authorities/Indian housing authorities State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education City or township governments Native American tribal governments (Federally recognized) Small businesses Special district governments Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | Independent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 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. |
| Link to Additional Information: | |
| Grantor Contact Information: |
Terrin Brown
Grants Management Specialist 240-402-7610
|