Food and Drug Administration · Department of Health and Human Services
Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
Key facts
- Deadline
- Opening date not announced
- Award size
- Up to $300K
- Total available
- $600K · about 2 awards
- Match ?
- Not required · Work out your budget and match
- Who can apply
- Nonprofit with 501(c)(3), School district, County government, Tribal government, Nonprofit without 501(c)(3), Larger business, Public college or university, Small business, Private college or university, Tribal organization, State government, Special district (utility, fire, etc.), City or town government, and others named in the official notice
- Where
- Anywhere in the U.S., including Tennessee
Opening soon: the funder has announced this grant, but you can't apply yet. Use the time to get ready and check whether it fits.
Before you apply: federal grants require an active SAM.gov registration (Unique Entity ID) and a Grants.gov account. Registration is free but can take weeks, so start now, not when the deadline is close. Get-ready checklist
How this fits you
- Available in Tennessee (nationwide program)
- No match required
- Past Tennessee awards on file: 42
Tell us who you are to see whether you're eligible.
Official notice: https://simpler.grants.gov/opportunity/d0033870-c493-41da-a2e3-98e2e341ea90 · Printed from grantme.click/grants/ad7a881d-85e6-4629-aac3-5600b6db3b6c
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About this grant
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.
Who can apply, from the official notice
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
Who in Tennessee has won this program
20 awards to Tennessee groups in 5 counties since 2016. Largest shown:
| Past winner | Where | Amount | Fiscal year |
|---|---|---|---|
| University of Tennessee | Knoxville, Knox County | $6.5M | 2020 |
| State of Tennessee | Nashville | $2.7M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $2.5M | 2019 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $2.4M | 2020 |
| University of Tennessee | Memphis, Shelby County | $2M | 2017 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.9M | 2020 |
| University of Tennessee | Knoxville, Knox County | $1.8M | 2025 |
| Franklin Special School District | Franklin, Williamson County | $1.8M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $1.6M | 2022 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.3M | 2021 |
| Tennessee Department of Health | Nashville, Davidson County | $1.3M | 2020 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.3M | 2016 |
Source: USAspending.gov, Federal Audit Clearinghouse. Past awards show who this program funds. They don't guarantee future awards.
Tennessee groups that got this money through a state agency or another organization
This federal money also reaches local groups as pass-through grants. 22 pass-through grants on file. Largest shown:
| Past winner | Where | Through | Amount | Fiscal year |
|---|---|---|---|---|
| Combinedbrain, Inc | Brentwood | Duke University | $538K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Harvard Pilgrim Health Care | $241K spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of California, San Francisco, the | $75K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of California, San Francisco, the | $69K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic Hospital | $51K spent that year | 2025 |
| Volumetrix Inc. | Nashville, Davidson County | The Children's Hospital of Philadelphia | $50K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic | $43K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic | $43K | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Cumberland Pharmaceuticals Inc | $42K spent that year | 2025 |
| Loch & Key Productions, LLC | Knoxville, Knox County | Association of Public Health Laboratories, Inc. (THE) | $33K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | The Queen's Medical Center | $32K | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of California-San Francisco | $29K spent that year | 2025 |
Source: USAspending.gov pass-through reports (the first recipient reports each one of $30,000 or more).
About the federal program
Food and Drug Administration Research, also called “General Grant Funding”
Program number 93.103 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, Food and Drug Administration · Cooperative agreement (a grant with close agency involvement), project grant
How applications are judged
Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the specific evaluation criteria that applies.
Match
None required (federal program listing).