ForecastedOpportunity FOR-FD-24-002

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

Food and Drug Administration · Department of Health and Human Services

At a glance

Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional is a forecasted federal cooperative agreement opportunity from the Food and Drug Administration (Department of Health and Human Services). The agency has forecast this opportunity but has not yet set an application deadline. Individual awards are listed as up to $300K, with about 2 awards expected and $600K in total estimated funding. Applicant types listed as eligible include state governments, county governments, city or township governments, special district governments, independent school districts and 10 more. Cost sharing is not required. It is funded under Assistance Listing 93.103 (Food and Drug Administration Research).

Summary assembled from the official notice's fields. The official notice governs.

Key facts

Posted: Nov 21, 2023
Est. close date: Not listed
Award floor: Not specified
Award ceiling: $300,000
Est. total funding: $600,000
Expected awards: 2
Cost sharing: Not required
Funding instrument: Cooperative Agreement
Opportunity category: Discretionary
Fiscal year: FY2024

Who can apply

State governments
County governments
City or township governments
Special district governments
Independent school districts
Public colleges & universities
Federally recognized tribal governments
Public & Indian housing authorities
Native American tribal organizations
501(c)(3) nonprofits
Nonprofits without 501(c)(3) status
Private colleges & universities
For-profit organizations (not small businesses)
Small businesses
Others (see notice)

Additional information on eligibility (from the 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

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

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.

Assistance Listing

What is an ALN?

93.103Food and Drug Administration ResearchProgram →

Reported obligations under ALN 93.103

Historical data · not a prediction

FY18

$173M

FY19

$199M

FY20

$212M

FY21

$219M

FY22

$256M est.

FY23

$247M est.

Source: SAM.gov Assistance Listing 93.103. Program-wide totals, not awards from this specific opportunity.

Agency contact (as published)

Terrin Brown Grants Management Specialist
Terrin.Brown@fda.hhs.gov
240-402-7610

Quick answers

Is this opportunity open for applications yet?

Not yet. It is a forecast — an agency's advance notice of an expected opportunity. Forecast details and dates can change.

Who is eligible to apply for this opportunity?

The official notice lists these applicant types as eligible: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public colleges & universities, Federally recognized tribal governments, Public & Indian housing authorities, Native American tribal organizations, 501(c)(3) nonprofits, Nonprofits without 501(c)(3) status, Private colleges & universities and 3 more. Additional restrictions may apply; review the full notice.

How much funding is available through this opportunity?

Per the notice, individual awards are listed as up to $300k, total estimated program funding is $600,000 and the agency expects to make about 2 awards.

How do I apply for this opportunity?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity FOR-FD-24-002), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.

ForecastedALN 93.103