Opportunity Information: Apply for RFD FD 18 018
This funding opportunity, issued by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA), supports the development of a virtual bioequivalence (BE) trial simulation platform. The core goal is to create a tool that can run realistic, population-based simulations of how drug products behave in the body and then use those simulations to support statistical bioequivalence assessments, particularly in situations where the underlying models are complex and computationally demanding.
A key feature of the project is the integration of population pharmacokinetic (PopPK) modeling algorithms into physiologically based pharmacokinetic (PBPK) models. PBPK models are mechanistic models that represent physiological processes affecting drug absorption, distribution, metabolism, and elimination, and they can be especially important for predicting performance across different patient characteristics. PopPK methods, on the other hand, are designed to quantify variability across individuals and support population-level inference. By combining these approaches, the platform is expected to enable simulated BE trials that reflect real-world variability and allow statistically sound comparisons between brand-name (reference) and generic (test) products.
The platform is intended to handle drugs formulated in both complex and non-complex dosage forms and to be applicable to products administered through oral and non-oral routes. That emphasis matters because complex formulations and alternative routes of administration can introduce challenging absorption and disposition behaviors that are difficult to characterize using simpler modeling or traditional trial designs alone. The platform is expected to support population-based statistical analyses at a level suitable for regulatory decision-making, meaning it should be capable of producing outputs that can help evaluate whether a generic product is bioequivalent to its reference product under relevant conditions.
From a regulatory and public health perspective, the deliverable is positioned as a decision-support capability for generic drug development. The simulated trials generated by the platform would be used to predict in vivo drug product performance, evaluate bioequivalence, and ultimately inform FDA regulatory decisions. In practice, this kind of platform can help explore scenarios that are difficult, expensive, or time-consuming to study empirically, while also improving the rigor and transparency of model-based BE assessments when PBPK models are used.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism (U01), which typically means substantial scientific or programmatic involvement by the funding agency during the project period. The opportunity number is RFD FD 18 018, and it was created on April 20, 2018, with an original closing date of June 20, 2018. The total funding cap per award is listed as $1,800,000, with an expectation of making 2 awards.
Eligibility is broad and includes state governments, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized tribal governments and other tribal organizations, small businesses, and nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding universities in those nonprofit categories). The funding activity category is listed under agriculture, consumer protection, and food and nutrition, and the CFDA number is 93.103, aligning the program administratively with FDA-related assistance listings.
In short, the grant targets the creation of a sophisticated simulation environment that merges PopPK variability and inference with PBPK mechanistic modeling, specifically to support virtual BE trials that can strengthen and streamline generic drug evaluation and the FDA decision process, especially for products where traditional approaches are more difficult to apply.Apply for RFD FD 18 018
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Apr 20, 2018.
- Applicants must submit their applications by Jun 20, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,800,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the purpose of this FDA funding opportunity?
This opportunity supports the development of a virtual bioequivalence (BE) trial simulation platform. The aim is to create a tool that can run realistic, population-based simulations of drug product behavior in the body and use those simulations to support statistical bioequivalence assessments, especially when the underlying models are complex and computationally demanding.
Which federal agency is offering this grant?
The funding opportunity is issued by the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA).
What is the main deliverable expected from the project?
The key deliverable is a virtual BE trial simulation platform that integrates population pharmacokinetic (PopPK) modeling algorithms into physiologically based pharmacokinetic (PBPK) models and supports population-based statistical analyses suitable for regulatory decision-making.
What is meant by a "virtual bioequivalence trial simulation platform" in this context?
In this opportunity, a virtual BE trial simulation platform is a software/tool capability that can simulate in vivo drug product performance across a population and generate simulated trial data that can be used to conduct statistical bioequivalence comparisons between a reference (brand-name) product and a test (generic) product.
What kinds of analyses should the platform support?
The platform is intended to support population-based statistical analyses that are appropriate for evaluating bioequivalence and producing outputs that can inform FDA regulatory decisions.
Why does the opportunity emphasize both PBPK and PopPK approaches?
PBPK models are mechanistic models representing physiological processes affecting absorption, distribution, metabolism, and elimination. PopPK methods quantify variability across individuals and support population-level inference. By combining them, the platform is expected to produce simulated BE trials that reflect real-world variability while remaining grounded in mechanistic physiology, enabling statistically sound comparisons.
What is the role of PBPK models in this project?
PBPK models are intended to represent the physiological mechanisms driving drug behavior in the body. The platform is expected to use PBPK modeling as the mechanistic backbone, which can be especially important for predicting performance across different patient characteristics.
What is the role of PopPK modeling in this project?
PopPK algorithms are intended to capture and quantify variability among individuals and enable population-level inference. Integrating PopPK methods into PBPK models is a central technical feature of the proposed platform.
What kinds of drug products and dosage forms should the platform be able to handle?
The platform is intended to handle drugs formulated in both complex and non-complex dosage forms.
Which routes of administration are included?
The platform is intended to be applicable to products administered through oral and non-oral routes.
Why is there an emphasis on complex formulations and non-oral routes?
Complex formulations and alternative routes of administration can introduce challenging absorption and disposition behaviors that may be difficult to characterize with simpler modeling approaches or traditional trial designs. The platform is positioned to help address those challenges through simulation and population-based inference.
How is the simulated trial output intended to be used?
The simulated trials are intended to predict in vivo drug product performance, evaluate bioequivalence, and serve as a decision-support capability for generic drug development and FDA regulatory decision-making.
What is the broader public health or regulatory value described for this project?
The project is positioned as a way to strengthen and streamline generic drug evaluation by enabling exploration of scenarios that may be difficult, expensive, or time-consuming to study empirically, while also improving the rigor and transparency of model-based BE assessments when PBPK models are used.
What type of funding mechanism is used for this opportunity?
This is a discretionary funding opportunity using a cooperative agreement mechanism (U01).
What does a cooperative agreement (U01) imply for how the project may be managed?
A cooperative agreement (U01) typically involves substantial scientific or programmatic involvement by the funding agency during the project period.
What is the opportunity number for this grant?
The opportunity number is RFD FD 18 018.
When was this opportunity created, and what were the key dates listed?
The opportunity was created on April 20, 2018, and the original closing date was June 20, 2018.
What is the maximum funding amount per award?
The total funding cap per award is listed as $1,800,000.
How many awards does the opportunity expect to make?
The opportunity lists an expectation of making 2 awards.
Who is eligible to apply for this opportunity?
Eligibility is broad and includes state governments, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized tribal governments and other tribal organizations, small businesses, and nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding universities in those nonprofit categories).
Are small businesses eligible?
Yes. Small businesses are explicitly listed among eligible applicants.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments and other tribal organizations are listed as eligible.
Are colleges and universities eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations, both 501(c)(3) and non-501(c)(3), are listed as eligible, with an exclusion noted for universities within those nonprofit categories.
What funding activity category is associated with this opportunity?
The funding activity category is listed under agriculture, consumer protection, and food and nutrition.
What CFDA number is associated with this opportunity?
The CFDA number listed for this opportunity is 93.103.
How does this project relate to generic drug evaluation?
The platform is positioned as decision-support for generic drug development by enabling simulated BE trials that compare test (generic) and reference (brand-name) products under relevant conditions and generate outputs intended to support regulatory decision-making.
What specific comparison is the platform expected to help evaluate?
The platform is expected to support statistically sound comparisons between brand-name (reference) and generic (test) products for purposes of assessing bioequivalence.
What problem is this platform intended to address when models are "complex and computationally demanding"?
The opportunity specifically calls for a tool that can support BE assessments in situations where the underlying models are complex and computationally demanding, implying the platform should be capable of running realistic simulations and enabling statistical evaluation even when modeling complexity would otherwise make assessment difficult.
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| Funding Opportunity |
|---|
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
| Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) Apply for RFA FD 18 022 Funding Number: RFA FD 18 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) Apply for RFA FD 18 025 Funding Number: RFA FD 18 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 18 827 Funding Number: PAR 18 827 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints Apply for RFI NOT FD 18 014 Funding Number: RFI NOT FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional) Apply for RFA FD 19 003 Funding Number: RFA FD 19 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional Apply for RFA FD 19 011 Funding Number: RFA FD 19 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional Apply for PAR 19 190 Funding Number: PAR 19 190 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional Apply for PAR 19 216 Funding Number: PAR 19 216 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed) Apply for RFA FD 19 021 Funding Number: RFA FD 19 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional) Apply for RFA FD 19 020 Funding Number: RFA FD 19 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
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