Opportunity Information: Apply for RFA FD 18 018
This FDA cooperative agreement (U01) funding opportunity focuses on building a virtual bioequivalence (BE) trial simulation platform that combines physiologically based pharmacokinetic (PBPK) modeling with population pharmacokinetic (PopPK) statistical algorithms. The core problem the RFA is trying to solve is practical and timely: PBPK models are already widely recognized as strong, mechanism-based tools for predicting how a drug is absorbed, distributed, metabolized, and eliminated, and they are increasingly useful in generic drug development and BE assessment. However, despite the growing use of PBPK, there is not an accessible, dedicated platform that makes it straightforward to (1) develop PBPK models that reflect real-world variability across people and studies, and (2) run realistic, population-based virtual BE trials that can support development decisions and regulatory evaluation.
The scientific rationale rests on what PBPK does well and what it still needs help doing at scale. PBPK models can merge multiple categories of information into one framework: human physiology (system parameters like organ sizes, blood flows, enzyme abundances), drug properties (physicochemical traits and interactions with enzymes/transporters), and drug product attributes (formulation type and performance characteristics). This gives PBPK an advantage over purely empirical approaches because it can represent causal mechanisms and can be adapted to different populations and formulations. At the same time, the RFA highlights that the best-performing PBPK workflows increasingly rely on optimization and parameter estimation routines that can capture inter-subject and intra-subject variability. That variability can come from differences in age, weight, sex, and other anthropometrics, plus experimental variation (for example, variability in in vitro dissolution or drug release tests) and study design effects (inter-occasion variability, inter-trial variability, and subject-by-formulation interactions). The opportunity is essentially about bringing mature population-level inference methods into complex PBPK settings so the models are not just mechanistic, but also statistically grounded and usable for virtual trial-based decision making.
The main objective is to develop and implement a user-friendly, potentially open-source software platform capable of running computationally intensive PBPK models while also supporting population-based statistical analyses. In practice, that means the platform should allow users to estimate parameters using individual-level data when available, quantify variability, and then propagate that variability through PBPK simulations to generate virtual BE trials. The intended users are broad: regulators (including FDA), generic drug manufacturers, and academic researchers. The long-term value is that this platform could help predict in vivo performance of generic and reference products, assess BE without always requiring new human studies, and inform regulatory decisions, especially in situations where real trials are difficult, unethical, or impractical.
A major technical requirement is implementing at least one robust PopPK algorithmic approach that can be tightly coupled to PBPK models. The RFA suggests multiple acceptable directions, and encourages novelty, but also recognizes established methods. Examples listed include non-linear mixed effects (NLME) modeling, maximum likelihood methods (including methods that linearize ODE systems as well as methods designed for stiff vs non-stiff differential equations), exact maximum likelihood approaches using Expectation-Maximization (without linearization), Bayesian population PBPK methods using Markov Chain Monte Carlo (MCMC), and nonparametric approaches. Beyond simply coding an algorithm, applicants are expected to think about how to test and benchmark it in realistic PBPK contexts, including evaluating sensitivity to initial parameter guesses, bias, precision, accuracy, convergence behavior, and computation time. Importantly, the algorithm should be evaluated in full-body PBPK models across different levels of complexity (low to high), using both simulated datasets and real datasets, and handling both rich sampling (dense PK profiles) and sparse sampling data (more typical of many clinical settings).
On the PBPK side, the platform is expected to support model structures that reflect the needs of generic drug development for both oral and non-oral products. The RFA calls for flexibility in dosing routes, including administration into the gastrointestinal tract as well as other organs or tissues represented in the model (for example skin for transdermal delivery or lung for inhaled products). It also emphasizes the ability to mechanistically represent a wide range of dosage forms, from immediate-release and extended-release tablets/capsules to solutions and suspensions, aerosols, and topical products such as creams, ointments, emulsions, and transdermal systems. A key theme is that formulation matters, so the platform should be able to incorporate formulation critical quality attributes (CQAs) into the model in a way that can influence predicted in vivo performance. Examples of CQAs mentioned include content uniformity, particle size and particle size distribution, viscosity and rheology parameters, in vitro dissolution or drug release characteristics, and for inhalation/topical systems, aerodynamic and adhesion properties.
Another central expectation is population extrapolation: the PBPK framework should allow users to shift from one population to another by modifying physiology-related parameters. This is especially relevant because BE studies are typically done in healthy adult volunteers, while the real target populations may be patients, older adults, or pediatric populations where conducting BE studies can be ethically and logistically challenging. The platform is meant to make it more feasible to explore these “what happens in the intended patients?” questions by changing physiological assumptions (and variability distributions) and then re-running virtual BE trials.
Study design simulation is also explicitly part of the platform scope. The platform should support common BE trial designs, including crossover and parallel designs, as well as fully replicated designs. It should also handle both single-dose studies and multiple-dose studies, including steady-state scenarios. This matters because BE conclusions can be sensitive to design choice, variability structure, and dosing regimen, and the RFA is aiming for a tool that can test those design decisions in silico before committing to expensive real-world studies.
Model validation and qualification are treated as a desirable, practical requirement rather than an afterthought. The RFA indicates that the platform should enable users to validate PBPK models using appropriate datasets from independent, credible literature sources, in-house data if available, or newly designed and conducted studies to generate the necessary evidence. The datasets used for validation are expected to match the key features represented in the models, meaning they should reflect the relevant subpopulations, study designs, and dosage form characteristics. This emphasis is consistent with regulatory expectations: a simulation platform is only useful for decision making if its models can be shown to perform reliably in contexts similar to where they will be applied.
Finally, applicants are expected to demonstrate the platform’s utility through a well-defined research plan and concrete case examples. The RFA specifically calls for simulated virtual BE studies that test the platform’s ability to distinguish cases where products are known to be bioequivalent from cases where they are known not to be bioequivalent. In other words, the platform should be able to reproduce “positive controls” (true BE) and “negative controls” (true non-BE) based on model outputs and statistical analysis. Running multiple scenarios is encouraged to show flexibility, sensitivity, and predictability, rather than a single showcase example.
Administratively, this opportunity is sponsored by the Department of Health and Human Services, Food and Drug Administration, using a Cooperative Agreement (U01) mechanism, meaning FDA would typically have substantial scientific/programmatic involvement compared with a standard grant. The funding opportunity number is RFA-FD-18-018 (with a noted correction to the posting), created May 23, 2018, with an original closing date of June 20, 2018. The award ceiling listed is $1,800,000, with an expectation of two awards. Eligible applicants include a wide range of organizations, such as state governments, tribal governments and organizations, public and private institutions of higher education, and nonprofits (both 501(c)(3) and non-501(c)(3)), among others as clarified in the full eligibility text.
In plain terms, the grant is trying to catalyze a missing piece of infrastructure for generic drug development: a practical, extensible platform where mechanistic PBPK models and population-level statistical estimation live together, so stakeholders can run credible virtual BE trials, explore variability and formulation effects, extrapolate to special populations, and generate evidence that can support development choices and regulatory review.Apply for RFA 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 May 23, 2018.
- Applicants must submit their applications by Jun 20, 2018 RFA was posted on 04/20/2018 - due to a an error it was posted as RFD-FD-18-018. This is a correction on the title of the RFA. (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, Others (see text field entitled Additional Information on Eligibility for clarification).
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| 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 |
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| 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 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 019 Funding Number: RFA FD 19 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required Apply for RFA FD 19 015 Funding Number: RFA FD 19 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $37,500,000 |
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| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 19 016 Funding Number: RFA FD 19 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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