Opportunity Information: Apply for RFA FD 20 018
This FDA cooperative agreement (U01; clinical trials not allowed) funds research aimed at improving how bioequivalence (BE) can be evaluated for generic ophthalmic (eye) drug products when traditional BE testing is difficult or impractical. In many locally acting eye products, drug levels at the actual site of action in human eye tissues cannot be measured routinely because sampling is invasive, ethically challenging, and expensive. As a result, developers often rely on comparative clinical endpoint studies as a surrogate, even though these trials can be lengthy, variable, and inefficient. The opportunity is designed to advance alternative, scientifically defensible approaches, especially physiologically-based pharmacokinetic and pharmacodynamic (PBPK/PD) modeling, to predict drug exposure and effects in human ocular tissues using a combination of in vitro data, animal data, and limited clinical information.
The scientific focus is on extrapolating ophthalmic PK/PD models from rabbits to humans. Rabbits are widely used in preclinical ophthalmic development because their ocular anatomy and physiology share meaningful similarities with humans, and because drug concentrations can be measured directly in multiple rabbit eye tissues (for example, aqueous humor, cornea, conjunctiva, and iris/ciliary body). Those measurements allow researchers to build and refine rabbit PK/PD models with relatively rich tissue concentration data. The central challenge comes later: translating those models to human PBPK/PD models while accounting for rabbit-human differences in ocular physiology and anatomy, and then validating the human models despite the fact that human ocular tissue data are sparse. In practice, human aqueous humor concentrations might be obtained only in narrow contexts such as cataract surgery, and most other tissue measurements are not feasible in routine clinical studies. On the PD side, the opportunity highlights intraocular pressure (IOP) as a key measurable endpoint, especially relevant to glaucoma therapies, since IOP reduction is commonly used in both preclinical and clinical settings to quantify pharmacodynamic response.
The project’s overall objective is to systematically evaluate what models and datasets already exist on both the animal and human sides, identify where the evidence is strong versus where it is thin, and then use that foundation to build credible rabbit-to-human extrapolation workflows. The intended outcome is a clearer understanding of current knowledge gaps that prevent robust translation (for example, limited human validation data, uncertainty in parameter scaling, or incomplete descriptions of formulation-dependent behavior), along with practical solutions that could make model-based approaches more acceptable and useful for BE assessment of future generic ophthalmic products. The FDA’s broader motivation is to support innovation in BE standards, improve the efficiency of generic development, and ensure high-quality generics can be evaluated using approaches that remain clinically meaningful even when direct measurement at the site of action is not possible.
The funding opportunity lays out five specific aims. First, awardees are expected to produce a comprehensive report describing available rabbit ophthalmic PK and PD models and the underlying preclinical data used to support them. Second, they must produce a corresponding report summarizing available human ophthalmic PK and PD models and the clinical datasets that inform those models. Third, they must perform the actual extrapolation work: scaling or translating the rabbit models into human PBPK/PD models by incorporating rabbit-versus-human differences in ocular anatomy and physiology. Fourth, they must compare and verify the newly developed human models against the human models and data collected in the second aim, and explicitly analyze where translation works well versus where it breaks down, identifying knowledge gaps and proposing solutions to improve rabbit-to-human scale-up and validation. Fifth, they must prepare manuscripts for dissemination, with the solicitation noting that much of this writing is expected in the third year (and that this is associated with a reduced budget in that final year), though manuscript preparation may begin earlier.
Administratively, this is a discretionary FDA grant under the Department of Health and Human Services, using a cooperative agreement mechanism (U01), which typically implies substantial programmatic involvement from the funding agency during the project. The opportunity number is RFA-FD-20-018 (CFDA 93.103). It anticipated up to five awards with an award ceiling of $400,000. A wide range of applicants are eligible, including federal recognized tribal governments and organizations, state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), and for-profit entities including small businesses. The emphasis, however, is not on running clinical trials, but on leveraging existing data and conducting modeling, simulation, evaluation, and reporting that can strengthen the scientific foundation for model-informed BE assessment in ophthalmic generics.Apply for RFA FD 20 018
- 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 "Physiologically-based pharmacokinetic/pharmacodynamic model extrapolation to human from rabbit for ophthalmic drug products (U01) Clinical Trials Not Allowed" 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 Dec 20, 2019.
- Applicants must submit their applications by Feb 27, 2020. (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 $400,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is this funding opportunity about?
This FDA cooperative agreement supports research to improve how bioequivalence (BE) can be evaluated for generic ophthalmic (eye) drug products when traditional BE testing is difficult or impractical. The work focuses on developing and evaluating alternative, scientifically defensible approaches, with an emphasis on physiologically-based pharmacokinetic and pharmacodynamic (PBPK/PD) modeling to predict drug exposure and effects in human ocular tissues.
What is the main problem the FDA is trying to solve?
For many locally acting ophthalmic products, drug levels at the actual site of action in human eye tissues cannot be measured routinely because tissue sampling is invasive, ethically challenging, and expensive. As a result, developers often rely on comparative clinical endpoint studies as a surrogate for BE, even though these trials can be lengthy, variable, and inefficient. This opportunity aims to strengthen model-based approaches that remain clinically meaningful when direct site-of-action measurements are not feasible.
Are clinical trials allowed under this cooperative agreement?
No. The mechanism is U01 and the solicitation specifies "clinical trials not allowed." The emphasis is on modeling, simulation, evaluation, and reporting, leveraging existing data and limited clinical information rather than running clinical trials.
What types of products or therapeutic areas are most relevant?
The opportunity is centered on generic ophthalmic drug products, especially locally acting eye products where traditional BE testing is challenging. It highlights intraocular pressure (IOP) as an important pharmacodynamic endpoint, which is especially relevant to glaucoma therapies.
What scientific approach is emphasized?
The opportunity emphasizes PBPK/PD modeling to predict drug exposure and pharmacodynamic effects in human ocular tissues using a combination of in vitro data, animal data, and limited clinical information.
Why does the opportunity focus on extrapolating models from rabbits to humans?
Rabbits are widely used in preclinical ophthalmic development because their ocular anatomy and physiology share meaningful similarities with humans. In rabbits, drug concentrations can be measured directly in multiple ocular tissues (such as aqueous humor, cornea, conjunctiva, and iris/ciliary body), enabling richer PK/PD model development. The challenge is translating those rabbit-based models to humans while accounting for rabbit-human differences and validating the human models despite sparse human ocular tissue data.
What kinds of rabbit data are considered useful for building the animal models?
The opportunity describes rabbit tissue concentration measurements as particularly valuable, including concentrations in aqueous humor, cornea, conjunctiva, and iris/ciliary body. These measurements support building and refining rabbit PK/PD models with relatively rich tissue-level data.
Why is human ocular tissue data described as limited?
In humans, direct sampling of many ocular tissues is typically not feasible in routine clinical studies because it is invasive and ethically challenging. The opportunity notes that human aqueous humor concentrations may be obtainable only in narrow contexts, such as cataract surgery, and most other tissue measurements are not routinely possible.
What is the role of intraocular pressure (IOP) in this project?
IOP is highlighted as a key measurable pharmacodynamic (PD) endpoint. It is especially relevant for glaucoma therapies because IOP reduction is commonly used in both preclinical and clinical settings to quantify PD response, making it a practical endpoint to connect modeling predictions to measurable outcomes.
What is the overall objective of the funded project?
The overall objective is to systematically evaluate what rabbit and human ophthalmic PK/PD models and datasets already exist, determine where evidence is strong versus thin, and use that foundation to build credible rabbit-to-human extrapolation workflows for human PBPK/PD modeling that can support BE assessment.
What outcomes is the FDA looking for?
The intended outcomes include: (1) a clearer understanding of knowledge gaps that limit robust rabbit-to-human translation (such as limited human validation data, uncertainty in parameter scaling, or incomplete descriptions of formulation-dependent behavior) and (2) practical solutions that could make model-based approaches more acceptable and useful for future BE assessment of generic ophthalmic products.
What are the five specific aims described in the opportunity?
The opportunity lays out five aims:
- Produce a comprehensive report describing available rabbit ophthalmic PK and PD models and the underlying preclinical data supporting them.
- Produce a report summarizing available human ophthalmic PK and PD models and the clinical datasets that inform those models.
- Perform rabbit-to-human extrapolation by scaling/translating rabbit models into human PBPK/PD models using rabbit-versus-human differences in ocular anatomy and physiology.
- Compare and verify the newly developed human models against the human models and data gathered in Aim 2, analyze where translation works well versus breaks down, identify knowledge gaps, and propose solutions to improve scale-up and validation.
- Prepare manuscripts for dissemination (with much of the writing expected in the third year, which is associated with a reduced budget in that final year, though writing may begin earlier).
What does "cooperative agreement (U01)" imply for how the project will be run?
A U01 cooperative agreement typically implies substantial programmatic involvement from the funding agency during the project. In this opportunity, that means FDA is expected to have an active role consistent with a cooperative agreement mechanism.
What is the opportunity number and CFDA listing?
The opportunity number is RFA-FD-20-018, and the CFDA listing is 93.103.
How many awards are anticipated and what is the award ceiling?
The opportunity anticipated up to five awards, with an award ceiling of $400,000.
Who is eligible to apply?
A wide range of applicants are eligible, including federally recognized tribal governments and organizations, state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), and for-profit entities including small businesses.
Is the work mainly experimental, clinical, or computational?
Based on the description provided, the emphasis is on leveraging existing data and conducting modeling, simulation, evaluation, and reporting. The solicitation is not focused on running clinical trials.
What types of data sources are expected to support the modeling work?
The opportunity describes using a combination of in vitro data, animal (rabbit) data, and limited clinical information. It also calls for summarizing existing preclinical datasets supporting rabbit models and existing clinical datasets informing human models.
What is meant by "bioequivalence (BE)" in the context of ophthalmic generics?
In this context, BE refers to demonstrating that a generic ophthalmic product performs comparably to a reference product. The opportunity is focused on improving evaluation methods when direct measurement at the site of action in humans is not feasible, and when comparative clinical endpoint studies are used as a surrogate but may be inefficient.
Why are comparative clinical endpoint studies described as inefficient?
The opportunity notes that comparative clinical endpoint studies used as a surrogate for BE can be lengthy, variable, and inefficient, which can slow development and add uncertainty when the endpoint has high variability or requires large and long studies.
What knowledge gaps does the opportunity explicitly mention?
Examples of gaps mentioned include limited human validation data, uncertainty in parameter scaling between rabbits and humans, and incomplete descriptions of formulation-dependent behavior that can affect model performance and translation.
What does validation look like when human tissue concentrations are sparse?
The opportunity anticipates that validation will rely on comparing newly developed human PBPK/PD models against available human models and the limited human datasets summarized in Aim 2, and explicitly analyzing where rabbit-to-human translation performs well or fails, then proposing solutions to strengthen scale-up and validation.
What deliverables are explicitly expected?
Deliverables include: a rabbit-model landscape report (Aim 1), a human-model landscape report (Aim 2), translated human PBPK/PD models and an extrapolation workflow (Aim 3), a verification and gap analysis with proposed solutions (Aim 4), and manuscripts for dissemination (Aim 5).
Is manuscript preparation part of the planned project timeline?
Yes. The solicitation notes that much of the manuscript writing is expected in the third year, and that the final year has a reduced budget associated with that writing-focused period (while manuscript preparation may begin earlier).
What is the FDA's broader motivation for funding this work?
The FDA aims to support innovation in BE standards, improve the efficiency of generic development, and ensure high-quality generics can be evaluated using approaches that remain clinically meaningful even when direct measurement at the site of action is not possible.
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