Opportunity Information: Apply for RFA FD 18 019
This FDA cooperative agreement opportunity (U01; RFA-FD-18-019) focuses on improving how scientists and regulators predict the performance of topical dermatological drug products and transdermal delivery systems by using dermal physiologically-based pharmacokinetic (PBPK) models that explicitly account for formulation quality. PBPK modeling is presented as a mechanistic, "bottom-up" approach that combines system-specific parameters (skin and whole-body anatomy and physiology, tissue volumes, blood flows, protein/enzyme abundance, etc.) with drug-specific physicochemical properties (molecular weight, solubility, pKa, logP, and related traits). While PBPK methods have existed for decades, the grant emphasizes that modern computing and growing in vitro and in vivo datasets now make PBPK particularly valuable for complex products applied to the skin, where absorption, distribution across skin layers, and potential systemic exposure are governed by both biology and formulation design.
A central problem the opportunity tries to address is that bioequivalence for topical products is hard to establish because the drug often acts locally in the skin and concentrations at the site of action are rarely measured in humans. Many topical products also produce little to no quantifiable systemic concentrations, which limits the usefulness of traditional pharmacokinetic studies. Transdermal systems add another layer of complexity because systemic delivery still depends on transport through the skin, an organ with multiple heterogeneous layers and barrier properties that can vary across individuals and conditions. The FDA frames dermal PBPK models as a way to bridge these gaps by predicting drug amounts and concentrations in different skin compartments and by allowing sensitivity analyses to identify which physiological parameters, drug properties, and formulation attributes most strongly influence local and systemic bioavailability.
The main objective is to incorporate drug product quality attributes into dermal PBPK models for both topical dosage forms and transdermal delivery systems, then use those models to (1) identify formulation- and product-specific critical quality and performance attributes and (2) run virtual bioequivalence assessments comparing brand (reference) and generic products to support regulatory decision-making. The opportunity is closely tied to generic drug development needs: generic products share the same active ingredient and intended use as the innovator but can differ in formulation, which may alter release from the dosage form, partitioning into the stratum corneum and viable epidermis/dermis, and ultimately therapeutic performance. The grant explicitly connects this to established regulatory concepts of formulation sameness: Q1 (qualitatively the same components), Q2 (quantitatively similar component levels), and Q3 (similar microstructure or arrangement of matter). It also situates the work within "quality by design" practices, where developers define and control critical quality attributes (CQAs) and performance attributes to ensure consistent product behavior.
The requested work is laid out as a staged research program. First, awardees are expected to conduct an extensive literature-based search to identify formulation quality and performance attributes relevant to dermatological products. The examples given are broad and reflect both stability and performance drivers, including crystallization, phase separation, sedimentation, rheology and viscosity changes, volatility, mixing conditions, temperature effects, color and odor changes, physical appearance and smoothness, preservative and antimicrobial systems (including antioxidants and chelating agents), uniformity, pH, dissolution behavior, globule size and distribution for emulsions, in vitro release testing, in vitro skin permeation, adhesion properties (especially relevant to patches and films), and excipient effects. The opportunity also highlights active pharmaceutical ingredient (API) attributes that may be critical, such as solubility, melting point, salt versus free base/acid form, particle size, polymorphism, whether the API is present as a liquid or solid, degree of saturation or supersaturation, and crystal habit. The FDA notes that additional attributes may be prioritized in collaboration with the FDA research team to meet specific regulatory needs.
Second, applicants are expected to compile these attributes into an organized, accessible database by pulling information from multiple independent, credible sources (peer-reviewed literature, textbooks, and similar references). Where data are missing, the opportunity allows using in-house data or designing and conducting new studies to generate the necessary experimental measurements, including studies that may target special populations of interest. The emphasis is on creating a structured evidence base that can be used consistently across modeling efforts rather than relying on scattered, non-standardized inputs.
Third, the project must develop dermal PBPK models for topical and transdermal products that incorporate the collected formulation attribute information in a meaningful way. The FDA encourages selecting dermatological products and APIs that span a wide range of physicochemical properties and permeability behaviors, because these properties can substantially affect formulation stability, drug release from the dosage form, and transport/partitioning across skin layers. The announcement suggests (without requiring) a Biopharmaceutics Classification-like strategy for choosing APIs so that the resulting model set is not narrowly tuned to one type of compound. Product types of interest explicitly include creams, ointments, gels, emulsions, suspensions, lotions, solutions, films, and patches, with the possibility of adding other dosage forms through collaboration with the FDA research team.
Fourth, the models must be validated and/or qualified using appropriate datasets that match the modeled subpopulations, study designs, dosage forms, and the specific quality/performance attributes encoded in the model. Validation sources can include independent literature datasets, in-house datasets, or newly generated experimental data if needed. The intent is model qualification in a regulatory-relevant sense: demonstrating that the model can credibly predict outcomes for the contexts in which it will be used, particularly when formulation differences are the key variable.
Fifth, once qualified, the models should be used to simulate virtual bioequivalence studies for generic formulations versus reference products. The FDA expects multiple simulation scenarios to show flexibility, sensitivity, and predictive performance, which in practice implies exploring how differences in CQAs (for example, viscosity, droplet size distribution, crystallinity, adhesion, or in vitro release rates) propagate through the mechanistic model to change predicted local skin exposure and/or systemic exposure for transdermal systems. The long-term regulatory value is that such simulations could inform when in vitro data and modeling may reduce the need for certain in vivo studies, help interpret Q1/Q2/Q3 differences, and support more science-based decisions about equivalence for complex topical and transdermal products.
Administratively, this is a discretionary funding opportunity from the Department of Health and Human Services, Food and Drug Administration, using the cooperative agreement mechanism (U01), which generally implies substantial FDA scientific involvement during the project. It falls under CFDA 93.103. The announcement listed an award ceiling of $250,000 and anticipated two awards. Eligibility was broad, spanning federal recognized tribal governments and organizations, state and local governments, public and private higher education institutions, nonprofits (with or without 501(c)(3) status), individuals, and for-profit organizations (including small businesses). The original posting date was March 21, 2018, with an original closing date of May 28, 2018.Apply for RFA FD 18 019
- 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 "Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems (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 Mar 21, 2018.
- Applicants must submit their applications by May 28, 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 $250,000.00 in funding.
- The number of recipients for this funding is limited to 2 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, Individuals, For profit organizations other than small businesses, Small businesses.
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