Opportunity Information: Apply for RFA FD 18 014
This FDA cooperative agreement (U01), titled "Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery," focuses on improving how scientists and regulators predict where DPI drugs actually go in the respiratory tract, and why. DPIs typically blend very small active pharmaceutical ingredient (API) particles with much larger carrier particles. Patients provide the energy for drug delivery through their own inhalation, which fluidizes the powder and pulls it into the airflow. Because the API particles are so small, they often do not readily entrain on their own at typical inhalation flow rates, so the carrier helps move them through the device. The problem is that carriers are usually on the order of about 100 micrometers and cannot pass the mouth and throat effectively, while the therapeutic API ideally needs to be in the 1 to 5 micrometer range to reach the lungs. That means DPI performance depends heavily on two linked steps: (1) whether the carrier-API mixture is successfully entrained out of the device, and (2) how quickly and completely the API deagglomerates (separates) from the carrier, largely through impacts against the device interior plus airflow-driven forces.
A major regulatory driver behind the opportunity is generic drug approval for DPIs in the United States. Generic applicants must demonstrate bioequivalence using a "weight of evidence" approach that typically combines in vitro tests, pharmacokinetic (PK) studies for systemic exposure, and pharmacodynamic (PD) or clinical endpoint (CE) studies for local action in the lung. Product-specific FDA guidance for many DPIs emphasizes in vitro metrics such as single actuation content and aerodynamic particle size distribution (APSD). However, the announcement highlights a key gap: there is not currently solid evidence of an in vitro-in vivo correlation (IVIVC) for APSD or any other in vitro metric for any DPI product. The central challenge is that local drug concentrations at the site of action in the lung are extremely difficult to measure directly in people without changing the product.
To address that gap, the opportunity points to gamma scintigraphy as a potentially useful validation tool. Gamma scintigraphy uses a radiolabel (often technetium-99m) to generate 2D images of where inhaled material deposits, and it has been used broadly across oral inhalation drug products. It is not considered ideal for routine bioequivalence testing because radiolabeling alters the formulation, but the data can still be valuable as an external benchmark for validating physics-based computational predictions. That is where CFD modeling comes in: CFD can simulate airflow and particle transport and predict deposition patterns, but modeling DPIs is harder than modeling metered dose inhalers because DPI aerosols involve strong particle-particle and particle-wall interactions, irregular particle shapes, and cohesive forces that drive agglomeration and affect deagglomeration.
The scientific core of the grant is the development of an integrated CFD-DEM approach. CFD handles the airflow field, while DEM tracks individual particles (or particle clusters) and computes contact and interaction forces. The solicitation specifically calls for DEM code capable of capturing agglomeration forces such as van der Waals and electrostatic forces, and deagglomeration mechanisms driven by airflow and by impacts with device surfaces. It also emphasizes the need to handle non-spherical particle shapes, since real carrier and API particles are rarely perfect spheres, and shape can substantially change drag, collisions, and cohesive behavior. The practical aim is a usable set of DEM codes that can be coupled to CFD to predict DPI particle transport, deagglomeration behavior, APSD, and ultimately deposition outcomes.
A notable expectation is sharing: at minimum, the developed DEM codes are expected to be shared with the FDA Office of Generic Drugs (OGD) within CDER, and the announcement states a preference that the codes also be made publicly available. The funding notice also suggests, where feasible, designing the DEM code to work across multiple CFD platforms, and expresses a preference (though not a strict requirement) for compatibility with open-source CFD tools to make sharing and reuse easier.
After building the modeling tools, the project is expected to verify and validate them using a series of test cases drawn from the literature and/or newly generated in vitro experiments. These test cases are meant to demonstrate that the combined CFD-DEM method can reproduce the relevant physics and produce outputs comparable to real measurements. The notice encourages selecting multiple DPI drug products for these test cases to show broader applicability rather than a one-off model tailored to a single product. Depending on available data, the validation could focus on device performance and powder behavior inside the inhaler, on delivery through the upper airway (mouth-throat), or both. A specific validation target mentioned is predicting APSD, with in vitro APSD measured at the exit of a USP induction port as a potential comparison point.
Once the tool is developed and validated, the grant calls for a sensitivity analysis to understand how formulation differences may change delivered aerosol characteristics and, ideally, deposition. The notice lists examples of formulation properties to vary, including carrier mass, API mass, carrier particle size, and API particle size. APSD is identified as a key outcome metric, and the solicitation notes that APSD could be characterized at different locations such as the device mouthpiece and/or after the mouth-throat and/or the USP induction port. While not strictly required, exploring the impact of these formulation changes on regional lung deposition fractions is described as desirable, because that is ultimately the clinical-relevant endpoint the field wants to connect back to in vitro testing.
The work plan is organized into four phases. Phase 1 is algorithm and code development for DEM methods that represent agglomeration and deagglomeration forces as comprehensively as possible. Phase 2 is validation of the CFD and DEM models against published data and/or new in vitro data generated under the project. Phase 3 is the sensitivity analysis linking formulation property variations to APSD and preferably to regional deposition outcomes. Phase 4 is publication of manuscripts, intended mainly for the third year (with an implied reduced budget in that year because the emphasis shifts toward writing and dissemination), though manuscript preparation can begin earlier.
Administratively, this is an FDA (HHS) discretionary funding opportunity using a Cooperative Agreement (U01), meaning the agency is likely to have substantial scientific involvement compared with a standard grant. The opportunity number is RFA-FD-18-014, created March 22, 2018, with an original closing date of May 29, 2018. The award ceiling listed is $380,000, with an expectation of 2 awards. Eligibility is broad and includes various government entities, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), tribal governments and organizations, individuals, for-profit organizations (including entities other than small businesses), and small businesses. The overall purpose is to produce practical, shareable modeling capability that can help the FDA and the research community better connect DPI in vitro performance metrics to in vivo delivery, ultimately supporting more efficient and scientifically grounded bioequivalence assessments for generic DPIs.Apply for RFA FD 18 014
- 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 "Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery (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 22, 2018.
- Applicants must submit their applications by May 29, 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 $380,000.00 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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| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01) Apply for RFA FD 18 012 Funding Number: RFA FD 18 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 18 011 Funding Number: RFA FD 18 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Assuring Radiation Protection (U18) Apply for RFA FD 18 021 Funding Number: RFA FD 18 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24) Apply for RFA FD 18 016 Funding Number: RFA FD 18 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD 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 |
| 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 |
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