Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional | RFA FD 21 015

Opportunity Information: Apply for RFA FD 21 015

This funding opportunity, issued by the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services, supports research aimed at improving how generic orally inhaled drug products are developed and evaluated. The focus is on metered dose inhalers (MDIs) and dry powder inhalers (DPIs), where FDA product-specific guidances typically recommend a weight-of-evidence approach to demonstrate bioequivalence. In practice, that package commonly includes in vitro testing, an in vivo pharmacokinetics study, and then either an in vivo pharmacodynamics study or a comparative clinical endpoint bioequivalence study. Because meeting acceptance criteria across all of these components can be difficult and costly for generic developers, the opportunity targets a key gap: better connecting what is measured in vitro to what actually happens in the lungs.

The central scientific approach encouraged under this announcement is computational fluid dynamics (CFD). CFD can simulate airflow and particle or droplet transport through realistic models of the human respiratory tract, which makes it a strong candidate for predicting regional lung deposition patterns. The goal here is not just to run simulations, but to produce predictions that are verified and validated, meaning the modeling workflow should be demonstrated to be numerically sound (verification) and supported by evidence that the predictions correspond to real-world behavior (validation). Projects are expected to apply CFD to at least one currently marketed MDI or DPI and generate predictions of where drug is deposited across human upper and lower airways.

A major deliverable is the development of an in vitro-in vivo correlation (IVIVC) that links CFD-predicted regional lung deposition to at least one relevant in vitro metric. In other words, the project should identify measurable in vitro performance attributes (for example, common inhalation product test outputs used for characterizing aerosol performance) and establish a defensible relationship between those outputs and modeled deposition in lung regions. The practical intent is that generic drug developers could use the resulting IVIVC framework to interpret their in vitro results in a way that better anticipates in vivo performance, increasing confidence in product design decisions before moving into expensive and time-consuming human studies.

The award mechanism is a U01 cooperative agreement, which generally implies substantial scientific involvement or partnership from the FDA compared with a standard research grant. Clinical trials are listed as optional. The funding opportunity number is RFA-FD-21-015, and it sits under CFDA number 93.103. The program anticipated making about two awards, with an award ceiling of $400,000. The opportunity was posted on January 7, 2021, with an original closing date of March 15, 2021.

Eligibility is broad and includes many organization types that could credibly perform advanced computational and inhalation science work. Eligible applicants include federal recognized tribal governments and other tribal organizations, state and local governments, public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including those other than small businesses), and small businesses, along with additional categories as described in the announcement.

Overall, the opportunity is designed to strengthen the scientific bridge between standard in vitro inhaler testing and the biologically relevant outcome of where drug deposits in the respiratory tract. By producing validated CFD-based deposition predictions and translating them into an IVIVC tied to an in vitro metric, the program aims to provide tools that can reduce uncertainty and improve efficiency in the development of generic inhalation products while still aligning with FDA expectations for demonstrating bioequivalence.

• The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional" 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 Jan 07, 2021.
• Applicants must submit their applications by Mar 15, 2021. (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 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, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA FD 21 015

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