Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional | RFA FD 22 016

Opportunity Information: Apply for RFA FD 22 016

This funding opportunity from the U.S. Food and Drug Administration (FDA), under the Department of Health and Human Services, supports a research project to build a physiologically based pharmacokinetic (PBPK) model specifically aimed at understanding and predicting nose-to-brain drug delivery after intranasal administration. Traditional nasal products are usually developed either for local effects in the nasal tissues or for systemic delivery, where the drug enters the bloodstream and distributes throughout the body. The FDA is highlighting that a newer and increasingly important development goal is direct delivery from the nasal cavity to the brain, which can occur through multiple anatomical and physiological pathways. The agency notes that while PBPK models are well established in areas like toxicology and drug development, existing nasal PBPK models generally do not include explicit mechanisms or pathways that represent drug movement from the nose to the brain. This gap limits the ability to predict brain exposure and to evaluate how formulation, device performance, deposition patterns, and nasal physiology might influence central nervous system delivery.

The core objective of the grant is to fund development of a nasal PBPK model that includes at least one defined pathway for nose-to-brain transport and that is connected to a full-body PBPK framework containing, at minimum, an explicit brain compartment. In practice, that means the model should not stop at the nose or at systemic circulation, but should be able to represent the drug's fate across relevant tissues and blood flows while also accounting for brain disposition in a physiologically meaningful way. The solicitation emphasizes that the modeling should be grounded in experimental data as much as possible, and it leaves room for applicants to propose experimental studies if new measurements are needed to parameterize, calibrate, or validate the model. The expectation is that the final model will be capable of generating pharmacokinetic (PK) predictions for a preselected target compound, demonstrating that the framework is not purely theoretical but can be used to simulate real-world concentration-time profiles and potentially inform development and regulatory evaluation of intranasal products intended for brain delivery.

Administratively, this is a discretionary cooperative agreement (U01), meaning the FDA expects substantial involvement or collaboration during the project rather than a hands-off grant. The opportunity is labeled "Clinical Trial Optional," indicating that clinical studies are not strictly required but could be proposed if they are justified and align with the model development and validation needs. The Funding Opportunity Number is RFA-FD-22-016, and it falls under CFDA 93.103. The FDA planned a single award with an estimated maximum (award ceiling) of $600,000. The announcement was created on January 12, 2022, with an original closing date of March 31, 2022. Eligibility is listed as "Others (see text field entitled Additional Information on Eligibility for clarification)," which signals that applicants would need to consult the full notice for specific eligible organization types and any constraints, but the intent is to cast a broader net than only traditional academic institutions.

Overall, the grant is focused on creating a practical, data-informed modeling tool that fills a recognized gap in current PBPK capabilities: capturing direct and/or semi-direct transport routes from the nasal cavity to the brain and integrating those routes into a whole-body context. The deliverable is not only the model itself but also a demonstration of its utility through PK predictions for a specified compound, with experimental work included as needed to make the model credible and usable for decision-making in nose-to-brain drug development.

• The Department of Health and Human Services, Food and Drug Administration in the consumer protection, health, science and technology and other research and development sector is offering a public funding opportunity titled "Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial 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 12, 2022.
• Applicants must submit their applications by Mar 31, 2022. (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 $600,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).

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