Opportunity Information: Apply for RFA FD 14 016
Apply for RFA FD 14 016
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Evaluation of in vitro release methods for liposomal drug products" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Jun 9, 2014 and posted on Mar 31, 2014.
- Applicants must submit their applications by Jun 16, 2014 Correction to close date, to reflect a change in due date of application from June 1 to June 15, 2014.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: State governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Independent school districts City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education County governments Small businesses Native American tribal governments (Federally recognized).
- Foreign Recipients
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Opportunity Summary:
This FDA grant opportunity focuses on a key bottleneck in developing and approving generic liposomal drug products: there is no widely accepted, standardized, and biologically relevant in vitro release (IVR) method that reliably reflects how drugs actually come out of liposomes in the body. Many developers and reviewers still rely on a traditional dialysis-based approach where the liposomal formulation is dialyzed against a large volume of buffer. The announcement argues that this common method often fails to predict in vivo behavior because it does not reproduce important real-world conditions, such as interactions with the large pool of biological membranes in circulation, or the very different environments where liposomes may release drug (for example, at tumor sites or inside macrophages). As a result, the field has tried a range of modifications, such as dialysis against serum or protein solutions, adding surfactants, or using multi-stage dialysis designs. At the same time, newer separation technologies (filtration, centrifugation, solid phase extraction) have opened the door to alternative IVR assays that can operate in the presence of excess acceptor vesicles (multilamellar or unilamellar), which may better mimic the in vivo "sink" and lipid exchange conditions. The gap this program aims to address is that these different approaches have not been systematically compared for robustness and predictive performance, particularly for specific liposomal products.
The main objective is to evaluate multiple in vitro release methods for liposomal drug products and judge them on practical and regulatory-relevant criteria: how robust and reproducible they are, whether they can detect meaningful formulation differences, and whether they have predictive value for in vivo performance. The broader purpose is explicitly regulatory and public-health oriented: improving the scientific tools used in FDA review so that high-quality generic liposomal products can be assessed more efficiently and confidently, ultimately improving access for patients.
The project described in the announcement uses one or more marketed liposomal injections as model systems, specifically naming amphotericin B, daunorubicin citrate, and vincristine sulfate liposomal injections. The work begins with a literature and methods review to catalog existing IVR approaches used for the selected product(s). The next step is hands-on formulation work: applicants would prepare a series of liposome formulations that match the marketed reference product in overall composition but differ in process conditions, creating controlled variation that could plausibly occur in manufacturing. Those formulations would then be thoroughly characterized using physicochemical measurements that are known to matter for liposomes, including mean particle size and size distribution, surface charge, pH, shape, lamellarity, and other relevant attributes. This characterization is important because the program is not just asking whether a method produces numbers, but whether it can meaningfully respond to changes in properties that regulators and developers care about.
After the formulation set is built and characterized, the core experimental phase is to run dissolution/release studies on both the prepared formulations and the marketed model product using multiple in vitro release methods. The announcement leaves room for both conventional approaches (like dialysis-based methods) and innovative designs that take advantage of newer separation techniques or acceptor vesicle systems. A specific expectation is that investigators will vary IVR conditions and identify the critical factors that drive performance for each method, essentially mapping method sensitivity to parameters such as media composition (buffer vs serum vs protein solutions vs surfactants), staged conditions, and other controllable variables. The deliverable is not only a dataset of release profiles, but an understanding of which conditions make a method reliable, discriminating, and potentially more biorelevant.
A key decision point in the work is identifying which IVR methods can actually distinguish among liposome formulations that differ in measurable in vitro characteristics, rather than masking differences or producing inconsistent results. The program also pushes beyond purely in vitro comparisons by calling for integration of in vitro release data with animal or human data. The intent is to build an in silico platform and explore in vitro-in vivo relationships (IVIVC or related modeling approaches) for the selected liposomal product(s). In practical terms, the FDA is looking for evidence that a given IVR method is not only repeatable and discriminating, but also meaningfully linked to in vivo performance in a way that can support regulatory decisions for generics.
Administratively, this opportunity was issued by the Food and Drug Administration under Funding Opportunity Number RFA-FD-14-016 as a discretionary cooperative agreement in the health science and technology/research and development category. The program anticipated up to five awards, with total estimated funding of about $500,000 and individual award amounts in the roughly $450,000 to $500,000 range. Cost sharing was not required. Eligibility was broad, spanning various levels of government, public and private higher education institutions, nonprofits, and for-profit entities including small businesses, with the listing also indicating that foreign recipients were eligible. The original posting date was March 31, 2014, with an adjusted application deadline of June 16, 2014 (reflecting a corrected due date), and an archive date of July 16, 2014. The overall theme is method standardization and scientific validation: generating the comparative evidence needed to optimize and potentially standardize IVR testing for liposomal products, thereby strengthening the scientific basis for reviewing and approving generic liposomal drug applications.
Frequently Asked Questions (FAQs)
What is the main problem this FDA grant is trying to solve?
This opportunity targets a specific scientific bottleneck for generic liposomal drug products: the field does not have a widely accepted, standardized, and biologically relevant in vitro release (IVR) method that reliably reflects how drugs release from liposomes in the body. Because of that, developers and reviewers can struggle to compare products confidently or to interpret release results in a way that meaningfully supports regulatory decisions.
Why does the funding announcement criticize traditional dialysis-based IVR methods?
The announcement notes that a commonly used approach involves dialyzing a liposomal formulation against a large volume of buffer. It argues this setup often does not predict in vivo behavior because it fails to reproduce important real-world conditions, including interactions with the large pool of biological membranes in circulation and the very different environments where drug release may occur (for example, at tumor sites or inside macrophages).
What types of IVR method variations have been tried in the field, according to the opportunity?
The opportunity points to several modification strategies that have been attempted, such as dialysis against serum or protein solutions, adding surfactants, and using multi-stage dialysis designs. It also highlights newer separation technologies (filtration, centrifugation, solid phase extraction) that enable alternative IVR assays, including those conducted in the presence of excess acceptor vesicles (multilamellar or unilamellar).
What is the core objective of the funded project?
The main objective is to evaluate multiple IVR methods for liposomal drug products and judge them using practical and regulatory-relevant criteria, including robustness and reproducibility, ability to detect meaningful formulation differences, and predictive value for in vivo performance.
How does this project connect to FDA regulatory review and public health?
The purpose is explicitly regulatory and public-health oriented: improving the scientific tools used in FDA review so high-quality generic liposomal products can be assessed more efficiently and confidently, which is intended to improve patient access.
Which liposomal drug products are mentioned as model systems?
The announcement specifically names marketed liposomal injections including amphotericin B, daunorubicin citrate, and vincristine sulfate liposomal injections as model system candidates.
Does the project have to use all of the named model liposomal injections?
The description indicates using one or more marketed liposomal injections as model systems and then lists specific examples. Based on the provided information, it is not stated that all listed products must be used.
What is expected in the literature and methods review phase?
The work begins with a literature and methods review to catalog existing IVR approaches used for the selected liposomal product(s). This cataloging is meant to inform which methods and conditions should be tested comparatively in the experimental phase.
What formulation work does the opportunity expect applicants to perform?
Applicants are expected to prepare a series of liposome formulations that match the marketed reference product in overall composition but differ in process conditions. The intent is to create controlled variation that could plausibly occur during manufacturing, so that IVR methods can be tested for their ability to detect meaningful differences.
What kinds of liposome characteristics are expected to be measured?
The announcement calls for thorough physicochemical characterization of the prepared formulations, including mean particle size and size distribution, surface charge, pH, shape, lamellarity, and other relevant attributes. The point is to connect method performance to properties known to matter for liposomal products.
What is the main experimental phase of the project?
After building and characterizing the formulation set, investigators are expected to run dissolution/release studies on both the prepared formulations and the marketed model product using multiple IVR methods. The opportunity allows for conventional approaches (including dialysis-based methods) and innovative designs that use newer separation techniques or acceptor vesicle systems.
What does the FDA want investigators to do with IVR test conditions?
A specific expectation is to vary IVR conditions and identify critical factors that drive performance for each method. The opportunity describes mapping method sensitivity to controllable parameters such as media composition (buffer vs serum vs protein solutions vs surfactants), staged conditions, and other variables.
What is meant by a method being “robust and reproducible†in this program?
Within the context provided, robustness and reproducibility refer to whether an IVR method performs reliably and consistently when executed across conditions and experiments, producing results that can be trusted for scientific comparison and regulatory use.
What does it mean for an IVR method to be “discriminating�
In this opportunity, an IVR method is considered discriminating if it can distinguish among liposome formulations that differ in measurable in vitro characteristics, rather than masking differences or generating inconsistent outcomes that blur meaningful formulation effects.
Why does the announcement emphasize biological relevance and “biorelevant sink†conditions?
The announcement argues that traditional approaches may not reproduce key in vivo conditions, including the presence of large amounts of biological membranes that can accept drug or participate in lipid exchange. It highlights that alternative assays may operate in the presence of excess acceptor vesicles, potentially better mimicking in vivo sink and lipid exchange conditions.
What deliverables are implied by the project description?
The description implies deliverables that go beyond release profiles alone. It calls for comparative evidence about which IVR methods and conditions are reliable and discriminating, identification of critical method factors, and an assessment of which approaches show predictive value for in vivo performance.
Is the project expected to connect in vitro release data to animal or human data?
Yes. The program calls for integration of in vitro release data with animal or human data. The intent is to develop an in silico platform and explore in vitro-in vivo relationships (IVIVC or related modeling approaches) for the selected product(s).
What is the role of modeling (in silico work) in this opportunity?
The opportunity describes building an in silico platform to explore relationships between IVR data and in vivo performance. The FDA’s stated interest is evidence that an IVR method is meaningfully linked to in vivo behavior in a way that can support regulatory decision-making for generics.
What type of funding mechanism is used for this opportunity?
The opportunity is described as a discretionary cooperative agreement issued by the Food and Drug Administration in the health science and technology/research and development category.
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number provided is RFA-FD-14-016.
How many awards were anticipated and what was the estimated funding level?
The program anticipated up to five awards. Total estimated funding was about $500,000, and individual award amounts were described as roughly $450,000 to $500,000.
Is cost sharing or matching required?
No. The opportunity states that cost sharing was not required.
Who is eligible to apply based on the description provided?
Eligibility is described as broad and includes various levels of government, public and private institutions of higher education, nonprofits, and for-profit entities including small businesses. The listing also indicates that foreign recipients were eligible.
When was the opportunity posted and what were the key dates?
The original posting date was March 31, 2014. The application deadline was adjusted to June 16, 2014 (reflecting a corrected due date). The archive date was July 16, 2014.
What is the broader theme or intended outcome of the funded work?
The overarching theme is method standardization and scientific validation: generating comparative evidence to optimize and potentially standardize IVR testing for liposomal products, strengthening the scientific basis for reviewing and approving generic liposomal drug applications.
Does the announcement restrict applicants to only dialysis-based IVR methods?
No. The description leaves room for both conventional approaches (including dialysis-based methods) and innovative designs that use newer separation techniques or acceptor vesicle systems.
What separation technologies are specifically mentioned as enabling alternatives to dialysis?
The announcement mentions filtration, centrifugation, and solid phase extraction as examples of newer separation technologies that open the door to alternative IVR assays.
What are “acceptor vesicles†in the context provided?
Based on the provided information, acceptor vesicles refer to multilamellar or unilamellar vesicles present in excess during an IVR assay to help mimic in vivo sink and lipid exchange conditions.
What specific IVR media components or environments are mentioned as variables to study?
The opportunity highlights varying media composition, including buffer, serum, protein solutions, and surfactants, as well as staged conditions and other controllable variables.
Why does the project include creating formulations that differ only in process conditions?
The description indicates these controlled variations are meant to represent plausible manufacturing variability while keeping overall composition aligned with the marketed reference product. This allows IVR methods to be evaluated on whether they can detect meaningful differences that regulators and developers care about.
What is the “key decision point†described in the announcement?
A central decision point is identifying which IVR methods can distinguish among formulations that differ in measurable in vitro characteristics, rather than producing inconsistent results or masking differences.
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