Opportunity Information: Apply for RFA FD 16 012
Apply for RFA FD 16 012
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Investigation of Peptide-Polymer Interaction in Poly(lactide-co-glycolide) Microspheres (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 17, 2016 and posted on Mar 17, 2016.
- Applicants must submit their applications by May 20, 2016. (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 1 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.
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Opportunity Summary:
The grant opportunity "Investigation of Peptide-Polymer Interaction in Poly(lactide-co-glycolide) Microspheres (U01)" (RFA FD 16 012) is an HHS-FDA cooperative agreement focused on a longstanding scientific gap in long-acting injectable and controlled-release drug products: while PLGA microspheres are widely used to deliver peptide drugs over weeks to months, the field still lacks a thorough, mechanism-level understanding of how peptides chemically and physically interact with PLGA inside microspheres during manufacturing, storage, hydration, and in vivo-like release. The FDA is seeking a structured, systematic research approach that can reliably detect, explain, and measure these interactions so that product quality and therapeutic performance can be assessed more consistently, especially for generic versions of complex microsphere products.
At the core of the project is method development and application. The award is meant to support creation of an assessment framework that can (1) identify different types of peptide-polymer interactions occurring in PLGA microsphere dosage forms, (2) characterize and quantify peptide degradation impurities linked to those interactions, and (3) connect those findings back to root causes such as formulation choices, polymer attributes, water uptake and microclimate pH changes during hydration, polymer degradation kinetics, and manufacturing process variables. A major example called out in the opportunity is peptide acylation, where reactive species generated during PLGA degradation can form covalent adducts with peptide functional groups, creating modified peptides that may alter potency, safety, or immunogenicity risk. Beyond acylation, the intent is broad: the approach should be able to distinguish and categorize multiple interaction modes, including covalent modification, adsorption, ionic interactions, microenvironment-driven hydrolysis, and other pathways that can emerge as PLGA breaks down into acidic byproducts and as water gradually penetrates the microsphere matrix.
The practical outcome FDA is aiming for is better regulatory science to support evaluation of generic PLGA microspheres containing peptide drugs. Because microsphere products are complex and process-sensitive, two products that look similar on paper can behave differently in terms of peptide stability and release, particularly if peptide-polymer interactions differ. By funding a project that clarifies mechanisms and provides measurement tools for relevant impurities and interaction signatures, the agency can strengthen recommendations and expectations for demonstrating pharmaceutical equivalence and quality for follow-on products. In other words, the work is positioned to translate into clearer guidance on what to test, how to test it, and which formulation or process parameters are most critical to control when developing and reviewing generic peptide-loaded PLGA microspheres.
Administratively, this is a discretionary funding opportunity using a cooperative agreement (U01), which typically means substantial involvement by the funding agency in shaping priorities, milestones, or coordination during the project. The program was posted March 17, 2016, with an application due date of May 20, 2016. The anticipated budget cap (award ceiling) is $250,000, with one expected award, indicating a single, focused project rather than a large multi-site program. Eligible applicants are broad and include federal-recognized tribal entities and organizations, state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), and for-profit organizations (including small businesses), reflecting an interest in attracting both academic expertise in polymer/peptide chemistry and analytical methods as well as industry-relevant formulation and manufacturing knowledge.
In summary, the opportunity funds a targeted research effort to build a comprehensive, experimentally grounded way to evaluate how peptide drugs interact with PLGA in microsphere formulations, with special emphasis on identifying interaction types, quantifying degradation products such as acylated peptide adducts, and linking those outcomes to controllable formulation and process factors. The end goal is to improve FDA's ability to assess and provide recommendations for generic peptide-loaded PLGA microspheres by turning a complex, sometimes poorly understood set of degradation and interaction phenomena into measurable, comparable, and actionable quality attributes.
Frequently Asked Questions (FAQs)
What is the title and identifier of this grant opportunity?
The opportunity is titled "Investigation of Peptide-Polymer Interaction in Poly(lactide-co-glycolide) Microspheres (U01)" and is identified as RFA FD 16 012.
Which agency is offering this funding?
This is a U.S. Department of Health and Human Services (HHS) Food and Drug Administration (FDA) funding opportunity.
What type of award mechanism is being used?
The award mechanism is a cooperative agreement (U01). This typically involves substantial involvement by the funding agency during the project, such as participation in shaping priorities, coordinating activities, or working with the awardee on milestones and progress.
What problem is FDA trying to address with this project?
FDA is targeting a longstanding scientific gap in long-acting injectable and controlled-release drug products: despite widespread use of PLGA microspheres to deliver peptide drugs for weeks to months, the field still lacks a thorough, mechanism-level understanding of how peptides chemically and physically interact with PLGA inside microspheres across manufacturing, storage, hydration, and in vivo-like release conditions.
Why are peptide-PLGA interactions important for product quality and performance?
Peptide-polymer interactions can influence peptide stability, impurity formation, and release behavior. If interactions differ, two microsphere products that appear similar could still behave differently in terms of peptide degradation and therapeutic release performance, which can affect potency, safety, and overall quality.
What dosage form and polymer system is the focus of this opportunity?
The focus is on PLGA (poly(lactide-co-glycolide)) microsphere dosage forms that contain peptide drugs, particularly long-acting injectable and controlled-release products.
What is the primary scientific and technical focus of the funded work?
The core of the project is method development and application. FDA is seeking a structured, systematic research approach that can reliably detect, explain, and measure peptide-polymer interactions in PLGA microspheres and relate those interactions to measurable quality attributes and impurities.
What key capabilities should the proposed assessment framework include?
The framework is intended to: (1) identify different types of peptide-polymer interactions in PLGA microsphere dosage forms, (2) characterize and quantify peptide degradation impurities linked to those interactions, and (3) connect findings back to root causes such as formulation choices, polymer attributes, water uptake and microclimate pH changes during hydration, polymer degradation kinetics, and manufacturing process variables.
What types of peptide-polymer interaction modes are expected to be addressed?
The opportunity calls for a broad approach able to distinguish and categorize multiple interaction modes, including covalent modification, adsorption, ionic interactions, microenvironment-driven hydrolysis, and other pathways that can emerge as PLGA breaks down into acidic byproducts and as water gradually penetrates the microsphere matrix.
What example of a critical interaction pathway is highlighted by FDA?
Peptide acylation is explicitly highlighted. In this context, reactive species generated during PLGA degradation can form covalent adducts with peptide functional groups, creating modified peptides that may change potency and raise safety or immunogenicity risk.
What is meant by linking impurities and interaction signatures to "root causes"?
It means tying observed peptide degradation products and interaction patterns back to controllable drivers such as formulation parameters, polymer characteristics, hydration-driven changes (including water uptake and microclimate pH), polymer degradation kinetics, and specific manufacturing process variables.
What practical regulatory outcome is FDA aiming for?
FDA is aiming to strengthen regulatory science for evaluating generic PLGA microspheres containing peptide drugs. By clarifying mechanisms and providing measurement tools, the project is positioned to support clearer recommendations and expectations for demonstrating pharmaceutical equivalence and quality for follow-on (generic) microsphere products.
How does this project relate to evaluation of generic versions of complex microsphere products?
Microsphere products can be complex and process-sensitive. FDA wants tools and mechanistic understanding to better assess whether generic products match reference products in peptide stability and release behavior, especially when peptide-polymer interactions may differ between products.
What kinds of outputs is FDA implicitly seeking from the funded research?
Based on the description, FDA is seeking an experimentally grounded assessment framework and measurement approach that can identify interaction types, quantify relevant degradation impurities (including acylated adducts), and translate those findings into actionable factors that can be controlled and compared for quality assessment.
What is the anticipated maximum budget for this award?
The anticipated budget cap (award ceiling) is $250,000.
How many awards does FDA expect to make under this opportunity?
One award is expected, indicating a single, focused project rather than a larger multi-site program.
When was this funding opportunity posted?
The opportunity was posted on March 17, 2016.
What was the application due date?
The application due date was May 20, 2016.
Who is eligible to apply?
Eligible applicants are broad and include federal-recognized tribal entities and organizations, state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), and for-profit organizations (including small businesses).
Is this opportunity limited to academic institutions?
No. The eligibility list includes both academic and non-academic organizations, including nonprofits and for-profit organizations such as small businesses.
Why does the eligibility list include both academic and industry applicants?
The opportunity is designed to attract expertise spanning polymer/peptide chemistry and analytical methods (often found in academia) as well as industry-relevant formulation and manufacturing knowledge.
What stages of the microsphere product lifecycle are relevant to the proposed research?
The opportunity emphasizes interactions occurring during manufacturing, storage, hydration, and in vivo-like release, reflecting the need to understand how interactions evolve over time and conditions.
What role does hydration play in the interaction mechanisms being studied?
Hydration is tied to water uptake and microclimate pH changes within microspheres. As water penetrates the matrix and PLGA degrades into acidic byproducts, these internal conditions can drive or alter peptide-polymer interactions and degradation pathways.
What is the overarching purpose of developing a "structured, systematic research approach"?
The purpose is to create a reliable way to detect, explain, and measure peptide-PLGA interactions so that product quality and therapeutic performance can be assessed more consistently, particularly when comparing complex microsphere products and their generic counterparts.
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