Opportunity Information: Apply for PA 13 224
Apply for PA 13 224
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Improvement of Animal Models and Development of Technologies for Stem Cell Based Regenerative Medicine (STTR)(R41/R42)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.351 Research Infrastructure Programs 93.859 Biomedical Research and Research Training.
- This funding opportunity was created on May 8, 2013 and posted on May 8, 2013.
- Applicants must submit their applications by May 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The grant opportunity titled "Improvement of Animal Models and Development of Technologies for Stem Cell Based Regenerative Medicine (STTR) (R41/R42)" (Funding Opportunity Number PA 13 224) is a National Institutes of Health (NIH) Small Business Technology Transfer (STTR) solicitation designed specifically for eligible small business concerns. It supports grant-funded research and development projects that aim to strengthen the tools, methods, and animal model systems needed to evaluate stem cell based regenerative medicine approaches before they move into human clinical testing. In practical terms, the FOA is focused on helping small businesses work in partnership with research institutions to create technologies and model systems that make preclinical stem cell research more predictive, more reproducible, and more directly useful for eventual clinical translation.
The core purpose of the program is to enable the creation and improvement of animal models and enabling technologies that can be used to obtain, characterize, test, and validate animal and human stem cells, as well as stem cell derived products. The emphasis is on building informative preclinical platforms that can better assess both safety and therapeutic potential, since stem cell therapies often require careful evaluation of issues like functional integration, durability of effect, immune responses, biodistribution, and risks such as abnormal growth or tumor formation. By improving how well animal models mirror relevant aspects of human disease and human stem cell behavior, the initiative aims to reduce uncertainty in preclinical development and improve decision making before entering costly and high risk clinical trials.
The FOA highlights three main technical and scientific focus areas. First, it encourages comparative analysis between animal and human stem cells, with the idea that systematic comparisons can help the field choose the most predictive model systems. This can include understanding species differences in cell identity, differentiation capacity, maturation, functional behavior in tissues, immunogenicity, and response to environmental cues. The intention is to generate evidence that supports selecting specific animal systems, stem cell sources, and evaluation strategies that best forecast human outcomes, rather than relying on convenience models that may not translate well.
Second, the program calls for development of new or improved technologies for stem cells and their derivatives, spanning the full pipeline from production to testing. This includes methods and tools for obtaining cells, expanding and manufacturing them, characterizing their quality and identity, and assessing potency or function. It also includes technologies related to transplantation and delivery, such as approaches that improve engraftment, survival, targeting, monitoring, or controlled differentiation after implantation. The underlying theme is to strengthen the technical foundation that allows stem cell based products to be made and evaluated in a way that is consistent, scalable, and meaningful for therapeutic development.
Third, the FOA supports improvement of animal disease models intended for stem cell based therapeutic applications. Many diseases targeted by regenerative medicine are complex, chronic, and involve multiple cell types and tissue level changes, so simplified models may miss key barriers to translation. This funding encourages projects that refine existing models or create new ones so they better capture relevant pathology, functional deficits, and clinically meaningful endpoints. Improved models can make it easier to test whether a stem cell derived intervention truly restores function, modifies disease progression, or integrates appropriately into damaged tissue, and whether it does so safely across appropriate timeframes.
Although the FOA is research oriented, its endpoint is strongly commercialization oriented, consistent with STTR goals. The stated ultimate objective is the development of commercial products and technologies that can help enable future clinical therapies, meaning applicants are expected to be moving toward deliverables that the broader regenerative medicine ecosystem can use. Examples of the kinds of outputs implied by the announcement include standardized stem cell characterization platforms, validated transplantation or tracking technologies, better predictive animal models, and other preclinical evaluation tools that would be attractive to pharmaceutical developers, biotech companies, academic translational groups, and clinical programs.
Administratively, this is a discretionary grant opportunity using the NIH STTR mechanisms R41 and R42, which correspond to Phase I and Phase II STTR projects. It falls under NIH health related research activity categories and is associated with CFDA numbers 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health), 93.351 (Research Infrastructure Programs), and 93.859 (Biomedical Research and Research Training). The opportunity does not require cost sharing or matching. Eligibility is limited to small businesses, aligning with the STTR program structure that supports small business led innovation carried out in formal collaboration with a nonprofit research institution. The FOA was posted May 8, 2013, with an original and final closing date of May 7, 2016, and an archive date of June 7, 2016. The full announcement was made available through the NIH grants portal, and NIH Office of Extramural Research contact points were provided for access or linking issues.
Frequently Asked Questions (FAQs)
1) What is the title of this grant opportunity?
The opportunity is titled "Improvement of Animal Models and Development of Technologies for Stem Cell Based Regenerative Medicine (STTR) (R41/R42)."
2) What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PA 13 224.
3) Which agency is offering this opportunity?
This is a National Institutes of Health (NIH) funding opportunity offered under the NIH Small Business Technology Transfer (STTR) program.
4) What kind of grant mechanism is used (Phase I vs Phase II)?
The solicitation uses NIH STTR mechanisms R41 and R42, which correspond to STTR Phase I (R41) and STTR Phase II (R42) projects.
5) What is the main purpose of this FOA?
The purpose is to support research and development that strengthens tools, methods, technologies, and animal model systems used to evaluate stem cell based regenerative medicine approaches before they move into human clinical testing. The emphasis is on improving how predictive, reproducible, and clinically relevant preclinical stem cell research can be.
6) What types of projects does this FOA aim to support?
Projects focused on creating and improving animal models and enabling technologies that can be used to obtain, characterize, test, and validate animal and human stem cells, as well as stem cell derived products, for preclinical evaluation.
7) Why does this FOA emphasize animal models and preclinical tools?
The FOA is intended to reduce uncertainty in preclinical development and improve decision making before entering costly and high risk clinical trials by making models more reflective of relevant aspects of human disease and human stem cell behavior.
8) What kinds of safety and performance issues are these projects expected to help assess?
The FOA highlights the need to assess both safety and therapeutic potential, including issues such as functional integration, durability of effect, immune responses, biodistribution, and risks such as abnormal growth or tumor formation.
9) What are the main scientific and technical focus areas highlighted in the FOA?
The FOA highlights three main areas: (1) comparative analysis between animal and human stem cells; (2) development of new or improved technologies for stem cells and their derivatives across the pipeline from production to testing; and (3) improvement of animal disease models intended for stem cell based therapeutic applications.
10) What does "comparative analysis between animal and human stem cells" mean in this FOA?
It refers to systematic comparisons designed to help select the most predictive model systems. Examples described include comparing species differences in cell identity, differentiation capacity, maturation, functional behavior in tissues, immunogenicity, and responses to environmental cues, with the goal of choosing models and evaluation strategies that best forecast human outcomes.
11) What kinds of technology development does the FOA encourage?
The FOA encourages technologies spanning the full pipeline, including methods for obtaining cells, expanding and manufacturing them, characterizing quality and identity, assessing potency or function, and technologies related to transplantation and delivery (such as improving engraftment, survival, targeting, monitoring, or controlled differentiation after implantation).
12) What does the FOA mean by improving animal disease models?
It supports refining existing models or creating new ones so they better capture relevant pathology, functional deficits, and clinically meaningful endpoints. The intent is to make models more suitable for testing whether a stem cell derived intervention restores function, modifies disease progression, integrates appropriately into damaged tissue, and does so safely over appropriate timeframes.
13) Is this program focused only on basic research?
No. While it is research oriented, the endpoint is strongly commercialization oriented, consistent with STTR goals. The stated ultimate objective is development of commercial products and technologies that can enable future clinical therapies.
14) What kinds of deliverables or outputs are implied by the FOA?
Examples implied include standardized stem cell characterization platforms, validated transplantation or tracking technologies, better predictive animal models, and other preclinical evaluation tools that would be useful for translational and clinical development efforts.
15) Who is eligible to apply?
Eligibility is limited to small businesses, consistent with the STTR program, and projects are expected to be carried out in formal collaboration with a nonprofit research institution.
16) Does the FOA require a partnership with a research institution?
Yes. The opportunity is described as an STTR solicitation designed for small businesses working in partnership with research institutions, with formal collaboration with a nonprofit research institution as part of the STTR structure.
17) Is cost sharing or matching required?
No. The FOA specifies that cost sharing or matching is not required.
18) What are the associated CFDA numbers?
The opportunity is associated with CFDA numbers 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health), 93.351 (Research Infrastructure Programs), and 93.859 (Biomedical Research and Research Training).
19) When was this FOA posted?
The FOA was posted on May 8, 2013.
20) What were the original and final closing dates?
The original closing date and the final closing date were both May 7, 2016.
21) When was the FOA archived?
The archive date was June 7, 2016.
22) Where was the full announcement made available?
The full announcement was made available through the NIH grants portal.
23) Who should be contacted for access or linking issues?
The NIH Office of Extramural Research contact points were provided for access or linking issues.
24) What is the practical goal for the broader regenerative medicine ecosystem?
The FOA aims to help small businesses develop tools and model systems that make preclinical stem cell research more predictive and reproducible, supporting decision making for clinical translation and producing commercial products useful to pharmaceutical developers, biotech companies, academic translational groups, and clinical programs.
25) What kinds of diseases or conditions are these improved models intended to address?
The FOA frames regenerative medicine targets as often complex and chronic, involving multiple cell types and tissue level changes, and therefore encourages disease models that capture relevant pathology and clinically meaningful endpoints for stem cell based therapeutic applications.
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