NIH Highlighted Topic: Research on Short-Lived and Long-Lived Plasma Cells in Humans
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is seeking innovative research proposals through the SBIR Program focused on the biology of Short-Lived Plasma Cells (SLPCs) and Long-Lived Plasma Cells (LLPCs) in human health and disease. NIH is particularly interested in technologies and therapeutic approaches that improve understanding of plasma cell differentiation, antibody production, immune memory, autoimmune disease mechanisms, vaccine durability, aging-related immune dysfunction, and allergic or transplant-related immune responses.
Long-Lived Plasma Cells play a critical role in sustaining lifelong immunity, but they are also implicated in autoimmune diseases, allergic disorders, and transplant rejection. NIH is encouraging research that advances human-relevant characterization of plasma cell biology through ex vivo human sample analysis, New Approach Methodologies (NAMs), computational modeling, and advanced immunology platforms. Companies developing immunology technologies, computational biology tools, AI-enabled immune modeling systems, vaccine platforms, antibody therapeutics, diagnostics, or autoimmune disease solutions may be strong candidates for funding.
NIH is especially interested in projects investigating plasma cell precursor populations, immune aging, tissue-specific plasma cell environments, microbiome interactions, vaccine response durability, and mechanisms influencing plasma cell differentiation and persistence. Research focused on women’s health, autoimmune disease progression, and sex-specific immune responses is also encouraged.
Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.
This highlighted topic is supported primarily by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Aging (NIA), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and the Office of Research on Women’s Health (ORWH), all of which may give special consideration to high-impact applications advancing immunology, vaccine science, autoimmune disease research, and healthy aging technologies.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of technologies and therapeutic approaches related to plasma cell biology, antibody-mediated diseases, vaccine durability, autoimmune disorders, and immune aging.
Eligible activities may include:
Computational modeling and AI-enabled analysis of plasma cell differentiation and immune responses
Development of New Approach Methodologies (NAMs) for plasma cell and antibody research
Ex vivo human tissue and immune cell analysis platforms
Vaccine technologies designed to promote durable Long-Lived Plasma Cell (LLPC) responses
Therapeutic approaches targeting pathogenic LLPCs in autoimmune disease, allergy, or transplant rejection
Biomarker discovery associated with plasma cell phenotypes, immune persistence, or immune aging
Research into plasma cell precursor populations and differentiation pathways
Technologies studying microbiome, aging, or host-factor effects on plasma cell function
Development of diagnostics or therapeutics for autoimmune and antibody-mediated disorders
Immune profiling platforms evaluating sex-specific immune responses and women’s health outcomes
Research investigating immune aging, frailty, cognitive decline, and age-associated plasma cell disorders
Tissue engineering, organoid, or advanced cellular modeling approaches for immunology research
Validation studies, translational research, prototype development, and regulatory preparation activities
Commercialization planning and scale-up activities for immunology and vaccine-related technologies
Funding may also support personnel, laboratory testing, software development, computational infrastructure, prototype fabrication, clinical data analysis, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable solution aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have ≤ 500 employees including affiliates.
Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
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