NIH Highlighted Topic: Advancing Childhood and Adolescent & Young Adult (AYA) Cancer Research
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 encouraging innovative research proposals focused on accelerating childhood, adolescent, and young adult (AYA) cancer research across the full continuum of prevention, diagnosis, treatment, survivorship, and long-term care. This highlighted topic supports multidisciplinary projects designed to improve understanding of pediatric and AYA cancer biology while advancing precision medicine, AI-enabled analytics, therapeutic development, and patient-centered care approaches.
NIH is particularly interested in projects addressing the unique challenges associated with pediatric and AYA cancers, including rare disease subtypes, limited patient populations, lack of robust preclinical models, treatment-related toxicities, fragmented datasets, and disparities in access to specialized care and clinical trials. Companies developing AI and machine learning platforms, pediatric oncology diagnostics, precision medicine technologies, clinical analytics systems, digital health platforms, survivorship monitoring tools, or decentralized clinical trial infrastructure may be strong candidates for funding.
Areas of interest include multi-omics analysis, AI-ready data infrastructure, fusion-driven cancer biology, synthetic lethality approaches, immunotherapy, tumor microenvironment research, treatment resistance, decentralized clinical trials, survivorship studies, prevention of treatment-related toxicities, and long-term quality-of-life monitoring. NIH is also encouraging projects focused on oral and craniofacial cancer complications, healthcare access, and integration of real-world evidence and electronic health record (EHR) data into pediatric cancer research.
Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.
This highlighted topic is supported primarily by the National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR), and the Office of Disease Prevention (ODP), all of which are seeking transformative innovations that improve pediatric and AYA cancer prevention, diagnosis, treatment outcomes, survivorship, and quality of life.
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 pediatric oncology technologies, AI platforms, diagnostics, therapeutics, clinical analytics systems, and survivorship care solutions.
Eligible activities may include:
AI and machine learning platforms for pediatric and AYA cancer research
Multi-omics data integration and predictive analytics systems
Precision oncology diagnostics and biomarker discovery technologies
Fusion-driven cancer and synthetic lethality therapeutic platforms
Immunotherapy and tumor microenvironment research technologies
Pediatric cancer imaging, pathology, and molecular analysis systems
Decentralized clinical trial infrastructure and patient recruitment technologies
Survivorship monitoring and long-term toxicity assessment platforms
Digital health and remote patient monitoring tools for pediatric oncology
Clinical decision support and treatment optimization systems
Real-world evidence and EHR-integrated oncology analytics platforms
Preclinical cancer models, organoids, and translational research systems
Oral, dental, and craniofacial oncology technologies and treatment monitoring tools
Prevention and mitigation technologies for treatment-related side effects
Healthcare access and continuity-of-care platforms for pediatric cancer patients
Data harmonization and AI-ready pediatric oncology research infrastructure
Prototype development, translational studies, and clinical validation research
Commercialization planning, regulatory preparation, and manufacturing scale-up activities
Funding may also support personnel, software engineering, cloud computing infrastructure, AI model development, genomic sequencing, laboratory testing, bioinformatics analysis, clinical trial preparation, survivorship research, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable pediatric oncology or healthcare technology 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:
Triple your likelihood of success through proven strategy and insider-aligned proposal development
Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations
Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.
