PA-25-169
Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)
Summary
Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)
Research Focus & Contribution
This R21 Exploratory/Developmental Research Grant supports early-career investigators pursuing transdisciplinary research at the interface of engineering or physical sciences (physics, mathematics, chemistry, computer science) with biomedical sciences. The program targets high-risk, high-impact projects that are exploratory, developmental, proof-of-concept, or technology design-directed—approaches that differ substantially from current practice and address unmet biomedical research needs. Rather than requiring extensive preliminary data, applications should demonstrate innovation through conceptual framework, literature justification, and analytical models. Successful projects should establish foundations for subsequent R01 funding and may include early-stage clinical trials (Phase I, first-in-human, safety, or feasibility studies) that inform technology development. Participating institutes—the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Eye Institute (NEI), and National Institute on Aging (NIA)—each support distinct research areas; NIBIB emphasizes technologies with broad applicability across multiple disorders rather than single-disease focus.
At-a-Glance
- Who can apply: NIH-defined New and Early Stage Investigators only; ineligible if concurrent R01, R15, or R21 application pending with same primary institute in same review cycle.
- Funding & project length: $400,000 direct costs over 3 years.
- Award mechanism: R21 Exploratory/Developmental Research Grant.
- Key dates: Open January 16, 2025; earliest due date February 16, 2025; expiration May 8, 2026; earliest start July 2025.
- Best fit for: Early-career engineers, physicists, computational scientists, or biomedical researchers proposing novel cross-disciplinary methods, imaging technologies, or bioengineering solutions with minimal or no preliminary data; clinical trial applications limited to Phase I/feasibility studies.
Key Facts
Deadline
Thu, May 7, 2026
Posted
Wed, January 8, 2025
Award / Year (direct costs)
$133,333
Max Total
$400,000
Max Duration
3 years
Keywords
Research Areas
Gotchas (5)
Preliminary data limit is strictly enforced with automatic rejection: applications exceeding one-half page OR more than one figure of preliminary data will be deemed noncompliant and not forwarded to
95%
Source Text
“Applications including data more than one-half page or more than one figure will be considered noncompliant with the NOFO instructions and will not go forward to review.”
Applicants cannot submit R01, R15, or any other R21 application with a participating IC as primary IC in the same review cycle; concurrent Trailblazer awards are prohibited. This creates a submission
95%
Source Text
“Applicants will be considered ineligible for this funding opportunity if they have submitted an R01, R15 or any other R21 application, with a participating IC as the primary IC within the same review cycle. An awardee may not hold concurrent Trailblazer awards.”
Clinical trials are restricted to early-stage only (Phase I, first-in-human, safety, feasibility, or small trials informing early-stage technology development). Phase II, III, IV, pivotal trials, or t
95%
Source Text
“For applications submitted that propose clinical trials, this NOFO will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. This NOFO will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.”
NIBIB will withdraw applications whose principal focus is basic biological function/mechanism development rather than technology development with broad applicability across multiple disorders
92%
Source Text
“An application is not within the NIBIB mission and will be withdrawn from consideration if its principal focus is development of technologies whose goal is to understand basic biological function or mechanisms. Additionally, NIBIB only supports projects whose technology would ultimately be applicable to a broad spectrum of disorders and diseases rather than being limited to only a single tissue, organ, or physiological condition.”
FOA expiration date was extended from January 08, 2026 to May 08, 2026 per NOT-EB-25-007; applicants must verify current deadlines
85%
Source Text
“Expiration Date: New Date May 08, 2026 per NOT-EB-25-007 (Prior Date January 08, 2026).”