Image-guided Drug Delivery (R01) | Apply Online

Frequently Asked Questions (FAQs): Image-guided Drug Delivery (R01) (PAR-16-044)

What is the Image-guided Drug Delivery (R01) funding opportunity?

Image-guided Drug Delivery (R01) (PAR-16-044) is a National Institutes of Health (NIH) research grant announcement from HHS (listed as HHS-NIH11). It supports innovative research projects that improve how drugs and biologics are delivered using medical imaging, with a strong emphasis on guiding, optimizing, and verifying delivery inside the body.

What does "image-guided drug delivery (IGDD)" mean in this FOA?

In this announcement, IGDD refers to using medical imaging as an active tool to direct and validate therapeutic delivery. The goal is to move beyond indirect assumptions about where a treatment goes, and instead enable researchers and clinicians to see and measure whether a therapeutic agent reaches the intended target, in the intended amount, at the intended time, and whether the target responds.

What is the main goal of the research supported by this FOA?

The main goal is to advance approaches that integrate imaging and therapy so that delivery can be guided in real time, monitored over time, and characterized quantitatively in vivo, including both the delivery process and the biological response.

Does the FOA focus on imaging alone or drug development alone?

No. The emphasis is on tying imaging and therapy together. The FOA is looking for research that integrates these components so delivery can be directed, measured, and validated, rather than developing a drug or an imaging method in isolation.

What kinds of projects are specifically encouraged?

The announcement highlights several priority directions, including: (1) integrated, imaging-based systems that enable delivery of drugs or biologics; (2) quantitative imaging assays for drug delivery (objective measurement of delivery parameters); and (3) strategies aligned with early intervention where imaging supports earlier identification of disease, earlier triggering of treatment, or confirmation of effective delivery before disease progression limits benefit.

Is cancer a specific area of interest?

Yes. The FOA calls out cancer as a particular focus for integrated, imaging-based delivery systems, while also noting that other diseases are relevant when precise targeting and early treatment can meaningfully affect outcomes.

What does the FOA mean by "integrated, imaging-based systems"?

Integrated systems may combine elements such as imaging hardware, image processing, delivery devices, and therapeutic formulations designed to work together. The intent is to enable imaging to guide delivery and to verify and quantify what happened during and after delivery.

What are "quantitative imaging assays for drug delivery" in practical terms?

Quantitative imaging assays are tools and methods that measure delivery objectively in vivo. Examples of the kinds of parameters described include concentration at the target site, spatial distribution, kinetics of uptake and clearance, and correlations with biomarkers of response.

What is meant by "real-time image guidance" in this announcement?

Real-time image guidance refers to approaches where imaging is used during the delivery process itself to direct or optimize therapeutic administration, rather than only imaging before or after treatment.

Does the FOA also care about monitoring after delivery?

Yes. A central emphasis is placed on ongoing monitoring and quantitative, in vivo characterization of both the delivery process and the biological response, not just a single guidance step.

How does "early intervention" relate to this funding opportunity?

Early intervention is described as a relevant objective. This suggests interest in approaches where imaging helps identify disease earlier, triggers treatment sooner, or confirms effective delivery early enough to improve outcomes before disease progression reduces benefit.

What funding mechanism does this opportunity use?

This opportunity uses the NIH R01 mechanism, which generally supports discrete, investigator-driven research projects.

What is the funding instrument type and activity category?

The funding instrument type is a grant. The activity category is listed as Education and Health, reflecting the biomedical research and translational focus of the opportunity.

Are award ceilings or the expected number of awards provided?

No. The supplied listing does not provide a specific award ceiling or an expected number of awards.

Which CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.286, 93.394, and 93.395, corresponding to NIH program areas tied to imaging, cancer, and broader biomedical research efforts.

Who is the sponsoring agency for this FOA?

The sponsoring agency is the U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), listed as HHS-NIH11.

When was this opportunity created and posted?

The listing indicates it was created and posted on November 24, 2015.

What is the closing date for this opportunity?

The listing states an original and current closing date of November 22, 2018.

What types of organizations are eligible to apply?

Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public/state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; other tribal organizations; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those categories); public housing authorities/Indian housing authorities; for-profit organizations other than small businesses; small businesses; and additional applicants as described in the FOA's eligibility clarification text.

Does the eligibility language suggest who NIH wants to participate?

Yes. The breadth of eligible organization types suggests NIH aimed to encourage participation from universities, medical centers, research institutes, industry developers, and public-sector entities that can contribute imaging technologies, delivery platforms, and quantitative validation methods.

What is the core theme or "through line" across the FOA priorities?

The core theme is precision and measurability: using imaging not just for diagnosis, but as a quantitative tool to guide treatment, confirm delivery, and connect delivery metrics to biological response in patients or model systems.

What kinds of outcomes or deliverables does the FOA appear to value?

Based on the description, the FOA values measurable deliverables in image-guided delivery, validation of delivery to the intended target, and quantitative assessment of delivery parameters and response.

Does this FOA support work involving biologics as well as drugs?

Yes. The opportunity explicitly references improving how drugs and biologics are delivered using medical imaging.

Is the FOA limited to a specific disease area?

No. While cancer is specifically highlighted as an important area, the FOA also mentions other diseases where precise targeting and early treatment can change outcomes.