Drug Screening with Biofabricated 3-D Skin Disease Tissue Models (U18 Clinical Trial Not Allowed) | RFA TR 19 020

Frequently Asked Questions (FAQs)

What is the purpose of this NIH/NCATS funding opportunity?

This funding opportunity supports work to advance practical drug screening methods that use biofabricated, three-dimensional (3-D) human skin disease tissue models. The intent is to move beyond traditional two-dimensional (2-D) cell culture systems by using more physiologically relevant skin tissues that better reflect real human disease biology in a screening context.

What is the main scientific goal of the program?

The main goal is to demonstrate that 3-D skin disease tissue models can function reliably in drug screening platforms, especially when implemented in standardized multi-well formats that enable parallel testing of many compounds. The focus is on evidence of performance (reproducibility, meaningful biology, and consistent readouts) rather than tissue construction alone.

Why is the FOA emphasizing 3-D models instead of 2-D cell cultures?

The FOA emphasizes 3-D biofabricated skin disease tissues because they are intended to be more physiologically relevant than flat 2-D systems, with the expectation that they can better mimic disease biology and therefore provide more informative screening responses for translational drug discovery and preclinical evaluation.

What does "biofabricated" mean in the context of this FOA?

Based on the FOA summary provided, "biofabricated" refers to engineered, three-dimensional human skin disease tissue models, including bioprinted skin tissue approaches, that are created to resemble human skin disease states and can be used in drug screening workflows.

What types of outcomes is NCATS looking for from funded projects?

NCATS is looking for proof-of-concept and practical evidence that validated 3-D biofabricated skin disease tissues can be used as effective screening tools. This includes showing reproducible performance, disease-relevant responses, consistent screening readouts, and the ability to compare compounds and conditions in a systematic way.

Is this opportunity about building new tissues, or proving they work for screening?

The emphasis is on demonstrating utility in drug screening: showing the models work reliably, generate consistent outputs, capture disease-relevant biology, and function in multi-well screening formats. The FOA framing suggests the priority is not just impressive tissue creation, but validated and usable screening performance.

What screening format is specifically highlighted?

The FOA specifically highlights implementation of validated 3-D disease skin tissues into standardized multi-well screening formats (i.e., multi-well plates) to enable systematic testing of drug candidates in parallel.

What does the FOA mean by "validated" 3-D disease skin tissues?

From the information provided, validation is tied to demonstrating reproducibility, biological meaningfulness, consistent readouts, and disease-relevant responses that support drug screening and comparison across compounds and conditions.

How does this FOA relate to prior NCATS work?

This announcement builds on progress made under an earlier NCATS effort focused on collaborative drug discovery using bioprinted skin tissue. It is positioned as the next step: moving from prior progress to placing validated 3-D disease skin tissues into multi-well screening formats and demonstrating successful, practical screening use.

What funding mechanism is used for this opportunity?

The mechanism is a U18 cooperative agreement.

What does a U18 cooperative agreement imply for awardees?

A U18 cooperative agreement indicates substantial scientific involvement from the funding agency compared to a typical research grant. Awardees should expect active engagement from NIH/NCATS in the scientific direction and execution consistent with a cooperative agreement structure.

Does the FOA require NIH intramural and extramural collaboration?

Yes. The FOA emphasizes intramural-extramural collaboration, meaning NIH intramural researchers and external organizations are expected to work together to implement the screening platform and demonstrate successful use.

Are clinical trials allowed under this opportunity?

No. The FOA is labeled "Clinical Trial Not Allowed," so projects must remain in the preclinical or technology development space and cannot include clinical trial activities or clinical intervention studies.

What general stage of research does this FOA support?

It supports translational technology and platform development and preclinical evaluation approaches, centered on demonstrating a working 3-D skin disease screening platform suitable for drug discovery decision-making before more costly downstream studies.

Who is eligible to apply?

Eligibility is broad and includes many U.S. governmental entities, academic organizations, nonprofits, and for-profit organizations (including small businesses). The FOA also explicitly identifies multiple institution types and special categories as eligible, including certain minority-serving institutions, tribal entities, U.S. territories, and non-U.S. (foreign) organizations.

Are for-profit organizations eligible?

Yes. For-profit organizations other than small businesses, as well as small businesses, are listed as eligible applicants.

Are nonprofit organizations eligible even if they do not have 501(c)(3) status?

Yes. Nonprofit organizations with or without 501(c)(3) status are listed as eligible.

Are universities and colleges eligible to apply?

Yes. Eligible applicants include public and state-controlled institutions of higher education as well as private institutions of higher education.

Are state, county, or local government entities eligible?

Yes. Eligibility includes state governments, county governments, local governments, and special district governments, as well as independent school districts.

Are minority-serving institutions specifically mentioned as eligible?

Yes. The FOA explicitly calls out eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

Are tribal governments eligible?

Yes. The eligibility list includes tribal governments that are not federally recognized.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly included in the eligible applicant groups.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. Non-U.S. (foreign) organizations are explicitly listed as eligible in the information provided.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are explicitly included in the eligible applicant groups.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly listed as eligible.

What is the funding opportunity number for this FOA?

The funding opportunity number is RFA-TR-19-020.

What is the CFDA number and funding category?

The CFDA number is 93.350. The opportunity is categorized as discretionary funding under the health funding activity category.

What is the award ceiling?

The listed award ceiling is $400,000.

How many awards will be made?

The summary information provided does not specify the exact number of expected awards. It suggests the program is likely designed to support a limited number of collaborative projects capable of convincingly demonstrating a working 3-D skin disease screening platform.

When was this FOA created and when did it close?

The FOA was created on May 21, 2019. The original application closing date was July 31, 2019.

What kind of evidence should applicants be prepared to generate?

Based on the provided description, applicants should be prepared to generate practical, screening-relevant evidence such as consistent readouts, reproducibility across runs or conditions, disease-relevant biological responses, and clear comparisons across compounds and experimental conditions within a multi-well screening platform.

What is the broader translational impact expected from this work?

The FOA frames the impact as improving translational drug discovery and preclinical evaluation by providing a more credible, repeatable screening tool that can help prioritize therapies before more expensive downstream studies.