Early Stage Pharmacological Validation of Novel Targets and Accompanying Pre Therapeutic Leads for Diseases of Interest to the NIDDK (R01) | Apply Online

Frequently Asked Questions (FAQs) - NIH PAR-13-007 (NIDDK R01)

What is PAR-13-007?

PAR-13-007 is an NIH funding opportunity announcement (FOA) that used the R01 research project grant mechanism and was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It focused on moving promising basic science discoveries closer to practical drug development by supporting early stage pharmacological validation activities.

What is the main goal of this funding opportunity?

The main goal was to bridge the gap between mechanistic/basic research and the point where a biological target is credible and actionable enough to justify a dedicated drug discovery and development effort. The FOA emphasized building a stronger evidence package for a novel target and producing tools and early lead molecules that reduce uncertainty for later-stage programs.

What does "early stage pharmacological validation" mean in the context of this FOA?

In this FOA, early stage pharmacological validation meant generating pharmacology-focused evidence that modulating a novel biological target changes disease-relevant biology. This typically included demonstrating target engagement and functional impact using pharmacological approaches in disease-relevant experimental systems, and creating practical toolsets that support future drug discovery.

Is this FOA intended to fund full drug development or clinical trials?

No. The intent was not to fund full clinical development. Instead, it aimed to produce a clear rationale and actionable foundation for later drug discovery and development activities, such as medicinal chemistry and preclinical development campaigns.

What types of outcomes or deliverables were emphasized?

The FOA emphasized translationally useful outputs, such as robust pharmacological evidence that a target is disease-relevant when modulated, along with pre-therapeutic leads and enabling resources. Examples described include high-quality assays, reagents, and early lead compounds or chemical matter that can serve as starting points for downstream drug discovery.

What kinds of research activities fit within the scope described?

Projects were expected to go beyond descriptive biology and build a stronger evidence package using pharmacological approaches. This included demonstrating target engagement and functional impact in disease-relevant systems and generating key tools needed for downstream discovery work (for example, assays, reagents, and early chemical matter).

What scientific areas and diseases were included in the scope?

The scientific scope was broad but limited to diseases and conditions within NIDDK's mission. The FOA described coverage that includes obesity, diabetes, endocrinology and metabolism topics, digestive and liver diseases, nutrition-related disorders, kidney and urological diseases, hematology, and certain NIDDK-relevant areas of cystic fibrosis.

Do proposed projects need to align with NIDDK's mission areas?

Yes. Projects were expected to be clearly tied to one or more areas within NIDDK's mission and to emphasize outcomes that are useful for translation toward drug discovery and development.

What funding mechanism was used?

This opportunity used the NIH R01 funding instrument.

Which NIH institute sponsored this opportunity?

The opportunity was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

How is this opportunity categorized administratively?

It was described as a discretionary grant opportunity categorized under food and nutrition/health and mapped to CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).

What was the award ceiling listed for PAR-13-007?

The award ceiling listed in the provided information is $500,000.

Was cost sharing or matching required?

No. The opportunity stated there was no cost sharing or matching requirement.

When was PAR-13-007 posted and when did it close?

It was posted on October 10, 2012. The original and final closing date listed was March 7, 2016. The archive date was April 7, 2016.

Is PAR-13-007 currently open for applications?

No. Based on the closing and archive dates provided, the FOA is no longer open. It remains useful as a reference point for the type of translational, early pharmacology work NIDDK has sought to support.

Who was eligible to apply?

Eligibility was broad and included many types of U.S. organizations. Examples listed include public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits); and government entities at multiple levels (state, county, city/township, special districts, and certain housing authorities).

Were historically underrepresented or mission-focused institution types included in eligibility?

Yes. The FOA explicitly included a range of institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, and U.S. territories or possessions.

Could foreign institutions apply?

Yes. Foreign institutions were eligible to apply, based on the provided information.

Are non-U.S. components of U.S. organizations eligible?

No. The information specifies that non-U.S. components of U.S. organizations are not eligible.

Are foreign components allowed under this FOA?

Yes. Foreign components (as defined by NIH policy) were allowed.

Where can someone find the full archived announcement?

The FOA directed applicants to the NIH Grants Guide page for PAR-13-007 to locate the full archived announcement and detailed requirements.

What if someone has trouble accessing the archived FOA or needs help with links?

The provided information indicates that NIH Office of Extramural Research contact support was available for access or linking issues related to the archived announcement.

What is the core "bridge" this FOA aimed to fund?

It aimed to bridge fundamental mechanistic research and the stage where there is credible target validation plus a strong experimental toolkit, sufficient to justify a dedicated medicinal chemistry and preclinical development campaign.

What distinguishes the expected evidence package from typical early basic research?

The FOA described an expectation to go beyond descriptive findings by using pharmacological approaches to demonstrate target engagement and functional impact in disease-relevant systems, and by generating practical enabling tools (assays, reagents, early chemical matter) that de-risk downstream discovery.

Does the FOA require projects to produce chemical matter or lead compounds?

The FOA emphasized generating early lead compounds or chemical matter as potential starting points and described these as important translationally useful outcomes, along with assays and reagents. The overall intent was to provide an actionable foundation for later drug discovery work.

Does the FOA focus on a narrow disease area or multiple areas?

It covered multiple disease and research areas within NIDDK's mission, rather than a single narrow disease area.