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Phase II: Submission Requirements

Phase II: Prototype Development and Use Case Demonstration

IP Considerations

The TRDNT Challenge aims to maximize public access to winning technology solutions (defined as RNA-targeting technologies), to maximize the number of people who can benefit from RNA-targeting therapeutics utilizing the winning technologies, regardless of the prevalence of their disease. 

 

To balance these objectives with encouraging appropriate licensing and commercialization of the technology, the NIH is requiring participants to include a Public Access and Dissemination Plan (PADP) as part of the Stage II final submission. 

 

Only the Phase II: Stage II submission requires a PADP.

 

Interim milestone participants are not required to submit a complete PADP at this time; however, they must provide an early-stage description of how the technology will be made publicly accessible and should keep the final PADP requirements in mind when developing a response to this milestone (Milestone 3).

Stage I: Interim Milestone Submission Requirements

The focus is to build an initial prototype of an RNA-targeting technology and demonstrate evidence that this technology can be used to target human disease-relevant RNA targets through a real-world use case.

Title and Executive Summary

  1. A brief description of the technology and how it will help to develop novel RNA-targeting therapies across multiple diseases. 

  2. Do not include any proprietary or confidential information, as the title and executive summary may be publicly shared if the participant is selected to win a prize across any Phase of this Challenge (see Participation Rule 7).

Milestone 1: Prototype Design

  1. Successful early-stage development of the technology platform and quantifiable progress towards initial performance testing.

  2. Describe how the proposed technology will address a significant health need in the context of targeting endogenous RNA and demonstrate the ability of the technology to address RNA targets that can affect multiple diseases. Appropriate details should also be included to outline the technical development and capabilities of the solution:

  • ​Justify how the proposed design is innovative, creative, and novel compared to existing approaches/methodologies.

  • Provide appropriate details on the technical development and capabilities of the solution.

  • Provide details concerning initial performance testing and utility, as applicable.

Milestone 2: Early Validation Plans 

  1. Provide a detailed summary of the proposed use case that will be utilized to validate the efficacy of the prototype technology in human disease, including justification for why the particular use case was selected. 

  2. Summary must include a detailed description of expected validation steps and include quantifiable outputs.

Milestone 3: Early-Stage Dissemination Plans 

  1. Early-stage description of how the technology will be made publicly accessible, to include proposed collaborations or partners as needed. A full PADP is not needed at this time, but participants should keep the final PADP requirements in mind when developing a response to this milestone (additional PADP details can be found under the anticipated Phase II: Stage II Final Submission Requirements below). Under this milestone, the submitters must address:

  • Team composition as it relates to their ability to feasibly develop and disseminate the technology.  

  • Feasibility of the public access strategy and likelihood that this strategy will result in either a marketable product or open access product.

  • Plans for engagement of appropriate end-user, industry, regulatory, and/or patient communities that would benefit from this technological development.

Participants must submit all of the above to be considered for a Stage I: Interim Milestone prize in Phase II of this Challenge. 

Letters of Support (Optional)

Participants may submit letters of support to strengthen their submission. There is no limit to the number, as these will not be counted against the total page limit of your submission.

Submission Format

​All submissions must follow the format and instructions described below:

​

  • Single PDF file with page size set to 8.5” x 11” and at least 1-inch margins.

  • Page limit:

    • Title & executive summary (1 page)

    • Main proposal to include figures as needed (15-page limit)

    • References (no page limit)

    • Letters of Support (no page limit).

  • Font no smaller than 11-point Arial and line spacing no less than 1.0.

  • Be written in English.

  • Adhere to any page length requirements as stipulated in the submission portal. 

  • Do not use the HHS logo, official seal, or the logo of NIH in the entries and must not claim federal government endorsement.

  • AI tools may be used to support your submission. However, reviewers will consider the extent to which AI was used to develop the written content when scoring your submission.

Phase II: Stage II: Final Submission Requirements
ANTICIPATED

  1. A final performance-tested technology prototype.

  2. Documented use of the technology via use case to serve as early-stage validation of the technology in treating human disease.

  3. Demonstrated capability to move into Phase III of this Challenge.

  4. A final PADP (details below), including recruited external partners where needed, to illustrate how the technology will be made publicly available. 

 

Only those Participants that have been selected as interim winners of Phase II: Stage I will advance to Phase II: Stage II of the Challenge.

Public Access and Dissemination Plan (PADP)

Phase II: Stage II participants must submit a Public Access and Dissemination Plan (PADP) to maximize public access to the winning technology solutions and the number of people who can benefit from RNA-targeting therapeutics utilizing the winning technologies, regardless of the prevalence of their disease. 

 

The PADP must describe how the participant will:

  • Disseminate information about the solution and make the solution available under non-exclusive licenses for research purposes. 

  • Allow others to utilize the solution in the event the participant is unable themselves to maximize public access to the solution. The PADP must include specific licensing schemes and scenarios when such schemes would be employed.

  • Permit the U.S. government to allow interested parties to utilize the solution if the participant themselves fails to utilize the solution and does not permit others to utilize the solution under reasonable terms. The plan must describe any licensing schemes and scenarios that will accomplish this plan.

 

To receive an award, participants will be required to agree to abide by the terms of the PADP submitted by the participants for this challenge. Additionally, NIH intends to post or otherwise publicly display the PADP submitted by the Participants on the web or elsewhere.

 

Additional specific evaluation criteria for Phase II: Stage II final submissions will be provided in late 2026/early 2027.

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Phase II: Stage I Applications Opening Soon! 

Be first in line when Phase II applications open.

Stay Informed

Interested participants are encouraged to review the official rules and scope to determine whether their technology is a fit for the TRDNT Challenge.
 

Visit the official NIH challenge page for rules and updates.
 

For questions, contact the challenge team at info@trdntchallenge.com. 

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