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Research

Overview of TRND Application

The TRND program is intended for broad use by academic laboratories, not-for-profit organizations and for-profit companies. Foreign organizations also may apply.

Submitted research proposals will be reviewed for scientific merit and technical feasibility as well as program balance and availability of resources. Successful applicants will partner with TRND to create and implement a therapeutic project plan. No grant funds are awarded for this program.

Applications to TRND are evaluated for (criteria and weight of criteria):

  1. Target and therapeutic validation (30 percent)
  2. Strength of current data package (30 percent)
  3. Feasibility to reach first-in-human status (20 percent)
  4. Medical impact relative to current standard of care (10 percent)
  5. Likelihood of external adaption (10 percent)

A review committee of experts in drug development will review the applications according to these criteria. In addition, they will rate the strength of the development project in:

  • Medicinal chemistry
  • Absorption, distribution, metabolism and excretion
  • Pharmacokinetics/pharmacodynamics
  • Toxicology
  • In vivo models
  • Secondary and tertiary assays
  • Formulation
  • Chemical manufacturing and controls — small molecules
  • Expression/purification — biologics        

Project Management

Project Team: Once the project is selected for collaboration (and as the collaborative agreement is being discussed), a project team will be formed of both TRND and applicant investigators. The project team will develop a Project Plan and define the:

  • Development plan
  • Timeline
  • Milestones and deliverables
  • Go/no-go decision points

Project Plan: The Project Plan will be approved by TRND leadership. Any changes to the Project Plan will need to be approved by TRND leadership. Go/no-go decisions will be evaluated by the project’s Research Committee, which will make recommendations to TRND leadership regarding project termination, if necessary.

Project Termination: Upon not meeting timeline, milestones and/or deliverables, or with the recommendation of the project’s Research Committee, TRND will terminate a project. Whenever possible, the applicant investigators will be provided guidance on how to move the project forward. Applicants will be encouraged to submit a new application if barriers are overcome.

Selection Process

Review Process Diagram

Resubmissions

A resubmission is submission of an application that has previously been reviewed and not selected. TRND will accept only two (2) resubmissions, for a total of three (3) submissions for a specific application. The resubmission consists of a Resubmission Summary, not to exceed two (2) pages, and an amended concept application in which changes are marked. Reviewers will have access to the original application. The resubmission should include the following:

  1. A Resubmission Summary not to exceed two pages.
    • Explain how the application has been modified and strengthened.
    • Respond to the comments and recommendations from the scientific reviews. Address any disagreements with reviewers’ comments.
  2. Applicants are encouraged to submit an amended version of the original concept application to highlight substantial scientific changes.
    • The amended application should follow the current “TRND Proposal Instructions” as described under “Required Documents for Therapeutics for Rare and Neglected Diseases Applications” and should not exceed five pages.
    • Substantial scientific changes must be clearly marked with underlining, italics, bold or other formatting. However, if the changes are so extensive that essentially all of the text would be marked, explain this in the Resubmission Summary.

Applications should be resubmitted according to the published TRND submission cycle.

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