How does TRND support projects?

TRND is not a grant-based funding program. TRND is an intramural NIH research program that allows partnerships with external investigators. Collaborating partners do not receive funds from the TRND program.

External partners work with TRND scientists to develop and execute a milestone-driven drug development program. TRND supports project management and drug development, such as medicinal chemistry, animal pharmacology or Investigational New Drug (IND) application-enabling studies to advance the project, using internal TRND funds. Partners set drug starting points for the project and ongoing guidance in the rare or neglected disease. The specific resources provided to each collaborative partnership depend on the project’s stage and development needs.

What type of agreement does TRND use to establish collaborations?

It depends on the project. NIH has several available mechanisms to start a collaborative partnership through the TRND program, such as the Cooperative Research and Development Agreement or a Research Collaboration Agreement. The type of mechanism used depends on the project scope and the status and type of intellectual property involved in the TRND collaboration. The decision on what agreement to use is made in consultation with the collaborating partner. Learn more about available standard model agreements.

Are non-U.S. entities eligible to collaborate with TRND?

Yes.

Does an investigator need an existing NIH intramural collaborator to work with TRND?

No. Anyone with a qualified drug development program that has at least moved up to the lead candidate stage may propose a partnership with TRND. Extramural researchers do not need to have pre-existing joint relationships with any NIH intramural investigators.

What types of therapeutics are of interest to TRND?

TRND is interested in developing a range of different therapeutics, including proteins, peptides, antibodies, oligonucleotides, gene- or cell-based therapies, and small molecule drugs. Currently, TRND does not support development of vaccines, devices, diagnostics or medical procedures.

Would TRND consider a natural product for Investigational New Drug (IND)–enabling studies?

Potentially. The biomass and the isolation procedures must be well established so that kilogram quantities are readily available, which means difficult-to-harvest or endangered sources of the natural product would not be appropriate candidates for TRND partnerships.

Would TRND take on a natural product for lead optimization?

Potentially. If the biomass required for the natural product starting material is plentiful and the process to isolate the natural product could yield multi-gram quantities, TRND would consider a natural product lead molecule. The TRND chemistry team offers expertise in realizing a developmental candidate from a natural product lead, semi-synthetically.

Is the proposed project advanced enough for TRND?

It depends. Projects typically must be at least at the stage of a validated small-molecule lead or lead series — or related stage in biologics development — to be considered. “Validated” means:

• Lead optimization stage, including clear structure-activity relationships in at least two structurally distinct chemical series or a well-defined biological lead (e.g., an affinity-matured and humanized antibody)
• Reproducible activity in primary and orthogonal assays
• Efficacy in an accepted animal model (or when not available, cellular model) of the disease
• Initial indications of favorable absorption, distribution, metabolism and excretion properties

Projects requiring earlier-stage resources may be considered for a more limited collaboration to fill defined preclinical gaps.

Is the proposed disease of interest considered “rare” or “neglected” for the purposes of collaborating with TRND?

The TRND program relies on external investigators to know their disease areas and decide whether their disease is rare or neglected. In most cases, this can be done with a literature analysis. In general, TRND considers rare diseases as defined by the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development and the Orphan Drug Act (i.e., affecting fewer than 200,000 patients in the U.S.) and neglected tropical diseases as described by the World Health Organization. Additionally, investigators can contact NCATS’ Genetic and Rare Diseases Information Center, the nonprofit National Organization for Rare Disorders or any patient advocacy nonprofit organizations that work in specific disease areas of interest.

May an investigator collaborate with TRND if they already have received funding from another NIH program or plan to submit a separate NIH grant proposal?

Yes. It may make sense to seek partnership with TRND to advance certain aspects of the proposed project, particularly considering TRND’s primary expertise and focus on preclinical drug development. However, TRND would not support development tasks already supported through other NIH grants or contracts. When considering new proposed partnerships, TRND seeks feedback from other NIH institutes and centers regarding potential program synergies and overlap.

If the proposed project already is a collaboration among multiple parties, is it “too big” for TRND?

No. Multiple parties can jointly submit a proposal for partnership with TRND, such as an academic investigator and a foundation or a pharmaceutical company and multiple academic researchers. The strengths and resources inherent in such proposals can improve the overall quality of the proposed partnership.