TRxA BRIDGe Awards: Stage 3 Grant

The TRxA BRIDGe Awards: Stage 3 aims to support academic researchers in advancing early-stage therapeutics through IND-enabling studies. This funding program, led by the Critical Path Institute, provides resources and guidance for developing comprehensive data packages critical for attracting investments in clinical trials. Eligible projects include small molecule therapeutics, focusing on candidate selection and optimizing strategies. Faculty at universities and non-profit institutions globally can apply for these awards, which are pivotal in bridging the drug development gap.

NOTE:
The deadline for submitting a pre-proposal through the portal is by midnight in the time zone in which you are located. It is recommended that you set up your username and password at least one week prior to this submission deadline to allow sufficient time for troubleshooting in the event you experience any technical difficulties.Prior to submission of an application, you can schedule a time to speak with the TRxA team to gain consensus on the appropriate funding level.
Translational Therapeutics Accelerator (TRxA)
The Critical Path Institute’s (C-Path) Translational Therapeutics Accelerator (TRxA) is a global drug discovery and development program focused on supporting academic scientists in defining optimal strategies for advancing new, cutting-edge therapeutics from the lab to patients.
TRxA operates as a not-for-profit drug accelerator providing the following for academic researchers who have applied for and received a grant award:
Resources and hands-on guidance, working closely with academic researchers to develop comprehensive data packages for potential drug candidates, a key to garnering interest from biotechnology and pharmaceutical companies to invest in clinical trials.Tactical and strategic drug discovery and development leadership, including regulatory science considerations, bringing diverse expertise to pivotal early-stage academic study designs and implementation.Engagement of contract research organizations (CRO) to perform critical discovery phase experiments (e.g., key toxicology and other specialized studies) and/or validate academic studies to develop the type of comprehensive data package pharmaceutical companies require when licensing drug products.
TRxA’s focus is translating early-stage novel therapeutics into Investigational New Drug (IND) supporting data packages that garner interest for licensing opportunities; we are helping “BRIDGe” (Breakthrough Research and Innovation in Drug Development Grants) the drug development valley of death.  Projects eligible for TRxA BRIDGe funding and support include early lead optimization through IND-enabling studies of small molecule therapeutics. Biologics, including natural peptides or antibodies, cell and gene therapy applications, and diagnostic and medical devices are not eligible at this time; nor are drug repurposing initiatives.
TRxA funding and support is reserved for faculty at universities and non-profit institutions, anywhere around the world. Awards are not limited to specific therapeutic indications. TRxA offers funding and support for three (3) types of translational projects, ranging from early lead optimization to IND enabling studies.
Stage 1Early lead optimization to late lead seriesStage 2Late lead series to selection of clinical candidate Stage 3Candidate selection through IND enabling studies
Entry criteriaDefined target product profile (TPP)Optimized molecule meeting candidate selection success criteriaCharacterized in vitro and in vivo pharmacology properties including demonstrated efficacy in in vivo efficacy modelCharacterized ADME properties (in vitro and rodent/non-rodent in vivo)Characterized Toxicology properties (in vitro and rodent/non-rodent in vivo)Defined nonclinical formulationDefined good manufacturing practices (GMP) API scale up and characterization planSuccess criteriaAdherence to the TPP and regulatory plan (or modifying it as needed)Well characterized molecule with completed toxicology package to enable FIH (first-in-human) studyGeneral toxicologySafety pharmacologyGenetic toxicologyOptimized API scale up strategy