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 leverages C-Path's proficiency in translational and regulatory science to bridge the drug development "valley of death" by providing academic researchers with funding and guidance for the advancement of novel therapeutics from the lab to clinical trials and, ultimately, commercialization and patient care.

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 among pharmaceutical companies for licensing opportunities.

Projects eligible for TRxA collaboration include early lead optimization through IND-enabling studies of small molecule approaches.

Biologicals, including peptides or antibodies, cell and gene therapy applications and medical devices are not eligible at this time.

Priority Areas:

• Infectious Diseases 
• Immunology and Hematology
• Neuroscience
• Pediatrics
• Rare/Orphan Diseases

TRxA offers funding and support for three (3) types of translational projects, ranging from early lead optimization to IND-enabling studies.

• Stage 1: Early lead compound (at minimum validated activity in vitro, some SAR established) to late lead series (well defined compound progression pathway, characterized in vitro and in vivo pharmacology, ADME).
  • Project is in early drug lead optimization
  • Tractable drug leads from multiple chemical series have been identified (demonstration of optimizable structure-activity-relationships [SAR])
  • Established in vitro pharmacology assays (biochemical and cell-based potency and selectivity)
  • Established in vivo pharmacodynamic model
• Stage 2: Late lead series to selection of clinical candidate
  • Well defined compound progression pathway with established success criteria
  • Optimized leads from multiple series (demonstration of optimizable SAR)
  • Established in vivo efficacy model
• Stage 3: Candidate selection through IND enabling studies
  • Defined target product profile (TPP)
  • Optimized molecule meeting candidate selection success criteria
  • Defined good manufacturing practices (GMP) API scale up and characterization plan

Indirect costs are capped at 10%.

In case of interest, both as possible coordinator or partner, please click on "m'interessa" and we will contact you.