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.
Challenges in Drug Development
Drug development has several phases that are categorized as discovery (preclinical), development (clinical trials), and commercialization, once approved by regulatory agencies such as the U.S. Food and Drug Administration. For many reasons, the transition from discoveries in the academic environment to drugs entering the pipelines of pharmaceutical companies is often a place where significant opportunities for innovative therapies are lost – frequently referred to as the drug development “valley of death”.
The TRxA Solution
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 is made possible by a grant from Research Corporation Technologies, Inc’s Frederick Gardner Cottrell Foundation.