The Problem

Drug development has several phases: discovery (preclinical), development (clinical trials) and commercialization. For many reasons, the transition from discoveries in the academic environment to promising compounds 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 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 that provides 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 preclinical development and clinical trials.
• Tactical and strategic drug discovery and development leadership, including regulatory science considerations; TRxA brings diverse expertise to pivotal early-stage academic study designs and implementation.
• Management and engagement of contract research organizations (CROs) to perform critical discovery phase experiments (e.g., in vitro ADME, 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.

The Impact

In its first year since inception, after careful evaluation of several proposal submissions, TRxA has funded two projects that are currently ongoing. One, “Epigenetic therapy for Prader-Willi syndrome by novel small molecule G9a inhibitors,” is led by Dr. Yon-Hui Jiang at Yale University. The other, “Establishing a pleiotropic brain-penetrant small-molecule to impede glioblastoma,” is led by Dr. Christopher Hulme at the University of Arizona. For both therapeutic areas, there is a large unmet medical need, with these projects offering a new approach to treat patients living with these diseases.

It is anticipated that TRxA will fund between four and six more projects in its second year, with reviews of multiple international submissions currently underway.

To learn more about TRxA, be informed when the next award application period opens, and out how to apply for an award, contact us at TRxA@c-path.org.

TRxA is made possible by a grant from the Frederick Gardner Cottrell Foundation.