Our Translational Therapeutics Core is a state-of-the-science paradigm for the preclinical testing of traumatic brain injury (TBI) treatments that are intended to alleviate post-injurious symptoms experienced by service members.
In abidance with our value of urgency, the Translational Therapeutics Core will use a standardized, complex TBI mouse model to conduct interventional trials that yield fast, high quality decisive results. The Translational Therapeutics Core will conduct these studies in collaboration with expertise and resources at the Uniformed Services University for preclinical TBI models and behavioral assessments combined with advanced neuroimaging. The preclinical trials are designed with outcome measures that are relevant for translation from mice to humans. Promising candidate treatments will be shared with our Clinical Trials Unit, accompanied with the supporting data and techniques required for planning early phase clinical trials.
The Translational Therapeutics Core has developed a proof-of-concept complex, chronic TBI mouse model that will be used to test novel treatment options. This model addresses missing design elements in TBI clinical trials and incorporates rigorous clinical trial requirements to enhance the translational potential of promising therapeutics. The complex, chronic mouse model combines repeated blast exposures with impact and/or rotational forces and stressful stimuli to generate injuries that are analogues to TBIs experienced by service members. Soon, this standardized model will become an efficient pipeline that rapidly and effectively evaluates candidate interventions. These interventions will be designed to yield a decisive determination of the treatment’s effect (e.g., success or failure) on the primary outcome measure and will build in secondary outcome measures to improve future studies and clinical translation.
The Translational Therapeutics Core is in continuous contact with our Clinical Research Division, generating advances among both groups. Feedback from translational trials will be shared with our Clinical Trials Unit and Clinical Core Facilities. This information will be used to strengthen clinical study designs. The Clinical Trials Unit will also share trial feedback with the Translational Therapeutics Core, such as information about non-responders, challenges in demonstrating target engagement, or limitations in patient stratification. In turn, the Translational Therapeutics Core can adjust its methods to address this feedback.
The Translational Therapeutics Core works closely with our Informatics Core to generate preclinical data management that enhances data sharing, data quality, and statistical analysis. The Translational Therapeutics Core also provides instructional and consultative services to CNRM-funded and collaborative investigators.