The Translational Therapeutics Core is a state-of-the-science paradigm for the preclinical testing of traumatic brain injury (TBI) treatments intended to alleviate highly relevant post-injury symptoms experienced by Service Members. Along with the Optimizing Ferret TBI Experiment, it is one of the newest initiatives within the Translational Research Division. In congruence with our value of urgency, the Translational Therapeutics Core will use a standardized, complex mouse injury model to conduct interventional trials that will yield fast, high quality decisive results. The Translational Therapeutics Core collaborates closely with the Preclinical Studies Core to carry out these studies. 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 model of TBI in mice to test the effectiveness of novel treatment options. This model strategically addresses missing elements in the design of decisive TBI clinical trials, incorporating rigorous clinical trial requirements that enhance the translational potential of promising therapeutics to future successful early phase clinical trials. The model incorporates the combination of blast exposure, impact and/or rotational force, and stressful stimuli analogous to the complex environment and TBI exposures experienced by Service Members. Soon, the 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 the Clinical Research Division, generating advances among both groups. Feedback from translational trials will be shared with the Clinical Trials Unit and the clinical core facilities. This information will be used to strengthen clinical study designs. The Clinical Trials Unit will share feedback with the Translational Therapeutics Core, such as information about non-responders, challenges in demonstrating target engagement, or limitations in patient stratification. In response, the Core can adjust its methods to address this feedback.
The Translational Therapeutics Core leads preclinical data process development with the Informatics Core for data management to enhance data sharing, and use of best practices for data quality and statistical analysis. The Translational Therapeutics Core also provides instructional and consultative services to funded and collaborative investigators.