MEDSCHOOL, MED, Research, Translational Medicine Unit (TMU) - What We Do

WHAT WE DO

Purpose

The US Military needs countermeasures to prevent and treat a range of medical threats in an increasingly complex multi-domain operating environment.  The TMU works with preclinical investigators and product sponsors to rapidly evaluate the clinical feasibility of candidates with promise in animal models.  TMU supports development efforts by conducting adaptive data-rich learning trials in healthy volunteers and patients.  Sponsors can gain rapid insights permitting them to ‘fail early’ and adjust based on thorough and impartial data generated by the TMU.  The TMU also conducts observational studies including natural history and pharmacogenomics.

Our Mission

The TMU conducts clinical trials for early clinical-stage development of warfighter-relevant products.

Current Studies and Capabilities

The TMU has conducted basic science and Phase 1, 2, and 3 human clinical trials since 1989. The TMU is currently involved in active collaborations throughout the University, in the areas of pharmacogenomics, COVID-19 therapeutics and diagnostics, alcohol use disorder, and cardiovascular medicine. In addition the Division of Clinical Pharmacology and Medical Toxicology supports a Fellowship in Clinical Pharmacology run jointly by USU and the Walter Reed Army Institute of Research (WRAIR).

The TMU maintains active collaboration within the University to include the Military Cardiac Outcomes Research Program (MICOR), the Center for Neuroscience and Regenerative Medicine (CNRM), American Genome Center (TAGC), the USU Infectious Disease Division, and Departments of Physical Medicine and Rehabilitation, Psychology, Surgery and Microbiology.  Collaborations outside the University include the Walter Reed Army Institute of Research (WRAIR) and the Joint Program Executive Office for Chemical and Biological Defense (JPEO).  The TMU has a full complement of regularly updated standard operating procedures and work instructions for the conduct of clinical trials aligned with GCP and ICH guidelines.

TMU staff has extensive expertise in study design, protocol development, regulatory management and compliance.