Successfully accelerating translational research at an academic medical center: the University of Michigan-Coulter translational research partnership program

Abstract

Translational research encompasses the effective movement of new knowledge and discoveries into new approaches for prevention, diagnosis, and treatment of disease. There are many roadblocks to successful bench to bedside research, but few have received as much recent attention as the "valley of death". The valley of death refers to the lack of funding and support for research that moves basic science discoveries into diagnostics, devices, and treatments in humans, and is ascribed to be the result of companies unwilling to fund research development that may not result in a drug or device that will be utilized in the clinic and conversely, the fact that researchers have no access to the funding needed to carry out preclinical and early clinical development to demonstrate potential efficacy in humans. The valley of death also exists because bridging the translational gap is dependent on successfully managing an additional four risks: scientific, intellectual property, market, and regulatory. The University of Michigan (UM) has partnered with the Wallace H. Coulter Foundation (CF) to create a model providing an infrastructure to overcome these risks. This model is easily adoptable to other academic medical centers (AMCs).

Figure 1

The translational continuum. The translational paradigm has been subdivided into four steps. T1 research is the traditional bench to bedside work that leads to approval of a drug, device, or diagnostic. T2 research assesses the value of the approved application in medical practice and establishes guidelines for use. T3 research studies the movement of evidence‐based guidelines into health practice through delivery, dissemination, and diffusion research. T4 research evaluates the “real‐world” health outcomes of a T1 application in practice. ²

Figure 2

Bridging the valley of death. The University of Michigan‐Coulter Foundation Program addresses the major risks necessary to translate a discovery to the clinic. These include scientific peer review, identifying funding, identifying potential markets, and managing intellectual property and regulatory risks.