Traversing the valley of death: a guide to assessing prospects for translational success

On the basis of our experience in drug and device development, we have identified six broad categories of issues that profoundly affect the probability for successful translation of basic scientific discoveries into effective therapies. Within each category, we propose a series of questions that form the beginnings of a self-guided global risk assessment tool. Although this preliminary tool will require validation and adjustment, we offer it to stimulate a discussion about more rigorous methods for selecting and conducting translational projects.