Estimates vary, but the time it takes to successfully bring a drug to market is more than 12 years, and it costs over a billion dollars. Failure rates exceed 95 percent. Lack of “translatability” is frequently cited as being at the root of the lack of clinical success.
Overcoming translational barriers requires a deep understanding of human disease biology, and biomarkers are needed to precisely define different diseases or response characteristics. Only then can the correct populations be selected, the right targets pursued, and preclinical models that match key aspects of disease be designed. This is at the heart of translational or “precision” medicine.