[How to design the translational research--special reference to gene therapy products]

The previous borders among basic research and clinical research are bridged by the system commonly termed as 'translational research(TR)'. TR encompasses i) the guidelines for drug development or for the identification of clinically relevant biomarkers; ii) experimental nonhuman studies conducted to show the 'proof of concept' for new therapeutic strategies; iii) initial clinical investigations for the development of new therapies; and iv) extensive clinical trial initiated in accordance with the above goals. Unfortunately, even though the current efforts by physicians and pharmaceutical companies, there are a number of hurdles that delay TR, especially in Japan.