Despite Japanese leadership in basic research and discovery, its prominence in early phase oncology drug development is less established, and frequently, separate trials have been required because of the differing pharmacology of drugs in Asian patients. To date, relatively few first-in-human studies have been conducted in Japan, for the reasons described above with the majority using data from first-in-human studies from other countries to support starting doses. Many first-in-human studies of anticancer drugs are conducted in two sites in different countries, usually in North America (United States or Canada) and the other in Europe. Additional phase I studies including Japanese patients are often required for later marketing approvals in Japan. A number of major initiatives have been implemented since 2004 involving the Pharmaceuticals and Medical Devices Agency (PMDA), and Ministry of Health, Labor and Welfare (MHLW), including initiatives to improve the infrastructure for clinical trials in Japan by supporting clinician researchers (investigators) and medical institutions in conducting clinical trials and developing clinical trial networks. Remarkably, as a new measure to promote early phase clinical studies, the MHLW has been creating infrastructure for early-stage and exploratory clinical trials in Japan since 2011. Given the fact that most Japanese phase I institutes are not sufficiently equipped with effective infrastructures to conduct a fair number of ‘novel’ first-in-human studies, urgent improvements are currently required to strengthen their capabilities. Based on the experience of the phase I operation at START (South Texas Accelerated Research Therapeutics, San Antonio, TX, USA) phase I center, this session will involve discussion of required capabilities for Japanese Phase-I institutes, in addition to introduction of the exemplary Phase-I operation system of US phase I centers.