Mr. Shigeki Shimasaki

Biography

 Mr. Shimasaki, before joining Nobelpharma Co., Ltd., was constantly involved in pharmaceutical research and development operations at the Mitsubishi Chemical Holdings Corporation Group, and contributed to obtaining approvals for 8 products including Radicut. In addition, being responsible for the clinical data management division, he also greatly contributed to the planning and promotion of clinical trials in Japan and overseas. After graduating from the School of Health Sciences of the Faculty of Medicine at the University of Tokyo in 1980, he joined Mitsubishi Kasei Corp., now Mitsubishi Chemical Corporation, and was immediately assigned to the Pharmaceuticals Development Division. He worked on the application for Theodur’s import license, and was engaged in survey and planning operations of new development themes. He also worked on clinical development of liver supporting medicine, recombinant hepatitis B vaccine and antithrombotic drug, Argatroban. From 1990, he worked in operations at the Medical Information Division and the Sales Planning Division, to provide technical support for sales activities. Fom 1992, he also became responsible for the Clinical Data Management Division of the Pharmaceuticals Development Division where he was involved in each step of clinical trials carried out in Japan and overseas, from planning to analysis. His contribution to statistical analysis operations for obtaining approvals for the manufacture of Argatroban (cerebral thrombosis) and Radicut (cerebral infarction), was notably recognized, which led him to win the President Award in 2001. Assuming the role of General Manager of Clinical Development from 2002, he directed large clinical trials of 1,500 samples in Japan, as well as post-marketing clinical trials for Radicut, tests for additional indication for Omeprazole, and tests for additional indication for Urso. Mr. Shimasaki has many other achievements, having experienced development operations in various aspects he was also involved in the restructuring of the company and the development of operational policies before and after the enforcement of the new GCP (Good Clinical Practice) standards in Japan

Research Interest

 Mr. Shimasaki, before joining Nobelpharma Co., Ltd., was constantly involved in pharmaceutical research and development operations at the Mitsubishi Chemical Holdings Corporation Group, and contributed to obtaining approvals for 8 products including Radicut. In addition, being responsible for the clinical data management division, he also greatly contributed to the planning and promotion of clinical trials in Japan and overseas. After graduating from the School of Health Sciences of the Faculty of Medicine at the University of Tokyo in 1980, he joined Mitsubishi Kasei Corp., now Mitsubishi Chemical Corporation, and was immediately assigned to the Pharmaceuticals Development Division. He worked on the application for Theodur’s import license, and was engaged in survey and planning operations of new development themes. He also worked on clinical development of liver supporting medicine, recombinant hepatitis B vaccine and antithrombotic drug, Argatroban. From 1990, he worked in operations at the Medical Information Division and the Sales Planning Division, to provide technical support for sales activities. Fom 1992, he also became responsible for the Clinical Data Management Division of the Pharmaceuticals Development Division where he was involved in each step of clinical trials carried out in Japan and overseas, from planning to analysis. His contribution to statistical analysis operations for obtaining approvals for the manufacture of Argatroban (cerebral thrombosis) and Radicut (cerebral infarction), was notably recognized, which led him to win the President Award in 2001. Assuming the role of General Manager of Clinical Development from 2002, he directed large clinical trials of 1,500 samples in Japan, as well as post-marketing clinical trials for Radicut, tests for additional indication for Omeprazole, and tests for additional indication for Urso. Mr. Shimasaki has many other achievements, having experienced development operations in various aspects he was also involved in the restructuring of the company and the development of operational policies before and after the enforcement of the new GCP (Good Clinical Practice) standards in Japan