Sase Kazuhiro

SASE Kazuhiro, M.D., Ph.D.

Short Biography

1980-1986	M.D. Kyoto University School of Medicine
1987-1989	Residency, Internal Medicine & Anesthesiology, Kitano Hospital
1989-1993	Ph.D. Kyoto University Graduate School of Medicine
1994-1997	Research Fellow, Cardiovascular Division , Brigham and Women’s Hospital, Harvard Medical School, USA
1997-1998	Senior Cardiologist, Shimabara Hospital
1998	Planning Division / ER, National Cardiovascular Center
1999-2000	Senior Medical Reviewer, Pharmaceuticals and Medical Devices Evaluation Center, Ministry of Health, Labour and Welfare
2001-2005	Director of Clinical Research Unit, National Cardiovascular Center
2005-	Professor, Clinical Pharmacology, Juntendo University

Keywords

• Regulatory Science
• Clinical Pharmacology
• Clinical Evaluation of Medical Devices
• Global Regulatory Harmonization
• Cardio-oncology

Main Research Topics and Interests

• International Consortium for Cardiovascular Registries (ICCR)
• US-Japan Harmonization by Doing (HBD)
• Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS)
• Distributed Data Model and Unique Device Identifier (UDI)
• In Vitro Diagnostics and Molecular Biomarkers for Precision Medicine

Publications (in English)

• Original Articles (25) <Citations: 1,245>
• Review Articles (2) <Citations: 70>
• Books (3)

Recent Main Publications

• Kataoka Y, Yasuda S, Miyamoto Y, et al: Clinical Predictors of Atheroma Progression Despite Optimal Glycemic Control in Early-Stage Diabetic Patients with Coronary Artery Disease: Insight from the DIANA Study. J Atheroscler Thromb, 2014; 21; 509-518.
• Kamide K, Asayama K, Katsuya T, et al: Genome-wide Response to Antihypertensive Medication Using Home Blood Pressure Measurements: A Pilot Study Nested within the HOMED-BP Study. Pharmacogenomics, 2013; 14; 1709-1721.
• Kataoka Y, Yasuda S, Miyamoto Y, et al: Effects of Voglibose and Nateglinide on Glycemic Status and Coronary Atherosclerosis in Early-Stage Diabetic Patients. Circ J, 2012; 76; 712-720.
• More

Other Specific Comments

Global Regulatory Harmonization and Related Activities

2005-	Steering Committee, US-Japan Harmonization by Doing (HBD).
2005-2012	Study Group 5 (Clinical Evaluation), Global Harmonization Task Force (GHTF).
2006-2013	Co-chair, Working Group 2 (Post-Markting Registry of Medical Devices). US-Japan Harmonization by Doing (HBD)

Japanese Government/Academic Committee Responsibilities

2001-2003	Project member, Translational Research Informatics Center. City of Kobe
2003-2005	Technical Advisory Committee, Japanese Medical Association Center for Clinical Trials (JMACCT)
2005-2005	Working Group, High-Speed IP Handover for Mobile Telemedicine to Support Pre-Hospital Care and Emergency Medicine. Kinki Bureau of Telecommunications. Ministry of Internal Affairs and Communications
2005-2006	Senior Research Fellow (Imura-Group/Proposal for National Policy on Clinical Research), Center for Research and Development Strategy, Japan Science and Technology Agency (CRDS/JST)
2006-2007	Group on Implantable Mechanically Assisted Circulatory Support. Committee for Evaluation of Next-Generation Medical Devices, National Institute for Health Sciences, Ministry of Health, Labour, and Welfare
2006-	External Advisory Board Member, Pharmaceuticals and Medical Devices Agency (PMDA)
2007-	Operational Committee, Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS). Pharmaceuticals and Medical Devices Agency (PMDA)
2007-	Steering Committee, Japanese Regisry for Mechanically Assisted Circulatory Support (J-MACS), Pharmaceuticals and Medical Devices Agency (PMDA)
2008-	Senior Member, Division of Regulatory Sciences, The Pharmaceutical Society of Japan
2009-2009	Advisory Board to the Committee on Health Research Initiatives, Cabinet Office
2012-	Reviewer. Program to Develop Medical Equipment and Devices to Solve Unmet Medical Needs, Ministry of Economy, Trade and Industry

Link

Department of Clinical Pharmacology