Mr. John Winebarger has lived and worked in Japan since 1984. He has focused his career on assisting Japanese pharmaceutical companies in developing US/EU regulatory and development strategies as well as supporting and advising western companies through innovative approaches to accelerating and integrating Japan and Asia into global drug development. Mr. Winebarger worked for Otsuka Pharmaceutical Co., Ltd. in Japan and the US from 1988 to 1996, where he helped establish and manage Otsuka’s expanding global clinical development operations. In 1997, Mr. Winebarger joined PPD and initially served as Executive Director of Pan-Asian Business Development. In this position he was instrumental in building PPD’s product development business which focused on Japanese, Korean and Taiwanese companies seeking entry into the US market. Mr. Winebarger also drove the formation of PPD’s Asian presence, establishing PPD Japan as well as PPD Thailand. In 2004, Mr. Winebarger left PPD to establish IDA.  To date IDA has worked with 50+ companies to enable accelerated drug development strategies for Japan and Asia, including Regulatory Consultations, Orphan Drug and SAKIGAKE Designations and full-service clinical trial implementation as a Clinical Trial In Country Caretaker ("CT-ICC").