Mr. Winebarger first worked for Otsuka Pharmaceutical Co., Ltd. in Japan and the US from 1988 to 1996, where he assisted in establishing and managing 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 then drove the formation of PPD’s Asian presence both establishing PPD Japan and led a partnering and acquisition strategy that culminated in PPD having a presence in Japan, Korea and 5 Southeast Asian countries.
Mr. Winebarger left PPD in 2004 to establish Integrated Development Associates Co., Ltd. (IDA), where he worked to develop a unique model for enabling US and European companies to integrate Japan and Asia into their global drug development strategies. Through his leadership of IDA, Mr. Winebarger assisted more than 60 companies without a base of Japanese operations in understanding the Japanese medical, regulatory and development landscape, and helping them gain consensus and endorsement from KOLs and PMDA regarding clinical development programs to gain Japanese regulatory approvals. Under Mr. Winebarger’s leadership, IDA also established a Clinical Trial In-Country Caretaker (“CT-ICC”) and MAH infrastructure to operationalize the integration of Japan into global clinical trials and for product registration including for Orphan Drugs and drugs designated by MHLW with particularly high unmet medical needs.
In 2018, Mr. Winebarger founded Ascent Therapeutics Co., Ltd. to assist companies with establishing Pan Asian development strategies that integrate regulatory pathways to approval in Asia’s major pharmaceutical markets particularly, Japan (PMDA) and China (NMPA). Moreover, Ascent supports companies in leveraging all Asian in order to support the most efficient implementation of clinical trials in the region.