Since leaving PPD in 2004 to found IDA, Mr. Winebarger has worked with US and European companies to integrate Japan and Asia into their global drug development strategies. Through his leadership of the IDA team, Mr. Winebarger has assisted more than 50 companies without a base of Japanese operations in understanding the Japanese medical, regulatory and development landscape, and has helped them gain consensus and endorsement from KOLs and PMDA regarding clinical development programs to gain Japanese regulatory approvals. Moreover, under Mr. Winebarger’s leadership, IDA has 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 2007, Mr. Ando joined Quintiles Transnational Japan as Senior Director of Clinical Research where he managed a large team of research scientists and oversaw dozens of clinical studies. He moved to Mundipharma’s Japanese subsidiary in 2009 as the Head of Clinical Development, working to integrate global drug development strategies. Prior to joining IDA in early 2014, Mr. Ando was the Deputy General Manager and Head of Trial Operations at ICON Japan where, under his management, the company saw vast improvements in its gross margin and operating profits.
In addition to his proven management record, Mr. Ando’s cross-cultural work experience in Australia, France and Taiwan makes him well-positioned to build relationships between Japanese and global stakeholders.
After leaving JMS in 2005, Mr. Serie continued to serve in senior positions within the medical device, biopharma and CRO industries, including time spent as the Director of Regulatory and Clinical Affairs at Johnson & Johnson KK, Head of Regulatory Affairs at PPD Japan and Director of Regulatory Affair and Clinical Operations at Aegerion Pharmaceuticals KK, where he led the filing process for the company’s first J-NDA.
IDA welcomed Mr. Serie to its team in June 2016 as its new Director of Regulatory Strategy.
In 2000, Dr. Ruckle joined Radiant Research in Honolulu, Hawaii, where he served as Medical Director, leading the development of Phase 1 studies with an emphasis on Japanese bridging studies. Dr. Ruckle stayed on as Medical Director when the same Phase 1 unit was acquired by Covance in 2006, continuing to conduct Japanese bridging, pan-Asian, First-in-Human and microdose studies in a variety of subject populations. In 2008, Mr. Ruckle founded Pacific Pharma Group, LLC, a niche consulting company specializing in Phase 1 protocol design, product development strategy from IND to proof-of-concept, and medical monitoring.
Dr. Ruckle has worked with IDA as a Senior Advisor since 2008 assisting IDA clients with Phase 1 ethnic bridging trial designs and analysis plans to support Japanese registration of new drugs.
In 2008, Mr. Sugihara set up the Regulatory Consulting Department within the Global Clinical Trial Operation Division at Asklep to handle global clinical trials as an In-Country Clinical Caretaker (ICC) as well as NDA consulting services for US/EU and/or APAC Pharma/Biotech without local representation in Japan. He also contributed to obtaining and maintaining ISO9001 and provided qualified products and documents to clients, regulatory authorities as well as medical institutions. Mr. Sugihara would go on to continue his work planning and implementing ICC activities forJapan at both ICON and IDA. To date he has prepared and attended more than 20 PMDA consultation meetings and handled 12 clinical trials as an ICC.
Currently at IDA, Mr. Sugihara is in charge of all regulatory operations related to clinical trial implementation, such as the preparation and submission of Clinical Trial Notifications (CTNs), clinical trial supply management, and safety reporting. To date, Mr. Sugihara has managed IDA’s ICC responsibilities for more than 10 protocols for drug and combination products. Mr. Sugihara also functions as the Pharmacovigilance Manager for IDA’s Marketing Authorization Holder activities.
Mr. Ozawa has also led the implementation of Risk Based Monitoring (RBM) for several global trials, including performing RBM training for CRAs, CRCs and investigators, establishing RBM processes and preparing RBM monitoring plans. Mr. Ozawa is also a member of the Drug Information Association (DIA) Six Sigma Community, where he continues to aid in the implementation of RBM in Japan with a focus on quality management and cooperation between sites, CROs and the pharmaceutical industry.
Joining IDA in early 2014, Mr. Ozawa has already begun leveraging his substantial clinical experience to oversee the planning and implementation of IDA’s clinical trials, including ex-Japan Phase 1 trials implemented at IDA’s partnering site, De La Salle Health Sciences Institute in the Philippines.
Dr. Hayashi is fully bilingual, with significant experience working in an international settings both based in Japan and abroad. He started his career in 1988 in clinical research and development at Chugai Pharmaceutical Co., Ltd. where he worked for 12 years before moving to Europe to work as a Clinical Pharmacologist at F.Hoffmann-La Roche AG and Novartis Pharma AG and then as a director at Pfizer Ltd. After returning to Japan, Dr. Hayashi spent time at Merck Serono and ICON before joining IDA in June 2017 as a Senior Manager of the IDA Product Development team.
Ms. Osorio joined IDA in early 2015 and is responsible for the planning and implementation of clinical trials in the Philippines including Phase 1 studies at IDA’s partner site, De La Salle Health Sciences Institute.
Ms. Kubo joined IDA in early 2015, where she continues to manage Japan safety reporting and other critical regulatory functions pursuant to IDA’s role as the “Clinical Trial In-Country Caretaker” (CT-ICC) for both local and global clinical trials on behalf of overseas clients.