John Winebarger
Founder & Managing Consultant
Mr. 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.
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Mr. Winebarger 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 also drove the formation of PPD’s Asian presence, first establishing PPD Japan (with clinical and DM operations) as well as PPD Thailand. He also led PPD’s Asian partnering strategy that culminated in the acquisition of ProPharma Pte Ltd., expanding PPD’s operations throughout Asia.

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.
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Yoshitaka Ando
Senior Vice President & Head of Clinical Operations
Mr. Ando has over 20 years of experience in leadership roles in the biotechnology and pharmaceutical industries. He earned his Bachelor of Science in Applied Microbiology from the University of Tokyo in 1978, and later studied Business Management at both Harvard Business School in Boston, Massachusetts and UCD Michael Smurfit Graduate Business School in Dublin, Ireland.
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Between 1996 and 2006, Mr. Ando held multiple positions within Kirin’s Pharmaceutical Division, culminating in his advancement to General Manager of Kirin Pharmaceuticals in Taiwan. Under his management, the company achieved continuous growth in sales and net profits.

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.
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Jon Ruckle, MD
Senior Advisor, Clinical Pharmacology
Jon Ruckle, MD has over 30 years of medical/clinical experience, over which time he has served as the Investigator for more than 350 clinical studies, including over 50 Japanese bridging studies, for drugs in areas such as oncology, diabetes, biologics, renal impairment and cardiovascular/hypertension. Dr. Ruckle possesses an extensive background in protocol design, product development strategy and medical monitoring, with significant expertise in ethnic comparison studies, primarily focusing on Japanese bridging.
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Dr. Ruckle graduated from Loma Linda University School of Medicine in 1980, before completing a 4-year residency in Internal Medicine at the Mayo Clinic in Rochester, Minnesota. After spending approximately 10 years working at various medical practices, Dr. Ruckle co-founded Northwest Kinetics in 1995, which he developed from the start-up phase into a profitable unit with approximately 30 full-time staff and over 5,000 registered subjects. At Northwest Kinetics, Dr. Ruckle served as the Medical Director, successfully completing over 80 clinical trials.

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.
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Masayuki Kawahara, MD
Senior Medical Advisor
Dr. Kawahara is a Japanese MD with over 10 years of pharmaceutical and medical device development experience, including over 4 years spent at the PMDA where he worked as a Medical Reviewer and GCP Inspector.
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In 1998, Dr. Kawahara graduated from Okayama University Medical School where he completed his residency in obstetrics and gynecology. Following his graduation, Dr. Kawahara spent the next approx. 8 years working as a Resident Doctor and Family Physician at several hospitals and clinics practicing in areas such as internal medicine, pediatrics, neonatology, anesthesiology, neurosurgery and obstetrics and gynecology.

In 2007, Dr. Kawahara began working in the Medical Affairs division at Schering-Plough K.K., where he would go on to be promoted to Department Head, responsible for strategic planning, KOL management and Pharmacovigilance for products in a wide array of indications. Following his time at Schering-Plough, he worked as the Associate Director for Project Management at Y’s Therapeutics Inc., USA, where he managed clinical development for antibody drugs in the oncology and transplantation space.

From 2010 to 2014 Dr. Kawahara worked for the PMDA as a Medical Reviewer in both the Office of New Drugs 3 (neurological and anesthetic medicines) and the Office of Medical Devices, and as a GCP Inspector for the Office of Conformity Audits. Since 2014, Dr. Kawahara has continued to work as a practicing physician as well as independent consultant.

Dr. Kawahara joined IDA as a Senior Medical Advisor in October 2017.
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Satoshi Sugihara
Director, Regulatory Operations
Mr. Sugihara has more than 30 years of experience in the domestic and global pharmaceutical and CRO industries with an extensive background including Regulatory, Clinical Operations, Post-Marketing Surveillance, Medical Affairs, and Quality Management across a broad range of therapeutic areas.
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After graduating from Tokyo University of Science with a BS in Applied Biological Science, Mr. Sugihara began his career as a Sales Rep. and CRA at several pharmaceutical companies throughout the 80s and 90s before entering the Japanese CRO space at Mediscience Planning and then Asklep, where he held roles of increasing responsibility including monitoring lead, clinical trial manager and project manager. Over this time Mr. Sugihara managed over 10 projects as part of cross-functional teams and helped develop more than 30 junior CRAs and other staff.

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.
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Goshi Ozawa
Senior Director, Clinical Operations
Goshi Ozawa has over 15 years of Clinical Development and CRA experience across a broad range of areas, as well as strong leadership skills and expertise in Risk Based Monitoring (RBM) and Process Development.
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After graduating from the Tokyo Institute of Technology with a Master’s degree in bioscience and bio-information, Mr. Ozawa began his career at Novartis Pharma KK in Tokyo, where he held positions of increasing responsibility between 2002 and 2014. As a Senior Lead CRA at Novartis, Mr. Ozawa managed CRAs and multiple sites, interfacing with KOLs and other site staff to ensure the timely achievement of target patient numbers, all while developing a strong understanding of global and local clinical trials in areas such as Parkinson’s Disease, osteoporosis, hypertension, diabetes, COPD and cardiovascular disease (ACS, AMI, OMI, AHF and CHF). Mr. Ozawa also served as Novartis’ Process Development Manager for Pan-Asian Clinical Development, where he utilized his black belt certification in Lean Six Sigma to lead several successful initiatives to improve the effectiveness of the overall clinical process.

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.
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Atsuhiro Masada
Clinical Program Director
Mr. Masada has over 30 years of experience in the pharmaceutical and CRO industry, with the bulk of his career spent in clinical research specializing in the development of oncology and gynecology products.
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After graduating from Kinki University with a degree in Medical Pharmacy, Mr. Masada became a licensed pharmacist in 1986. Two years later he obtained a Master’s Degree in Biochemistry with a focus on calcium-channel inhibitors from Kinki University’s Graduate School of Medicine.

In 1988 Mr. Masada joined Mochida Pharmaceutical, where he spent his first 10 years as a researcher in their Central Laboratory before transferring to Mochida’s Clinical Development Division. There he spent the next 10 years developing Mochida’s gynecology portfolio, first as a Clinical Monitor and Medical Writer and then as the Deputy Manager of the division. Over this period he was able to experience all phases of clinical trials, as well as manage KOL interactions and formal negotiations with the PMDA, including eventual J-NDA submission and approval for a gynecological drug in 2007.

Following his time at Mochida, Mr. Masada spent the next 10 years in positions of increasing responsibility at Shin Nippon Biomedical Laboratories and NanoCarrier. During this time he focused primarily on the development of oncology products and managed large global and domestic studies for indications such as pancreatic cancer and head and neck cancer.

Mr. Masada joined IDA in October 2017 as a Clinical Program Director.
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Akiko Tsutsui
Associate Director, Program Management
Ms. Tsutsui has approximately ten years of clinical research and project management experience in early and late phase clinical trials across a wide array of therapeutic areas, including significant time spent in academic, clinical and CRO settings.
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Following her high school graduation in Japan, Ms. Tsutsui moved to the United Kingdom to enroll in the University of Manchester. After receiving her Bachelors of Science in Physiology in 2008, she spent a year working as a Research Assistant in the university’s neural developmental biology research laboratory. She then moved to Hammersmith Medicines Research in London as a research associate and quality coordinator, serving as one of the core members of the early phase CRO’s newly established Japanese “ethnic bridging” study team.

In 2010 Ms. Tsutsui became a Clinical Research Practitioner at the Royal Free London NHS Foundation Trust, where she spent approx. 3 years managing Phase 2 through 4 oncology studies. After gaining clinical experience, Ms. Tsutsui moved into project management roles at King’s College London and Queen Mary University of London, where she was responsible for the oversight and delivery of multi-centre European studies in kidney transplantation and rheumatoid arthritis, respectively. In 2015, Ms. Tsutsui joined Chiltern UK as a Project Manager where she was responsible for the delivery of global phase 2 and 3 studies in the areas of respiratory and rare disease. From 2016, Ms. Tsutsui was given the additional role of Account Director, Business Development, with a focus on expanding relationships and generating business opportunities for Chiltern’s Japanese client base.

Ms. Tsutsui stayed in the Chiltern family by joining IDA in 2017 as an Associate Director of Program Management, where she is responsible for managing programs on behalf of IDA clients across both the regulatory strategy and clinical trial implementation phases, in addition to supporting IDA’s business and corporate development objectives.
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Robert Phillips
Associate Director, Project Management
Mr. Phillips has worked in the Japan clinical trials space for approx. 20 years, with experience in all stages of study implementation from protocol development up thru database lock and CSR drafting. In particular, Mr. Phillips has developed a specialization in comparative PK studies and ICH E5 bridging on behalf of overseas sponsors looking to develop their products in Japan.
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After receiving his bachelor’s degree in Chemistry from the University of Birmingham, Mr. Phillips began his career in the Japanese clinical trials space in 1998 at Shin Nippon Biomedical Laboratories (SNBL) as an Associate Project Manager where he worked on the development of the first comparative PK study conducted in Japan in compliance with ICH GCP and local regulations. The following year Mr. Phillips moved to SNBL’s CPC Clinical Trial Hospital located in Kagoshima where he worked for the next 17 years first as an Assistant Manager and then as Department Chief. During his time at the CPC Clinical Trial Hospital, Mr. Phillips managed all stages of single and multi-site Phase I/IIa studies, with a particular specialization in comparative PK bridging studies, of which he conducted 36. Additionally, during this time Mr. Phillips pursued a Master of Science degree in Clinical Trials at the University of London, School of Hygiene and Tropical Medicine, which he obtained in 2012.

More recently, Mr. Phillips managed the global phase I-IV clinical trials of an Ebola vaccine at 10 clinical centers in 5 countries (Europe, sub-Saharan Africa) under the funding of EU-Innovative Medicines International. Following his return to Japan he working at PPD as a Global Clinical Development Manager and as of October 2017 has joined IDA as an Associate Director for Program Management.
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Naoto Hayashi, PhD
Senior Manager, Product Development
Dr. Hayashi is an expert in clinical pharmacology (pharmacometrics) with total 30 years of drug development experience and a strong background in PK/PD, protocol design, and regulatory science including management of PMDA Formal Consultations and regulatory submissions such as CTN, J-NDA, etc.
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Dr. Hayashi graduated in 1986 with a Bachelor’s Degree in Biophysics from the Science University of Tokyo. Soon thereafter, in 1988, he attained his Master’s Degree in Biochemistry from the same university. In 2001, he completed his PhD in Pharmaceutical Sciences (Clinical Pharmacology) from Kyushu University and has published 15 journal articles with a primarily focus on PK/PD modeling and simulation analysis in the context of clinical development.

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 in the IDA Product Development team.
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Mary Anne Osorio
Manager, IDA Philippines
Mary Anne Osorio is a registered pharmacist with over 10 years of CRA and trial management experience at global CROs and pharmaceutical companies in a variety of areas, including oncology, nephrology, dermatology and psychiatry. In addition to her strong background in global regulatory and clinical operations, Ms. Osorio has also worked for the Philippines FDA, equipping her with a robust understanding of the Philippines’ local regulatory landscape.
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After graduating from the University of the Philippines in 2005 with a B.S. in Pharmacy, Ms. Osorio became a registered pharmacist and joined the Philippines FDA as a Pharmacist / Drug Evaluator, where she helped to process and evaluate product applications, including compliance documents. Following her time at the Philippines FDA, Ms. Osorio joined GlaxoSmithKline Philippines as a CRA and Post-Marketing Surveillance (PMS) Project Leader. At GSK, she was responsible for implementation of Phase 4 trials for vaccines, which included the supervision and training of other CRAs. Then in 2009, Ms. Osorio joined Quintiles Philippines as a CRA, where she worked for 3 years and was involved closely in the implementation of oncology studies, before joining RPS Research Philippines in 2012 as a Senior CRA / Local Trial Manager, where she managed studies in oncology, dermatology and psychiatry from study start-up through close-out. Starting in 2013, Ms. Osorio joined Novotech Philippines as a Senior/Lead CRA where she monitored and oversaw studies in Nephrology and Pain Management.

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.
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Akiko Kubo
Assistant Manager, Regulatory Operations
Ms. Akiko Kubo has over 10 years’ experience in regulatory and clinical operations, the majority of which she has spent managing pharmacovigilance / safety reporting for phase 1 thru 3 studies in a broad range of therapeutic areas, including oncology, pulmonology, cardiology, CNS, dermatology, rheumatology, and endocrinology.
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Ms. Kubo graduated in 2007 with a Bachelor’s Degree in Biology from the University of Utah, College of Science, after which she returned to Japan to join ICON KK. After working her first year as a CRA and gaining a strong familiarity with GCP and day-to-day clinical operations, Ms. Kubo became a Drug Safety Associate and would go on to be promoted to Senior Drug Safety Associate in 2013. During her time at ICON, Ms. Kubo’s bilingual capabilities enabled her to play a pivotal role in maintaining strong communication between local sites, global study teams, and overseas Sponsors.

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.
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