John Winebarger
President & CEO
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.
Show Details »
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.
Hide Details »
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.
Show Details »
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.
Hide Details »
Takefumi Gemba, PhD
Senior Vice President & Head of Product Development
Dr. Gemba has over 25 years of experience in all phases of drug development, from drug discovery to clinical trials and NDA submission, in a diverse range of therapeutic fields including neurology, cardiovascular, allergy, inflammatory, oncology and metabolic disease areas. After graduating from Osaka University in 1990 with an M.S. in Neurochemistry, Dr. Gemba entered Shionogi as a research scientist in the field of cardiovascular pharmacology. In 1995, he completed his PhD in the fields of Neurochemistry and Cardiovascular Pharmacology and continued his work at Shionogi, where he led several projects as Group Leader in the Immunology, Inflammatory, and Bone and Joint Group.
Show Details »
In 2003, Dr. Gemba joined Japan’s leading bioventure company, AnGes MG, as Manager of the Strategic Drug Discovery Department, rising to the post of Vice President of the Pharmaceutical Research Department in 2008 with a seat on the Board of Directors. At AnGes MG, Dr. Gemba led research and development for oligonucleotide-based medicines and gene therapy products, while also serving as Expert in the ICH Gene Therapy Working Group and an Advisory Committee member for Advanced Cell Therapy Products.

Dr. Gemba has subsequently served in senior executive roles with and on the boards of two newer bioventures, IMMD Inc. and Chiralgen, Ltd. Most recently, Dr. Gemba worked as Executive Officer of the Translational Research Division, at SNBL Ltd., a leading CRO, where his responsibilities included consulting on Drug Development within Regulatory Affairs and Project Management. Dr. Gemba is an expert on the regulatory process, having overseen several CTN (IND) submissions in Japan/US, NDA submissions and Orphan Drug Designation (ODD) in Japan.

Dr. Gemba joined IDA in 2013 and is responsible for overseeing all regulatory and scientific interactions with PMDA and MHLW, as well as IDA’s Clinical Trial In-Country Caretaker and Marketing Authorization Holder activities.
Hide Details »
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.
Show Details »
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.
Hide Details »
David Ng, PhD
Senior Advisor, Data Management, Biostatistics and IT
With over 25 years of experience in clinical development, business development and partnerships, and operational management of DM and Biostatistics, Dr. Ng has held key roles in designing and analyzing Phase I/II/III studies and managing systems and processes for optimal data management and biostatistical reporting.
Show Details »
After graduating from Brigham Young University with an MS in zoology, Dr. Ng went on to earn his PhD in zoology from University of Texas, Austin, with a focus in Population Biology and Genetics. In 1998, Dr. Ng began working at PPD in Austin, Texas, eventually becoming Director and then Vice President of Biostatistics and Data Management. He was General Manager of a PPD business unit until 2011, after which he initiated a consultancy where he developed survey tools for patient recruitment, site based EDC/eSource tools, and site, patient, and data management. His clinical development experience spans the fields of drugs, biologics, and devices in many therapeutic areas including oncology, cardiology, CNS, immunology, and infectious diseases. He has submitted several NDA ISSs/ISEs and has worked closely with KOLs and the FDA to successfully bring numerous products to market.

Dr. Ng also serves as Head of Biostatistics and Data Operations at ResearchPoint Global and has simultaneously served as an IDA Senior Advisor helping to prepare statistical analysis plans to meet as well as providing oversight of data management, biostatistics and medical writing operations for IDA’s clients Japanese and global studies.
Hide Details »
Kazuo Serie
Director, Regulatory Strategy
Mr. Kazuo Serie has over 35 years of experience in the global CRO and pharmaceutical industries, having led multiple Japan Regulatory Affairs teams where he has leveraged expertise in the management and conduct of PMDA Formal Consultations, various regulatory submissions such as Clinical Trial Notifications (CTNs) and Japanese New Drug Applications (J-NDAs), pharmacovigilance and KOL Management.
Show Details »
Mr. Serie graduated with a Bachelors in Health Sciences from the University of Tokyo, where he continued as a research student and fellow, specializing in Epidemiology and Biological Statistics and International/Domestic Health Policy. He began working at Chugai Pharmaceuticals in 1982 and within a few years gained management experience within the International Development, Clinical R&D, and Business Development departments. In 1994 Mr. Serie moved to JMS, a Japanese medical device company, continuing to serve in roles of increasing responsibility eventually becoming the Operating Officer of the Regulatory and Clinical Development Department where he managed successful regulatory filings and approval for multiple products.

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.
Hide Details »
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.
Show Details »
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.
Hide Details »
Goshi Ozawa
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.
Show Details »
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.
Hide Details »
Naoto Hayashi, PhD
Senior Manager, Regulatory Strategy
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.
Show Details »
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 of Regulatory Strategy.
Hide Details »
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.
Show Details »
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.
Hide Details »
Akiko Kubo
Supervisor, Regulatory Operations
Ms. Akiko Kubo has over 9 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.
Show Details »
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.
Hide Details »
© 2016 IDA Integrated Development Associates.