Yoshitaka Ando
Vice President & Head of IDA
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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Katsuhiro Kurushima
Executive Director, Regulatory Affairs
Mr. Kurushima has spent over 30 years working in the drug development industry, with a focus on Regulatory Affairs and deep experience with PMDA Consultations, Clinical Trial Notifications, Orphan Drug and Japan New Drug Applications (NDAs) for drugs and medical devices across broad range of indications.
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After receiving his Master’s degree in biology from the Pharmaceuticals Department at Kanazawa University, Mr. Kurushima joined Sumitomo Pharmaceuticals in 1985, where he spent his first 10 years as a clinical monitor and then worked in positions of increasing responsibility in both the Regulatory Affairs and Clinical Development departments, primarily focused the compilation, negotiation and submission of NDA packages, as well negotiation of clinical development strategy and trial design with the PMDA, including formal consultations and clinical trial notification submission. After leaving Sumitomo in 2005, Mr. Kurushima spent the next approximately 6 years as a manager in the Regulatory Affairs departments first at GSK and then at Allergan.

In 2011, Mr. Kurushima joined Merck Serono as the Head of Regulatory Affairs where he was responsible for managing both NDA activities and life cycle management mainly for gynecological products and anticancer drugs. Then, in 2013, he became CSL Behring’s Head of Regulatory Affairs where he assumed the same overall responsibilities for CSLB’s pipeline of blood products.

Mr. Kurushima joined IDA in April 2018 as the Executive Director of Regulatory Affairs, where he oversees all of IDA’s regulatory functions, including its ability to compile and file Japanese NDAs as a Designated Marketing Authorization Holder (D-MAH).
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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.

Having joined IDA in early 2014, Mr. Ozawa is able to leverage his substantial clinical experience to oversee the planning and implementation of IDA’s clinical trials.
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Masataka Date, MD, PhD
Senior Medical Advisor
Dr. Date is licensed physician and Fellow of the Japanese Society of Internal Medicine with over 15 years of clinical research experience focused in clinical pharmacology and medical affairs. Since 2003, Dr. Date has worked on over 40 clinical trials spanning phases 1 thru 4 across a range of therapeutic areas including cardiology, gastroenterology, pediatrics, pulmonology, and rheumatology. Additionally Dr. Data has been closely involved in the Japan NDA submission process for drugs with various gastroenterology indications.
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Dr. Date graduated with an MD from Kansai Medical University in 1992, after which he spent the next several years working in Internal Medicine at his alma mater and Saiseikai Izuo Hospital. He then received his PhD from Kansai Medical University after returning as a Clinical Fellow in 1998, before continuing his postdoctoral research at the Gastrointestinal Unit at Massachusetts General Hospital and Harvard Medical School.

Upon returning to Japan in 2000, Dr. Date taught Clinical Medicine at Jikei University School of Medicine and pharmacology at Osaka Dental University. Then in 2003, he joined AstraZeneca Japan as a Clinical Pharmacology Physician, rising to become the Medical Director in the Clinical Science Department from 2007 to 2014. In 2014 he became the Director at Tachibanaikai Medical Corporation.

Dr. Date joined IDA as a Senior Medical Advisor in 2017.
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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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Hiroshi Kambayashi, MBA
Associate Director, Regulatory Operations
Mr. Kambayashi has spent over 25 years of working in medical industries and hospitals, with deep experience in PMS and safety management as well as in medical-biology research and clinical immunology.
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Mr. Kambayashi started his career in 1988 as a Medical Technologist specializing in immunology at a general hospital, Toranomon Hospital, where he spent over 10 years engaged not only in immunological testing, but also conducting advanced research in diagnostic immunology by developing new diagnostic methods applying molecular biology and revealing etiology of immune function disorders. He then moved into academia in Canada as a research fellow in pathology and molecular medicine, where he spent about four years for research of immune-related diseases and neoplastic diseases. With this experience, Mr. Kambayashi joined a global pharmaceutical company as a Senior Scientist in bioscience and contributed in the discovery of Kinase-inhibitors from 2003.
Since 2007, Mr. Kambayashi spent years in positions of increasing responsibility in both Safety Management and PMS departments, which included PMS project management, safety review and evaluation of drugs including antiviral, anti-inflammatory, psychoneurotic and anti-allergic agents, and communication with PMDA. Mr. Kambayashi expanded his career in PMS management in several global pharmaceutical companies as he led development and maintenance of several PMS projects before he joined IDA as Associate Director of Regulatory Operations in 2018, where he manages IDA’s Clinical Trial In-Country Caretaker (ICC) responsibilities, including safety reporting to PMDA.
Mr. Kambayashi has strong business and communication skills based on his MBA education and his work experience at his own business consulting firm.
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Atsuhiro Masada
Regulatory Submissions 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.
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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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Naoto Hayashi, PhD
Associate Director, 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.
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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 / Quality Management
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.
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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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