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.
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).
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.
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.
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.
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.
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.
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.
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.
Ms. Osorio joined IDA in early 2015.
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.