Dr. Norisuke Kawai is Head of Clinical Research in Pfizer R&D Japan. Dr. Kawai joined Pfizer in 2003 after working in Yamanouchi Pharmaceutical for 6 years. Dr. Kawai has over 20 years’ experience of clinical drug development. Dr. Kawai received his M.S. and Ph.D. in Statistical Science from Osaka University. Dr. Kawai is a board member of the Japanese Society of Computational Statistics. Dr. Kawai also serves as an associate editor of the Japanese Journal of Statistics and Data Science.

Dr. Ichiro Arano is Head of Clinical Research at MSD. In this role, he is responsible for overseeing all clinical research activities and ensuring the successful execution of clinical programs. He has over 30 years of experience in drug development, clinical research, clinical operations, and regulatory affairs in Japan. Dr. Arano has experience of working at two U.S.-based pharmaceutical companies, Pfizer and Merck, where he acquired extensive experience with global drug development and cross-functional operations. He had a Ph.D. from the School of Health Sciences, Faculty of Medicine, Osaka University.

Osamu Komiyama is Associate Biostatistics, Statistical Research & Data Science, Pfizer R&D Japan and has about 30 years' experience in pharmaceutical industry. He has contributed to ICH EWG/IWG for several guidelines(E5 Q&A No.11, E3 Q&A, E17, and E8(R1)) in 15 years and received ICH award 2022. He was a chairman of JPMA Data Science Expert Committee from 2012-2020 and now a vice chairman of the committee.

Dr. Susumu Nakade is the Global Head of Clinical Pharmacology at Ono Pharmaceutical Co., Ltd. In this role, Dr. Nakade oversees the planning and execution of clinical pharmacology and biopharmaceutical studies, including pharmacometric analysis and bioanalysis. With over 30 years of experience at Ono Pharma, Dr. Nakade has extensive expertise not only in clinical pharmacology but also in pre-clinical and translational research. He has previously served as a part-time lecturer at Osaka University of Pharmaceutical Sciences and Kurume University School of Medicine, and he is currently a part-time lecturer at Kyushu University School of Pharmaceutical Sciences. Dr. Nakade holds a PhD in Pharmaceutical Sciences from Kyushu University.

Dr. Yanagisawa is the Deputy General Manager of the Development Regulatory Affairs Department at Mochida Pharmaceutical Co., Ltd. He has over 30 years of experience in the pharmaceutical industry, including in medicinal chemistry, regulatory affairs, and drug pricing. Over the course of his career, he served for about five years as the JPMA coordinator and representative at ICH meetings, and also chaired the Drug Evaluation Committee at JPMA for two years. Dr. Yanagisawa holds a Ph.D. in Pharmacy from Tokyo University of Science. In addition, he has contributed to DIA as a facilitator for the Regulatory Affairs Training Course and as a program committee member for the DIA Japan Annual Meeting.

Mr.Ryohei Tanigawa is the department manager of Global Clinical Development Department, Kowa Company Ltd., Tokyo, Japan.Mr.Tanigawa is responsible for leading all clinical development activities acros Kowa's clinical development programs. Mr.Tanigawa has over 20 years’ experience in the pharmaceutical industries.