Ryosei Leo Kawai
Chair and Founder: TS Expert Consultant
Leo Kawai is an international scientist and distinguished expert of translational drug research and development with 27 years of experience in the pharmaceutical industry. He has served in senior leadership roles at multiple global R&D sites in Switzerland, the US, and Japan focusing on Drug Metabolism and Pharmacokinetics (DMPK), clinical pharmacology, modeling & simulation, and translational medicine in global scope, as well as development strategy for regulatory approval in Japan.
Leo Kawai was formerly the leader in model aided drug discovery and development as Head of Pharmacokinetics and Pharmacometrics at Novartis AG, Switzerland, and continued to innovate development standards as Head of Clinical Pharmacology / Exploratory Clinical Development in Japan, also as Senior Expert Modeler in the Modeling & Simulation Department at Novartis Institute of Biomedical Research in the US. Being in Japan, he also served as Principal, Executive Director of the Translational Medicine and Clinical Pharmacology Department of Daiichi Sankyo Co. Ltd. in Tokyo, Head of Clinical Science Japan at Bayer Yakuhin Ltd.
Dr. Kawai was a member of the Editorial Advisory Board for the Journal of Pharmacokinetics and Pharmacodynamics (2003 – 2008), an Associate Editor for Drug Metabolism and Pharmacokinetics (2006 – 2012), a Council Member in the Japanese Society for the Study of Xenobiotics, and was recipient of the JSSX Fellow in 2008, the Kitagawa Memorial Award in 2010.
PMx Expert Consultant
Yoshiro Tomono is a distinguished expert of pharmacometrics (PMx) in pharmaceutical industry, also known as the frontier to apply PMx to facilitate clinical development and approval in Japan. He played leader’s roles in Eisai Co. Ltd., as head of biostatistics, as well as Pfizer Japan Inc., as head of Clinical Pharmacology & Biometrics, achieving innovations in novel drug development proven by many successful regulatory approvals in Japan. While being familiar to Clinical Pharmacology development, Yoshiro is well known as the leading expert of population PK (PPK) modeling in Japan, and has collaborated with academia to train and educate young experts for long years. His achievement had contributed largely to make PPK modeling as the current standard in pharmaceutical development and regulatory approval in Japan. Yoshiro initiated his consulting service in 2018 as self-employed expert, and joined CTS as PMx Expert Consultant in 2020.
On academic side, Yoshiro played roles of vice chair of Population Group in Japan (PAGJA; 2005 – 2010), vice chair of Japan Conference of Pharmacometrics (JCoP; 2008 – ), also publishing many original articles, as well as contribution to reviews / text books in PPK scope.
CTS Partner Consultants
Harmen Frobeen（based@Lörrach, Germany）
Harmen Frobeen is an internationally experienced IT GRC (Governance, Risk & Compliance) and Quality Management Professional with 25+ years working engagements in regulated industries, including banks, insurances, pharmaceuticals, diagnostics, life sciences, telecoms, service providers, industrial process automation, and software development. He helped organizations safeguard and enhance the ability to fulfil their mission by identifying and negotiating quality, information and operational risks and to comply with legal, regulatory, or corporate obligations. Strong analytical skills. Well able to cope with cross-functional and inter-cultural environments, interfacing the business domain and IT, with command of German (native), English (fluent), Japanese and French (basic). Harmen has supported business basis of CTS with his professional skills since CTS’s foundation in 2019, can also provide his professional service to client companies on request.
Prof. Ronald Sawchuk (based@Prior Lake, MN, USA)
Dr. Ronald J. Sawchuk is Professor Emeritus, Morse-Alumni Distinguished Teaching Professor of Pharmacokinetics, and Adjunct Professor in the Department of Pharmaceutics at the University of Minnesota. Until July 2015, he was Director of the Bioanalytic and Pharmacokinetic Services Laboratory in the College of Pharmacy at the University, has trained over 40 postdoctoral fellows, visiting scholars, and graduate students at the Masters or Ph.D. level at the University of Minnesota, and continues to teach pharmacokinetic modeling and simulation in graduate programs at the University, and on-line via web-based services.
In 2007, Professor Sawchuk received the APhA Research Achievement Award in the Basic Pharmaceutical Sciences. He is a member of the Academy of Distinguished Teachers at the University of Minnesota, and is a Fellow of the American Association of Pharmaceutical Scientists (AAPS), and of AAAS. Prof. Sawchuk also consults regularly with the pharmaceutical industry in the area of bioavailability and bioequivalence, evaluation of modified dosage form performance, and preclinical and clinical pharmacokinetic data analysis, modeling and simulation, either on-site or via web-based services.
In addition, CTS has several Expert Consultants on part-time basis, who are expertized in strategic regulatory business, including CMC as well as emerging novel therapies, such as regenerative medicines; they work as a part of CTS under strict confidentiality disclosure agreement (CDA).