Dr. Kawai’s expertise in DMPK, clinical pharmacology, modeling and simulation, and translational medicine, in addition to his expertise in Japanese development and regulatory strategy, makes him an excellent resource for our clients in the preclinical and clinical drug development phases.
ROCHELLE, Va. (PRWEB) May 22, 2019
NDA Partners Chairman Carl Peck, MD, announced today that Leo Kawai, PhD, an international scientist and distinguished expert on translational drug research and development, has joined the firm as an Expert Consultant. Dr. Kawai has 30 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 with a focus on Drug Metabolism and Pharmacokinetics (DMPK), clinical pharmacology, modeling & simulation, and translational medicine on a global basis, as well as development strategy for regulatory approval in Japan.
Dr. 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. Following his successful 21-year career with Novartis, he served as Principal, Executive Director of the Translational Medicine and Clinical Pharmacology Department of Daiichi Sankyo Co. Ltd. in Tokyo, after which he assumed the role of Head of Clinical Science Japan at Bayer Yakuhin Ltd.
“Dr. Kawai’s expertise in DMPK, clinical pharmacology, modeling and simulation, and translational medicine on a global basis, in addition to his expertise in Japanese development and regulatory strategy, makes him an excellent resource for our clients in the preclinical and clinical drug development phases,” said Dr. Peck. “We are very pleased to welcome him to NDA Partners.”
Dr. Kawai earned his doctorate, master’s degree, and bachelor’s degree from Chiba University’s School of Pharmacy in Chiba, Japan. He was a member of the Editorial Advisory Board for the Journal of Pharmacokinetics and Pharmacodynamics, an Associate Editor for Drug Metabolism and Pharmacokinetics, a Council Member in the Japanese Society for the Study of Xenobiotics, and recipient of the JSSX Kitagawa Memorial Award in 2010.
About NDA Partners
NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Earle Martin, Chief Executive Officer