Naoto HAYASHI

J-GLOBAL         Last updated: Nov 30, 2018 at 13:18
 
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Name
Naoto HAYASHI
URL
http://scholar.google.co.jp/citations?user=C3SpXhsAAAAJ&hl=ja&oi=ao
Affiliation
Merck Serono Co., Ltd.
Section
Clinical Development Center
Job title
Clinical Pharmacologist
Degree
Ph.D.(Kyushu University), M.Sc.(Science University of Tokyo)

Research Areas

 
 

Academic & Professional Experience

 
Jun 2017
 - 
Today
Associate Director, Regulatory Strategy, Integrated Development Associates, Co. Ltd.
 
Sep 2015
 - 
Aug 2016
DIrector in charge of international development and clinical pharmacology, Nanocarrier Co., Ltd.
 
2010
 - 
Aug 2015
Clinical pharmacologist, Clinical Development Center, Merck Serono Co., Ltd.
 
2007
 - 
2009
Director / Clinical Pharmacologist, Pfizer Limited, UK
 
2006
 - 
2007
Manager / Senior Pharmacokineticist, DMPK, Novartis Pharma KK
 

Education

 
Apr 1986
 - 
Mar 1988
Faculty of Applied biological science, Graduate School of Science & Engineering, Science University of Tokyo
 
Apr 1982
 - 
Mar 1986
Faculty of Applied biological science, Department of Science and engineering, Science University of Tokyo
 

Committee Memberships

 
Nov 2012
 - 
Today
Japanese society of Clinical pharmacology and therapeutics  Council
 

Published Papers

 
Naoto HAYASHI
Kyushu University      2001   [Refereed]

Misc

 
Doi T, Hamaguchi T, Shitara K, Iwasa S, Shimada Y, Harada M, Naito K, Hayashi N, et. al.
Chemother Pharmacol.   79 569-578   2017   [Refereed]
The prospect of atacicept treatment in SLE patients - based on the results of Study APRIL and other information -
Naoto HAYASHI
Rheumatology Jpn   53(5) 522-530   May 2015   [Refereed]
Naoto HAYASHI
Clinical Evaluation   40(2) 296-301   Mar 2013   [Invited]
Background, history and the relationship of pharmacometrics with Clinical pharmacology
Naoto HAYASHI
Japanese journal of clinical pharmacology and therapeutics   44 S189-S189   2013   [Invited]
Jean-Luc Vachiery, Sandrine Huez, Hunter Gillies, Gary Layton, Naoto Hayashi, Xiang Gao, and Robert Naeije
British Journal of Clinical Pharmacology   71(2) 289-292   2011   [Refereed]
Naoto HAYASHI
Japanese journal of clinical pharmacology   41(5) 191-198   Sep 2010   [Invited]
Jean-Luc Vachiery, Sandrine Huez, Hunter Gillies, Gary Layton, Naoto Hayashi, Xiang Gao, Robert Naeije
American Journal of Respiratory and Critical Care Medicine   181 A3358-A3358   2010   [Refereed]
Naoto Hayashi, Lutz Harnisch
Population Aproach Group in Europe      2009   [Refereed]
Naoto HAYASHI
Pharm Stage.   7(3) 26-30   2007   [Invited]
Pharmacokinetics and pharmacodynamics of the DPP-4 inhibitor, Vildagliptin, in Japanese patients with Type 2 diabetes
N. Hayashi, M. Karube, Y. Kumagai, Y. Fujita, S. Irie, Y. Ikeda, Y. L. He
Journal of Clinical Pharmacology and Therapeutics   81 S68-S68   2007   [Refereed]
Naoto Hayashi, Yuko Tsukamoto, William M. Sallas, Philip J. Lowe
British Journal of Clinical Pharmacology   63(5) 548-561   2007   [Refereed]
R Kawai, T Ichihara, A Shishido, G Gordon, N Hayashi
Workshop of Japanese Society for the Study of Xenobiotics.   19 113-118   Apr 2005
Naoto HAYASHI
Drug metabolism and pharmacokinetics   20(6) 8-12   2005   [Refereed][Invited]
Naoto Hayashi, Klaas P. Zuideveld, Paul Jordan, Ronald Gieschke
Population Aproach Group in Europe      2003   [Refereed]
Naoto Hayashi, Ronald Gieschke
Osteoporosis International   13 S23-S23   2002   [Refereed]
Naoto Hayashi, H Aso, M Higashida, H Kinoshita, S Ohdo, E Yukawa, S Higuchi
European journal of pharmaceutical sciences   13(2) 151-158   2001   [Refereed]
Naoto Hayashi, Haruki Kinoshita, Eiji Yukawa, Shun Higuchi
The Journal of Clinical Pharmacology   39(6) 583-592   1999   [Refereed]
Naoto Hayashi, Haruki Kinoshita, Eiji Yukawa, Shun Higuchi
British Journal of Clinical Pharmacology   46(1) 11-19   1998   [Refereed]

Books etc

 
Dose Setting in Clinical Studies and Managing Risk in Clinical Development.
Naoto HAYASHI (Part:Joint Work, Section 6 Examples of Clinical PK / PD studies and Searching Biomarkers - From the aspect of dissemination of pharmacometrics in oversea countries -)
Science & Technology   May 2013   ISBN:9784864280686

Conference Activities & Talks

 
Naoto HAYASHI
34th annual meeting of Japan Society of Clinical Pharmacology and Therapeutics   Dec 2013   
Naoto HAYASHI
2nd International Symposium of Early Stage Clinical Trial   Feb 2012   
Utility of M&S in Clinical Development and its circumstance in Europe and US. [Invited]
Naoto HAYASHI
Symposium in 30th annual meeting of Japan society of Clinical Pharmacology and Therapeutics   Dec 2009   
Naoto Hayashi, Lutz Harnisch
18th annual meeting of Population Approach Group in Europe   Jun 2009   
Naoto HAYASHI
Population Approach Group in Japan   Jul 2006   
Naoto Hayashi, K. P. Zuideveld, P. Jordan, R. Gieschke
12th annual meeting of Population Approach Group in Europe   Jun 2003   

Works

 
Approval of new indicaiton of Erbitux® to treat head and neck cancer in Japan
The Others    - Dec 2012
Approval of the intravenous formulation of Revatio® by the European Commission
The Others    - Jan 2010
Approval of Xolair® for asthma in Japan
The Others    - Jan 2009
Approval of Lucentis® to treat age-related macular edema in Japan
The Others    - Jan 2009
Approval of Certican® in Organ Transplant Recipients in Japan
The Others    - Jan 2007
Approval of new formulation of Neutrogin® (lenograstim) in Japan
The Others    - Aug 1999
Tocilizumab (Actemra®) FIH study (MRA001JP)
The Others   Jul 1997
Approval of new indication, anemia caused by chronic kidney disease in patients before dialysis, of EPOGEN® (epoetin alfa) in Japan
The Others    - Mar 1994