Yuzuru Kato

Experience

• 

  Kyowa Hakko Kogyo Co., Ltd.

  Apr 1983 - Jun 1986

  Researcher

  Cancer Chemotherapy, Pharmacology

• 

  Kyowa Hakko Kogyo Co., Ltd

  Jul 1986 - Mar 1996

  Researcher, Toxicological Research Laboratories,

  Toxicology and Pharmacology

• 

  Kyowa Hakko Kogyo Co., Ltd.

  Apr 1996 - Apr 1998

  Senior Researcher, Toxicological Research Laboratories

  Toxicology and Pharmacology

• 

  Kyowa Hakko Kogyo Co., Ltd

  May 1998 - Sept 2005

  Supervised and managed toxicological research of antibodies and low molecular weight compounds in all stages of development. ・Prepared documents of drug for urinary incontinence, and submitted an IND to FDA in 2001, and a CTX to MCA in 2002.・Prepared documents of monoclonal anti-melanoma antibody, and submitted an IND to FDA in 2002.・Managed all non-clinical studies of anti-CCR4 antibody conducted at in-house laboratories and Contract Research Organizations (CROs).

  • Director, Toxicological Research Laboratories,

    Apr 2004 - Sept 2005

  • Manager, Nonclinical Development Department,

    May 1998 - Mar 2004
• 

  Kyowa Hakko Kirin Co., Ltd.

  Oct 2005 - Mar 2007

  Director, Nonclinical Development Department,

  ・Supervised and managed non-clinical development of antibodies and low molecular weight compounds.

• 

  Kyowa Hakko Kogyo Co., Ltd

  Apr 2007 - Sept 2008

  Manager, Safety Assessment Department

  ・Managed the collection, evaluation and reporting of drug safety information

• 

  Kyowa Hakko Kirin Co., Ltd.

  Oct 2008 - Mar 2018

  ・Reviewing the following documents and reports related to Pharmacovigilance, and proposing the necessary amendments All documents and reports which will be submitted to PMDA, FDA and EMEA including IND, DSUR, CTD, BLA, NDA, Package Inserts, Medication Guides, PSUR, Periodic Safety Reports, Non-Serious Unlisted Periodic Reports, Adverse Reaction & Infection Case Reports, RMP, etc.・Proofreading the English documents and reports such as Package Inserts, Medication Guides, documents concerning IND, BLA & NDA submissions ・Reviewing the documents regarding R&D meeting, and giving advice and making suggestions to boss Show less

  • Senior Manager (Assistant to Director)

    Apr 2015 - Mar 2018

  • Manager,Drug Safety Management Department, Pharmacovigilance and Quality Assurance Division

    Oct 2008 - Mar 2015
• 

  Aspen Japan K.K.

  Apr 2018 - Aug 2019

  Senior Consultant, Medical Affairs Department
• 

  Randstad K. K.

  Oct 2019 - now

  WHO drug code Reviewer and Approver

  Review and approval of the WHODrug codes for drugs used in clinical trials

• 

  PointPath.Biz K. K.

  Oct 2022 - now

  Partner

  Pharmaceutical Development & Consulting