President, BCG-Japan. Chuo-ku, Tokyo

President, BioManufacturing Consultation, Inc.

• Consulting work for manufacturing and licensing of biologics and evaluation of early phase projects

Independent Consultant

• Freelance consulting work for several companies in biomanufacturing area

CMC Planning and Coordination Department, Chugai Pharmaceutical Co., Ltd..

• Responsible for manufacturing of new antibody therapeutics projects,
  
• Contact to CMOs
  
• Feasibility of non-mammalian cell manufacturing
  

Associate Director, Business Development and Licensing, Chugai Pharma USA LLC, (formerly Chugai Biopharmaceuticals, Inc.). San Diego, CA.

• Handling contract manufacturing organizations in North America for manufacturing antibody therapeutics from technical, management, business and legal viewpoints,
  
• U.S. contact for manufacturing,
  
• Liaison role for global project development
  

Group Leader, Business Development Department, Chugai Pharmaceutical Co., Ltd.

• Responsible for new technology acquisition
  
• Managing the initiation of discussions for feasibility studies on sustained release formulation for rEPO with several DDS venture companies in the U.S. and Europe,
  
• Responsible for the business negotiation and agreements with contract manufacturing companies in North America and Europe for manufacturing antibody therapeutics,
  
• Early scientific evaluation and the following business negotiation for in-licensing the antisense therapeutics from a U.S. company,
  
• Early scientific evaluation and the following business negotiation for in-licensing the bi-specific antibody from a U.S. company,
  
• Out-licensing of the in-house technologies, such as cloned genes.
  

Group Leader, Business Development Department, Chugai Pharmaceutical Co., Ltd.

• Managing the in-licensing activity,
  
• Contact, discussion and evaluation of the in-licensing project candidates from bioventure companies and gene therapy companies,
  
• Initiation of contract manufacturing discussion for antibody therapeutic products in mammalian cells.
  

staff of Ethical Product Planning Department, Chugai Pharmaceutical Co., Ltd.

• Development of recombinant human erythropoietin (EPO);
  
  • Daily communications with Genetics Institute during early research period,
    
  • Early analysis of carbohydrate composition of expressed EPO, particularly sialic acid quantitation,
    
  • Discussion and negotiation of "Cell Validation" with Microbiological Associates (at that time) for viruses and all translation work for NDA in Japan,
    
  • Scientific discussion with Dr. Hayakawa of the National Institute,
    
  • Project management,
    
  • Preparation of ELA/PLA to FDA (Responsible for writing all molecular biology and biochemistry sections),
    
  • Preparation of NDA to Japanese Ministry of Health and Welfare (Kosei-syo),
    
  • Efforts made to differentiate Chugai's EPO from Amgen's; Based on personal background in carbohydrate biochemistry, two publications made by Chugai and Amgen for carbohydrate structure analysis, by Prof. Fukuda of La Jolla Cancer Research Foundation and Prof. Kobata of the University of Tokyo, respectively, were compared and the difference was revealed. Using such differences, the hypothesis was constructed and submitted to FDA and Kosei-sho, resulting in "epoetin- " and "epoetin- "
    
  • Observation of the U. S. Court Trials with Amgen,
    
  • Education of Chugai marketing people for glycosylation difference between epoetin- (Kirin-Amgen) and epoetin- (Chugai).
    
• Advisory role to the NDA submission of recombinant G-CSF
  
• Search for licensing opportunities of anti-viral and anti-cancer agents
  
• Thorough investigation of antisense therapeutic approach
  
• Member of a team evaluating the therapeutic approach proposed by GenProbe/CBI
  
• Liaison role in the research collaboration with MGH for recombinant PTH project
  
• Liaison role in Cold Spring Harbor Laboratory sponsorship
  
• Liaison role in U.S. based Japanese academic researchers sponsored by Chugai
  
• Management, business discussion and negotiation of the research collaboration with ImClone for flk-2 ligand
  
• Management and business negotiation for licensing to the flk-2 ligand with Immunex.
  

Worked at Dr. Saul Roseman's laboratory; as a Ph.D. student. Search for the molecule responsible to cell-cell interactions: Characterization and microquantitation of sialic acid of Gangliosides

Worked as a technique student on the purification of developmental stage-specific newly synthesized mRNAs in Dictiostellium at Dr. Robert Duttin's laboratory of the Department of Biology, The Johns Hopkins University.

Scientific Presentations:

PUBLICATIONS

Review: Glycoproteins. Iyakuhin Kenkyu 20(6):1157-1164, 1989.

Page Updated: April 22, 2008