Takeo Murakawa, Ph.D. - Drug Development & Regulatory Affairs Specialist

Qualifications

Over 35 years diverse experience at a pharmaceutical company in research and development area and at CRO.

 

Projects include:

1. Scale-up studies of new drug production
2. Screening, evaluation and basic and development studies on antibiotics
3. International new drug development and project management
4. Global development & project management of new drugs including preparation and maintenance of registration dossier such as IND, DMF and CTX
5. Supervise and advise global new drug development and regulatory affairs. Provided establishment of new drug evaluation methodology, and global clinical development and efficient project management & coordination expertise on new drugs with good knowledge of global regulatory affairs and health care in the world．
6. Teaching new drug development process, its concept and regulatory affairs at Graduate School of Pharmaceutical Sciences, Kyoto University, Graduate School of Pharmaceutical Sciences、Tokushima University and Graduate School of Medicine, Yokohama City University, as a lecturer. Recently many experiences with preparation/submission of Japanese master files and Accreditation of Foreign drug manufacturer as In-country caretaker or Japanese agent.

Work History

	2009 - Present	Senior Consultant	D.H. Gold Associates, Inc.
		Drug Development and Regulatory Affairs Specialist
	2002 - 2009	Consultant for International/Domestic Drug development & Regulatory affairs	Independent Consultant
		Consultation service for more than 10 pharmaceutical companies. Lecturer at Seminar for drug development & regulatory affairs (International & Domestic). In-country Caretaker for J-DMF & Japanese Agent for Accreditation of Foreign manufacturer．
	2001 - 2002	Senior Advisor, Consulting Division	PAREXEL International Inc. Japan
		Consultation on registration (regulatory affairs)/development strategies of new drugs in Japan and overseas with several companies. Supervising drug registration strategy in Japan including new drug development, switch OTC drug and for KIKO meeting.
	1966 - 2001	Fijisawa Pharmaceutical Co., Ltd
	1997 - 2001	Supervisor on Global Development and Regulatory Affairs.	Development Division
		Responsible for developing strategy planning and advising international development and regulatory affairs. Supervised preparation and maintenance of IND and DMF of more than 10 new projects. Made lecture at seminar on global drug development and regulatory/healthcare affairs   Two scientific books on Pharmacokinetics / Pharmacodynamics of antimicrobial Agents (in English) published as editor/author (See Publication list)
	1989 - 1997	Director, International Development and Coordination	Development Division
		Major Accomplishments:   Managed and coordinated development of new compound of FK 366 (aldose reductase inhibitor) for diabetic neuropathy in North America. Clinical evaluation criteria were established and its phase II b study was successfully completed to lead its development a positive results Managed and coordinated international development of cephalosporins (cefixime, and cefdinir) in US, European countries and several Asian countries under license base and supervised Fujisawa’s supportive studies and mutual document usage between licensees. NDAs (MMA) were submitted and approved in relevant countries. Managed and coordinated the development of Zotepine (psychiatric agents) in Europe, Taiwan and Korea under license base and supervised development registration and documentation of FK245 (nilvadipin, Ca antagonist) in Germany and Korea. Supervised to conduct various phase studies, registration and documentation  internationally for Rhizoxin/FK901228, FK780 (IGF-1), so on and regulatory affairs and documentation on INDs, DMF, and NDAs in North America, Europe and Asia. Supervised international clinical development of FK506 (Prograf), FK565 (immunomodulator) FK3311/FK201 (anti-inflammatory agent) FK453 (adenosine antagonist), FK664, FK176, FK973, FK786 and NCWS. As a member of Development Committee, advised planning of the global  development strategies for new compounds.
	1986 - 1989	Vice Director, International Product Development	International Development Division
		Managed and coordinated key developments including various phases of new compounds and drugs. New compounds and drugs are: FK366: phaseⅠ, phase Ⅱ FK037 (parenteral cephalosporin) FK482 (cefdinir, oral cephalosprin) FK027 (cefixime, oral cephalosporin) 10 licenses obtained
	1982 - 1986	Project Manager for Antibiotics, International Product Development	Product development, Overseas Group
		Responsible for international development of cephalosporins and for scientific promotion of cephalospoins.   Major Accomplishments include: Successfully obtained new drug approval of ceftizoxime in major 20 countries. This was the first case for a Japanese company to register the product at FDA by itself. Coordinated to initiate FK027 development in Japan, and US. Managed and coordinated to establish joint-manufacturing of cefazolin vials with   Chinese Pharmaceutical Division at Chong Quing, China.
	1980-1982	Project Manager, International Product Development(concurrent position)	New Product Development ,Overseas Group
		Responsible for advising, and coordination of overseas antibiotic projects (specially involved in fosmidomycin project)
	1968 - 1982	Head/Senior Scientist Central Research Laboratories	Chemotherapy Research Dept.
	1978 - 1982	Project Manager / Senior Scientist	Central Research Laboratories
	1976 - 1978	Central Research Laboratories	Central Research Laboratories
	1968 - 1976	Research Scientist	Central Research Laboratories
		Major Accomplishments Established screening system and in vitro and in vivo evaluation system for Cephlosporin antibiotics.  And through the screening system, ceftizoxime, cefixime, cefdinir, cefocelis were found, evaluated and on market. Established and implemented computer based data management system for antibiotic screening and evaluation programs.
	1966 - 1968	Research Scientist	Scale up study, Technical Laboratories
		Responsible for scale up study on cephalosporin C production.   Major Accomplishments Established Know-how for extraction and purification of cephalosporin C from fermentation broth.

 

Academic Experience:

• 2008～2010 Lecturer (Part time), Graduate School of Medicine, Yokohama City University, Yokohama Japan, Subject: Clinical Research

• 2006～2007 Lecturer (Part time), Pharmaceutical Sciences, College of Osaka Medical Technology, Osaka, Japan     Subject: New Drug Development & Process

• 1999～2005 Lecturer (Part time), Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan     Subject: New Drug Development & Process

• 2001, 2003, 2005, 2007, 2009
  Lecture (Part time), Graduate School of Pharmaceutical Sciences, Tokushima University, Tokushima Japan, Subject: Drug Information

Education

 

	1960 - 1964	BS－Applied Microbiology	University of Osaka Prefecture
	1964 - 1966	MS－Applied Microbiology	University of Osaka Prefecture, Graduate School
	1970 - 1971	Research Associate, Dept. of Clinical Microbiology	Toho University, School of Medicine
	1990	Ph.D. in Medical Science	Toho University, School of Medicine
	1975 - 1976	Research Associate, Section of Infectious Disease, Dept. of Internal Medicine	University of Minnesota School of Medicine, Minneapolis ,MN，USA

Academic Memberships:

• Regulatory Science Society of Japan for Pharmaceuticals & Medical Devices
• Japanese Society for Bacteriology
• Japanese Society of Chemotherapy
• Japanese Society for Bioscience, Biotechnology and Agro chemistry
• American Society for Microbiology
• New York Academy of Science

International Editorial Board of Scientific Journals:

2001～Present:	Asian J. of Drug Metabolism and Pharmacokinetics (Hong Kong)
1988 ～ 1995:	International Journal of Experimental and clinical Chemotherapy
1990 ～ 1998:	International Journal of Antimicrobial Agents

 

 

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