Consultant Profiles

Assoc. Consultants

GMP/QMS

Akio Nakao, Ph.D.

Akio Nakao, Ph.D. Nakao started his career in 1976 at Tanabe Seiyaku Co., Ltd. After carrying out research in synthetic organic chemistry and process chemistry (industrialization) at the company, he successively took the positions of quality assurance manager, director and general manager of production, and managing director in charge of management planning. After Tanabe merged with Mitsubishi to become Mitsubishi Tanabe Pharma Corporation, Nakao became Managing Executive Officer and Chief Director of Medicine Manufacturing. Through his experience in dealing with FDA inspections and activities at the Parenteral Drug Association (PDA), Nakao became convinced that GMP is an "exact science."
Finding that his beliefs were reflected in CM Plus Corporation's enthusiasm for improving GMP education, Nakao joined CM Plus in 2011 as a Director and be promoted as executive vice-president in 2012.
From April 2018, he was appointed to Fellow of CM Plus Corporation.

Syunichi Hirashima

Syunichi Hirashima Hirashima joined Fujisawa Pharmaceutical Co., Ltd. (now Astellas Pharna Inc.) in1980. He was engaged in the production of pharmaceutical products and quality assurance for 37 years. Meanwhile, he was appointed to the president in Astellas pharma Tech Co., Ltd. and successfully managed all the domestic group plants. Then, he was appointed to the head of the quality department being globally responsible including Japan, US and Europe of Astellas Pharma Inc. He has got thorough knowledge of site problems as well as management regarding pharmaceutical manufacture.
He joined CM Plus in January 2017 as a member of the Board. He was appointed to Senior Vice President in April 2018, then promoted to Executive Vice President in July 2020.

Yoshihiro Shimada, Ph.D.

Yoshihiro Shimada, Ph.D. Shimada joined Kirin Brewery Company (current Kyowa Kirin Co., Ltd.) in 1985 and had worked at Pharmaceutical Division for 33 years. He had experienced bio-pharmaceutical research, development and regulatory affairs(mainly physicality, specification and stability) as well as quality control and quality assurance of pharmaceutical products. He had served as QC manager at Takasaki Factory, QA Group Manager at the head office, and QA/QC manager at Fuji Factory. Meanwhile, he also served as an adjunct professor at Waseda University.
He joined CM Plus in January 2018.

Shigehiro Tahara

Shigehiro Tahara CM Plus Singapore Pte. Ltd. Director
CM Plus Vietnam Co., Ltd. Chairman
Tahara joined a major engineering company in 1982. After working on process design and test-runs of overseas oil refineries and LNG plants, he focused on production facility management, including management of pharmaceutical production facilities. He has consulted for drug manufacturing facilities and performed numerous GMP assessments. He joined CM Plus Corporation in March, and became Director in July 2008. He moved to become Managing Director & COO of CM Plus Singapore Pte.Ltd in February 2014. And he has been also holding the post of General Director & COO of CM Plus Vietnam Co., Ltd. since July 2015. From April 2018, he was appointed to Director of CM Plus Singapore Pte. Ltd. and Chairman of CM Plus Vietnam Co., Ltd.

Makiko Kawamata

Makiko Kawamata GMP consultant, CM Plus Corporation
Kawamata had been engaged in the study of stem cells in the hair and also involved in the study of the mechanisms of metastasis using prostate cancer cells and breast cancer cells at the School of Medicine in Akita University since 2001.
She joined UMN Pharma Inc. in 2011. After working for vaccine development at the Research Center, she had been involved in the validation document review and SOP creation as a member of QC at the start-up of the Akita cite under UNIGEN, the subsidiary of UMN. She experienced in validation document creation and record review at the pharmaceutical plant site office for the two big projects.

Hiroshi Sakamoto

Hiroshi Sakamoto Since 1982, I have been engaged in the job related in the development and CMC regulatory (Specification & Ttest methods, stability study) for pharmaceuticals (solid preparations and injections). After moving to the factory, I was engaged in the job related in GMP and GQP(Quality assurance). Since 2006, I experienced the job related in GQP(Quality assurance), CMC regulatory (including GMP compliance inspection, foreign manufacturer accreditation, MF registration) for generic drugs (solid preparations and injections) to import to Japan in several pharmaceutical companies.
Joined CM Plus Co., Ltd. in January 2020.

Kozue Sato

Kozue Sato Sato was engaged in R&D and quality control for veterinary medicinal products for 4.5 years from 1985. She was also engaged in quality control, R&D and works for ensuring GMP compliance for 12 years from 1988. For 8 years from 2002, she was engaged in analysis and evaluation works for transdermal products and works for ensuring GMP compliance for investigational drugs. In 2013. she was appointed to Quality Assurance Officer while she became in charge of quality assurance at a marketing authorization holder of biological-origin API, preparations, and sterile API. In 2016, she left the company and joined CM Plus Corporation.

Osamu Takahashi, Ph.D.

Osamu Takahashi, Ph.D. Senior Consultant, GMP Platform, CM Plus Corporation
Takahashi joined Nippon Mining Co., Ltd. (current ENEOS Corporation) in 1987. and worked on start-up of GMP organization for clinical trial materials, process development for chemical APIs, etc. After 2002, he experienced quality assurance duties including quality audits at Sumitomo Pharmaceuticals Co., Ltd. (current Dainippon Sumitomo Pharma Co., Ltd.), Mochida Pharmaceutical Co., Ltd., and Novartis Pharma K.K. (Novartis Pharmaceuticals Japan). He joined CM Plus in September 2013, and was certified as "APIC Certified Auditor" in April 2014 by Active Pharmaceutical Ingredients Committee, a sector group of European Chemical Industry Council (CEFIC).

Yasuo Ueda, Ph.D.Associate Consultant

Yasuo Ueda, Ph.D. Ueda entered Green Cross Corporation and was assigned to Central Research Institute in 1974. Then he was designated as manager of pharmaceutical research department and general manager of central research institute successively. After merger with former Yoshitomi Pharmaceutical, he was designated as the manager of conformity audit office and take charge of total GXP inspection. He had experienced working in regulatory auditing department, quality assurance unit and regulatory affairs department since the foundation of joint venture -Mitsubishi Pharma Corporation and Mitsubishi Tanabe Pharma Corporation. In 2008, he entered Nipro Pharma Corporation and consecutively held the post of manager of quality assurance unit in head office and Shirokita Factory.

Seichiro KoshikawaAssociate Consultant

Seichiro Koshikawa Koshikawa started his career at Tanabe Pharma Co., Ltd. (currently Mitsubishi Tanabe Pharma Corporation). He started with manufacturing, production management, and quality assurance works at a chemical synthetic drug substance manufacturing plant. Then, he transferred to Tanabe’s subsidiary, Sun Chemical Co., Ltd. in 2005. He had hold various posts at this company, such as Plant Manager, General Manager, and Quality Assurance Manager.
Pursuing the appropriate on-site GMP based on the multifaceted thinking from both manufacturing and QA perspectives, he spent tremendous effort to embody the importance of GMP awareness that is essential for operation. Koshikawa retired from Sun Chemical in April 2019, and since May, became an associated consultant of CM Plus.

Shinichi KodatoAssociate Consultant

Shinichi Kodato GMDP Consultant (Pharmaceutical Quality Science Advisor)
Kodato had been engaged in discovery research with synthetics, process development research, CMC project development, investigational drug quality assurance and corporate QA at Tanabe Seiyaku Co., Ltd. (now Mitsubishi Tanabe Pharma) from 1979. He had served the management and supervision of QA/QC from 2008 at Bushu Pharmaceuticals Ltd. and reform of the quality system and the quality assurance works for investigational drugs and pharmaceuticals at Chugai Pharmaceutical Co. Ltd. from 2009. After career change to Astellas Amgen BioPharma in 2013, he had constructed the systems for CMC, supply chain and quality assurance as a manager. Since 2015, he has been working as a business development advisor for healthcare products at MITSUI-SOKO HOLDINGS Co., Ltd. and retired in March 2020. Also since 2015, he has been supporting drug development as an adviser at Department of Clinical Research Support, Translational Medical Center, National Center of Neurology and Psychiatry.
Since April 2020, he has been responding to requests for Good Practices support as a free GMDP consultant, utilizing his abundant experiences with the quality of the pharmaceuticals through all of the stages from research and development to storage and distribution.

Kazuhito TakahashiAssociate Consultant

Kazuhito Takahashi President and CEO, Pharma Planning Co.,Ltd.
Takahashi joined Kobayashi Pharmaceutical Company(now I'rom pharmaceutical company) in 1983. Having worked on pharmaceutical engineering, GMP management and validation, he became a quality assurance manager, then a quality department manager and finally an quality assurance division officer . He established Pharma Planning after retirement in 2010. He has been engaged in various GMP consultation and education service since he became an associate consultant of CM plus in 2011.

Masayuki Takahira, Ph.D.Associate Consultant

Masayuki Takahira, Ph.D. Representative of Aid Pharma
Adviser of NPO-QA Center
Mr. Takahira entered Shionogi & Co., Ltd in 1979 and accumulated plentiful experience of pharmaceutical production and quality assurance. He had contributed to the GQP/GMP/QMS/CMC compliance and GQP/GMP/QMS compliance audit of the 170 pharmaceutical plants in Japan and overseas relevant to Shionogi’s products for nearly 10 years. He has also participated in partial and minor production/test method change applications, product management and documentation customization for quality assurance complying with domestic and overseas GMP. He had been appointed to an executive as a product strategist at Ace Japan Co., Ltd since December 2011. He was engaged in the quality assurance, production/test, marketing relating affairs of API and intermediates from management perspective. He took up his current position in Jun 2016.

Susumu HondaAssociate Consultant

Susumu Honda Honda joined Shionogi & Co., Ltd. at 1972, and served as engineering manager and process technology research director. He had been on temporary assignment to Bushu Pharmaceutical Co., Ltd. from 2003, at that he was board member and technical director and also responsible for validation and environment management. He moved to Nipro Pharma Co., Ltd. after retirement from Shionogi & Co., Ltd in 2007, at which he was responsible for GMP inspection and GQP at the quality assurance department. He retired the company in 2015. He has the extensive knowledge and experience with the equipment, operation and formulation about both API and finished pharmaceuticals.
He has experienced GMP inspection for domestic and foreign API manufacturing plant and familiar with inspection technics and knowledge. He is active in the industry organization and administration member and COP leader at ISPE and planned and handled the GMP seminar in Society of Chemical Engineers, Japan Kansai Branch.

Takayoshi MatsumuraAssociate Consultant

Takayoshi Matsumura Former quality assurance manager of Eisai Co., Ltd
He joined Eisai in 1979. After having been engaged in international GMP related jobs such as global document control, management for inspection by the competent authorities of the US and Europe etc., he started GMP consultation in 2011. He is a topic leader of quality risk management of ICH-Q9 in Japan and got an award from FDA with the evaluation of long term performance in ICH in 2011.

Akira MiyakiAssociate Consultant

Akira Miyaki Takasaki University of Health and Welfare TR Center, Former Director (Representative Director)
Former PMDA GMP Expert
Currently he serves as the consultant and adviser for pharmaceutical companies, through the career of Astellas Pharma Inc.、 Novartis Pharmaceuticals, Kirin Brewery Pharmaceutical Division , Pharmaceuticals and Medical Devices Agency (PMDA) and Jobu University Nursing Department full-time lecturer. He has been Japan Society of Pharmaceutical Machinery and Engineer supervisor since October 2011. He has a great deal of experience with investigation and inspections of pharmaceutical GMP of domestic and overseas manufacturing plants from the view of both pharmaceutical manufacturer and authorities ,with many literary work and lectures related GMP.

Michiko MiyashitaAssociate Consultant

Michiko Miyashita Former GMP promotion department manager of Astellas Pharma Tech Co., Ltd. Fuji Factory
Miyashita joined Fujisawa Pharmaceutical Co., Ltd. (now Astellas Pharma Inc.) in 1975. She had been engaged in quality department business of manufacturing plants consistently. She had been engaged in quality management service related independence from the former Fujisawa Pharmaceutical Co., Ltd., company name change, merger of the manufacturing plants due to the merger with the parent company (former Yamanouchi Pharmaceutical Co.), and response to The revised Pharmaceutical Affairs Act which came into force in the meantime, at the same plant.She is convinced that she has contributed to improve the quality based on the concept of GMP, regardless of the inside and outside of the company, in mind to send out to the world constantly a good product with stable quality.
She retired Astellas Pharma Tech Co., Ltd in March 2013 and joined CM Plus as Associate consultant in June 2013.

Tadashi YoshiharaAssociate Consultant

Tadashi Yoshihara Yoshihara joined Itoham Food Inc. in 1976. After working at Central Research Institute developing functional materials for food, cosmetic and biomedical applications, he assigned in 1991 to work at Itoham’s subsidiary located in California. The company manufactured chemically synthesized peptides under GMP, and sold peptides in Japan market through Itoham’ pharmaceutical section.
In 2002, he returned to Japan. In 2004, he resigned Itoham and decided to move to USA with his family permanently. In 2010, he obtained CQA from ASQ and became a registered auditor of SQA Services, Inc. in California. He was assigned to audit many raw material suppliers in Japan on behalf of US clients. He joined Hayashibara which is famous of Trehalose from 2014 through 2019 as Technical Advisor for Quality. In 2019, he established Yoshihara Quality Consulting Japan, LLC.

Interpreter

Lily Yu

Lily Yu Representative of CM Plus Corporation China Liaison Office, GMP Platform Consultant
After Lily graduated from Shenyang Pharmaceutical University in 2005, she entered in a big Japanese engineering company. As a validation engineer of GMP Department, Lily took part in Japanese Pharmaceutical companies' new factories construction project and worked on validation and DQ/IQ/OQ documentation. In 2010, Lily joined in Shanghai Tofflon Science and Technology Co., Ltd. and worked as International Affairs Director to coordinate the cooperation with Japanese companies.
Lily has taken part in PMDA'S GMP inspection to Chinese API plant as an interpreter for several times. Lily can speak Chinese, Japanese and English, and now she is responsible for translation and interpretation relating to engineering and validation as well as interpretation of domestic and oversea GMP inspections.

Akiko YamaguchiAssociate Consultant

Akiko Yamaguchi President, T.T.T. Studio Ltd. Tokyo
After working as an interpreter/translator for a foreign pharmaceutical company,
and subsequently as a freelance, Yamaguchi founded T.T.T. Studio Ltd Tokyo in 1998.
Yamaguchi has an extensive experience of over 30 years in pharmaceutical interpreting
and translation including attendance to FDA inspections, mock inspections, and other authorities inspections.
Have translated entire CGMPs, validation documents, clinical trial reports, CMCs, DMF related documents, etc.

CSV・Data Integrity

Kiyoshi MochizukiAssociate Consultant

Kiyoshi Mochizuki CEO, Xpro Associates, LLC
Mochizuki joined Yamatake-Honeywell Co., Ltd (now Azbil Corporation) in1973, and developed a part of US Honeywell's DCS (Distributed Control System). He has provided consultation on Part 11 and Computerized System Validation to major pharmaceutical companies in Japan. He has also contributed to the education and promotion of Rapid Microbiological Methods (RMM). He launched the consultation office in May 2015.

Processing/Packaging

Nobuaki Ishii, Ph.D.Associate Consultant

Nobuaki Ishii, Ph.D. Professor, Kanagawa University Faculty of Engineering
Ishii was born in Yokohama City, Kanagawa Prefecture in 1959.He joined JGC Corporation in 1984, after finished Graduate School (Industrial Engineering and Management) of Tokyo Institute of Technology. He had been in charge of the energy section, commercialization plan of pharmaceutical sector, facility planning, planning, designing and introduction of information system for production and product management. He also worked at U.S. Purdue University IE Faculty as Visiting Fellow, and Bunkyo University as Professor. From 2016 He has been worked in Kanagawa University Faculty of Engineering. He is also the commissioner of The Society of Project Management and the commissioner of Information Systems Society of Japan.

Fumio TakiAssociate Consultant

Fumio Taki Taki joined Rhoto Pharmaceutical Co., Ltd. in 1980. After working at engineering department and information system department, he engaged in new factory construction project. He built a pharmaceutical GMP compliant manufacturing execution system (MES) that linked with automatic transfer equipment, performed these CSV’s, and submitted a declaration of use of ER/ES to US FDA in 2002 (according to 21 CFR Part11 / first in Japanese pharmaceutical companies). Since 2004, he has served as manager of production engineering department, factory manager of Ueno plant and director of contract manufacturing subsidiary of pharmaceuticals (CMO). From 2016 to 2019, as the factory manager, he experienced on-site inspection of aseptic preparations such as US FDA, Taiwan FDA, Korea MFDS. He became an associated consultant of CM Plus in 2020.

Masahiko NozakiAssociate Consultant

Masahiko Nozaki Nozaki joined NEC Corporation after getting a master degree of applied physics at Nagoya University. He amassed much experience in operation management in the field of semiconductor for roughly 30years and moved to Taisho Pharmaceutical Co., Ltd. as an officer in charge of manufacturing management. He has been engaged in consultation of manufacturing management as an adviser based on his both experience in the field of semiconductors and pharmaceuticals.

Kenichi MurataAssociate Consultant

Kenichi Murata K. M. Consulting, Inc. Representative Director
Murata joined Fujisawa Pharmaceutical Co., Ltd. (now Astellas Pharma Inc.) in 1978.He had been engaged in the works of injection products manufacturing, aseptic validation technology development, dealing with FDA inspection, development of mission-critical system (SAP), successively in production division, medium-term strategy planning, and spin-off promotion of the factory and merger preparation committee. At post-merger Astellas, after served at the Strategic Planning section, he was responsible for the promotion of the outsourcing business of production.
He left the company in 2012, and established K. M. Consulting, Inc., specialized in the management and improvement of the supply chain including SAP development, mainly counting management such as the cost of the plant.

Anri Morikawa, Ph.D.Associate Consultant

Anri Morikawa, Ph.D. Representative of Anri Consulting
He joined Asahi Kasei in 1977. He had been consistently engaged in research of synthesis of screening compounds and process chemistry, and awarded a PhD during this period.
In addition, he also dealt with the production of investigational drugs such as anticancer drugs and the inspection by the competent authorities of the U.S., Italy, Australia and Korea during he was a plant manager of bulk drug for 10 years.

Toru YamaguchiAssociate Consultant

Toru Yamaguchi Four Seasons Science Laboratories (Consultant for sterilization, microbiological control, and radiation modification).
Yamaguchi was born in 1955. He was engaged in development of pharmaceuticals, medical devices, quasi-drugs, and cosmetics (microbe-related works, development of analytical methods, EOG sterilization validation), quality assurance, and regulatory affairs at Johnson & Johnson K.K. In 2001, he joined Japan Electron Beam Irradiation Services Co., Ltd. and became in charge of modification by electron beams, R&D of sterilization technologies, and establishment of sterilization conditions for introduction of electron beam sterilization to pharmaceuticals and medical devices, and microbiological tests and physicochemical tests outsourced by its clients. In 2015, he left the company and started his career as a consultant (sterilization, microbiological control, radiation modification).
He was a member of ISO/TC 198/WG 8 National Committee and ISO/TC 85/WG 3 National Committee. He also was a member of committees to convert ISO into JIS for ISO/TC 198/WG 8 and ISO/TC 85/WG 3. He is currently a member of the Society for Antibacterial and Antifungal Agents, Japan and the Society of Polymer Science, Japan.

Katuhiro WagaAssociate Consultant

Katuhiro Waga President , Harmony Management Consultant
Waga joined Kawasaki Heavy industries Ltd.in 1974. He switches company to Santen Pharmaceutical Co.Ltd through P&G Japan. He worked as GMP project reader to develop facility and documentation. He successively took the position of director and general manager of production, director and managing officer of production and distribution, and director for society and environment.
In such service he had been engaged in the new plant construction, strategic planning of global production system, promotion of CSR and environmental management system.
He has been at present post from July 2009.

Equipment

Norio SatoAssociate Consultant

Norio Sato President and CEO, FS Studio Co., Ltd
Sato joined Nippon volatile oil Corporation(now JGC Corporation) in 1975. Having amassed a broad range of experience in design and construction of HVAC system, plumbing and sanitary system, and process support system for nuclear power plant facilities, hospitals, laboratories, food factories and pharmaceutical factories etc. He established FS Studio just after retirement in 2011. His expertise is energy saving for production facilities and participated in establishment of ESCO business as well with the much experience in the field of industry such as semiconductor, ceramics, precision machine and metal processing.

Atsushi NunomeAssociate Consultant

Atsushi Nunome Nunome Professional Engineer Office
Professional Engineer in Japan( Sanitary engineering : water quality control)
Nunome joined Kurita Water industries in 1972. He moved to Nomura Micro Science Co., Ltd in 1992 and has been engaged in consultation work as a specialist in pharmaceutical water.

Takashi HoshinoAssociate Consultant

Takashi Hoshino After he graduated from Osaka University, Faculty of Engineering, Department of Mechanical Engineering in March 1971, he entered Takeda Pharmaceutical Company Limited in April. Until he retired in March 2014, he had engaged in plant construction project of the company and the associated companies, including production facility of pharmaceutical product, vitamin bulk, seasoning bulk, chemical product, agrochemicals and research center. Furthermore, some of those projects are overseas, and some are collaborative projects with other company. Additionally, he had ever worked as manager of maintenance department and utility department, so he is a professional engineer with comprehensive knowledge and experience.
He has successively served as director and executive director of ISPE (International Society for Pharmaceutical Engineering) Japan Affiliate. And he is also the director of Project Management Association of Japan.
At present, he founded Star Enterprise and worked as independent consultant (project management, engineering and invent planning).

Development/Application

Masataka Togashi (Ph.D. in pharmacy)

Masataka Togashi (Ph.D. in pharmacy) Consultant, Translation and Technology Team, and GMP Platform, CM Plus Corporation.
Togashi received his master's degree in life science and technology in 2007 then received his Ph.D. in pharmacy in 2010. In that year he joined Otsuka Pharmaceutical Co., Ltd. At the company, he was engaged in development of in vitro diagnostics for tuberculosis in Diagnostic Division, Research Department. He joined CM Plus Corporation in 2012.
He is in charge of collecting domestic/overseas information on GMP and biochemistry, translation of documents on topics primarily of fields of his expertise, in-house training, etc.

Hikohito Fujinawa

Hikohito Fujinawa Pharmacist
Since 1988, has been involved in drug production management, process development and industrialization research at a chemical synthetic drug substance manufacturing plant, and has been involved in Business development, Clinical development of new drugs and generic drugs, Statistical analysis, and application for approval at pharmaceutical companies.
He established Japan's first SMO in 1997, and has experience listing on the First Section of the Tokyo Stock Exchange as a board member (Managing director) and also being a clinical trial coordinator for about 100 clinical trials (including Multi-Regional Clinical Trials) conducted in Japan.
In 2004, he established a CRO and has consulting experience with overseas pharmaceutical companies (including ventures) to enter the Japanese market.
From 2006, he has been involved in reliability assurance (GQP, GVP) division for about 15 years as a board member (Director and General Marketing Supervisor) of domestic and foreign pharmaceutical companies. In the meantime, he has experience in formulation development (Sterile formulation : soft-bag formulation), clinical development (GCP), Designated Marketing Authorization Holder (DMAH) Service, M&A, and establishing a Japanese subsidiary of a foreign pharmaceutical company.

Hisao Yamamoto, Ph.D.

Hisao Yamamoto, Ph.D. Senior Consultant, GMP Platform, CM Plus Corporation
Yamamoto joined Sapporo Breweries Limited at 1974. After engaging quality control on beer manufacturing, he had been involved in the development of the in-vitro diagnostics and anticancer agent for diversification of business. He removed to Seikagaku Corporation with the pharmaceutical development business withdrawal in Sapporo Breweries. He had been concerning the drug development, research management, application of drug and medical device and quality assurance successively, and retired in March 2010. He joined CM Plus Corporation at March 2012 through a medical device maker Dentsuply Sankin. He has been engaged in GMP consulting including gathering and analysis of information, translation and appreciation support. In his career on research and development, quality management and application to domestic and foreign authority, he convinces that GMP should be regarded as no other than scientific matter, and should not be the oppression of advance in pharmaceuticals.

Toru HibiAssociate Consultant

Toru Hibi Hibi graduated from Graduate School of Pharmaceutical Science of Kyoto University in 1974. The same year, he entered a big chemical cement company in Yamaguchi Prefecture and was engaged in the research of synthetizing new agrochemicals in the research center. In 1981, he joined a multi-national chemical/pharmaceutical company and went into pharmaceutical development in pharmaceutical product research center. And then he studied abroad under Professor Takeru Higuchi in the University of Kansas from 1984 to 1985. And he came back to the multi-national chemical/pharmaceutical company after he received training in the pharmaceutical development department of a group company in America. After that he accumulated experience in the research center of a national medium-sized company and pharmaceutical business department of a big scale company with major business in other industry. He had also work as production manager in the pharmaceutical plant of the big scale company for 4 years. In 2004, he returned to the medium-sized company he had ever work for and worked on pharmaceutical development in the American subsidiary company. In 2011, he retired and then works as independent consultant.

Kaneo MiyamotoAssociate Consultant

Kaneo Miyamoto Miyamoto joined Fujisawa Pharmaceutical Co., Ltd. (now Astellas Pharna Inc.) in 1973. He was assigned to Headquarters’ Quality Control Department, Physical Properties Research Lab, and engaged in stability test as well as specification and analysis method establishment related to pharmacochemical analysis work for API and drug formulation. During this period, he also experienced preparing drug registration documents for new and already-launched pharmaceutical products, as well as responding to inquiries. After that, he transferred to Quality Assurance Division, where he was mainly in charge of quality assurance for imported/purchased goods and manufacturing regulatory. During this time, he held the post of Manufacturing Manager for pharmaceutical manufacturing sites, and experienced technology transfer for eye drops. Following the M&A of Fujisawa, Miyamoto retired from his post and transferred to a CRO. He carried out raw data investigation (pharmacology, pharmacokinetics) based on reliability standard and GCP audit. He then challenged with new fields of work like undertaking Masterfile (MF) registration and Foreign Manufacturer Accredition Application. After that, he transferred to Towa Pharmaceutical and engaged in raw data investigation, GCP audit and investigational drug GMP audit based on reliability standard. In 2016, he retired from Towa and started working as an independent consultant, serving as an advisor for an investigational drug CMO. From July 2017, he became a partner consultant of CM Plus Corporation.

Eisaku YamauchiAssociate Consultant

Eisaku Yamauchi MedChum K.K. President
Yamauchi joined Nippon Organon K.K in 1986 and had been engaged in clinical development of psychotropic drug and anesthetics. From 1992, he had been engaged in management of biostatistics, DM, and CSV as well as and development and application of orphan drug at Allergan, Inc. He had been served as development department director of the ophthalmic drug in university venture since 2007. He currently works as independent development consultant for drug and medical device.

International Business

Kazuyuki Kashiba

Kazuyuki Kashiba The director of a business planning (overseas), GMP Platform, CM Plus Corporation
Kashiba joined at Tanabe Seiyaku Co., Ltd. in 1981. He took the director of the international business and promotion management departments at Mitsubishi Tanabe Pharma Corporation in 2007. He took up the position of the president at Mitsubishi Tanabe Pharma Korea Co., Ltd. in 2011 and then P.T. Tanabe Indonesia in 2013. He had been engaged in international projects for 35 years including residing in overseas for total 14 years. He had been the person in charge of local corporation in Western countries and as the executive officer of Brazil, Korea and Indonesia. He joined CM Plus in 2016. Through his experience, which had been planned and carried out overseas business development by own company and business partners, in dealing with serving to mediate between Japan and ASEAN such as supporting products sales opportunities for Japanese firms in ASEAN.

Michimasa KoideAssociate Consultant

Michimasa Koide Tokyo University School of Science Pharmaceutical Sciences Graduated
Ph.D. (The University of Georgia College of Pharmacy)
Pharmaceutist
V Farm Consulting Co., Ltd. Representative Director
After graduated the university, he had been engaged at Lion Corporation, in the formulation development studies mainly on pharmaceuticals about 25 years. Meanwhile he obtained his doctorates in oversea study in U.S.A.. He had been served as the quality assurance director and the academic director in the company. After retired the company, he founded the consulting company and has been creating the documents for application and giving advice until now , with pharmaceuticals in ASEAN especialy Vietnam ,in collaboration with consultant companies and universities at home and abroad.

Takeshi ShigiharaAssociate Consultant

Takeshi Shigihara Shigihara joined Daiichi Pharmaceutical Co., Ltd. (currently Daiichi Sankyo Company, Limited) in 1978. For the following 30 years or so, he was in charge of overseas business including sales of the company's one of subsidiaries which marketed fine chemical products as an expatriate in the U.S. and China.
In 2007, the company started its operation as Daiichi Sankyo Co., Ltd. following consolidation. Shigihara became in charge of revenue of products out-licensed to Europe and the U.S. as well as operation in Asian and Middle-and-South American countries. Then he was appointed to General Manager and President of Daiichi Sankyo (China) Holdings Co., Ltd. He has wide-ranging experience in international pharmaceutical business.
Between 2012 and 2018, as International Director of Japan Pharmaceutical Manufacturers Association, he was mainly in charge of Europe and the U.S., and addressing international and industrial issues on global health.

Dr. Azedine BarikAssociate Consultant

Dr. Azedine Barik Dr. Azedine Barik has a combined Biology/Chemistry B.Sc. from Surrey University (U.K.) and a PhD in Immunology from London University (U.K.). He worked for over 10 years in an American biopharmaceutical company; Therapeutic Antibodies, Inc, where he managed the preclinical, clinical and pharmaceutical development (CMC) of a number of drug candidates. After arriving in Japan in 1994, Dr. Barik worked as a biomedical writing consultant for a number of Japanese pharmaceutical companies before founding PMP Consulting Co., Ltd in 1995. As CEO of PMP Consulting, Dr. Barik has over the past 20 years helped a number of clients develop effective preclinical / clinical research, CMC strategies and manufacturing / quality control operations. He is currently involved in a number of strategic projects and provides various seminars on technical and regulatory issues related to pharmaceutical development (CMC), excipients GMP, and drug packaging qualification and quality control. Dr. Barik is regularly invited to oversee on-the-job training at a number of pharma companies and coordinate internal / supplier audits.

Biopharmaceuticals

Haruhiko Tsumura, Ph.D.Associate Consultant

Haruhiko Tsumura, Ph.D. Haruhiko Tsumura was entered the Kirin ltd 1986, since he engaged in process of Bio drug substance, Biopharmaceutical development, manufacturing sales approval application compliant.
And also in cooperation with Amgen and other overseas biopharmaceutical manufacturers. After merging with Kyowa Hakko, he experienced the Production Planning Department, the CMC Development Department, the Bio Production Technology Institute, the Director of Production Development Center of Kyowa Kirin Fuji Film Biologics, and the Director of Production Planning Division.
After retiring in 2015, he is active as a consultant in the biotechnology CMC field and as owner and manager of a sake bar.

Atsushi YasumotoAssociate Consultant

Atsushi Yasumoto Nexredge Inc. President
After working on biopharmaceutical research and the production of investigational new drug (industrialization), Yasumoto had been responsible for the production technology and the facility management in Kaketsuken , in which he had been engaged factory construction and designing of new production system for sterile injectables and experienced considerably with start-up , operation and inspection handling. He joined CM Plus Corporation in 2013 and had been involved in drug development consulting, regulatory consulting and facility building project. He established Nexredge Inc. in 2015 that is focused on the development support for biopharmaceuticals and regenerative medicine related industry.
He is a member of Japan PDA sterile formulation GMP Committee and ISO TC276 Biotechnology National Committee.

Medical Devices/IVD

Mitsuhiko Sano

Mitsuhiko Sano Senior Consultant, GMP Platform, CM Plus Corporation
Pharmacist, Medical Technologist
After joining Terumo Corporation in 1978, Sano experienced the process control and quality assurance of injectable drugs and Blood Bags. After that, he had been in charge of FDA application as a member of pharmaceutical affairs section, successively in charge of ISO9001 Certification for CE mark and foundation of the India subsidiary as PJ leader. He had been also responsible to launch the prefilled syringe manufacturing process and the activities associated with Revised Pharmaceutical Affairs Law (2005) as the manufacturing manager. Since 2011, he had been the leader of validation activity in subsidiaries at Vietnam, Philippine and Yamaguchi, and to establish GMP/QMS. He joined CM Plus Corporation in August 2015.

Tatsuo Furuya

Tatsuo Furuya GMP consultant, CM Plus Corporation
Engaged in sterilization process development & validation for medical devices, and microbiological laboratory works at Johnson and Johnson, Create Medic and Boston Scientific, followed by Quality Assurance works. Joined CM Plus Corporation in 2013 as a GMP consultant.
During the career in medical device companies, Furuya has participated in the Science Research group for MHLW, and also some industry group for sterilization science as an EO sterilization specialist.

Norimichi IharaAssociate Consultant

Norimichi Ihara QM Service.IHARA(Individual consultant)
Started from Baxter Co., Ltd. as a manufacturing engineer in yr1983 and became a manufacturing technical development manager for renal solution at Gifu and Miyazaki plant. Major responsible jobs were GMP activities, new process validation, sterilization cycle development and drug delivery system development. After yr2002, he worked for Abbot Japan, Abbott Vascular Japan and Boston Scientific Japan as Medical device GQP officer and conducted GQP/QMS process establishment/improvement, government communication related QMS audit/Product recall and so on. In June 2015, he joined to CM-Plus as associate consultant at the same time of individual consultant office open.

Masaaki SasajimaAssociate Consultant

Masaaki Sasajima Sasajima Global Consulting CEO
Sasajima has extensive experience in the field of life science for 30 years. He started his career in research and development of prescription drugs. He has been active in global diagnostic companies, chemical companies, global medical device companies, and recently in domestic medium companies. He has been engaged in business development, research and development, business restructuring in addition to pharmaceutical application and global clinical trial. He has assumed current position since June 2014.
He is expert in research and development, business development and marketing in life science business field (medical device, in vitro diagnostic, drug discovery support, cell culture, regenerative medicine, material science, nanotechnology, various measuring techniques and production of biomaterials)

Regenerative medicine

Hazuki SamejimaAssociate Consultant

Hazuki Samejima Immunotherapy and Cell Therapy Association Secretariat, Japan Biotherapy Research Institute, Inc., Business Promotion Department, General Manager.
Samejima joined Cellseed Co., Ltd. in 2008 after completing her master's degree at Keio University Graduate School of Medicine. She was responsible for the development and quality assurance of clinical use cell-processed products in regenerative medicine, and the operation of the cell culture processing facility at that time (GMP compliant). In 2012, she joined Japan Biotherapy Research Institute Co., Ltd., and adapted the company to Regenerative Medicine related Laws and regulations and obtained a manufacturing license for specified cell products.
She held the post of facility manager of a cell processing facility that manufactures more than 3000 batches of specific cell processed products annually, and executed various operations such as design and operation preparation of new manufacturing facilities, documents establishment, etc.
In the Immunotherapy and Cell Therapy Association, as part of the Association Secretariat, she operated the help desk so support medical institutions who plan to engage in regenerative medicine research in regards of registration works. She has supported more than 200 projects in planning.
In addition, she has established an ICTA-specifically certified Regenerative Medicine Committee in the organization, and as the committee secretariat, has been handling drug screening for regenerative medicine.

Hiromoto KawanoAssociate Consultant

After experiencing various quality-related operations (mainly manufacturing management, quality control, supply chain management, audits / inspections, etc.) in the manufacturing and marketing fields at pharmaceutical companies, Kawano engaged in pharmaceutical regulation affair, and prepared application documents based on pharmaceutical related regulations, as well as negotiate with regulatory registration related organizations.
After that, at a regenerative medicine venture company, he provided support such as strategic consultations through material preparation, face-to-face consultations, and inquiries response, and also actively involved in establishing the Cell Processing Center.
Now, at iPS Portal, Kawano is actively supporting for research and product development promoted by academia and corporations, as well as providing regulatory consulting for venture companies.

Overseas consultant

Le Van Truyen

Le Van Truyen Ph.D. (Pharmaceutical Science)
Assoc. Prof., and Former Vice Minister of Health, Vietnam Government.
After Dr. Truyen received his PhD from Bucharest Univ. of Medicine and Pharmacy, Romania in 1971, he worked as a lecturer at Hanoi University of Pharmacy for 15 years. In 1986, he joined Thua Thien Pharmaceutical Manufacturer as a Director. Since June 1992, He had served for the government for 10 years as Sr. Vice-Minister of Health as well as Dep. Representative of Vietnam National Assembly. He founded in 2000 the Vietnam Pharmaceutical Companies Association (VNPCA), and elected to be the 1st President (2000-2004). In 2005, he joined Savipharm Project (SVP) as the Vice General Director, and managed successfully to receive J-GMP Certificate in 2010. He served as the Senior Expert of UNIDO in Vietnam (2010-2013), and Advisor of World Health Organization (WHO) Geneva and Hanoi. He has taught at many Universities of Pharmacy and involved in consultation for GMP and research in the pharmaceutical sector.
Dr. Truyen has been the Senior Advisor of CM Plus Vietnam since December 2014.

Charles I. AhnAssociate Consultant

Charles I. Ahn Aegis Managing Director, Aegis Beacon Consulting, LLC
Lecturer at Peking Univ. (Pharmaceutical Eng. Management Masters Program)
In the 27 years of career of Mr. Ahn with FDA (1986-2012), he had worked as Investigator, Compliance Officer, Inspection Program Expert, Enforcement Case Management Officer and the Assistant Country Director of the newly created Agency’s China Office (2009-2011). He was a member of the working group for establishment of FDA’s regulatory policies such as API guidance, new cGMP regulations, electronic records regulations, manual recognition agreement with EU, and FDA intern-office GMP policy. For all those years, he had also continuously participated in inspections of various pharmaceutical manufacturing facilities, including for APIs or finished dosage forms, complex computerized systems, and non-sterile or sterile operations.
After retirement from FDA in 2012, he has been providing advisory opinions and training on GMP to many pharmaceutical companies with his multi-cultural background.

Sundoro IswantoAssociate Consultant

Sundoro Iswanto Iawanto had worked as an Area Sales Manager regarding Infant food formula at PT. Mirota KSM Inc. to 1985. Then he joined PT. Pfrimmer Infusol Indonesia as a Production Manager and produced Large Volume Parenterals (LVPs) as well as Small Volume Parenterals (SVPs). After that he joined at PT. Triyasa Nagamas Frama as a Production Manager and produced aseptic family planning hormones vials and oral anti-baby pills.
In 1993 he joined at Roche Indonesia and had been engaged in a Plant Manager producing tablets, oral liquid, semisolid and sterile anti- neoplasma until 2004. He was engaged in PT. Bayer Indonesia as a Site Manager regarding OTC medicine. After he retired, He has worked for several pharmaceutical companies as a freelance consultant.

Vincent H. Chang, Ph.D. (Org. Chem.)Associate Consultant

Vincent H. Chang, Ph.D. (Org. Chem.) M.D., Yili Consulting LLC
Following B.Sc. in Taiwan, Dr. Chang received his Ph.D. from Duke Univ., USA. After he worked as research scientist for 9 years, he joined Abbott, Chicago in 1990. He was responsible for quality operations in Pacific Asia, Australia, Africa and Japan, then, finally appointed as QA Director responsible for contract operations. He joined Yili in 2015 and provides multi-cultural consulting services to lead strategic plans for NDA, SNDA, DMF and PAI as per FDA, EU, TGA, ANVISA, WHO and PIC/S.

Gordon J. FarquharsonAssociate Consultant

Gordon J. Farquharson Principal & M.D., Critical Systems Ltd.
Mr. Farquharson has more than 30 years working experience and offers excellent and unique consulting service converting GMP philosophy into a practical reality of facility design and SOPs. He has extensive knowledge of EU-GMP, PIC/S, WHO and cGMP as well as engineering expertise particularly for isolators and containment technology. Based in U.K., he has been active in Europe, ASEAN countries and Australia.

Bruce D. Myrehn (MBA)Associate Consultant

Bruce D. Myrehn (MBA) President, StS LLC: Solution through Synergy
Majored in both mechanical engineering and economics, Mr. Bruce D. Myrehn obtained MBA in Indiana university in 1993.
He worked for a mega-pharma in the US over 32 years, including such professional experience as a program director, an adviser for engineering/manufacturing, a six sigma master blackbelt, a manager of operations, a manager of QA/QC and a site head of a plant in Japan.
He has led success of authorities inspections for a Japanese pharmaceutical company as a consulting project head, not only by FDA but also ANVISA , FIMEA and Korean-FDA.
StS LLC: Solution through Synergy site, https://stsllc.solutions/

Kanhoji MohiteAssociate Consultant

Kanhoji Mohite He had been responsible for or timely deliveries of quality tablets, capsules and liquid orals from own facility and from toll manufacturing unit to meet the sales forecast of the division at Sandoz India Ltd, India from 1975. From 1991 he had been in charge of construction of a new formulation facility as well as productivity improvement and etc. as the head of pharmaceutical formulation at Bayer Health care India. From 2004 as the head of pharmaceutical operations of BHC plant ,he had been achieved successful renegotiation, inculcation of cost saving culture, productivity improvement projects and leading of various GMP audits.
He retired in 2013. He has been active with various lectures and seminars as well as support of the manufacturing.

Daniel PriceAssociate Consultant

Daniel Price Managing Director, QSight Ltd.
Worked in the pharmaceutical industry for more than 18 years in various validation areas, including software validation, computerized system validation and equipment validation. Roles have included validation leader, project manager, validation expert, test leader, trainer, auditor and others. Previous role was the QA manager for information systems at a multi-national pharmaceutical company. Prior to this role, worked as a senior consultant for equipment and systems validation at a pharmaceutical consultancy firm. Expert knowledge in FDA Part 11 and computer system validation regulations, Japan PMDA ERES and Computer System Guidelines, GAMP5, PIC/S computer system validation guides, EU GMP Annex 11, GCP/GVP/GPSP system validation and GxP system data integrity.

Jon R. WallaceAssociate Consultant

Jon R. Wallace Wallace worked for 10 years with FDA as a consumer safety officer and 17 years for pharmaceutical and biotechnology companies in USA occupying operational positions responsible for QA and FDA GXP compliance. Wallace has been offering in these 12 years consulting services to cover an extensive domain from biotechnology, pharmaceutical drugs to medical devices inclusive of helping a Japanese pharmaceutical company for FDA inspection successfully.

Drug Delivery Experts, LLC.Associate Consultant

Drug Delivery Experts, LLC. Drug Delivery Experts specializes in drug-device combination product development supporting clients from research to clinical development and commercialization with contracted drug product development R&D services.
Our team works on injectable products from solution to complex (liposome, suspension, long-acting formulations) including lyophilization, and on alternative delivery systems including nasal, pulmonary, and liquid filled capsule for biologics delivery, and has experience translating delivery technology from research into the clinic and to commercial.
Each of our experts has more than twenty years of experience in pharmaceutical research, development, and commercialization at pharma and biotech companies and has been in CMC development interacting with research, clinical, and commercial supply chain.
Our firm provides expert consultancy to facilitate the most effective translation from research through clinical development, with a key focus on integration of the delivery system with the development program to enhance the product profile and maximize commercial potential Please visit http://drugdeliveryexperts.com/

Nelson M Lugo ConsultingAssociate Consultant

Nelson M Lugo Consulting provides Quality Manufacturing Solutions to large and small organizations. Mr. Lugo has worked in process scale-up, development and manufacturing of products derived from multiple sources including plasma proteins, recombinant antigens, antibodies, synthetic peptides and small molecules. He has managed the technology transfer of products from R&D into the Commercial space as well as overseen multiple contract CMOs and CDMOs for DS (API) and DP Drug Product, fill/finish operations including vial, cartridges, syringes, pen assembly and secondary packaging sites

Berea BioVentures, LLCAssociate Consultant

Berea BioVentures, LLC Berea BioVentures is a privately held life sciences firm with expertise in the pharmaceutical, biotechnology and medical device industries. Located in the heart of Southern California's 'Biotech Beach', Berea is comprised of in-house expertise as well as consultant networks that spans several critical functional areas. Berea’s primary consulting services are in support of asset valuation and business development (for Discovery through Phase III) and strategic commercial consulting for product launch and in-line marketing (for Approval through ongoing Commercialization). For a list of clients hired by Berea, please visit bereabioventures.com

David Parkes, Ph.D.Associate Consultant

David Parkes, Ph.D. Dr. Parkes is a founder and president of DGP Scientific, Inc. He is a biotechnology Professional with extensive drug development and preclinical pharmacology experience in the fields of diabetes, obesity, NASH and cardiovascular disease - led preclinical development of exenatide, a first-in-class treatment for Type 2 diabetes, now approved worldwide as Byetta and Bydureon.
His Specialties are: Diabetes, NASH and Obesity Drug Development, In Vivo Models, Regulatory Submissions (IND/NDA/CTD), Medical Affairs, Education and Document Planning, New Technology Evaluation, Scientific Communication, Life-Cycle Planning, Academic Outreach, Cross-functional Team Leadership.
Current representative relationships include:
- Prosciento - Preclinical Scientific Consultant
- Gilead - Senior Scientific Consultant
- Astra Zeneca - Senior Consultant
- Fractyl - Senior Consultant
- Prolynx - Senior Consultant

Soumitra S. Ghosh Ph.D.Associate Consultant

Dr. Soumitra Ghosh is the president of Doon Associates LLC.
He provides consulting services to pharmaceutical and biotech companies in the areas of drug discovery and development, devices, drug delivery, R&D strategy, life cycle planning and intellectual property for metabolic and inflammatory disease indications.
He received his MS and Ph.D. degrees in Chemistry from the Indian Institute of Technology and the University of Chicago and conducted his post-doctoral work at the Rockefeller University.
He had worked at a biotechnology startup MitKor, and Amylin Pharmaceuticals (acquired by BMS and AstraZeneca). He is currently advising several startups with extensive experience in the areas of drug design, drug target discovery, drug development, genetic analysis and proteomics. Offering.
Areas of expertise include the development and management of interdisciplinary research programs and external collaborations, the evaluation of the intellectual property portfolio, the identification and evaluation of external drug candidate assets and potential technologies, and the provision of expertise in the due diligence process and scientific expertise in patent litigation cases.

Robert D. Johnson Ph.D.Associate Consultant

Robert D. Johnson Ph.D. Dr. Robert D. Johnson is the owner and principal consultant of Phase X Bio Consulting.
Dr. Johnson is a consultant about the production and development of recombinant DNA-based drugs, synthetic drugs and biotherapeutics in the United States and abroad.
His scientific or technical expertise includes process engineering, process characterization and validation, analytical method development and validation, regulatory submissions to U.S. and international health authorities, subcontracting manufacturers and subcontractors for the manufacture and development of biologics, including investigational drugs supplied in clinical trials and approved drugs that have received marketing approval. Planning and supervising tests and consulting on the investigation of process deviations and product non-conformities.
Prior to joining Amylin responsible for drug substance development for synthetic and recombinant molecules, Dr. Johnson worked for 4 years at Genentech Inc. (South San Francisco, CA) and 8 years at Nabi Biopharmaceuticals (Boca Raton, FL). At these companies he held positions in Manufacturing Sciences, Product Development, Quality Control, and Quality Assurance. He received his B.S. in Agricultural and Biological Engineering from Cornell University, C.P.G.S. in Biochemistry from Cambridge University, and Ph.D. in Chemical Engineering from the California Institute of Technology.

Engineering Consultant

Satoshi Suekane

Satoshi Suekane President, CM Plus Corporation
Suekane joined a major engineering company in 1985 and assigned to construction management tasks of domestic and foreign chemical plants. Then, he was transferred to Life Science Project Department in 1989 and appointed to engineering manager and project manager responsible for various sorts of project such as synthetic drugs, eye drops, solid formulations, bio and injections etc. He was finally promoted to a group leader of the Project Department.
The ISPE Facility of the Year 2009 Finalist was awarded to the project successfully managed by him.
He was moved to the Overseas Projects Department in 2009, and became responsible for management of mega-sized projects as the project control manager or engineering manager.
He joined CM Plus Corporation in October 2014 and actively engaged in life science projects. He was appointed to a member of the Board in Sept. 2015, then promoted to Senior Vice President in April 2018. From July 2020, he is President of CM Plus Japan.

Susumu Tsukada

Susumu Tsukada Executive Officers, CM Plus Corporation
First Class Architect, Certificated Construction Manager of Japan (CCMJ)
Tsukada joined a major engineering company in 1983. He engaged in civil and building design of both domestic and overseas plants including construction management for major EPC projects. He was appointed to Engineering Manager, and Deputy Senior Manager of Architect Department. In 2006, he was assigned to Director of the Indonesian subsidiary company to lead more than 700 local employees under him. He directed many Indonesian middle-small sized projects until he returned to Japan Head Office in 2014. His overseas career for over 15 years included Indonesia, UAE, Thailand, Iran, China, Qatar, etc.
After he joined CM Plus in April 2016, he assisted clients for their project management as an expert consultant both for domestic and overseas plants of solid dosage, food & beverage and medical device (basic design, inquiry and selection of contractors, and project execution).
In April 2018, he was appointed to Executive Officer of CM Plus.

Shigeru Nakamura

Shigeru Nakamura Fellow, CM Plus Corporation
First-class registered architect
Nakamura joined a major civil and building company in 1973 and engaged in the architectural design for life science facilities. His career included overseas construction for power plants in Dubai and Kuwait. In 1988, he was appointed to the Head of High-tech Facility Design Depts to be responsible for planning and conceptual design of life science and semiconductor facilities. Thereafter he was appointed to Deputy Manager of the R&D and Factory Design Department and became responsible for the architectural design of R&D and pharmaceutical facilities projects. In 1997, he moved to the Engineering Division, and newly established the Pharmaceutical Project Business Department to lead all pharmaceutical-related business in Japan and abroad.
He joined CM Plus Corporation in 2013. He has worked successfully as project manager of various pharmaceutical projects in Japan as well as superintendent for all overseas business including CM Plus subsidiary companies in Vietnam, Singapore and Indonesia. In September, 2014, he was appointed to a member of the Board and in April 2018, he was appointed to Fellow of CM Plus Corporation.
He has been actively enaged in ISPE Japan Affiliate since its foundation. He participated in the 2001 ISPE Annual Meeting held in USA and served as the Treasure, the Head of Secretariat, then Vice-President, and in 2008 to the President. In 2016, he was appointed to the Pacific Co-Chairman of ISPE.

Takayuki Tsuji

Takayuki Tsuji Executive Officers, CM Plus Corporation
First- class Certified Civil Construction Supervisor
Tsuji joined a major engineering company in April 1980. After services for design and construction for domestic energy plants, he was transferred in 1989 to Industrial Project Division. Throughout his 21 years of service, he achieved excellent performances as project manager and proposal manager in various domestic and overseas projects for both Japanese and foreign clients. His experience includes R&D Center, Factory, Electronic Device Manufacturing and Infrastructure Facilities. In 2010, he was promoted to Senior Manager of EPC Project Department of the newly established organization of Business Promotion & Execution Division. He successfully controlled Engineering (E) Procurement (P) and Construction (C) in many projects including hospital and solar power plant projects, always going along with the plant owner.
In April of 2015, he joined CM Plus Corporation. In April 2018, he was appointed to Executive Officer.

Tetsuo Fujioka

Tetsuo Fujioka Chairman, CM Plus Corporation,
Professional engineer (General Technology / Management Engineering), APEC engineer, PMS (Project Management Association of Japan), First grade piping construction engineer, First grade building construction engineer
Fujioka joined a food company in 1980 and worked for development of powder and granular material handling machinery, plant design and construction. In 1991, he joined a major engineering company, and served as engineering manager, project manager, project director and department director responsible for pharmaceutical factory projects in Japan as well as overseas for 20 years.
In August 2009, he joined CM Plus Corporation. He takes always a leading role in life science projects with a spirit of “go along with the customer”. He is fully competent to operate a wide variety of services, covering architectural equipment, manufacturing facility, estimate and evaluation, procurement, detailed design, construction management and C & Q. He participated in the EM COP and the Maintenance COP of ISPE Japan. He became company director in September 2015, and promoted to President in August 2016, then appointed to Chairman of CM Plus Japan in July 2020.

Susumu Machida

Susumu Machida Executive Vice president, CM Plus Corporation
Machida joined a major engineering company in 1989 and assigned to the task of engineering and project management of pharmaceutical plant. He engaged in the plant design for biotechnological API, sterile drugs, solid dosages, chemical API including qualification/validation activities. He was a founding member of ISPE Japan Affiliate. His contribution includes creation of the Japanese Review of Guideline of Biotechnological API, and subsequently received “Acknowledgement” of appreciation from Mr. Robert P. Best - the President CEO of ISPE International Headquarters.
He joined CM Plus Cooperation in 2010. His broad experience includes animal cell culturing (4 projects from 3 domestic clients), chemical API (2 projects from 2 domestic clients), sterile drug (3 projects from 2 domestic clients, 2 projects from 3 overseas clients) solid dosage (5 projects from 3 domestic clients), chemical hazard product (2 projects from 2 domestic clients) and SOP/CSV review (3 projects from 2 domestic clients).
He was appointed as a member of the Board in September 2013 and further promoted as Managing Director in September 2014. From April 2018, he is Executive Vice President of CM Plus Japan.

Masaru Fujinuma

Masaru Fujinuma 1stClass Architect, Registered Architect of JIA
Since 1985, he has served as architectural designer and supervisor for one of the major design institutes in Japan, and since 2011 as Deputy General Manager in charge of the Design Division, then promoted to Executive Vice President in 2013. In 2018, he has established an enterprise namely “WIST architects”, and in 2019, concluded a general agreement for cooperation with CM Plus.
He has extensive experience in many projects for hospitals and pharmaceutical facilities both in Japan and abroad such as a laboratory renovation for Pharmaceuticals, a new drug R&D center in Japan, a pharmaceutical factory in USA, National Blood Transfusion Center in Sri Lanka, an anthropoid center (BSL-4) in Thailand, including many others in Nepal, Indonesia, Senegal, Philippines, Iraq, Haiti, Mongolia, etc.
Book: “Application of Japanese Facilities and Technologies to the Hospitals as per Each Social Level of Developing Countries.”(JICA)

Process Architect

Naoko Takahashi

Naoko Takahashi Engineering Manager, CM Plus Corporation
First-class Architect, Certified Construction Manager of Japan
She majored in Applied Life Science at university and graduate school. After receiving a master's degree in agriculture in 2001, she developed another career to architecture. She started the career in architecture at a company of housing design and also studying at the department of architectural design of night school. She got a Second-class Architect in 2004 and moved to an engineering firm. She was in charge of an architectural engineer in various construction projects for buildings and facilities used for pharmaceutical research and production. She promoted the projects taking advantage of the background in the life sciences. She moved to a construction company in 2008 and was responsible as the laboratory designer in execution design of one of the largest construction in Japan for research center of drug development. She accomplished, as a major staff, the design required to cover all of the important functions of this research center which consists of wide variety fields, such as animal experiment research, biochemical research, and chemosynthesis research.
She joined the CM Plus corporation in October, 2011.
Using the strength to be able to approach from both point of view of the architecture and the life sciences, she is leading many projects as the engineering manager especially for research facilities and production facilities taking coordination between the user and the contractor, also each facility.

Legal/Contract

Yutaka Kokubun

Yutaka Kokubun Fellow and Auditor, CM Plus Corporation
Kokubun joined a major engineering company in 1973. He was engaged in many overseas projects such as petroleum refineries and LNG plants, in charge of all phases of project execution including cost estimating, planning, procurement, material control, subcontracting, schedule control, cost control, commissioning, handover, and job close-out. In 1997, he was appointed to Manager of Cost Estimate and Subcontracts Section responsible for all overseas projects. In 2003 he was appointed to the General Manger of Construction Department responsible for all projects abroad to manage 10-15 on-going sites of approximately 50,000 workers with a total budget of $15 billion per annum. In 2005, he was promoted to Associate Director. In 2007 he was appointed to General Manager of Project Operation Services Division to oversee four (4) departments (Procurement, QC, Construction and Commissioning).
He joined CM Plus Corporation in October 2010. In April 2018, he was appointed to Fellow and Auditor of CM Plus Corporation.

Nao TakadaAssociate Consultant

Nao Takada Ms. Takada is a U.S. attorney and a patent attorney of Takada Legal P.C.
She received her bachelor's law degree from the University of Tokyo, biology from Amherst College, and her Ph.D. from Columbia University. She graduated from New York University School of Law and was admitted to the New York State Bar. She is also a registered U.S. Patent Attorney.
Since 2012, she has been involved in litigation and prosecution of life science companies at several U.S. firms, using her expertise and experience in the area of intellectual property, with a particular focus on patents.
Since establishing Takada Legal, she has been involved in litigation and license agreements, as well as acting as legal counsel to Japanese companies operating in the US on general legal issues.

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