Barriers of Knowledge in Biopharmaceutical Research and Development in Japan

Authors

  • TAKAAKI OHARA KOCHI Unversity of Technology
  • Seigo Nasu KOCHI Unversity of Technology

DOI:

https://doi.org/10.5912/jcb837

Keywords:

Japanese Biopharmaceutical, R&D Management, Knowledge, Indices for research assessment, Therapeutic Antibodies

Abstract

The purpose of this research was to explore major barriers and issues in knowledge for biopharmaceutical research and development (R&D) in Japan and discuss why Japan had lagged behind Western nations in the field of biopharmaceutical R&D.

Cases of three therapeutic antibodies and one therapeutic protein originating and released in Japan were studied and the Web of Science Core Collection was used to analyze biopharmaceutical drugs of Japan and the US with various indexes. Analysis results suggested that establishment of a high-level clinical research network connected with global networks would lead to development of blockbusters. Many of Japanese pharmaceutical companies failed to establish such clinical research network and this is presumably one reason of the gap between Japan and Western nations.

On the other hand, acquisition and exchange of knowledge within and between organizations were also explored. The few successful Japanese companies acquired not only formal knowledge but also implicit knowledge for various R&D phases from basic researches to applied researches from top pharmaceutical companies of Western nations, whereas most Japanese companies have not successfully acquired such knowledge. It was assumed that this has also contributed to the gap from Western counterparts.

Author Biographies

TAKAAKI OHARA, KOCHI Unversity of Technology

I am a graduate student and also a PhD candidate of School of Economics & Management at Kochi University of Technology.

Seigo Nasu, KOCHI Unversity of Technology

Professor of Graduate School of Engineering and Director of Department of Management/Research Center for Social management at Kochi University of Technology.

References

Grilo, A.L.,Mateus M., Aires-Barros, M.R., Azevedo, A.M. (2017) Monoclonal antibodies production platforms: an opportunity study of a non protein A chromatographic platform based on process economics. Biotechnology Journal Sep.13, Epub ahead of print.

Akabane, Hirotomo (2017) Production trends of biopharmaceuticals, OPIR views and actions 51:9-14.

International pharmaceutical intelligence (Eds.) (2017) Biologics Market 2016. International pharmaceutical intelligence 1080:16-23.

Hughes, S.S. (2001) Making dollars out of DNA. The first major patent in biotechnology and the commercialization of molecular biology, 1974-1980. Isis 92(3): 541-575.

Fujiwara, Takao (1993) The management of technology change. CHUOKEIZAI-SHA HOLDINGS, INC.

Saito, Yukinori and Emura, Yoko (1985) Successive entries of bioindustry: the future prediction of each product and plan of each company, Yano Research Institute Ltd.

Edwards, Christopher G., Elkington, John and Murray, Alison M. (1984) Japan taps into new biotech Bio/technology 2: 307-321.

Yamaguchi, Masahiro and Wakasa, Ryoichi (1982) Bioindustry Frontline SHIJYO-SHIMBUNSHA.

Tanaka, Masami (1985) A Japanese view of Japan’s biotechnology. Bio/technology 3: 176.

Kukawa, Momoko (2002) Noble business person in the pharmaceutical world. Nikkei Business 1157:124-126.

Kojima, Masaru et al. (2007) Current patent issues of biopharmaceuticals. Patent 60(8): 67-80.

Nishijima, Masahiro and Kawasaki, Nana (2013) From the basics of development to next-generation pharmaceutical products. KAGAKU-DOJIN.

Klausner, Arthur (1987) The TNF waiting game. Bio/Technology 5(4): 335-339.

Kayano, Eiko (2002) Biotechnological Development of Biotechnology and Patent System. BIO INDUSTRY 19(7):54-61.

Tajima, Ken et al. (2005) Why is it so difficult to enter from the other sectors? Nikkei Bio Business 54:36-47.

Tomita, Minoru (2000) Japan may hold superiority in a 25 trillion yen market. Weekly Economist 78(13):86-87.

Sawai, Hitoshi (1987) Patience and the technology to fill gaps. Nikkei Business 469:125.

Usui, Masumi (2012) Entrepreneurs Number 379. Diamond Weekly (100) 1: 150-151.

Kubota, Aya (2017) Daiichi Sankyo had halted the development of Etanercept as biosimilar. Nikkei Biotech 860:17.

Shinohara, Tadashi (2013) New Trends of Management: Fuji film Holdings. Nikkei Business 1683: 112-116.

Takahashi, Koki (2016) Fuji film: New company was established. Nikkei Biotech 841:20.

Tanaka, Hiroshi (2014) Expectations and remaining problems of biopharmaceuticals. Medical care and society 24(2):159-170.

Miyata, mitsuru (1999) The vision and development of bioindustry. Kansai Economics Research Center.

Nagaoka, Sadao (eds.) (2016) New drug development. Nikkei Business Publications.

Ohsugi, Yoshiyuki (2013) The birth of new drug Actemra. Iwanami Shoten, Publishers.

Ohtomo, Toshihiko (2006) Conceptions of biopharmaceuticals. Pharm Stage 5(12): 69-75.

Honjo, Tasuku (2016) Healing Cancer. Kagaku 86(6): 526-531.

Kobatake, Choei, Amo Masato, Shitara Kenya (2012) New drug for Adult T-cell Leukemia/Lymphoma, “POTELIGEO”, a humanized anti-CCR4 monoclonal antibody. Saibou 44(8): 355-359.

Ishii, Toshihiko (2013) Development 0f an anti-CCR4 antibody, mogamulizumab, the first approved antibody made by POTELLIGENT technology. Folia Pharmacologica Japonica 142: 167-171.

Tsukasaki, Asako (2014) Mogamulizumab. Medical ASAHI 43(12): 78-81.

Honda, Goichi, Suzuki, Hideaki, Aoki, Yoshikazu (2011) Development of recombinant thrombomodulin from the view point of translational research. Folia Pharmacologica Japonica 138: 56-59.

Suzuki, Kohji (2009) Thrombomodulin: Recomodulin. Japanese Journal of Thrombosis and Hemostasis 20(1): 9-11.

Hirsch, J.E. (2005) An index to quantify an individual’s scientific research output. Proceedings of the National Academy of Sciences of the United States of America 102(46): 16569-16572.

Shimizu, Takeshi (2009) Objective and quantitative indices for the research assessment. Joho Kanri 52(8): 464-474.

S. Alonso, S., Cabrerizoy, F.G., Viedmaz, E. Herrera, Herreraz, F. (2008) hg-index: A New Index to Characterize the Scientific Output of Researchers Based on the h-and g- Indices. Scientometrics 82: 391-400.

BiHui, Jin, LiMing, Liang, ROUSSEAU, Ronald, EGGHE, Leo (2007) The R- and AR-indices Complementing the h-index. Chinese Science Bulletin 52(6): 855-863.

Anonymous (2015) Report of patent application technical trends surveys -Antibodies-. JAPAN PATENT OFFICE.

Anonymous (2000) 75-year history of Chugai Pharmaceutical. Chugai Pharmaceutical.

Argyris, C. & Schön, D. A. (1978) Organizational learning: A theory of action perspective. Massachusetts: Addison Wesley.

Matsuyuki, Yasuo, Matsuyuki, Akiko (2002) Interorganizational Learning. HAKUTO-SHOBO publishing.

Nonaka, Ikujiro, Takeuchi, Hirotaka (1996) The knowledge creating company. Toyo Keizai.

Badaracco, Joseph L. (1991) The Knowledge Link: How Firms Compete Through Strategic Alliances. Harvard Business Review Press.

Polanyi, Michael (1967) The Tacit Dimension. New York: Anchor Books.

Yamakura, Kenshi (2007) New Strategic Management. Dobunkan Shuppan.

Published

2019-02-06

Issue

Section

Articles