Drug Delivery System
Online ISSN : 1881-2732
Print ISSN : 0913-5006
ISSN-L : 0913-5006
Volume 26, Issue 2
Displaying 1-6 of 6 articles from this issue
Feature articles “Solutions for 2010's problem” Editor : Tohru Mizushima
  • Mime Egami
    2011 Volume 26 Issue 2 Pages 88-98
    Published: 2011
    Released on J-STAGE: June 30, 2011
    JOURNAL FREE ACCESS
    Japanese Government announced New Growth Strategy for “Life Innovation” to lead sustainable growth, international contribution and creation of ¥4.5 trillion market and, 2.8million jobs by 2020 in Japan, while net import surplus of pharmaceuticals & medical devices exceeded ¥2.56 trillion in FY2009. This aggressive strategy has to be translated into challenging actions by newly set up Medical Innovation Promotion Office. EU and the United States have already been taking timely actions to establish brand new development framework for advanced therapy such as regenerative medicine which framework vision is still missing in Japan. By observing innovative progress of “Cell Sheet Engineering” regenerative medicine and newly established industry consortium in Japan, FIRM(Forum for Innovative Regenerative Medicine), I would like to discuss essential actions in this country to create self-disciplined development framework for bringing world class advanced therapy to bedside in the World.
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  • Hiroshi Kikuchi, Hiroshi Ishihara, Takuya Suzuki
    2011 Volume 26 Issue 2 Pages 99-105
    Published: 2011
    Released on J-STAGE: June 30, 2011
    JOURNAL FREE ACCESS
    The keyword, life cycle management(LCM)of medicines has recently attracted attention, because the patents of many blockbuster drugs will expire or have expired around 2010. There are many strategies for LCM, and drug delivery system(DDS)is one of the useful approaches. But, it seemed that the development of DDS medicines in Japan was a little bit difficult compared to that in US or Europe. There were many factors such as drug price system, safety tests of new additives, etc. The circumstances for DDS development in Japan have recently become much better through the political efforts of Japanese government.
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  • Tohru Mizushima, Takushi Namba
    2011 Volume 26 Issue 2 Pages 106-112
    Published: 2011
    Released on J-STAGE: June 30, 2011
    JOURNAL FREE ACCESS
    As a new strategy for drug discovery and development, we propose here the establishment of drug re-profiling strategy. In this strategy, the actions of existing medicines, whose safety and pharmacokinetic effects in humans have been confirmed already, are examined comprehensively at the molecular level and the results are used for the development of new medicines. For example, identification of the mechanisms underlying the side effects of medicines enables us to develop safer drugs.
    The results can also be used for developing existing drugs for use as medicines in treatment of other diseases. Promoting this research strategy could provide breakthroughs in drug discovery and development by pharmaceutical companies.
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  • Go Sato, Hiromichi Kimura
    2011 Volume 26 Issue 2 Pages 113-117
    Published: 2011
    Released on J-STAGE: June 30, 2011
    JOURNAL FREE ACCESS
    Medical industry, including pharmaceutical industry is cntered on growing expectations of a knowledge-intensive industry to lead the Japanese economy. However, Japanese pharmaceutical companies are subordinated to the global pharmaceutical companies. They seek to improve their status by innovative medical technologies. The innovators are being diversified to academia and start-up companies ; accompanying with progress of medical, engineering, and pharmaceutical research. In the medical industry, platform to lead open-innovation is required to improve in globalization.
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  • Jin Shiomura, Ryoichi Suzuki, Mitsuo Ozeki
    2011 Volume 26 Issue 2 Pages 118-125
    Published: 2011
    Released on J-STAGE: June 30, 2011
    JOURNAL FREE ACCESS
    The role of venture companies has become more important in the pharmaceutical industry. Big pharmas depend on venture companies for the creation of new drugs. The pharmaceutical industry is a typical example of an intellectual industry that combines scientific technologies together. Japan, a country poor in natural resources, promotes the industry as a matter of national policy. However, the public budget for the bio-industry is meager, and the private financial environment is poor. In Japan, bio-venture companies are not well nurtured, due to a lack of public aid for clinical tests and research, a difference that stands out in comparison to the US.
    Japan's basic research results are drawing near to clinical applications, so we must decide to invest public funds in clinical research.
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  • Kenichi Tamiya
    2011 Volume 26 Issue 2 Pages 126-134
    Published: 2011
    Released on J-STAGE: June 30, 2011
    JOURNAL FREE ACCESS
    The government has been taking various measures for the development of innovative drugs and the growth of pharmaceutical industry, based on “The 5-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices” set in 2007. As a new measure to promote clinical studies, the Ministry of Health, Labour and Welfare(MHLW)will create infrastructure for early-stage and exploratory clinical trials in Japan next fiscal year. Moreover, in order to assess innovations appropriately, MHLW introduced a new scheme on a trial basis in the 2010 drug price revision, where the price reduction of new drugs meeting certain requirements is transiently mitigated until a generic product is marketed, expecting that this will promote the new drug development.
    The government will continue to advance unified approaches among industry, academia and government, based on “The New Growth Strategy” decided by the Cabinet in June 2010.
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