Drug Delivery System
Online ISSN : 1881-2732
Print ISSN : 0913-5006
ISSN-L : 0913-5006
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Volume 39, Issue 2
Drug Delivery System
Displaying 1-11 of 11 articles from this issue
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FOREWORD
OPINION
[Feature articles] “Social implementation of basic research” Editor:Takuro Niidomei
  • The importance of academic research to the parallel development of drug discovery science and regulatory science
    Masatoshi Hori
    2024 Volume 39 Issue 2 Pages 86-94
    Published: March 25, 2024
    Released on J-STAGE: June 25, 2024
    DOIhttps://doi.org/10.2745/dds.39.86
    JOURNAL FREE ACCESS
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    In recent years, many biologics have been developed and the modalities of new drugs have diversified. In order to respond to this diversification, there is also a need to develop regulatory science and technology related to the safety and quality of new modalities. In response, pharmaceutical companies have converted their management policies to a system of open innovation, in which the initial stages of drug discovery and development are conducted by academia and bio-ventures. In Japan, this trend is the same, and the development of various types of basic research is necessary in all research fields to raise the level of drug discovery science and regulatory science in various ways. For researchers in academia, it is necessary for Japan, as a scientific nation, to acquire knowledge of drug discovery science and regulatory science, and to promote research with an awareness of these fields. The TRS Academia Consortium supports education and research in drug discovery science and regulatory science research by academia researchers across disciplines.
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  • Arrangement for social implementation of basic research by reagent manufacturers
    Yuki Masuda
    2024 Volume 39 Issue 2 Pages 95-98
    Published: March 25, 2024
    Released on J-STAGE: June 25, 2024
    DOIhttps://doi.org/10.2745/dds.39.95
    JOURNAL FREE ACCESS
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    We will discuss development approaches of general product in the reagent industry and introduce examples of efforts to apply university-originated technologies to practical uses. In particular, we considered problems in implementing university-developed technologies into society by separating them into matching incentives and markets, and summarized proposals to come close to resolving the problems. I hope that Japanese advanced basic researches will move quickly to the stage of social implementation, and attempts that lead to social contribution of both universities and companies will be promoted.
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  • University startups and their fundraising
    Noriyuki Kawata
    2024 Volume 39 Issue 2 Pages 99-107
    Published: March 25, 2024
    Released on J-STAGE: June 25, 2024
    DOIhttps://doi.org/10.2745/dds.39.99
    JOURNAL FREE ACCESS
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    Based on the recent focus on startups and policies to promote startups, the number of university startups and VCs investing in them has increased, and the amount of startup funding has also increased. On the other hand, VC investment has entered a phase of selecting startups, as the number of startups available for funding has decreased and the amount raised has varied greatly. This report provides an overview of university startups and VCs, as well as types of funding and how to deal with VCs for those who aim to commercialize their technology through startups in the future. At the end, I introduce the activities of QB Capital investing in university startups mainly in Kyushu.
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  • From NapaJen to Immunohelix: Transitioning to the Next Level
    Kazuo Sakurai, Kenji Arima
    2024 Volume 39 Issue 2 Pages 108-115
    Published: March 25, 2024
    Released on J-STAGE: June 25, 2024
    DOIhttps://doi.org/10.2745/dds.39.108
    JOURNAL FREE ACCESS
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    Since the discovery of polysaccharide nucleic acid complexes in 2000, NapaJen Pharma Inc. has been established, faced struggles during the COVID-19 pandemic, and has been revitalized with the support of new investor, Remiges Ventures. Recently, the company has renamed its Japanese corporate entity to Immunohelix and is focusing on developing new pipelines. In this article, we want to introduce our foundational technology and discuss what is necessary to transform this basic technology into practical applications through innovation.
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  • Development of transcutaneous vaccine by using microneedles technology
    Ying-shu Quan
    2024 Volume 39 Issue 2 Pages 116-122
    Published: March 25, 2024
    Released on J-STAGE: June 25, 2024
    DOIhttps://doi.org/10.2745/dds.39.116
    JOURNAL FREE ACCESS
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    The dissolving microneedles（MN） made of water-soluble polymers and coating MN made of biodegradable polymers were developed, and the world’s first skin care cosmetics applying hyaluronic acid MN technology was commercialized in 2008. In the medical field, MN formulations were developed for the transdermal delivery of protein/peptides such as exendin-4（anti-diabetic drug） etc., and their kinetic behaviors were almost equivalent to subcutaneous injection. The MN is a promising vaccine administration method that minimizes pain, allows for minimally invasive and self-administration, and enables large-scale and rapid vaccination during pandemic emergencies. The clinical studies using influenza vaccine MN have shown that it is safe and effective against type A and type B strains according to the European Medicines Agency（EMA） criteria. The immune response to A/H1N1 and A/H3N2 strains induced by MN administration was almost equivalent to that by subcutaneous injection, and the immune response to B/Brisbane strain was higher than that by subcutaneous injection. In particular, we have developed DonutNeedlesⓇ, which has significantly improved skin puncture properties, and are making progress toward the development of novel vaccine.
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  • Clinical application and business strategy of a novel regenerative medicine product for severe ocular surface disease
    Tetsuro Hamafuji
    2024 Volume 39 Issue 2 Pages 123-131
    Published: March 25, 2024
    Released on J-STAGE: June 25, 2024
    DOIhttps://doi.org/10.2745/dds.39.123
    JOURNAL FREE ACCESS
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    A novel regenerative medicine product for limbal stem cell deficiency （LSCD） with ocular surface adhesions is progressed in clinical application since 2023. This ophthalmologic surgery, transplantation of cultivated autologous oral mucosal epithelial cell sheet using human amnion membrane substrate, had been researched and developed by ophthalmologists of an academic institute, Kyoto Prefectural University of Medicine. According to the results of phase 3 investigator-initiated clinical trial, we, Hirosaki-LI Inc., received the manufacturing and sales approval of this product from Japan regulatory agency. A high insurance reimbursement price was obtained through accounting cost calculation, it is due to the evaluation of the novelty of this treatment method. This accomplishment, an unlisted company obtained approval to manufacture and sell regenerative medicine products, is the first time in Japan. Furthermore, its clinical application and business has been successfully progressing. The fact appears to be a remarkable model case for social implementation of university-originated technology.
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Front line of DDS development in pharmaceutical industries
  • Clinical characteristics and recent reports based on appropriate use of controlled-release dinoprostone vaginal insert（PROPESSⓇ）
    Daisuke Mikami, Koichi Matsumura, Atsushi Nakano
    2024 Volume 39 Issue 2 Pages 133-137
    Published: March 25, 2024
    Released on J-STAGE: June 25, 2024
    DOIhttps://doi.org/10.2745/dds.39.133
    JOURNAL FREE ACCESS
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    PROPESSⓇ is composed of a hydrophilic polymer containing 10 mg of dinoprostone and the retrieval string; PROPESS is inserted so as to stick to the target area of ​​the cervix, and able to penetrate the cervix by continuously releasing dinoprostone. The pharmacokinetics, safety, and tolerability of PROPESS vaginal inserts 10 mg（dinoprostone vaginal insert） were evaluated in a phase I trial（228） in Japanese and non-Japanese women; the efficacy and safety were evaluated in multicenter, open-label, phase III trials（261 and 262）. In January 2020, PROPESS was approved for the indication of “initiation of cervical ripening in patients after 37 completed weeks of gestation”. PROPESS has been used appropriately in accordance with the risk management in the drug risk management plan and the guidelines for obstetrical practice by the Japan Society of Obstetrics and Gynecology and the Japan Association of Obstetricians and Gynecologists 2023 edition. The results of clinical research have also been reported.
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