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Proposal of Standard for Medical Science Liaison (MSL) Profession in Japan: A Viewpoint from the Japanese Association of Pharmaceutical Medicine (JAPhMed)

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Abstract

Medical science liaisons (MSLs) are field-based professionals sited in medical affairs (MA) departments who contribute to the generation of medical evidence and exchange advanced medical and scientific information with healthcare professionals to standardize treatments and maximize the value of medical products for patient outcomes. As such, it is essential for companies to have MSL training programs that cover areas such as advanced scientific expertise, pharmaceutical regulations, and medical communication proficiency and to certify the knowledge and skills that enable MSLs to perform their tasks effectively. The lack of a standardized training curriculum, assessment of MSL capabilities, and key performance indicators (KPIs) in Japan has made it difficult for MSLs to carry out these tasks. It is important to clarify the status of MSLs in MA divisions within the Japanese pharmaceutical industry. The mission of the Japanese Association of Pharmaceutical Medicine (JAPhMed) is to promote pharmaceutical medicine by enhancing the knowledge, expertise, and skills of pharmaceutical professionals. JAPhMed established an accreditation system for the MSL certification programs of individual companies in early 2015 and then embarked on defining the individual MSL qualifications from late 2015 to mid-2017. Here, we describe the MSL recommendation that covers (1) MA in Japan, (2) definition of MSL, (3) roles and activities of MSLs, (4) regulation and compliance for MSLs, (5) qualification requirements for MSLs, (6) KPIs for MSLs, and (7) a training curriculum for MSLs. In the training curriculum, JAPhMed considered the relevance of each part of the training curriculum in terms of the fixed roles and activities of MSLs.

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Acknowledgements

The authors thank Dr. Stewart Geary for critical reading and helpful suggestions, and Dr. Ichiro Uchida for advice, during the preparation of this manuscript. The following task force team members also participated in discussion of the contents: Kazuyuki Inoue, Hirohisa Mizuno, Hideyuki Shiba, Harumi Mukai, Yuzo Tomohira, Hiromi Oka, Hideaki Takimoto, Yoichi Inoue, Yuko Hino, Hideo Yoshikawa, Yukio Karita, Hiroyuki Taruno, Yukiko Sakakibara, Tokuhiko Kushido, Natsuki Moriyama, and Takashi Yokaichiya.

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Authors and Affiliations

  1. Japanese Association of Pharmaceutical Medicine, Shibaura Shimizu building, 4-15-33, Shibaura, Minato-ku, Tokyo, 108-0023, Japan

    Michiko Tomiyasu, Kunihiko Hayashi, Yukio Moritsugu, Narihisa Miyachi, Kazuya Iwamoto, Masahiro Nitta, Masahiko Mori & Koji Iwasaki

  2. Kyowa Kirin Co., Ltd., Tokyo, Japan

    Kunihiko Hayashi

  3. MSD K.K., Tokyo, Japan

    Yukio Moritsugu

  4. PharmaEssentia Japan K.K., Tokyo, Japan

    Narihisa Miyachi

  5. Covance Japan Co., Ltd. , Tokyo, Japan

    Kazuya Iwamoto

  6. Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan

    Masahiro Nitta

  7. Eisai Co., Ltd., Tokyo, Japan

    Masahiko Mori

  8. Medical Center for Translational Research, Osaka University Hospital, Osaka, Japan

    Koji Iwasaki

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  1. Michiko Tomiyasu
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  2. Kunihiko Hayashi
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  4. Narihisa Miyachi
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  5. Kazuya Iwamoto
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  6. Masahiro Nitta
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  7. Masahiko Mori
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Corresponding author

Correspondence to Michiko Tomiyasu.

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No sources of funding were used to conduct this study or prepare this manuscript.

Conflict of interest

Michiko Tomiyasu, Kunihiko Hayashi, Yukio Moritsugu, Narihisa Miyachi, Kazuya Iwamoto, Masahiro Nitta, Masahiko Mori, and Kouji Iwasaki have no conflicts of interest that are directly relevant to the content of this article. All authors are members of the Japanese Association of Pharmaceutical Medicine. Kunihiko Hayashi is a salaried employee of Kyowa Kirin Co., Ltd. Tokyo, Japan. Yukio Moritsugu is a salaried employee of Merck & Co., Inc., Kenilworth, NJ, USA. Narihisa Miyachi is a salaried employee of PharmaEssentia Japan K.K. Kazuya Iwamoto is a salaried employee of Covance Inc., Princeton, NJ, USA. Masahiro Nitta is a salaried employee of Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan. Masahiko Mori is a salaried employee of Eisai Co., Ltd., Tokyo, Japan. Koji Iwasaki is a visiting professor of the Medical Center for Translational Research, Osaka University Hospital, Osaka, Japan.

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Author contributions

All authors contributed to the conception, analysis, and interpretation of the manuscript, based on the MSL recommendation report by the task force team at the JAPhMed. The authors prepared the draft and revised and approved all of its contents. The corresponding author undertook most of the revisions arising from peer review, which were subsequently approved by all authors. The authors agree to be accountable for all aspects of this publication.

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Tomiyasu, M., Hayashi, K., Moritsugu, Y. et al. Proposal of Standard for Medical Science Liaison (MSL) Profession in Japan: A Viewpoint from the Japanese Association of Pharmaceutical Medicine (JAPhMed). Pharm Med 34, 315–326 (2020). https://doi.org/10.1007/s40290-020-00355-8

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  • DOI: https://doi.org/10.1007/s40290-020-00355-8

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