Highlights of the 14th Japan Bioanalysis Forum Symposium

Author:

Arakawa Tomoko1ORCID,Nishiguchi Yumi2,Hashimoto Masayo3ORCID,Mabuchi Masanari4,Koyama Noriyuki5,Niwa Makoto6ORCID,Yamaguchi Takeru7,Yoshinaga Ryosuke8,Takamatsu Yuki9ORCID,Komaba Junji10,Nakamura Takahiro11,Saito Tetsu12,Ohtsu Yoshiaki13ORCID,Takahashi Makoto14,Yagi Ryotaro15,Hanari Suguru2,Hashimoto Yoshitaka16,Uchihashi Shinsuke17

Affiliation:

1. Clinical Bioanalytics Group, Clinical Pharmacology and Bioanalytics, Pfizer R&D Japan G.K., Shibuya-ku, Tokyo, Japan

2. Bioanalysis Research Department, CMIC Pharma Science Co., Ltd, Nishiwaki, Hyogo, Japan

3. Preclinical Research Unit, Drug Research Division, Sumitomo Pharma Co., Ltd, Osaka, Osaka, Japan

4. DMPK Research Laboratories, Mitsubishi Tanabe Pharma Corp., Yokohama, Kanagawa, Japan

5. Tokushima Research Center for Drug Discovery, Otsuka Pharmaceutical Co., Ltd, Tokushima, Tokushima, Japan

6. Discovery Research Laboratories, Nippon Shinyaku Co., Ltd, Kyoto, Kyoto, Japan

7. Osaka Laboratory, Sumika Chemical Analysis Service, Ltd, Osaka, Osaka, Japan

8. Biomedical Analysis Laboratories,Toray Research Center, Inc., Kamakura, Kanagawa, Japan

9. Center of Excellencefor Drug Metabolism, Pharmacokinetics and Modeling, Preclinical and Translational Sciences, Research, Takeda Pharmaceutical Co., Ltd, Fujisawa, Kanagawa, Japan

10. Pharmacokinetic Research, Ono Pharmaceutical Co., Ltd, Tsukuba, Ibaraki, Japan

11. Drug Safety Research Laboratories, Shin Nippon Biomedical Laboratories, Ltd, Kagoshima, Kagoshima, Japan

12. Integrated & Translational Science, Axcelead Drug Discovery Partners Inc., Fujisawa, Kanagawa, Japan

13. Pharmacokinetic Research Laboratories, Kyowa Kirin Co., Ltd, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

14. Quantitative Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd, Shinagawa-ku, Tokyo, Japan

15. Toxicology and Pharmacokinetics Laboratories, Toray Industries, Inc., Kamakura, Kanagawa, Japan

16. Bioanalysis Group, Translational Research Laboratories, Ono Pharmaceutical Co., Ltd, Osaka, Osaka, Japan

17. Drug Metabolism & Pharmacokinetics Research Group, Drug Development Research Laboratories, Maruho Co., Ltd, Osaka, Osaka, Japan

Abstract

The 14th Japan Bioanalysis Forum Symposium was held at Tower Hall Funabori, Japan from 1–3 March 2023. The conference theme, ‘Bringing Together – the Expertise of Bioanalysis’, aimed to enable people from various fields to gather, learn and collaborate together for the common goal of delivering medicines to patients faster. Approximately 360 participants from various fields, including pharmaceutical industries, contractors, academia and regulatory authorities, gathered at an in-person symposium which had an online participation option, for the first time in 4 years. The symposium offered a wide range of topics including ICH M10, new modalities, biomarkers, immunogenicity, electronization and patient-centric sampling. The latest research results were provided from domestic and overseas scientists. This report summarizes the major topics.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference4 articles.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH M10: Bioanalytical Method Validation and Study Sample Analysis. (2022). https://database.ich.org/sites/default/files/M10_Guideline_Step4_2022_0524.pdf

2. oecd series on principles of good laboratory practice and compliance monitoring. Number 22. Advisory Document of the Working Party on Good Laboratory Practice on GLP Data Integrity. https://one.oecd.org/document/ENV/CBC/MONO(2021)26/en/pdf

3. Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry. Draft Guidance for Industry. (2022). www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-antibody-drug-conjugates-guidance-industry

4. Japan Bioanalysis Forum. The 14th JBF symposium: program. https://bioanalysisforum.jp/en/topics/img/pdf/14thJBF_Sympo_PG_E-2.pdf

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