Imaging Mass Spectrometry (IMS) for drug discovery and development survey: Results on methods, applications and regulatory compliance

Eric Solon; M Reid Groseclose; Stacy Ho; Kouji Tanaka; Naoyuki Nakada; Stefan Linehan; Masanobu Nishidate; Hiroyuki Yokoi; Hidefumi Kaji; Yoko Urasaki; Kenichi Watanabe; Tomomi Ishida; Rika Komatsu; Kenji Yoshida; Hiroshi Yamazaki; Kosuke Saito; Yoshiro Saito; Yukari Tanaka

doi:10.1016/j.dmpk.2021.100438

Imaging Mass Spectrometry (IMS) for drug discovery and development survey: Results on methods, applications and regulatory compliance

Drug Metab Pharmacokinet. 2022 Apr:43:100438. doi: 10.1016/j.dmpk.2021.100438. Epub 2021 Dec 16.

Authors

Eric Solon¹, M Reid Groseclose², Stacy Ho³, Kouji Tanaka⁴, Naoyuki Nakada⁵, Stefan Linehan⁶, Masanobu Nishidate⁷, Hiroyuki Yokoi⁸, Hidefumi Kaji⁹, Yoko Urasaki¹⁰, Kenichi Watanabe¹¹, Tomomi Ishida¹², Rika Komatsu¹³, Kenji Yoshida¹⁴, Hiroshi Yamazaki¹⁵, Kosuke Saito¹⁶, Yoshiro Saito¹⁷, Yukari Tanaka¹⁸

Affiliations

¹ Member of Executive Committee, Imaging Mass Spectrometry Society (IMSS), Madrigal Pharmaceuticals, Inc., Four Tower Bridge, 200 Barr Harbor Drive, West Conshohocken, PA, 19428, USA. Electronic address: [email protected].
² Member of Executive Committee, IMSS, GlaxoSmithKline, 1250 S, Collegeville Rd., Collegeville, PA, 19426, USA. Electronic address: [email protected].
³ Member of Executive Committee, IMSS, Drug Metabolism and Pharmacokinetics, Pharmaceutical Sciences, Roche Innovation Center Shanghai (RICS), Building 5, No. 371, Lishizhen Road, Pudong New Area, Shanghai, China. Electronic address: [email protected].
⁴ Member of Japan Association for Imaging Mass Spectrometry, DMPK Research Laboratories, Sohyaku. Innovative Research Division, Mitsubishi Tanabe Pharma Corporation, 1000, Kamoshida-cho, Aoba-ku, Yokohama, Kanagawa, 227-0033, Japan. Electronic address: [email protected].
⁵ Member of Japan Association for Imaging Mass Spectrometry, Analysis&Pharmacokinetics Research Labs., Drug Discovery Research, Astellas Pharma Inc., 21, Miyukigaoka, Tsukuba, Ibaraki, 305-8585, Japan. Electronic address: [email protected].
⁶ Asia-Pacific (APAC) Outreach Liaison, IMSS Boston, MA, USA. Electronic address: [email protected].
⁷ Member of Japan Association for Imaging Mass Spectrometry, Pharmaceutical Science Dept., Chugai Pharmaceutical Co., Ltd., 200 Kajiwara, Kamakura, Kanagawa, 247-8530, Japan. Electronic address: [email protected].
⁸ Member of Japan Association for Imaging Mass Spectrometry, Drug Metabolism and Pharmacokinetics Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd., 463-10 Kagasuno, Kawauchi-cho, Tokushima-shi, Tokushima, 771-0192, Japan. Electronic address: [email protected].
⁹ Member of Japan Association for Imaging Mass Spectrometry, Drug Development Service Segment, LSI Medience Corporation13-4, Uchikanda 1-chome, Chiyoda-ku, Tokyo, 101-8517, Japan. Electronic address: [email protected].
¹⁰ Member of Japan Association for Imaging Mass Spectrometry, Drug Metabolism and Pharmacokinetics Research Laboratories, Daiichi Sankyo Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan. Electronic address: [email protected].
¹¹ Member of Japan Association for Imaging Mass Spectrometry, Preclinical Research Unit, Sumitomo Dainippon Pharma Co.,Ltd., 3-1-98 Kasugade-naka, Konohana-ku, Osaka, 554-0022, Japan. Electronic address: [email protected].
¹² Member of Japan Association for Imaging Mass Spectrometry, Global Drug Metabolism and Pharmacokinetics, Eisai Co., Ltd., 5-1-3 Tokodai, Tsukuba, Ibaraki, 300-2635, Japan. Electronic address: [email protected].
¹³ Member of Japan Association for Imaging Mass Spectrometry, Laboratory for Drug Discovery Pharmaceuticals Research Center, Asahi Kasei Pharma Corporation.632-1 Mifuku, Izunokuni, Shizuoka, 410-2321, Japan. Electronic address: [email protected].
¹⁴ Member of Japan Association for Imaging Mass Spectrometry, Drug Development Solutions Planning Department, Pharmaceutical Sciences Division, Sekisuimedical Co., Ltd., 2117 Muramatsu, Tokai, Ibaraki, 319-1182. Electronic address: [email protected].
¹⁵ Member of Japan Association for Imaging Mass Spectrometry, Showa Pharmaceutical University, 3-3165 Higashi-tamagawa Gakuen, Machida, Tokyo, 194-8543, Japan. Electronic address: [email protected].
¹⁶ Member of Japan Association for Imaging Mass Spectrometry, Division of Medicinal Safety Science, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, 210-9501, Japan. Electronic address: [email protected].
¹⁷ Member of Japan Association for Imaging Mass Spectrometry, Division of Medicinal Safety Science, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, 210-9501, Japan. Electronic address: [email protected].
¹⁸ Leader of Japan Association for Imaging Mass Spectrometry, Drug Metabolism and Pharmacokinetics, Laboratory for Drug Discovery and Development, Shionogi & Co., Ltd., 3-1-1, Futaba, Toyonaka, Osaka, 561-0825, Japan. Electronic address: [email protected].

PMID: 35091331
DOI: 10.1016/j.dmpk.2021.100438

Abstract

Imaging mass spectrometry (IMS) is increasingly used for drug discovery and development to understand target enagement, tissue distribution, drug toxicity, and disease mechanisms, etc. However, this is still a relatively new technique that requires further development validation before it will be an acceptable technique to support regulated development of new drugs. Thus, best practices will need to be established to build more confidence and gain wider acceptance by the scientific community, pharmaceutical industry, and regulatory authorities. The Imaging Mass Spectrometry Society (IMSS) and the Japan Association for Imaging Mass Spectrometry (JAIMS) have conducted a thorough survey to gather information on the current state of IMS and to identify key issues. The survey was sent to researchers or managers in the position who are currently using IMS techniques in support of their drug discovery and development efforts and/or who plan to use such tools as best practices are established. The survey probes questions related to details regarding technical aspects of IMS, which includes data acquisition, data analysis and quantitation, data integrity, reporting, applications, and regulatory concerns. This international survey was conducted online through the Survey Monkey (https://www.surveymonkey.com) in both English and Japanese from September 14 through September 30, 2020.

Keywords: ADME; Drug discovery and development; Drug quantitation; Imaging mass spectrometry (IMS); Survey.

MeSH terms

Diagnostic Imaging*
Drug Discovery*
Drug Industry
Mass Spectrometry / methods
Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization / methods
Tissue Distribution