Report of the AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Japan Pharmaceutical Manufacturers Association: Questionnaire survey on AI pathology and utilization of whole slide image database

Masaki YAMAZAKI; Emi TOMIKAWA; Miyoko OKADA; Satoru KAJIKAWA; Yui TERAYAMA; Shino KUMABE; Tetsuya SAKAIRI; Akira INOMATA; Izumi MATSUMOTO; Gen SATO; Mutsumi SUZUKI

doi:10.1293/tox.2024-0099

Masaki YAMAZAKI, Emi TOMIKAWA, Miyoko OKADA, Satoru KAJIKAWA, Yui TERAYAMA, Shino KUMABE, Tetsuya SAKAIRI, Akira INOMATA, Izumi MATSUMOTO, Gen SATO, Mutsumi SUZUKI

Author information

Masaki YAMAZAKI
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
Chugai Pharmaceutical Co., Ltd., Chugai Life Science Park Yokohama, 216 Totsuka-cho, Totsuka-ku, Yokohama, Kanagawa 244-8602, Japan
Emi TOMIKAWA
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
Toray Industries, Inc., 10-1 Tebiro 6-chome, Kamakura, Kanagawa 248-8555, Japan
Miyoko OKADA
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
Janssen Pharmaceutical K.K., 3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo 101-0065, Japan
Satoru KAJIKAWA
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba-shi, Ibaraki 305-8585, Japan
Yui TERAYAMA
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
Otsuka Pharmaceutical Co., Ltd., 463-10 Kagasuno, Kawauchi-cho, Tokushima 771-0192, Japan
Shino KUMABE
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
Nippon Shinyaku Co., Ltd., 14 Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto 601-8550, Japan
Tetsuya SAKAIRI
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
Mitsubishi Tanabe Pharma Corporation, Shonan Health Innovation Park, 2-26-1 Muraoka-Higashi, Fujisawa, Kanagawa 251-8555, Japan
Akira INOMATA
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
FUJIFILM Toyama Chemical Co., Ltd., 4-1 Shimo-Okui 2-chome, Toyama-shi, Toyama 930-8508, Japan
Izumi MATSUMOTO
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
Sumitomo Pharma Co., Ltd., 3-1-98 Kasugade-naka, Konohana-ku, Osaka 554-0022, Japan
Gen SATO
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
Eisai Co., Ltd., 5-1-3 Tokodai, Tsukuba-shi, Ibaraki 300-2635, Japan
Mutsumi SUZUKI
AI Pathology Task Force, Non-clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceuticals Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan
Kyowa Kirin Co., Ltd., 1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8731, Japan

Keywords: AI pathology, non-clinical, questionnaire survey, digital pathology

JOURNAL OPEN ACCESS Advance online publication

Article ID: 2024-0099

DOI https://doi.org/10.1293/tox.2024-0099

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Abstract

In recent years, the development of Artificial Intelligence (AI) technology has led to the introduction and use of AI-based histopathological evaluation (AI pathology) by various companies and organizations. The AI Pathology Task Force of the Non-clinical Evaluation Expert Committee within the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) recognizes the importance of understanding the current use and needs surrounding AI pathology in Japan. This includes its role in non-clinical research fields, such as toxicity evaluation, drug efficacy evaluation, and basic research. In addition, assessing needs and challenges related to pathology image databases is essential. Between October and November 2023, with the cooperation of the Japanese Society of Toxicologic Pathology (JSTP), we conducted a questionnaire survey on non-clinical pathology image databases to explore these issues among JPMA-affiliated and JSTP-affiliated organizations. The questionnaire survey consisted of three items: (1) implementation and utilization of whole slide images, (2) use of AI pathology in non-clinical research fields, and (3) needs and feasibility of establishing a precompetitive pathology image database (repository) and AI pathology in the non-clinical pathology field. This report summarizes the survey results and serves as a foundation for guiding future directions in the use of AI pathology in non-clinical studies in Japan.

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