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 ^1,2, Emi Tomikawa ^1,3, Miyoko Okada ^1,4

¹AI 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.
²Chugai Pharmaceutical Co., Ltd., Chugai Life Science Park Yokohama, 216 Totsuka-cho, Totsuka-ku, Yokohama, Kanagawa 244-8602, Japan.
³Toray Industries, Inc., 10-1 Tebiro 6-chome, Kamakura, Kanagawa 248-8555, Japan.
⁴Janssen Pharmaceutical K.K., 3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo 101-0065, Japan.
⁵Astellas Pharma Inc, 21 Miyukigaoka, Tsukuba-shi, Ibaraki 305-8585, Japan.
⁶Otsuka Pharmaceutical Co., Ltd., 463-10 Kagasuno, Kawauchi-cho, Tokushima 771-0192, Japan.
⁷Nippon Shinyaku Co., Ltd., 14 Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto 601-8550, Japan.
⁸Mitsubishi Tanabe Pharma Corporation, Shonan Health Innovation Park, 2-26-1 Muraoka-Higashi, Fujisawa, Kanagawa 251-8555, Japan.
⁹FUJIFILM Toyama Chemical Co., Ltd., 4-1 Shimo-Okui 2-chome, Toyama-shi, Toyama 930-8508 Japan.
¹⁰Sumitomo Pharma Co., Ltd., 3-1-98 Kasugade-naka, Konohana-ku, Osaka 554-0022, Japan.
¹¹Eisai Co., Ltd., 5-1-3 Tokodai, Tsukuba-shi, Ibaraki 300-2635, Japan.
¹²Kyowa Kirin Co., Ltd. 1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8731, Japan.

⁰AI 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.

Journal of Toxicologic Pathology +

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July 3, 2025

View abstract on PubMed

Summary

A survey explored the use of Artificial Intelligence (AI) pathology in Japan's non-clinical research. Findings will guide future AI pathology applications in drug development and toxicity evaluations.

Area Of Science

Pathology
Toxicology
Artificial Intelligence

Background

Artificial Intelligence (AI) is increasingly used in histopathological evaluation (AI pathology).
Understanding AI pathology's current use and needs in Japan's non-clinical research is crucial.
This includes applications in toxicity, drug efficacy, and basic research, alongside pathology image database requirements.

Purpose Of The Study

To assess the current implementation and utilization of AI pathology in non-clinical research in Japan.
To explore the needs and challenges associated with pathology image databases.
To determine the feasibility of establishing a precompetitive pathology image database for AI pathology in non-clinical settings.

Main Methods

A questionnaire survey was conducted between October and November 2023.
The survey targeted JPMA-affiliated and JSTP-affiliated organizations.
Key areas covered were whole slide image implementation, AI pathology use, and database needs.

Main Results

The survey gathered insights into the current landscape of AI pathology and whole slide image utilization.
It identified specific needs and challenges related to pathology image databases.
Results provide a foundation for future AI pathology development in non-clinical studies.

Conclusions

The study summarizes current AI pathology use and database needs in Japanese non-clinical research.
Findings will inform future strategies for AI pathology implementation and database development.
This research supports the advancement of AI pathology in drug evaluation and toxicologic pathology.

Keywords:

Artificial Intelligence (AI) pathology digital pathology non-clinical questionnaire survey