Session Details
[S05☆]Establishing a Shared Industry-Academia Understanding to Ensure the Reliability of Nonclinical Study Results: Toward Delivering Better Medicines to Patients Even Sooner
Fri. Mar 27, 2026 9:30 AM - 11:30 AM JST
Fri. Mar 27, 2026 12:30 AM - 2:30 AM UTC
Fri. Mar 27, 2026 12:30 AM - 2:30 AM UTC
Room 09 (B401, Bldg. 1, Area 2 [4F])
Organizer: Emiko Takeuchi (GLP, JSQA), Hiromi Takano-Ohmuro (Fac. Pharm., Musashino Univ., GLP, JSQA)
Medicines are information products to which reliable scientific and ethical data are attached. Ensuring the reliability of all study results in drug development—nonclinical or clinical—is essential. The nonclinical pharmacology data discussed in this symposium support development decisions, subject safety, regulatory submissions, and proper use. As industry–academia collaboration grows, differences in understanding and practice of reliability assurance have become apparent, making shared principles and consistent implementation increasingly important.
To address these issues, GLP Division, Subcommittee 5,of the Japan Society of Quality Assurance conducted several initiatives to enhance the reliability of non-GLP studies in academia: (1) a survey on research-integrity education for science students, (2) preparation of a laboratory-notebook template outlining key items for reliability, (3) development of a guideline to support reliable pharmacology and pharmacodynamic studies, and (4)surveys on collaborative and contract research between academia and industry. These efforts aim to improve understanding of reliability principles and encourage appropriate judgment according to study conditions.
This symposium will present these findings and explore strategies to improve data reliability and strengthen collaboration toward delivering better medicines to patients even sooner.
To address these issues, GLP Division, Subcommittee 5,of the Japan Society of Quality Assurance conducted several initiatives to enhance the reliability of non-GLP studies in academia: (1) a survey on research-integrity education for science students, (2) preparation of a laboratory-notebook template outlining key items for reliability, (3) development of a guideline to support reliable pharmacology and pharmacodynamic studies, and (4)surveys on collaborative and contract research between academia and industry. These efforts aim to improve understanding of reliability principles and encourage appropriate judgment according to study conditions.
This symposium will present these findings and explore strategies to improve data reliability and strengthen collaboration toward delivering better medicines to patients even sooner.
Organizer's Opening Remarks (Purpose and Background)
Hiromi Takano-Ohmuro1,2（1GLP, JSQA , 2Fac. Pharm., Musashino Univ.）
[S05-1]Survey on research integrity education received during the academic years of newly hired science and engineering graduates
○Hideki Kozono1, Isao Watanabe1, Hiromi Takemoto1, Rie Sonoda1, Ayumi Ishiyama1, Kazunori Narumi1, Tamaki Wada1, Takayuki Kato1, Koji Ueshima1, Emiko Takeuchi1, Hiromi Takano-Ohmuro1,2 (1. GLP, JSQA, 2. Fac. Pharm., Musashino Univ.)
[S05-2]Identification of essential laboratory notebook entries for ensuring the reliability of test results and development of a laboratory notebook template
○Koji Ueshima1, Rie Sonoda1, Hiromi Takemoto1, Ayumi Ishiyama1, Kazunori Narumi1, Tamaki Wada1, Hideki Kozono1, Takayuki Kato1, Emiko Takeuchi1, Hiromi Takano-Ohmuro1,2 (1. GLP, JSQA, 2. Fac. Pharm., Musashino Univ.)
[S05-3]Development of a practical guide for ensuring the reliability of nonclinical pharmacology studies conducted in academia
○Hitoshi Kawano1, Sumiko Nagaki1, Emiko Takeuchi1, Koji Ueshima1, Takayuki Kato1, Ai Yakiwara1, Masato Sakaguchi1, Daisuke Sugiyama1,2, Chika Akagi1, Koki Murakami1, Miyuki Yamamoto1, Mutsumi Suzuki3, Toru Ogawa3, Hiromi Takano-Ohmuro1,4 (1. GLP, JSQA, 2. TRC, Hiroshima Univ., 3. Non-Clinical Evaluation Expert, Drug Evaluation, JPMA, 4. Fac. Pharm., Musashino Univ.)
[S05-4]Survey results and future academia–industry collaboration to improve the reliability of nonclinical pharmacology studies
○Sumiko Nagaki1, Daisuke Sugiyama1,2, Emiko Takeuchi1, Chika Akagi1, Ai Yakiwara1, Masato Sakaguchi1, Koki Murakami1, Takayuki Kato1, Miyuki Yamamoto1, Toru Ogawa3, Mutsumi Suzuki3, Hitoshi Kawano1, Koji Ueshima1, Hiromi Takano-Ohmuro1,4 (1. GLP, JSQA, 2. TRC, Hiroshima University, 3. Non-Clinical Evaluation Expert, Drug Evaluation, JPMA, 4. Fac. Pharm., Musashino Univ.)