The 37th Annual Meeting of the Japanese Society of Toxicology

President's Invited Lecture

President's Invited Lecture

June 17 (Thu) 16:00-17:00 Room1

IL-1

Chemical-induced toxicity, metabolism and species difference

Yasushi Yamazoe

Tohoku University

Chairperson:

Yoko Aniya

University of the Ryukyus

Special Lecture

Special Lecture 1

June 16 (Wed) 9:30-10:30 Room1

SL-1

Glutathione transferases: Old enzymes, new roles

Yogesh C. Awasthi

University of North Texas

Chairperson:

Tetsuo Satoh

Chiba University

Special Lecture 2

June 17 (Thu) 9:45-10:45 Room1

SL-2

Cardio-renal effects of cycloxygenase inhibitors: mechanism of toxicity

K. Nasir Khan

Pfizer DSRD

Chairperson:

Takemi Yoshida

Showa University

Educational Lecture

Educational Lecture 1

June 16 (Wed) 10:45-11:45 Room1

EL-1

On-chip cellomics: Constructive approach to make an functional organ model from cells on a chip

Kenji Yasuda

Tokyo Medical and Dental University

Chairperson:

Sunao Manabe

Daiichi Sankyo Co., Ltd.

Educational Lecture 2

June 17 (Thu) 11:00-12:00 Room1

EL-2

Idiosyncratic drug toxicity -Proposal of a new approach for circumventing human-specific toxicity, unprecictable from animal experiments-

Toshihiko Ikeda

Yokohama College of Pharmacy

Chairperson:

Yasuo Ohno

National Institute of Health Sciences

Special Seminar

Special Seminar

Message from women scientists

June 16 (Wed) 17:00-18:00 Room2

SS-1

Chikako Tanaka

Kobe University

SS-2

Hiroko Satoh

F. NIH ・Roche

Chairpersons:

Ikuo Horii

Showa University, Pfizer

Yoko Aniya

University of the Ryukyus

Symposium

Symposium 1

June 16 (Wed) 9:30-12:00 Room2

S1

Toxicomics

Chairpersons:

Jun Kanno

Division of Cellular and Molecular Toxicology, Biological Safety Research Center, National Institute of Health Sciences

Takao Yamori

Division of Molecular Pharmacology, Cancer Chemotherapy Center, Japanese Foundation for Cancer Research

S1-1

Systems biology approach to the toxicomics

Hiroaki Kitano

The Systems Biology Institute / Okinawa Institute of Science and Technology

S1-2

The cancer cell panel informatics for toxicomics

Takao Yamori

Division of Molecular Pharmacology, Cancer Chemotherapy Center, Japanese Foundation for Cancer Research

S1-3

Computational analyses of a large-scale toxicogenomics database for identification of safety biomarkers

○Yohsuke Minowa, Hiroshi Yamada

Toxicogenomics Informatics Project, Department of Biomedical Research, National Institute of Biomedical Innovation

S1-4

Current status and future prospect of percellome embryo-fetal toxicogenomics

○Satoshi Kitajima, Yuhji Taquahashi, Katsuhide Igarashi,
Kenichi Aisaki, Jun Kanno

Division of Cellular and Molecular Toxicology, Biological Safety Research Center, National Institute of Health Sciences

S1-5

Application of percellome toxicogenomics informatics for the toxicity prediction of food and food additive

○Jun Kanno, Satoshi Kitajima, Yuhji Taquahashi,
Katsuhide Igarashi, Kenichi Aisaki

Division of Cellular and Molecular Toxicology, Biological Safety Research Center, National Institute of Health Sciences

Symposium 2

June 16 (Wed) 9:30-12:00 Room3

S2

Toxicity-onset induced by compound and its circumvent:
Approach from the aspect of structure–toxicity-relationship

Chairpersons:

Kunitoshi Mitsumori

Tokyo University of Agriculture and Technology

Ikuo Horii

Showa University, Pfizer

S2-1

Toxicity data base and prediction of toxicity (1): database building

Takashi Yamada

National Institute of Technology and Evaluation

S2-2

Toxicity data base and prediction of toxicity (2): Utilization of database

Makoto Hayashi

Biosafety Research Center Foods, Drugs and Pesticides

S2-3

Chemical modification for toxicity circumvent

Chikara Uchida

Mitsubishi Tanabe Pharma

S2-4

Metabolism prediction for toxicity circumvent

Yashushi Yamazoe

Tohoku University

Symposium 3

June 16 (Wed) 13:45-17:15 Room1

S3

Challenge of clinical risk minimization through nonclinical & clinical joint discussion for betterpharmacovigilance-toward consolidated safety evaluation from preclinical and clinical perspectives-How should toxicologists interpret adverse reactions in cooperation with safety physicians?

Chairpersons:

Junko Sato

Pharmaceutical & Medical Devices Agency Director for Risk Management Director for Safety Measure Coordination Office of Safety II

E. Stewart Geary

Eisai Co., Ltd. Deputy Director Corporate Regulatory Compliance and Quality Assurance Headquarters

Masaru Iwasaki

GlaxoSmithKline Vice President Development & Medical Affairs Division

Kazuo Tsukidate

Eisai Co., Ltd. Director Drug Safety & Disposition

Kyoko Barata

Kyowa Hakko Kirin Co., Ltd. Drug Safety Management Department Pharmacovigilance and Quality Assurance Division

S3-1

Main message of symposium "Pharmacovigilance"
The Japanese Association of Pharmaceutical Medicine (JAPhMed) & Safety Evaluation Forum / Pharmacovigilance WG (SEF/PV-WG)

S3-2

Possible nonclinical and clinical approaches for pharmacology-related elevations of blood transaminase activities without findings indicative of frank hepatotoxicity: a discussion based on experiences during clinical decelopment of drug candidates

○Motomu Tan (1), Shoichiro Sugai (2), Takeshi Nagata (3)

(1) Pharmaceutical Information Department, Japan Tobacco Inc.

(2) Toxicology Research Laboratories, Central Pharmaceutical Research Institute, Japan Tobacco Inc.

(3) Clinical Research Planning Department, Japan Tobacco Inc.

S3-3

A system biology* study on drug-induced liver injury: The case of ximelagatran

Osamu Ohgoda

Preclinical Science department, R&D, AstraZeneca K.K.

* To understand complex biological systems requires the integration of experimental and computational research - in other words a systems biology approach.

S3-4

A review of the concordance of toxicity of pharmaceuticals in humans and animals

William M. Bracken

Director, Global Preclinical Safety, Abbott Laboratories

S3-5

Discussion

Symposium 4

June 16 (Wed) 14:30-17:00 Room4

S4

Research and development of bio-resources from Okinawa islands

Chairpersons:

Shizuo Narimatsu

Okayama University

Akira Naganuma

Tohoku University

S4-1

Cancer treatments: can we find treasures at the bottom of the Okinawan sea?

Chie Ishikawa

Transdisciplinary Research Organization for Subtropics and Island Studies, University of the Ryukyus

S4-2

A sleep improvement effect of Akinowasuregusa (Hemerocallis fulva L. var. sempervirona M. Hotta)

Eiko Uezu

Department of Health and Nutritional Science, Faculty of Education, University of the Ryukyus

S4-3

Anti-obesity activity of Okinawan herb Peucedanum japonicum Thunb

Hirosuke Oku

Molecular Biotechnology group, Tropical Biosphere Research Center, University of the Ryukyus

S4-4

Reserch and development of fermented bagasse (dietary fiber of new materials from sugar cane); As a prevention of metabolic syndrome

Naoshi Inafuku

Ryukyu bio-Resource Development Co., Ltd.

S4-5

Study of Bidens pilosa (Bidens pilosa L.var.radiata Scherff)

Yoshinori Sakurai

Musashino Research Institute for Immunity Co., Ltd.

Symposium 5

June 17 (Thu) 9:30-12:00 Room3

S5

Mitochondria-mediated toxicity

Chairpersons:

Yoko Aniya

University of the Ryukyus

Yasushi Yamazoe

Tohoku University

S5-1

Introduction: Role of mitochondria in drug-induced toxicity

Urs A. Boelsterli

University of Connecticut School of Pharmacy

S5-2

The mitochondrial permeability transition in apoptotic and necrotic cell death

John J. Lemasters

Medical University of South Carolina

S5-3

Mitochondria-mediated neurotoxicity in Alzheimer's disease

○Kazuhiro Takuma (1) and Toshio Matsuda (1), (2)

(1) Laboratory of Medicinal Pharmacology, Graduate School of Pharmaceutical Sciences, Osaka University

(2) Center for Child Mental Development, Graduate School of Medicine, Osaka University

S5-4

Evaluation of mitochondrial injury in preclinical safety assessment

○Takashi Yamoto (1), Atsushi Sanbuissho (1),
Sunao Manabe (2)

(1) Medicinal Safety Research Laboratories, Daiichi Sankyo Co., Ltd.

(2) Global Project Management Department, Daiichi Sankyo Co., Ltd.

S5-5

Oxidants-induced mitochondrial permeability transition

Yoko Aniya

University of the Ryukyus

Symposium 6

June 17 (Thu) 14:30-17:00 Room2

S6

Safety evaluation of drug metabolites

Chairpersons:

Shinsaku Naito

Otsuka Pharmaceutical Factory, Inc.

Tsuyoshi Yokoi

Faculty of Pharmaceutical Sciences, Kanazawa University

S6-1

Approaches for the prediction of metabolism-mediated drug-induced liver injury

Tsuyoshi Yokoi

Faculty of Pharmaceutical Sciences, Kanazawa University

S6-2

Non-clinical safety evaluation of drug metabolites: Efforts toward the drug discovery and development

  Koji Takekawa (1), (2)

(1) Mitsubishi Tanabe Pharma Corporation

(2) Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufactures Association

S6-3

Safety evaluation of metabolites and related guidelines of FDA and ICH

Yasuo Ohno

National Institute of Health Sciences

S6-4

Preclinical safety evaluation of drug metabolites: Current opinion of Japanese regulatory

Kenji Nakano

Pharmaceuticals and Medical Devices Agency

S6-5

Discussion and Conclusion

Symposium 7

June 18 (Fri) 9:00-11:30 Room2

S7

Evolution of new assessment methods for developmental neurotoxicity

Chairperson:

Chiharu Tohyama

Lab. Environ. Health Sci., Grad. School of Med., Univ. of Tokyo

S7-1

Developmental neurotoxicity by environmental chemicals

Noriyuki Koibuchi

Department of Integrative Physiology, Gunma University Graduate School of Medicine

S7-2

Effects of perinatal exposure to environmental chemical compounds on development of emotional and social behavior

○Sonoko Ogawa, Toshiro Sakamoto

Laboratory of Behavioral Neuroendocrinology, Graduate School of Comprehensive Human Sciences, University of Tsukuba

S7-3

The role of activity-dependent gene expression and morphological plasticity in the control of neuronal circuitry

Haruhiko Bito

Department of Neurochemistry, Graduate School of Medicine, University of Tokyo

S7-4

Novel cognitive behavioral toxicity test methods with a novel microscopic approach to explain molecular basis of behavioral changes

Masaki Kakeyama

Laboratory of Environmental Health Sciences, Center for Disease Biology and Integrative Medicine, Graduate School of Medicine, The University of Tokyo

Symposium 8

June 18 (Fri) 13:45-16:15 Room2

S8

Environmental risk assessment of pharmaceuticals: Current situation and challenges

Chairpersons:

Tetsuji Nishimura

National Institute of Health Sciences

Fumio Sagami

Japan Pharmaceutical Manufacturers Association, Eisai Co., Ltd.

S8-1

Introduction

Fumio Sagami

Japan Pharmaceutical Manufacturers Association, Eisai Co., Ltd.

S8-2

Environmental risk assessment of pharmaceuticals in the US/EU --- current regulatory situation and compliance overview

Keith C. Silverman

Merck & Co., Inc

S8-3

Approach of environmental risk assessment of pharmaceuticals in Japan

Tetsuji Nishimura

National Institute of Health Sciences

S8-4

A possibility of WET as the barometer of the environmental impact

Norihisa Tatarazako

National Institute for Environmental Studies, Research Center for Environmental Risk

S8-5

Environmental risk assessment/management of pharmaceuticals in Japan: Industry's thoughts

Yasuyoshi Azuma

Japan Pharmaceutical Manufacturers Association, AstraZeneca KK

S8-6

Discussion and Conclusion

Workshop

Workshop 1

June 16 (Wed) 13:45-16:15 Room2

W1

Roles of microRNAs in toxicology

Chairpersons:

Takemi Yoshida

School of Pharmacy, Showa University

Miki Nakajima

Faculty of Pharmaceutical Sciences, Kanazawa University

W1-1

Regulation of cytochrome P450s by microRNA

Miki Nakajima

Faculty of Pharmaceutical Sciences, Kanazawa University

W1-2

Role of micro RNA in testicular toxicity and future vision – Effect of EGME (ethylenglycol monomethylether) on microRNA expression in rat testis-

Tamio Fukushima

Shionogi Co,ltd. Drug Safety Evaluation, School of Pharmacy, Showa University

W1-3

Changes in micro RNA expression-Role of microRNA in placenta toxicity

Kenji Taki

Pfizer Japan Inc. (Drug Safety R&D, Pfizer Global R&D)

W1-4

Alteration of micro RNAs expression in anticancer drug-resistance cells

Yoshihiko Shibayama

Kagoshima University Hospital, Division of Pharmacy

W1-5

Summary
Changes in micro RNAs and its roles in toxic actions

Takemi Yoshida

School of Pharmacy, Showa University

Workshop 2

June 16 (Wed) 13:45-16:45 Room3

W2

Assessment of toxicity in recent primate research

Chairpersons:

Taketoshi Saijo

SNBL, Ltd.

Mamoru Nomura

Ina Research Inc.

W2-1

Current status and possibility of the future for use of non-human primates as laboratory animals

○Katsuhiro Fukunishi, Yumiko Shibota, Takuji Hara and
Taketoshi Saijo

Shin Nippon Biomedical Laboratories (SNBL), Ltd.

W2-2

Biologics risk assessment in nonhuman primates and opportunity of alternative approaches

○Kazuto Watanabe, Takayuki Sakurai

Chugai Pharmaceutical Co., LTD. Research Division, Safety Assessment Dept.

W2-3

Non-human primate major histocompatibility complex (MHC) and disease models

○Sakae Kohara，Naoto Horai，Takahiro Nakamura

Shin Nippon Biomedical Laboratories (SNBL), Ltd.

W2-4

The utility of gene expression analysis of cynomolgus monkeys by a DNA microarray

○Ryota Ise, Yasuhiro Uno

Shin Nippon Biomedical Laboratories (SNBL), Ltd.

W2-5

Incorporation of safety pharmacology test in the design of toxicity studies with monkeys

○Sou Wada, Tsunehiro Tanigawa, Yousuke Ochiai,
Makoto Hiroyasu, Norio Odagiri, Kiyoshi Wako,
Mayumi Obo, Masakazu Imaizumi, Kentarou Andou,
Hiroshi Atai, Yoshimasa Kurata, Keitarou Hashimoto

Mitsubishi Chemical Medience Corporation

W2-6

Utility of the Chronic Atrioventricular Block (AVB) Monkey as Proarrhythmic Model

○Yasue Sakaguchi (1), Kengo Sakamoto (1),
Mitsutsugu Ootani (1), Yoshio Wakasa (1),
Hiroshi Morikawa (1), Hiroko Miyazaki (1),
Atsushi Uematsu (1), Atsushi Sugiyama (2),
Mamoru Nomura (1)

(1) INA Research Inc.

(2) Yamanashi Research Center of Clinical Pharmacology

Workshop 3

June 17 (Thu) 9:00-12:00 Room2

W3

Cutting-edge on the safety assessment of biologics

Chairpersons:

Yoko Hirabayashi

Div. Cell. & Molecl. Tox., Center for Biol. Safery & Res. NIHS, Japan

Takahiro Nakazawa

Preclinical, Regulatory Affairs, Eli Lilly Japan

W3-1

Update of ICH S6 Guideline

Kazushige Maki

Office of Biologics I, Pharmaceutical & Medical Agency

W3-2

Preclinical Safety Assessment of Biopharmaceuticals in the U.S.A.

Ruth M Lightfoot-Dunn

Comparative Biology & Safety Sciences, Amgen Inc.

W3-3

Current situation of Biosimilar products in Japan-One year after the enforcement of the guideline-

Teruyo Arato

Office of Biologics I, Pharmaceuticals and Medical Devices Agency

W3-4

Quality and safety of advance therapy products, such as cell therapy and nucleotide products

Teruhide Yamaguchi

Division of Biological Chemistry and Biologicals, National Institute of Health Sciences

W3-5

Outline for the guideline on nonclinical evaluation of vaccines for protection against infectious diseases

Tomoko Ohsawa

Office of Biologics II, Pharmaceuticals and Medical Devices Agency

Workshop 4

June 17 (Thu) 14:30-17:00 Room3

W4

Evolution of in vitro drug-screening system exploiting human iPS cells and other pluripotent stem cells
- Unveiling in vitro innovation led by new findings in cells, hardware, and software -

Chairperson:

Sunao Manabe

Daiichi Sankyo Co., Ltd.

W4-1

Development of techniques to induce cardiomyocytes from human iPS cells
-Confirmation of cardiomyocyte function and potential translation from heart disease-derived human iPS cells to the techniques supporting drug discovery-

Keiichi Fukuda

Department of Regenerative Medicine and Advanced Cardiac Therapeutics, School of Medicine, Keio University

W4-2

Development of on-chip cellomics system: constructive cardiomyocyte network model and single-cell-based screening

Kenji Yasuda

Institute of Biomaterials and Bioengineering, Tokyo Medical and Dental University

W4-3

New strategy for preventing drug-induced long QT syndrome using human ES/iPS cell-derived cardiomyocytes

Atsushi Sugiyama

Department of Pharmacology, University of Yamanashi

W4-4

Human pluripotent stem cells for toxicology applications -Recent developments in hepatotoxicity-, cardiotoxicity-, and developmental toxicity testing

○Peter Sartipy, Petter Björquist, Raimund Strehl,
and Johan Hyllner

Cellartis AB

Workshop 5

June 18 (Fri) 9:00-11:30 Room3

W5

Progress in safety pharmacology evaluation of the cardio vascular system

Chairpersons:

Keiji Yamamoto

Development Research Center, Takeda Pharmaceutical Co., Ltd.

Atsushi Sugiyama

Department of Pharmacology, University of Yamanashi

W5-1

Integration of in silico and in vitro methods to avoid hERG blocking activity

○Mitsuyasu Tabo (1), Kiyoshi Hasegawa (2),
Masaki Honda (1), Masateru Ohta (2)

(1) Safety Assessment Dept.

(2) Discovery Platform Technology Dept., Chugai Pharmaceutical Co., Ltd.

W5-2

In vivo experimental approach for risk assessment of drug-induced long QT syndrome

○Katsuyoshi Chiba, Kiyoshi Takasuna, Atsushi Sanbuissho

Medical Safety Research Laboratories, Daiichi Sankyo Co., Ltd.

W5-3

Lorenz plots analysis for risk assessment of drug-induced QT prolongation in Cynomolgus Monkey

○Kentaro Ando (1), (2), Masayoshi Kuwahara (2),
Hirokazu Tsubone (1)

(1) Dept. of Comparative Pathophysiology, Graduate School of Agricultural and Life Sciences, The University of Tokyo

(2) Toxicological Science Division, Mitsubishi Chemical Medience Co.

W5-4

Non-clinical data for clinical cardiac safety trials -Present and future-

○Yuji Kumagai

Clinical Trail Center, Kitasato University East Hospital

Workshop 6

June 18 (Fri) 9:00-11:30 Room1

W6

Points to consider regarding the application of the ICH-S9 guideline for the development of anticancer pharmaceuticals

Chairpersons:

Dai Nakae

Tokyo Metropolitan Institute of Public Health

Shuichi Kai

SUGI Institute of Biological Science Co., Ltd

W6-1

Purpose of ICH-S9 guideline and notable deviations from other guidelines

Hiroshi Onodera and Osamu Fueki

Pharmaceuticals and Medical Devices Agency

W6-2

Interpretation and application of ICH-S9 guideline (1): Biotechnology-derived pharmaceuticals

James D Green

Biogen Idec, Inc.

W6-3

Interpretation and application of ICH-S9 guideline (2): Questions and answers

Shuichi Kai

SUGI Institute of Biological Science Co., Ltd

W6-4

Role of ICH-S9 guideline for clinical development of anticancer pharmaceuticals

Noritsugu Sakamoto

Banyu Pharmaceutical Co., Ltd.

W6-5

Discussion

Workshop 7

June 18 (Fri) 13:15-16:15 Room1

W7

The Question and Answer on Toxicity 2010

First session:

Risk assessment of drugs in mothers' milk

Chairpersons:

Kazuhiro Shimomura

Daiichi Sankyo Co., Ltd.

Kazuo Seki

Yokohama City University Medical Center

W7-1

The importance of breastfeeding for the mother and the infant

Kazuo Seki

Yokohama City University Medical Center

W7-2

The risk of an infant's exposure to a drug excreted in breast milk

Ken Nakajima

National Center for Child Health and Development

W7-3

Toxicity evaluation issues of drugs in milk

Kazuhiro Shimomura

Daiichi Sankyo Co., Ltd.

Second session:

Overview the technical term to interpretation of toxicities;
How to use these phases with toxicological background

Chairpersons:

Mutsumi Suzuki

Kyowa Hakko Kirin Co., Ltd.

Yuhji Taquahashi

National Institute of Health Sciences

W7-4

Overview

Yuhji Taquahashi

National Institute of Health Sciences

W7-5

Focus on evaluation of NOAEL

Junko Taketo

Chugai Pharmaceutical Co., Ltd.

W7-6

Focus on Pathological changes

○Mutsumi Suzuki (1), Ikuo Horii (2), (3)

(1) Kyowa Hakko Kirin Co., Ltd.

(2) Showa University

(3) Pfizer Inc.

Panel Discussion

Panel Discussion

June 18 (Fri) 13:15-15:45 Room4

PD

Regulatory acceptance using in vitro toxicology testing

Chairpersons:

Ikuo Horii

Showa University, Pfizer

Tohru Inoue

National Institute of Health Sciences

PD-1

OECD test guidelines on new skin sensitization and local irritation (skin or ocular) assays

Hajime Kojima

National Institute of Health Sciences

PD-2

Approach for the regulatory acceptance on alternative method developed by NEDO project

Noriho Tanaka

Hatano Research Institute, Food & Drug Safety Ctr.

PD-3

A role of in vitro genotoxicity testing for risk assessment

Masamitsu Honma

National Institute of Health Sciences

PD-4

Adoption of the in vitro screening method for the endocrine disrupting chemicals as the OECD guideline

Atsushi Ono

National Institute of Health Sciences