PROGRAM
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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 |