PROGRAM

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  • Luncheon Seminar / Evening Seminar

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