DIS (Directors Initiative Session) Symposium

DDS DIS (Symposium 3), Microphysiological System DIS (Symposium 2), New Modality DIS (Symposium 11), Regulation DIS (Symposium 10), Drug Metabolism and Drug Induced Toxicity DIS 1 (Symposium 1), Drug Metabolism and Drug Induced Toxicity DIS 2 (Symposium 5), Drug Metabolism and Drug Induced Toxicity DIS 3 (Symposium 6), Drug Efficacy and Safety DIS (Symposium 9), BioAnalysis and BioImaging DIS (Symposium 7), Systems Pharmacology DIS (Symposium 4), Transporter DIS (Symposium 12), MPS & SP DIS Joint (Symposium 8)

DDS DIS (Symposium 3)

14:30-17:00, Dec 10(Tue.), 2019 Room C (2F Conference Room 201)

Drug Delivery System Targeting to Blood Vessels

Overview

Drug delivery system (DDS) targeting to blood vessels is a feasible strategy to deliver drugs in a tissue- or a diseased site-specific manner. Because anatomical features and transport systems of blood vessels exhibit unique characteristics in specific tissues and diseases, clarifying the molecular mechanisms of vascular permeability is an important issue to develop the active drug targeting. In this symposium, fundamental and latest research topics on DDS targeting to blood vessels will be introduced by the experts on vascular pathophysiology, vascular engineering, molecular pharmaceutics, and DDS.

  • Organizer / Chair : Tatsuhiro Ishida
    Graduate School of Biomedical Sciences, Tokushima University
  • Chair : Masanori Tachikawa
    Graduate School of Biomedical Sciences, Tokushima University
  • SY-03-01 "Passive tumor targeting via EPR effect"
  • Speaker : Tatsuhiro Ishida
    Graduate School of Biomedical Sciences, Tokushima University
  • SY-03-02 "Heterogeneity of tumor blood vessels"
  • Speaker : Kyoko Hida
    Vascular Biology and Molecular Pathology, Graduate School of Dental Medicine, Hokkaido University
  • SY-03-03"Targeting of albumin to pancreatic cancer via endogenous albumin transport system"
  • Speaker : Yu Ishima
    Institute of Biomedical Sciences, Tokushima University
  • SY-03-04 "Blood-brain barrier-permeable proteins and transport characteristics in brain endothelial cells"
  • Speaker : Masanori Tachikawa
    Graduate School of Biomedical Sciences, Tokushima University
  • SY-03-05 "Microfluidic device for reproduction of in vivo microenvironment with three-dimensional vascular structure"
  • Speaker : Kenichi Funamoto
    Institute of Fluid Science, Tohoku University

Microphysiological System DIS (Symposium 2)

14:30-17:00, Dec 10(Tue.), 2019 Room A (2F Main Convention Hall)

Evolution of in vitro barrier tissue models by microphysiological systems

Overview

Microphysiological systems (MPSs), also known as organ(s)-on-a-chip, recapitulate the microenviroment of cells and are expected to be an important contribution to drug discovery. The Directors Initiative Section of the MPS has been encouraging interaction between academics, who are developing new MPSs, and the pharmaceutical industry, who will apply these technologies to drug discovery, since 2017. The symposium in 2019 focuses on barrier tissue models such as those of the small intestine, blood-brain barrier, and skin, and will examine cutting-edge topics on these organ models, supporting materials and culture devices, and their applications.

  • Organizer / Chair : Kazuhiro Tetsuka
    Analysis & Pharmacokinetics Research Laboratories, Astellas Pharma Inc.
  • Chair : Masatoshi Tomi
    Faculty of Pharmacy, Keio University
  • SY-02-01 "Development of a conditionally immortalized cell-based human blood-brain barrier model for CNS drug development"
  • Speaker : Tomomi Furihata
    Department of Clinical Pharmacy and Experimental Therapeutics, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences
  • SY-02-02 "Engineering of iPSC-based Organs-on-Chips to model intestinal function"
  • Speaker : Yu-suke Torisawa
    The Hakubi Center for Advanced Research & Department of Micro Engineering, Kyoto University
  • SY-02-03 "Fabrication of epithelial and endothelial barrier tissue models utilizing a collagen vitrigel membrane and their application to the system for predicting ADME/Tox of chemicals"
  • Speaker : Toshiaki Takezawa
    Institute of Agrobiological Sciences, National Agriculture and Food Research Organization
  • SY-02-04 "Nephrotoxicity, kidney transport, and disease modelling on organotypic kidney-on-a-chip models"
  • Speaker : Henriëtte Lanz
    MIMETAS B.V.
  • SY-02-05 "Development of proximal tubule-on-a-chip: fluid shear stress stimulates MATE2-K expression via Nrf2 pathway activation"
  • Speaker : Yasunori Fukuda
    Rare Disease Medical, Sanofi K.K.

New Modality DIS (Symposium 11)

13:15-15:45, Dec 12(Thu.), 2019 Room C (2F Conference Room 201)

Contribution of Pharmacokinetic Approach to Peptide-based Therapeutics

Overview

Recently, peptide-based therapeutics such as cyclic peptides have been proceeded, established a new position as one of new modality pharmaceuticals. In this symposium, the most recent research has been introduced and discussed in view of Pharmacokinetic contribution in this area.

  • Organizer / Chair : Takashi Kuwabara
    Laboratory of Biologics evaluation,Yokohama University of Pharmacy
  • Chair : Kazuhisa Ozeki
    Research Division, Chugai Pharmaceutical Co., Ltd
  • SY-11-01 "Pharmacokinetic control of bioactive peptides upon DDS approaches"
  • Speaker : Satomi Onoue
    Laboratory of Biopharmacy, School of Pharmaceutical Sciences, University of Shizuoka
  • SY-11-02 "Introduction of a modified membrane permeability assay considering intracellular distribution"
  • Speaker : Yuji Sakurai
    Laboratory of Biopharmacy, School of Pharmaceutical Sciences, University of Shizuoka
  • SY-11-03 "Crucial Transporters for Cyclic Peptide Drugs Discovery"
  • Speaker : Yasuto Kido
    Drug Metabolism & Pharmacokinetics, Research Laboratory for Development, Shionogi & Co.,Ltd
  • SY-11-04 "Peptide-based Carriers for drug delivery into cells and brain"
  • Speaker : Toshihide Takeuchi
    Osaka University Graduate School of Medicine

Regulation DIS (Symposium 10)

13:15-15:45, Dec 12(Thu.), 2019 Room A (2F Main Convention Hall)

Physiologically based pharmacokinetic model: Utilization of PBPK modeling and simulation in the drug development or approval review and current status on regulatory documents in the US, EU and Japan

Overview

The number of PBPK model-informed drug development and regulatory submission has recently been increasing. Quantitative predictions by PBPK modeling and simulation (M&S) can give useful information in the decisions on how to conduct certain clinical studies, interpretation or application of study results. Appropriate PBPK analyses can be utilized to support dosing recommendations and product label. In 2018, FDA and EMA issued regulatory guidance/guideline on PBPK analyses*. Also, the draft guideline has been developed in Japan. In this symposium, Utilization of PBPK M&S information and regulatory documents in the US, EU and Japan are presented and discussed.

  • Physiologically Based Pharmacokinetic Analyses-Format and Content (Final guidance, 2018/9/4)
    Guideline on the reporting of physiologically based pharmacokinetic modeling and simulation (2018/12/13)
  • Organizer : Naomi Nagai
    Musashino University
  • Chairs : Akihiro Ishiguro
    Office of Research Promotion, Center for Regulatory Science Pharmaceuticals and Medical Devices Agency (PMDA)
  •  Daisuke Nakai
    Daiichi Sankyo Co., Ltd.
  • SY-10-01 "Utilizing drug information from physiologically-based Pharmacokinetic modeling"
  • Speaker : Kosuke Doki
    Department of Pharmaceutical Sciences, Faculty of Medicine, University of Tsukuba
  • SY-10-02 "Current Status and Future Challenges in Quantitative Prediction by Physiologically-Based Pharmacokinetic Modeling: Case Studies of New Molecule Entities"
  • Speaker : Shinji Yamazaki
    Pharmacokinetics, Dynamics & Metabolism, Pfizer Worldwide Research & Development, San Diego, California, USA
  • SY-10-03 "PK and DDI evaluation in alignment with the EMA guideline document on qualification of PBPK modeling and simulations"
  • Speaker : Kenichi Umehara
    Pharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel
  • SY-10-04 "Current state of new drug review utilizing PBPK modeling and developing PBPK modeling guideline"
  • Speaker : Shinichi Kijima
    Pharmaceuticals and Medical Devices Agency, Office of Advanced Evaluation with Electronic Data

Drug Metabolism and Drug Induced Toxicity DIS 1 (Symposium 1)

9:30-11:45, Dec 10(Tue.), 2019 Room B (2F Convention Hall 200)

Pharmacokinetics and toxicity development in the skin

Overview

Our knowledge of metabolic enzymes and transporters is delayed compared to major clearance organs such as liver and kidney. There have also been some reports that accumulation of the parent compound or metabolite in the skin resulted in toxicity. Thus, it is important to understand the local dynamics of the skin based on its anatomical characteristics and factors involved in the distribution and metabolism of drug molecules. The skin is also known to be highly immunoreactive, and characteristic cellular responses and signaling pathways may be involved in the development of skin toxicity. This symposium aims to understand the mechanisms of the development of toxicity in the skin, both in terms of local pharmacokinetics and toxicological features.

  • Organizers : Miki Nakajima
    Drug Metabolism and Toxicology, Faculty of Pharmaceutical Sciences, Kanazawa University
  •  Kousei Ito
    Laboratory of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Chiba University
  • Organizer / Chair : Satoshi Yamaori
    Department of Pharmacy, Shinshu University Hospital
  • Chair : Shigeki Aoki
    Laboratory of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Chiba University
  • SY-01-01 "The interaction of tyrosine kinase inhibitors with keratinocytes and its dermal toxicity in humans"
  • Speaker : Yusuke Masuo
    Faculty of Pharmacy, Institute of Medical, Pharmaceutical, and Health Sciences, Kanazawa University
  • SY-01-02 "Drug-induced phototoxicity: prediciction and de-risking"
  • Speaker : Satomi Onoue
    Laboratory of Biopharmacy, School of Pharmaceutical Sciences, University of Shizuoka
  • SY-01-03 "Susceptibility to serious skin and subcutaneous tissue disorders and skin tissue distribution of sodium-dependent glucose co-transporter type 2 (SGLT2) inhibitors"
  • Speaker : Toshiyuki Sakaeda
    Department of Pharmacokinetics, Kyoto Pharmaceutical University
  • SY-01-04 "Role of STAT3 in hand-foot skin reaction induced by multi-targeted tyrosine kinase inhibitors"
  • Speaker : Kazuhiro Yamamoto
    Department of Pharmacy, Kobe University Hospital

Drug Metabolism and Drug Induced Toxicity DIS 2 (Symposium 5)

9:30-11:45, Dec 11(Wed.), 2019 Room C (2F Conference Room 201)

Mechanism and prediction of down-regulation of drug-metabolizing enzymes

Overview

Drug-metabolizing enzymes are mainly known to be induced by transcriptional activation, and the cut-off criteria are defined in the guidelines for its evaluation in the drug development. On the other hand, in cases of the down-regulation by drugs, the detailed mechanism is not fully understood, and even in the "DDI guidelines" shown in 2018 only recommended to consider clinical drug interaction studies. In addition, down-regulation of drug-metabolizing enzymes is known to affect pharmacokinetics even by physiological changes in the body. In this symposium, we would like to discuss in vitro/in vivo assessment and mechanism to predict down-regulation of drug-metabolizing enzymes in humans.

  • Organizer : Miki Nakajima
    Drug Metabolism and Toxicology, Faculty of Pharmaceutical Sciences, Kanazawa University
  • Organizers / Chairs : Kaoru Kobayashi
    Laboratory of DDS Design and Drug Disposition, Graduate School of Pharmaceutical Sciences, Chiba University
  •  Seigo Sanoh
    Department of Neurochemistry and Environmental Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University
  • SY-05-01 "Evaluation of in vitro CYP1A2 down-regulation using cryopreserved human hepatocytes"
  • Speaker : Chihiro Ishida
    Graduate School of Biomedical and Health Sciences, Hiroshima University / Pharmacokinetics and Safety Assessment Dept., Discovery Research Labs, Nippon Shinyaku Co., Ltd.
  • SY-05-02 "Cytochrome P450 induction and down-regulation in human hepatocytes at the lead-optimization stage of drug development"
  • Speaker : Mika Nagai
    Department of Pharmacokinetics and Safety, Drug Research Center, Kaken Pharmaceutical Co., Ltd.
  • SY-05-03"Prediction and analysis for down-regulation of drug metabolizing enzymes: Utility of 3D-cultured cells"
  • Speaker : Kaoru Kobayashi
    Laboratory of DDS Design and Drug Disposition, Graduate School of Pharmaceutical Sciences, Chiba University
  • SY-05-04 "Regulation of human drug metabolizing enzymes by two prevalent post-transcriptional modifications, A-to-I editing and methylation of adenosine"
  • Speaker : Masataka Nakano
    Drug Metabolism and Toxicology, Faculty of Pharmaceutical Sciences, Kanazawa University
  • SY-05-05 "The influence of drug administration during pregnancy evaluated from the pharmacokinetic analysis of embryo"
  • Speaker : Wataru Ochiai
    Department of Clinical Pharmacokinetics, School of Pharmacy and Pharmaceutical Sciences, Hoshi University

Drug Metabolism and Drug Induced Toxicity DIS 3 (Symposium 6)

9:45-11:45, Dec 12(Thu.), 2019 Room A (2F Main Convention Hall)

Challenges of ADME and safety research for "beyond rule of 5" chemical drug discovery

Overview

The drug discovery of middle molecule drugs (beyond rule of 5 chemicals) have received a lot of attention in recent years. The challenges in drug metabolism, pharmacokinetics and safety research for peptide and nucleotide drugs will be discussed in this symposium.

  • Organizer : Miki Nakajima
    Drug Metabolism and Toxicology, Faculty of Pharmaceutical Sciences, Kanazawa University
  • Organizers / Chairs : Shin-ichi Inoue
    Drug Metabolism & Pharmacokinetics Research Laboratories, Daiichi Sankyo Co., Ltd
  •  Tetsuya Nakagawa
    Preclinical Research Unit, Sumitomo Dainippon Pharma Co.,Ltd.
  • SY-06-01 "Drug discovery approach to challenging targets with ligands beyond Lipinski’s rule-Improvement of R&D productivity by AI-based activity prediction system-"
  • Speaker : Hirotsugu Komatsu
    Interprotein Corporation
  • SY-06-02 "Development of orally delivered biopharmaceuticals using the small intestine-permeable cyclic peptide"
  • Speaker : Shingo Ito
    Department of Pharmaceutical Microbiology, Faculty of Life Sciences, Kumamoto University
  • SY-06-03 "Contribution of DMPK researcher on antisense oligonucleotide drug discovery and development: A preclinical pharmacokinetics study"
  • Speaker : Syunsuke Yamamoto
    Drug Metabolism & Pharmacokinetics Research Laboratories, Research, Takeda Pharmaceutical Company Limited
  • SY-06-04 "Mechanistic investigation of RNaseH1-dependent hepatotoxicity caused by gapmer antisense oligonucleotides"
  • Speaker : Ayahisa Watanabe
    Research Laboratory for Development, Pharmaceutical Research & Development Division, Shionogi & Co., Ltd.

Drug Efficacy and Safety DIS (Symposium 9)

9:30-11:45, Dec 12(Thu.), 2019 Room D (1F Conference Room 101)

System biological approaches for development of pharmacological and diagnostic biomarkers

Overview

Identification of safety and efficacy biomarkers that are associated with clinical outcomes, as well as development of highly predictive simulation techniques, will improve the likelihood of successful drug development, shorten the time spent on research and development, and improve treatment outcomes in pharmacotherapy. In this symposium, we will discuss the topic of biomarker discovery with presentations focusing on "how to best utilize system biology research to discover biomarkers of the treatment effect and diagnosis".

  • Organizer / Chair : Satoru Koyanagi
    Kyushu University, Faculty of Pharmaceutical Sciences
  • Chair : Masanori Tachikawa
    Tokushima University, Institute of Biomedical Sciences
  • SY-09-01 "Finding novel aspects of drugs with profile data analysis and possibilities utilizing the outcomes for understanding diseases"
  • Speaker : Tadahaya Mizuno
    Graduate School of Pharmaceutical Sciences, The University of Tokyo
  • SY-09-02 "Development and application of arrhythmic hazard map under multiple ion channel block using heart simulator"
  • Speaker : Jun-Ichi Okada
    Future Center Initiative, The University of Tokyo
  • SY-09-03 "Linkage between metabolome properties and cancer drug resistance"
  • Speaker : Hiromi Sato
    Clinical Pharmacology and Pharmacometrics, Graduate School of Pharamceutical Sciences, Chiba University
  • SY-09-04 "Biomarker Search for Major Depressive Disease by Metabolomics Approach"
  • Speaker : Dongchon Kang
    Department of Clinical Chemistry and Laboratory Medicine, Kyushu University Graduate School of Medical Sciences
  • SY-09-05 "Exploration of the biomarkers for kidney diseases using chiral amino acid metabolomics"
  • Speaker : Tomonori Kimura
    National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN)

BioAnalysis and BioImaging DIS (Symposium 7)

9:45-11:45, Dec 12(Thu.), 2019 Room B (2F Convention Hall 200)

Advanced analytical techniques and technologies for pharmacokinetic evaluation of new modality drugs

Overview

Small-molecule compounds have for a long time been the mainstay of therapeutics, but in recent years, large-molecule therapeutics, represented by antibodies and chimeric proteins, are among the top sales of pharmaceuticals worldwide. In addition, the modalities of therapeutics are rapidly diversifying, such as nucleic acids and cells. With this situation, analytical techniques required for pharmacokinetic evaluation of such new modalities have also been complicated and advanced. This symposium presents the state-of-the-art analytical and analytical techniques required for these pharmacokinetic evaluations, focusing on nucleic acids, antibodies and cellular therapeutics.

  • Chair : Kosuke Saito
    Section Chief, Division of Medical Safety Science, National Institute of Health Sciences
  • Organizer / Chair : Junji Komaba
    Pharmacokinetic Research Laboratories, Ono Pharmaceutical Co.,Ltd
  • SY-07-01 "In vivo fluorescence imaging of transplanted stem cells labeled with quantum-nano materials for regenerative medicine"
  • Speaker : Hiroshi Yukawa
    Institute of Nano-Life-Systems, Institutes of Innovation for Future Society, Nagoya University
  • SY-07-02 "In vivo PET imaging and Radiolabeling techniques of Antibodies and Cells for therapeutic biologics"
  • Speaker : Takanori Sasaki
    Collaborative Research Center for Okayama Medical Innovation Center (OMIC), Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
  • SY-07-03 "Recent progress of bioanalysis of oligonucleotides and consideration on regulatory interaction"
  • Speaker : Takefumi Gemba
    Clinical & Regulatory Strategy, Covance Japan Co., Ltd.
  • SY-07-04 "Bioanalytical challenges for the quantification of total and free therapeutic antibodies: Points to consider for the PK/PD evaluation"
  • Speaker : Ichio Onami
    Research division, Fuji-Gotemba Laboratories, Chugai Pharmaceutical Co., Ltd.

Systems Pharmacology DIS (Symposium 4)

9:30-11:45, Dec 11(Wed.), 2019 Room A (2F Main Convention Hall)

Systems modeling in next 10 years

Overview

These days "reverse translational" research has been actively conducted with the use of vast amounts of clinical data and human biological specimen because the uncertainty in clinical predictability is becoming more increased with the increase in complexities of disease and growing diversities of modalities. The effective use of data/information newly obtained from such research activities would be indispensable to predict drug concentrations accurately in human tissues/organs and to deepen our understanding of pathophysiological processes quantitatively, which could lead to a breakthrough for efficient and rationalized drug discovery and development.

In this symposium, development and utilization of systems modeling approaches to date will be recapitulated, then future perspectives of the development of systems modeling based on effective use of translational research using human biomaterial and data science will also be discussed.

  • Organizer : Yasuhisa Nagasaka
    Quantitative Systems Pharmacology, Analysis & Pharmacokinetics Research Laboratories, Astellas Pharma Inc.
  • Chairs : Koji Chiba
    Laboratory of Clinical Pharmacology, Yokohama University of Pharmacy
  •  Takayo Ueno
    Department of Clinical Pharmacology Strategy, Bristol-Myers Squibb K.K.
  • SY-04-01 "Overview of systems modeling development during the past 10 years" (tentative)
  • Speaker : Donald E. Mager
    University at Buffalo, The State University of New York
  • Chairs : Hiroto Hatakeyama
    Laboratory of Clinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba University
  •  Tsuyoshi Minematsu
    Quantitative Systems Pharmacology, Analysis & Pharmacokinetics Research Laboratories, Astellas Pharma Inc.
  • SY-04-02 "Drug repositioning and target finding based on clinical evidence"
  • Speaker : Shuji Kaneko
    Department of Molecular Pharmacology, Graduate School of Pharmaceutical Sciences, Kyoto University
  • Chairs : Teruki Hamada
    Axcelead Drug Discovery Partners, Inc.
  •  Ryoko Sawamura
    Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd.
  • SY-04-03"Virtual clinical trial using QSP model and its case study"
  • Speaker : Takuya Miyano
    Biomarker & Translational Research Department, Daiichi Sankyo Co., Ltd.
  • Chairs : Masayo Oishi
    Quantitative Systems Pharmacology, Analysis & Pharmacokinetics Research Laboratories, Astellas Pharma Inc.
  •  Yasuhisa Nagasaka
    Quantitative Systems Pharmacology, Analysis & Pharmacokinetics Research Laboratories, Astellas Pharma Inc.
  • SY-04-04 "Integrated use of QSP (PBPK) and MPS; Current status, issues and future perspectives"
  • Speaker : Amin Rostami-Hodjegan
    Centre for Applied Pharmacokinetic Research, University of Manchester, UK / Certara, Princeton, New Jersey, USA.

Transporter DIS (Symposium 12)

13:45-15:45, Dec 12(Thu.), 2019 Room D (1F Conference Room 101)

Transporters at the crossroads of physiology, pathology, and drug development

Overview

Transporters play key roles in not only drug disposition, but also many aspects of human health, and are being exploited as possible drug targets for specific diseases. This DIS provides the platform for JSSX members to discuss in depth the latest insights presented by leading scientists in this research area, focusing on the pathophysiological function of transporters, and their involvement in oxidative stress and diseases. The future scope and prospects in transporter research will be also discussed.

  • Organizer / Chair : Katsuhisa Inoue
    School of Pharmacy, Tokyo University of Pharmacy and Life Sciences
  • Chair : Kazuya Maeda
    Graduate School of Pharmaceutical Sciences, The University of Tokyo
  • SY-12-01 "The xenobiotic transporter Mdr1 directs T cell adaptation to bile acids in the ileum"
  • Speaker : Hisako Kayama
    Institute for Advanced Co-Creation Studies, Osaka University
  • SY-12-02 "Blood-brain barrier P-glycoprotein activation as a new potential therapy of brain infarct"
  • Speaker : Yasuo Uchida
    Graduate School of Pharmaceutical Sciences, Tohoku University
  • SY-12-03 "Mechanism of the uptake of naked single-stranded oligonucleotides into living cells"
  • Speaker : Masayuki Takahashi
    Research Institute for Healthy Living, Niigata University of Pharmacy and Applied Life Sciences
  • SY-12-04 "Clinical impact on the role of parathyroid hormone in regulating ABCG2 and CYP3A"
  • Speaker : Hiroshi Watanabe
    Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University

MPS & SP DIS Joint (Symposium 8)

9:30-11:45, Dec 12(Thu.), 2019 Room C (2F Conference Room 201)

Impact of complemental use of Micro-Physiological Systems and Systems Modeling with in vitro-in vivo translation on drug discovery and development -current status and future perspective-

Overview

In recent years, modalities associated with drug candidates become much more diverse and shifted from small molecules to antibodies, viruses, synthetic nucleotides or cells and so on. Accordingly, the difficulty and cost of developing new drug candidates has been elevated to a new level as each candidate may require a different path. Therefore, employing new techniques to increase the predictability of response to new drug candidates in humans has become critical as a decision support to proceed from drug discovery to development. Such attempts often involve constructing representative in silico models of human biology in health and disease. These models are sophisticated and complex but more importantly they require relevant data from human samples in most physiological conditions possible. Micro-Physiological System (MPS) are, therefore, a natural companion for Quantitative Systems Pharmacology (QSP) models. The latter are sets of mathematical equations put together in pharmaceutical industries or academia that integrates known relationships between the components of the human body (pathways, receptors, channels, immunology and their interplay within the whole physiology and anatomical space). In order to characterize human biological responses to drugs quantitatively, it is indispensable to develop methodologies for in vitro-in vivo translation enabling complementary utilization of MPS and QSP.

In this symposium, we would like to discuss how to integrate these new technologies effectively, referring to recent progress, foreseen hurdles and longer-term horizon in the fields associated with MPS and QSP research.

  • Organizers / Chairs : Amin Rostami-Hodjegan
    Centre for Applied Pharmacokinetic Research, University of Manchester, UK / Certara, Princeton, New Jersey, USA.
  •  Shuichi Sekine
    Shiseido Co. Ltd., Global Innovation Center
  •  Yasuhisa Nagasaka
    Quantitative Systems Pharmacology, Analysis & Pharmacokinetics Research Labs, Astellas Pharma Inc.
  • SY-08-01 "Translation from In Vitro to In Vivo: Why it is not that simple?"
  • Speaker : Amin Rostami-Hodjegan
    Centre for Applied Pharmacokinetic Research, University of Manchester, UK / Certara, Princeton, New Jersey, USA.
  • SY-08-02 "Gut/liver microphysiological system for quantitative analysis of drug sequential metabolism and interorgan interaction"
  • Speaker : Yukio Kato
    Department of Molecular Pharmacotherapeutics, Faculty of Pharmacy, Kanazawa University
  • SY-08-03 "Prediction of Transporter-Mediated Disposition Using Primary Human Hepatocytes"
  • Speaker : Emi Kimoto
    ADME Sciences, Medicine Design, Pfizer Inc., Groton, CT, USA
  • SY-08-04 (IL 3) "Merging human microphysiological systems with quantitative systems pharmacology for in vitro in vivo translation (IVIVT)"
  • Speaker : Murat Cirit
    Javelin Biotech, Inc., USA.