DIS (Directors Initiative Session) Symposium

DDS DIS Symposium, Microphysiological System DIS Symposium, New Modality DIS Symposium, Regulation DIS Symposium, Drug Metabolism and Drug Induced Toxicity DIS Symposium 1, Drug Metabolism and Drug Induced Toxicity DIS Symposium 2, Drug Metabolism and Drug Induced Toxicity DIS Symposium 3, Drug Efficacy and Safety DIS Symposium, BioAnalysis and BioImaging DIS Symposium, Systems Pharmacology DIS Symposium, Transporter DIS Symposium, MPS & SP DIS Joint Symposium

DDS DIS Symposium

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

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.

Microphysiological System DIS Symposium

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

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.

New Modality DIS Symposium

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

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.

Regulation DIS Symposium

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

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)

Drug Metabolism and Drug Induced Toxicity DIS Symposium 1

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

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.

Drug Metabolism and Drug Induced Toxicity DIS Symposium 2

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

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.

Drug Metabolism and Drug Induced Toxicity DIS Symposium 3

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

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.

Drug Efficacy and Safety DIS Symposium

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

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".

BioAnalysis and BioImaging DIS Symposium

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

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.

Systems Pharmacology DIS Symposium

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

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.

Transporter DIS Symposium

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

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.

MPS & SP DIS Joint Symposium

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

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.