Japanese Society for Pharmacokinetics 14th Annual Short Course
What to see and hear
Session 1 MPS
Microphysiological System (MPS) technology reproduces the interactions between organs in vivo and between organs in vitro, and is expected to be an alternative method for testing in experimental animals in drug discovery. In Japan, the Japan Agency for Medical Research and Development (AMED) started the “Project for Development of Basic Technologies for Industrialization of Regenerative Medicine and Gene Therapy (Development of Basic Technologies to Support Drug Discovery by Applying Regenerative Medicine Technology)” five years ago, and industry, government, and academia are collaborating to promote research. In this symposium, researchers in academia who are active on the front lines and companies that are actively involved in this project will introduce their current status.
(Responsibility: Tamihide Matsunaga and Koichi Yoshinari)
Session 2 M&S
In the M&S session, as examples of new M&S approaches that have been incorporated into drug discovery and development in recent years, speakers will discuss spatial model analysis of local administration, mechanistic model analysis of switch antibodies, and simplification of Fully Mechanistic Models such as PBPK and QSP. Simplification of Fully Mechanistic Model for PBPK and QSP will be presented. We hope to provide hints on new contributions that pharmacokinetic researchers can make to the front-line issues faced by pharmaceutical companies, such as strategies for developing new modalities and how to utilize new mathematical analysis techniques such as QSP.
(Responsibility: Masayo Oishi and Koji Chiba)
Session 3: Brain Delivery & Omics
It is still a challenge to develop technologies to efficiently cross the brain barrier and deliver drug delivery modalities to the brain for CNS diseases with high unmet medical needs. In this session, we will present the latest findings on how to deliver drug modalities into the brain, including the construction of a brain barrier crossing strategy by understanding the brain barrier logistics system using quantitative proteome analysis, the development of an intranasal delivery technique that bypasses the brain barrier, and the practical brain barrier crossing technique, J-Brain The latest findings regarding Cargo will be presented.
(Responsibility: Shingo Ito and Tomoko Watanabe)
Session 4 Drug Discovery Modality
The paradigm shift in drug discovery modality has led to a major change in drug development trends from conventional small molecule drugs to new modality drugs such as nucleic acids, peptides, antibodies, medium and high molecules, cells and gene therapy. The change in modality is both an opportunity and a great challenge for pharmaceutical manufacturers. In the drug discovery timeline, which requires ever-accelerating drug development, one of the challenges is to optimize pharmacokinetic evaluation items that match the drug discovery strategy, to establish a measurement technology infrastructure, and to develop drugs in accordance with regulatory requirements, which are currently being tackled by each company through trial and error. In this session, nucleic acids and ADCs will be discussed, and the efforts of each company from the initial stage of drug discovery to the development will be introduced with actual examples, as well as suggestions from the regulatory perspective.
（The presentation will be useful for a wide range of pharmacokinetic evaluations, including suggestions from regulatory perspectives.)
Keynote Speech: “New Normal of Drug Discovery Modality from the Perspective of AI and Simulation: Beyond COVID-19
Digital Transformation (DX) does not simply mean a shift from analog to digital. In the pharmaceutical industry, DX has been suggested to have the potential to revolutionize the business model itself, from drug discovery to post-marketing distribution of pharmaceuticals. However, will DX really bring about a historic shift in an industry that has been tackling the high hurdle of drug discovery, which requires huge amounts of capital, human resources, and a long period of time? Dr. Yasushi Okuno, a leading researcher on drug discovery using computational technologies such as Big Data, AI, and supercomputers in Japan, will give a lecture on the current status and future prospects of DX in drug discovery, including the latest research examples. We are looking forward to seeing what the coming new era of drug discovery will look like!
(Responsibility: Hideki Hirabayashi)
Special Invited Lecture “Development of Heteroduplex Nucleic Acids
Nucleic acid drugs are attracting attention as a new drug discovery modality for genetic diseases, etc., which have been difficult with conventional drug discovery methods. At the same time, there are high expectations for delivery to target organs other than the liver, especially to the brain, in order to further improve efficacy and safety and meet the needs of medical/therapeutic settings. In this lecture, Dr. Yokota, who has been leading this research field as a frontrunner for many years, will present the latest findings on the development of innovative heterodouble-stranded nucleic acid drugs that can cross the blood-brain barrier, along with future prospects. This presentation will surely help you to consider the impact on future drug discovery applications and development strategies, as well as the possibility of contributing to medical care and patients. Don’t miss it!
(Responsibility: Takafumi Komori)