16th JBF Symposium

Program Summary


THE 16TH JBF SYMPOSIUM PROGRAM 
Date : Mon, 3rd Mar. – Wed, 5th Mar. 2025
Venue：Himeji Culture and Convention Center (Arcrea HIMEJI) (Hyogo)

Language translation script (Japanese / English) will be projected at the main venue (Medium Hall).

Day 1: Monday, 3rd Mar.

10:00-11:15 Basic Lecture (Conference rooms / Japanese)
A foundational course will be offered for individuals with limited practical experience. Additionally, a course will be planned to provide a basic understanding of statistics to facilitate comprehension of DG poster presentations.

  • Basic course on the development analytical methods using LC/MS / Katsunori Ieki (Shin Nippon Biomedical Laboratories, Ltd.)
  • Basic lecture on analytical method development for ADA in LBA / Shunki Yasui (Kyowa Kirin Co., Ltd.)
  • DG2024-73 Basic Course on Statistics Related to Bioanalysis / Hironosuke Kurisu（Pfizer R&D Japan)

 

12:30-12:50 Opening Remarks (Medium Hall / Japanese)

  • Welcome Greetings
  • Opening Remarks for 16th JBF Symposium

 

12:50-14:30 Quantitative Proteomics and its Application to Biomarker Research (Medium Hall / Japanese)
This discussion will focus on the clinical applications of quantitative proteomics and the approaches adopted at various stages of development.

Presentations / Presenters:

  • On Technical Assessment of Proteomics by Immuno-PCR Panel and Aptamer Panel / Yoshiya Oda (The University of Tokyo, Graduate School of Medicine)
  • Biomarker Discovery for ALS by Olink Proteomics / Makoto Yamazaki (DMPK Research Laboratories, Research Division, Mitsubishi Tanabe Pharma Corporation)
  • Exploration of biomarkers utilizing proteomic platform at Chugai /Kuniyasu Kato (Chugai Pharmaceutical Co., Ltd. Biological Technology Dept. Omics G)

 

14:45-15:45 Poster / Booth Viewing (Exhibition Hall)
Viewing hours will be established to facilitate discussions and networking. Additionally, a stamp rally will be conducted.

 

16:00-17:00 After the implementation of ICH-M10 guideline: Questions and concerns in the real bioanalytical field (Medium Hall / Japanese)
This session aims to address questions and concerns related to the implementation of ICH-M10 through discussions with expert panelists.

  • Panel discussion
  • Panelist: Tomoko Arakawa (Pfizer R&D Japan G.K.), Kousuke Iijima (Kyowa Kirin Co., Ltd.), Ryouko Saihara (Mediford Corporation), Koichiro Hotta (Eisai Co., Ltd.), Yuya Hosokawa (Ono Pharmaceutical Co., Ltd.), Takeru Yamaguchi (Sumika Chemical Analysis Service Ltd.), Ken-ichi Yamamoto (Shin Nippon Biomedical Laboratories, Ltd.)

 

17:00-17:30 EBF Activities for the Future of Bioanalysis (Medium Hall / English)
A speaker from European Bioanalysis Forum (EBF) will be invited to give talks on topics currently being discussed at the EBF.

Presentation / Presenter:

  • Our challenges for the Future – a perspective from the EBF / Philip Timmerman (European Bioanalysis Forum)

 

17:35-19:05 Advancing drug development: Comprehensive and optimum approaches to the immunogenicity assessment (1) (Medium Hall / English and Japanese)
As a comprehensive evaluation of immunogenicity in the drug development, lectures will be given on the immunogenicity risk assessment, the integrated immunogenicity assessment and its summary document for the BLA, the simpler immunogenicity assessment, and the draft Japanese immunogenicity guidelines. In addition to the discussions at the venue, we also plan to have round table discussions in small groups (Day 2).

Presentations / Presenters:

  • Crafting a Science-Driven Immunogenicity Risk Assessment / Joleen T White (Senior Bioassay Development Lead, Bill & Melinda Gates Medical Research Institute)
  • Rational is not Radical – A scientific perspective on immunogenicity risk and assessment / Lauren Stevenson (Immunologix Laboratories)
  • Lean approach (Assessment by S/N instead of 3 tired approach) / Kyra Cowan (EBF)

Day 2: Tuesday, 4th Mar.

9:10-10:10Advancing drug development: Comprehensive and optimum approaches to the immunogenicity assessment (2) (Medium Hall / English)

Presentations / Presenters:

  • The Kaizen of Integrated Summaries of Immunogenicity- the FDA-CDER perspective on ISIs from Phase I IND to BLA and Beyond / João A. Pedras-Vasconcelos (FFDA-CDER-OPQ-OPQAIII-DPQAXV)
  • Draft guideline for immunogenicity assessment of biopharmaceuticals / Akiko Ishii-Watabe (Division of Biological Chemistry and Biologicals, National Institute of Health Sciences)

 

10:10-11:55 Poster Presentation (Exhibition Hall)
The DG leaders will provide introductions to the posters.

  • Introductions to DG posters: 10:20-10:50
  • Core time for posters (1): 10:50-11:55 (Odd number)

 

12:10-13:10 Luncheon (Conference rooms / Basically Japanese, English speaker can present in English)

Thermo Fisher Scientific K.K.
  • Streamlining the workflow for protein biomarkers development with Stellar Mass Spectrometer / Ryoma Yamamoto （Thermo Fisher Scientific K.K.）
Sumika Chemical Analysis Service, Ltd.
  • Cancer Liquid Biopsy: Current Status and Future Perspectives of Circulating Tumor Cells / Agato Murata （Sumika Chemical Analysis Service, Ltd., Osaka Laboratory）
Nihon Waters K.K.
  • Analytical Tools for Oligonucleotide Therapeutics / Motoji Oshikata （Nihon Waters K.K.）， Hiroko Iwasaki （Nihon Waters K.K.）
Veolia Jenets K.K. / ELGA LabWater
  • Laboratory water purification technology, water quality maintenance, and precautions when using ultrapure water for analysis / Bajotto Gustavo（Veolia Jenets K.K. / ELGA LabWater）
Labcorp
  • Challenges in ADC clinical bioanalysis, payload and linker stability and Chromatography separation / Luke Bi （Labcorp）

 

13:25-15:10 iDG (Exhibition Hall / Japanese or English)
In a casual atmosphere, we will discuss topics related to bioanalysis that interest everyone. Engaging in dynamic discussions will provide opportunities to connect with many people.

  • Information session for iDG : 13:25-13:35
  • Discussion time : 13:35-15:10

 

15:25-16:55： JSQA Collaboration Session: Issues and Recommendations for Promoting Data Integrity in GLP Facilities (Medium Hall / Japanese)
Topics related to data integrity (DI) will be presented by the Japan Society for Quality Assurance (JSQA), and a panel discussion will be held to address challenges in promoting DI.

Presentations / Presenters / Programs:

  • Addressing OECD GLP Data Integrity Guidance -Solutions Considered Through Discussions with PMDA- / Tomoharu Shimokawa (Japan Society of Quality Assurance GLP Division / Toray Research Center, Inc.)
  • Ensuring the reliability for long-term archiving of analytical instrument data / Hiroyasu Ishiguro (Japan Society of Quality Assurance GLP Division / Lead Chemical Co., Ltd.)
  • Panel discussion
  • Panelist: Tomoharu Shimokawa (Japan Society of Quality Assurance GLP Division / Toray Research Center, Inc.), Hiroyasu Ishiguro (Japan Society of Quality Assurance GLP Division / Lead Chemical Co., Ltd.), Yumi Nishiguchi (CMIC Pharma Science Co., Ltd.), Hiroyuki Yamanaka (Kaken Pharmaceutical Co., Ltd.)

 

17:00-18:00
Progress in bioanalysis using new technology of mass spectrometry (1) (Medium Hall / Japanese)
This session will discuss new methods for the quantification of macromolecules and the visualization of bioactive substances using MS. The session will be structured in two parts.

Presentations / Presenters:

  • Application of High-Resolution Mass Spectrometry in the Bioanalysis of Medium and Large Molecule Compounds / Yoshiharu Hayashi (CMIC Pharma Science Co., Ltd.)
  • Visualization of Bioactive Molecules Using Ultra-High-Sensitivity Imaging Mass Spectrometry / Yuki Sugiura (Center for Cancer Immunotherapy and Immunobiology (CCII), Kyoto University)

 

15:25-18:00
(Parallel activity) Advancing drug development: Comprehensive and optimum approaches to the immunogenicity assessment(Round table discussion) (Conference Room / English)
A round table discussion will be held with international speakers to engage in advanced and detailed discussions.

  • Discussion time

 

18:10-20:30  Banquet

Day 3: Wednesday, 5th Mar.

9:10-10:10  Progress in bioanalysis using new technology of mass spectrometry (2) (Medium Hall / Japanese)

Presentations / Presenters:

  • Structural Analysis of Oxygen and Hydrogen Radical-Induced Dissociation in Mass Spectrometry / Hidenori Takahashi（Shimadzu Corporation）
  • Development of LC-MS/MS Methods for Bioanalysis of Antibody Therapeutics / Toshiko Yahata (Astellas Pharma Inc.)

 

10:25-11:55 Poster Presentation (Exhibition Hall)

  • Core time for posters (2): 10:55-11:55

12:10-13:10 Luncheon (Conference rooms / Basically Japanese, English speaker can present in English)

SCIEX
  • Elucidation of Protein Function and Inhibition Mechanisms by Mass Spectrometry Based on Structural Information / Tomoya Akashi （Mitsubishi Tanabe Pharma Corporation）
BioAgilytix Labs
  • Bioanalytical Strategies for Cell and Gene Therapies / Lynn Kamen （BioAgilytix Labs）
B2S Life Sciences
  • Introduction of the unique services by B2S Life Sciences / Hara Hisanori （B2S Life Sciences）
Meso Scale Discovery
  • MSD assay development trends in the market / Leonard Cox （Meso Scale Discovery）
ChromaNik Technologies Inc.
  • Exploring Quality and Innovation for HPLC Columns / Ryuji Koyama （ChromaNik Technologies Inc.）

 

13:25-14:55 Bioanalysis in Cellular and Gene Therapies: Standardization and Implementation (Medium Hall / Japanese)
An introduction to ICH-S12 and implementation of drug development in cell and gene therapy (CGT) will be provided.

Presentations / Presenters:

  • Overview of ICH S12 Guideline “Nonclinical Biodistribution Considerations for Gene Therapy Products” / Daisuke Temmizu (Japan Pharmaceutical Manufacturers Association) 
  • Key Considerations in Biodistribution Assessment of Cell Therapy Products: Towards Standardization / Shunsuke Yamamoto (Takeda Pharmaceutical Company Limited)
  • Implementation and Utilization of Bioanalytical Technologies in Cell and Gene Cell Therapy Programs / Satoshi Kitamura (Astellas Pharma Inc.)

 

15;00-16:30 Hot topics related to ADC: New Approaches and Innovations (Medium Hall / Japanese)
Analytical methods for biotransformation and determining the drug-to-antibody ratio (DAR) of antibody-drug conjugates (ADCs) will be provided and discussed.

Presentations / Presenters:

  • Development of analysis method for DAR of ADC in human plasma using LC/MS / Noritaka Hashii (National Institute of Health Sciences)
  • Bioanalysis and Biotransformation of Antibody Drug Conjugate / Yuki Kishino (Daiichi Sankyo Co., Ltd.)
  • Bioanalysis of ADC: Case Study of Measuring Blood Concentration of ADC and Constituent Parts in Astellas / Yuji Fujita (Astellas Pharma Inc.)

 

16:30-17:00 Closing Remarks(Medium Hall / Japanese)

  • Best poster award ceremony
  • Closing