14th JBF Symposium

Program Summary

THE 14TH JBF SYMPOSIUM PROGRAM (as of 25th Jan. 2023)
Date : Wed, 1st Mar. – Fri, 3rd Mar. 2023
Venue:Tower Hall FUNABORI (Tokyo) and Virtual meeting
Day 1: Wednesday, 1st Mar.
12:10-12:30      Opening Remarks
  • Executive Committee Chair of the 14th JBF Symposium
      Tomoko ARAKAWAPfizer R&D Japan
  • JBF Representative
      Yoshiro SAITONational Institute of Health Sciences

12:30-14:30      Towards Implementation of the ICH M10 Guideline
                          - Latest Discussion in Bioanalytical Communities -

          Chair:  Masayo HASHIMOTO[Sumitomo Pharma Co., Ltd.] 
                      Masanari MABUCHI[Mitsubishi Tanabe Pharma Corp.

  • Introduction and Overview of ICH M10 Guideline
    [Akiko ISHII-WATABE・National Institute of Health Sciences
  • ICH M10: JBF Workshop Report[Makoto TAKAHASHI・Japan Bioanalysis Forum (Daiichi Sankyo Co., Ltd.)]
  • AAPS Feedback and Discussions Regarding ICH M10 Guidance and Implementation
    [Chad BRISCOE・Celerion on behalf of AAPS
  • Feedback from the EBF Workshop on Harmonised Implementation of the ICH M10 Guideline[Philip TIMMERMAN・European Bioanalysis Forum]

14:45-16:15      JBF-JPMA Collaboration Session
          Chair:  Noriyuki KOYAMA[Otsuka Pharmaceutical Co., Ltd.]    
Makoto NIWA[Nippon Shinyaku Co., Ltd.

  • Questionnaire Survey on Development Strategy of Drug Concentration Analysis and Analytical Methods in Biological Samples

       [Kairi NAKAMURA, Miyuki TAMURANon-Clinical Evaluation Expert
          Committee, Drug Evaluation Committee, Japan Pharmaceutical
Manufacturers Association


17:00-18:30      Electronization in Bioanalysis 
          Chair:  Takeru YAMAGUCHI[Sumika Chemical Analysis Service, Ltd.]
Ryosuke YOSHINAGA[Toray Research Center, Inc.] 

  • Application of LIMS in the Field of Bioanalysis
    [Kazuo TOKUDA・Chugai Pharmaceutical Co. Ltd.
  • Current Utilization Status and Future Perspective of LIMS in SNBL Bioanalysis Operations
    [Katsunori IEKI・Shin Nippon Biomedical Laboratories, Ltd.
  • Digitalization and Automation for Bioanalysis
    [Katsutomo HATA・Shionogi & Co., Ltd.


10:30-11:40      Basic lecture of LC/MS and LBA

  • Basic Lecture of LC/MS on Biomarker AnalysisKoji ARAI・LSI Medience Corporation
  • Basic Lecture on Analytical Method Development for ADA in LBA[Tatsuki NOMURA・Shin Nippon Biomedical Laboratories, Ltd.


Day 2: Thursday, 2nd Mar.
        Bioanalysis of Oligonucleotides:
Various Approaches and Advancements
Chair:  Yuki TAKAMATSU[Takeda Pharmaceutical Co., Ltd.]
                    Makoto NIWA[Nippon Shinyaku Co., Ltd.

  • A Case Study for Visualizing Oligonucleotide Therapeutics by Using Imaging Mass Spectrometry[Hiroaki AIKAWA・LSI Medience Corporation
  • Points to Note in Bioanalysis of Therapeutic Oligonucleotides by Ion-Pair LC-MS/MS[Suguru FUKUDA・Shin Nippon Biomedical Laboratories, Ltd.
  • Comparison of Bioanalytical Methods for the Oligonucleotide Therapeutics[Yoshiharu HAYASHI・CMIC Pharma Science Co., Ltd.
  • Bioanalysis of Oligonucleotides: Challenges and SolutionsEric Thomas・Labcorp Drug Development


11:00-12:30      Poster Presentation   

12:40-13:40      Luncheon

  • Introducing Sciex's Mass Spectrometer Technology, the Next Level Quantitative/Quantitative Analysis[SCIEX]
  • Extracellular Vesicles & Circulating Tumor Cells: Recent Studies on Liquid Biopsy Techniques for Biomarker Detection
    Sumika Chemical Analysis Service, Ltd.
  • The Latest LC-MSMS Systems and Informatics to Achieve Reliable Bioanalysis of Middle-Molecule Drugs.Waters
  • Application of the TimsTOF Series to Biopharmaceutical Analysis
    Bruker Japan K.K.

13:50-15:50      Bioanalysis of Biomarkers and Application to

                         Translational Research 

         Chair:  Junji KOMABA[Ono Pharmaceutical Co., Ltd.]
                     Masayo HASHIMOTO[Sumitomo Pharma Co., Ltd.]

  • Development of Biomarker of Microglial Activation[Tatsuya IKEHARA・Shionogi & Co., Ltd.
  • Diversity of Biomarker Analysis - Case of qPCR, FCM and IHC - [Makoto YAMAZAKI・Mitsubishi Tanabe Pharma Corp.
  • Utilization of Sphingolipids as Translational Biomarkers[Youhei KOSUGI・Takeda Pharmaceutical Co., Ltd.]
  • Strategy to Select Fit-for-Purpose Bioanalytical Methods for Successful Measurement of Translational Biomarkers[Motohiko MORIHARA・Ono Pharmaceutical Co., Ltd.]

16:05-17:05       Data Integrity
         Chair:  Takahiro NAKAMURA
                          [Shin Nippon Biomedical Laboratories, Ltd.]

  • Considerations When Implementing a Computerized System 
    -Based on the Description in the OECD GLP Data Integrity Guidance-[Tomoharu SHIMOKAWA・Toray Research Center, Inc., Japan Society of Quality Assurance GLP Division

16:05-17:05       t-DG (temporal DG) 
          Additional Registration is Required to Attend this Session

17:20-18:20        What's New in Immunogenicity Assessment
 Chair:  Takahiro NAKAMURA
                          [Shin Nippon Biomedical Laboratories, Ltd.]
                Tetsu SAITO[Axcelead Drug Discovery Partners]

  • Immunogenicity Profile of the Port Delivery System with Ranibizumab in Patients with nAMD[Mauricio Maia・Genentech/Roche
  • Feedback from the EBF Workshop on Points to Consider on Cut Points for ImmunogenicityJoanne GoodmanEuropean Bioanalysis Forum

Day 3: Friday, 3rd Mar.
9:00-10:00         Patient Centric Sampling    
         Chair:   Makoto TAKAHASHI[Daiichi Sankyo Co., Ltd.]
      Yoshiaki OHTSUKyowa Kirin Co., Ltd.

  • Using Patient Centric Sampling for PK to Support COVID Oral Therapies – Method Validation, Bridging and Implementation[Katty Wan・Pfizer
  • Empowering the Clinical Trial Subject through Self Collection of Blood Samples[Sharin ROTH・Otsuka Pharmaceutical Development & Commercialization, Inc.


10:00-11:00        Development Strategy of Antibody-Drug Conjugates
         Chair:   Takahiro NAKAMURA
                                         [Shin Nippon Biomedical Laboratories, Ltd.]
                      Tetsu SAITO[Axcelead Drug Discovery Partners]

  • Bioanalytical Approaches to Evaluate in Vivo Behavior of ADCs[Hideo TAKAKUSA・Daiichi Sankyo Co., Ltd.
  • Bioanalysis of ADC Drugs (PADCEV, as an example)  Masanori NAGATA・Astellas Pharma Inc.

11:00-12:30      Poster Presentation   

12:40-13:40      Luncheon

  • 1. Introduction of Thermo Scientific™ Orbitrap™ Mass ​
        Spectrometer for Quantitative Analysis.
    2. The Benefits of Ion Mobility (Thermo Scientific™ FAIMS Pro Duo​
        interface) System for Bioanalysis.
    3. Seamless Output of MS Quantitative Data Reduce Repetitive
        Checking by Utilizing the New Report Templates for Analytical
        Method Validation.
    Thermo Fisher Scientific
  • Patient-Centric Sample Collection Enables Denser and More Reliable Data Collection in Clinical TrialsTasso, Inc.
  • 1. Development of Analytical Methods for Nanomedicines Using HPLC
    The Role of Global CRO in Drug R&D Bioanalysis
    Pharmaron Japan LLC
  • Benefit/Advantage of Conducting Clinical Sample Analysis at Labcorp Shanghai (Why Labcorp?)Labcorp Drug Development
13:50-15:55      Update of Public-Private Joint Research:
                   Bioanalytical Researches on Development and
                   Standardization of Analytical Methods for
                   Pharmacokinetic Evaluation of Four New Modality Drugs
         Chair:    Yuki TAKAMATSU[Takeda Pharmaceutical Co., Ltd.]
Junji KOMABA[Ono Pharmaceutical Co., Ltd.]
  • Public-Private Joint Research on Bioanalytical Methods for Four New Modality Drugs:Objectives and Overview[Yoshiro SAITO・National Institute of Health Sciences
  • Development and Standardization of Bioanalytical Methods for Oligonucleotide Therapeutics[Yuchen SUN・National Institute of Health Sciences
  • Standardization of Advanced Peptide Drug Bioanalysis: Research Concepts and Prospects[Kosuke SAITO・National Institute of Health Sciences
  • Analysis of Drug-to-Antibody Ratio Distribution of ADC in Blood Samples by Intact Mass AnalysisNoritaka HASHII・National Institute of Health Sciences
  • Development and Standardization of Methods for Measurement of Drug Concentrations in Gene Therapy Products[Yoichi TANAKA・National Institute of Health Sciences
15:55-16:05      Closure of Symposium
  • Poster Award Presentation
  • Closing Remarks​
    Executive Committee Chair of the 15th JBF Symposium
      Makoto NIWANippon Shinyaku Co., Ltd.

All information is subject to change.