13th JBF Symposium

Program Summary

THE 13TH JBF SYMPOSIUM PROGRAM (as of 17th Nov. 2021)
Date : Mon, 28th Feb. – Wed, 2nd Mar. 2022
Venue : Virtual meeting
Day 1: Monday, 28th Feb.
12:00-12:15      Opening Remarks
  • Executive committee co-chair of the 13th JBF Symposium
    Takeru YAMAGUCHI (Sumika Chemical Analysis Service, Ltd)
    Yumi NISHIGUCHI (CMIC Pharma Science)
  • Yoshiro SAITO (JBF Representative / National Institute of Health Sciences)
12:15-13:45      Technical chromatography
                      Naohito YAMADA[Japan Tobacco Inc.]
  • Bioanalysis of chiral amino acids
    [Sachise KARAKAWA・Ajinomoto Co., Inc.]
  • Quantitative lipidomics by supercritical fluid chromatography mass spectrometry and its latest applications
    [Hiroaki TAKEDA・RIKEN Center for Brain Science]
  • Optical resolution through minimum derivatization of chiral biological samples[Takuya MATSUI・Japan Tobacco Inc.]
14:00-15:15      Sponsored Seminar
  • Kentaro TAKAHARA (Thermo Fisher Scientific K.K.)
  • Yoshifumi KUROKI (Veolia Jenets K.K. ELGA LabWater)
  • Kazufumi KAWANO (Toray Research Center)
  • Luke Bi (Labcorp Pharmaceutical Research and Development (Shanghai) Co., Ltd.)

15:30-16:30      CRO Session 
          Additional registration is required to attend this session
      (This session will not be held as there will be no onsite symposium.)

15:30-16:45      Basic lecture of LC/MS and LBA
          Chair:  Takahiro NAKAMURA
                        [Shin Nippon Biomedical Laboratories, Ltd.]

  • Basic lecture on analytical method development using LC/MS
    [Makoto NIWA・Nippon Shinyaku Co., Ltd.]
  • Basic lecture on analytical method development in LBA
    [Hiroyuki SHIMIZU・Mitsubishi Tanabe Pharma Corp.]
17:00-17:45      10th Anniversary Lecture
       「Application of Molecularly Imprinted Polymers to Bioanalysis
Jun HAGINAKA (Institute for Biosciences, Mukogawa Women's University)
           Chair: Masanari MABUCHI[Mitsubishi Tanabe Pharma Corp.]


Day 2: Tuesday, 1st Mar.
        Biomarker assays: consideration of context of use (1)
        Chair:  Yoshiaki OTSU[Kyowa Kirin Co., Ltd.]
        Naohito YAMADA[Japan Tobacco Inc.]

  • Release of points to consider document on biomarker assay validation and study sample analysis in Japan and our new activities
    [Yoshiro SAITO・National Institute of Health Sciences]

10:00-10:15      Introduction of DG
         Chair:  Junji KOMABA[Ono Pharmaceutical Co., Ltd]

10:30-11:30      DG Session (1)

  • DG2020-47
  • DG2021-51
  • DG2021-53

12:15-13:15      Lunchtime Seminar

  • Nihon Waters K.K.
  • Sumika Chemical Analysis Service, Ltd.

13:20-14:05      Keynote lecture 
       Research on neurological diseases using human stem cells
         Keiko IMAMURA (Kyoto University)
         Chair:  Noriko KATORI[National Institute of Health Sciences]

14:10-15:10      t-DG (temporal DG) 
          Additional registration is required to attend this session

14:10-15:10      First step for solving problems in long-term storage

           of analytical instrument data
- The perspective of assurance of data integrity -

          Chair:  Takahiro NAKAMURA
                          [Shin Nippon Biomedical Laboratories, Ltd.]

  • Technical guidance and demonstration of usage of Long-term archiving for analytical instrument data[Satoshi MORINO・Eisai Co., Ltd.]
  • Ensuring reliability in long-term archiving for electronic data
    [Yoshikazu MASAKI・Otsuka Pharmaceutical Factory, Inc.]

15:20-15:50        Biomarker assays: consideration of context of use (2)
        Chair:  Yoshiaki OTSU[Kyowa Kirin Co., Ltd.]
        Naohito YAMADA[Japan Tobacco Inc.]

  • Biomarker Assay – how to apply Context-of-Use to your assay validation
    [Marianne Scheel Fjording・BioAgilytix]

16:00-18:00      Contribution of bioanalysis for development of cell and gene therapy products 
         Chair: Takahiro NAKAMURA
                        [Shin Nippon Biomedical Laboratories, Ltd.]
Hisao SHIMIZU [Takeda Pharmaceutical Company Limited]

  • Domestic and International Public-Private Partnership Platforms for the development and consensus building of tests for the tumorigenicity assessment of cell therapy products
    [Yoji SATO・National Institute of Health Sciences]
  • Landscape analysis and multi-site evaluation of non-clinical biodistribution studies for cell therapy products
    [Yoshiteru KAMIYAMA・Astellas Pharma Inc.]
  • Development of a cell quantification platform for pharmacokinetic analysis of cell therapy products
    [Shunsuke YAMAMOTO・Takeda Pharmaceutical Company Limited]
  • Bio-analysis and its guidelines for gene therapy products
    [Masafumi Onodera・National Center for Child Heath and Development]


Day 3: Wednesday, 2nd Mar.
9:00-10:30        COVID-19
         Chair: Junji KOMABA[Ono Pharmaceutical Co., Ltd]
                   Tomoko ARAKAWA [Pfizer R&D Japan G.K.]

  • Development and Validation of COVID-19 qPCR test
    [Motonari DAITHO・Sysmex Corporation]
  • BNT162b2 COVID-19 Vaccine Development -What have we learnt from the Pandemic? -[Osamu KOGAWARA・Pfizer R&D Japan G.K.]
  • Bioanalytical paradigm for COVID 19 vaccine development
    [Shabnam TANGRI・Navigate BioPharma Services, Inc]

10:30-11:30      DG Session (2)

  • DG2020-50
  • DG2021-52
  • DG2021-54

12:15-13:15      Lunchtime Seminar

  • Shimazu Corporation
  • CMIC Pharma Science Co., Ltd.
13:30-15:30      Trend of anti-drug antibody evaluation in drug development
        Chair:  Takahiro NAKAMURA
                        [Shin Nippon Biomedical Laboratories, Ltd.]
                    Naoaki MURAO [Chugai Pharmaceutical Co., Ltd.]
  • Evaluation of anti-drug antibodies and their neutralization activity in serum of rheumatoid arthritis patients treated with etanercept
    [Hiroko SHIBATA・National Institute of Health Sciences]
  • Long-term follow-up of pharmacokinetics and immunogenicity of the anti–PD-1 antibodies nivolumab and pembrolizumab
    [Masahide FUKUDO・Sapporo Medical University Hospital, Asahikawa Medical University]
  • ADA assay development and validation for therapeutic antibodies and its lifecycle management[Kousuke IIJIMA・Kyowa Kirin Co., Ltd.]
  • Comparability of immunogenicity assays – wishful thinking or could the “CP-ARC” concept help to reach the goal?
    [Roland STAACK・F. Hoffmann-La Roche, Ltd.]
15:30-15:45      Closing Remarks
  • Tomoko ARAKAWA (The 14th JBF Symposium Chair / Pfizer R&D Japan G.K.)

All information is subject to change.