• 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)

• 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.］

• 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.］

Day 2: Tuesday, 1^st Mar.
9:15-10:00        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

• AB SCIEX LLC
• 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, 2^nd 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.
• SEKISUI MEDICAL 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.］

• Tomoko ARAKAWA (The 14^th JBF Symposium Chair / Pfizer R&D Japan G.K.)

 
 [Note]
All information is subject to change.