• Executive Committee Chair of the 14th JBF Symposium
  　　Tomoko ARAKAWA［Pfizer R&D Japan］
• JBF Representative
  　　Yoshiro SAITO［National 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 TAMURA・Non-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 Analysis［Koji ARAI・LSI Medience Corporation］
• Basic Lecture on Analytical Method Development for ADA in LBA［Tatsuki NOMURA・Shin Nippon Biomedical Laboratories, Ltd.］

Day 2: Thursday, 2^nd Mar.
9:00-11:00        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 Solutions［Eric 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 Immunogenicity［Joanne Goodman・European Bioanalysis Forum］

Day 3: Friday, 3^rd Mar.
9:00-10:00         Patient Centric Sampling    
         Chair:   Makoto TAKAHASHI［Daiichi Sankyo Co., Ltd.］
　　　　　　Yoshiaki OHTSU［Kyowa 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 Trials［Tasso, Inc.］
• 1. Development of Analytical Methods for Nanomedicines Using HPLC​
  2. 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］

• 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 Analysis［Noritaka 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］

• Poster Award Presentation
• Closing Remarks​
  Executive Committee Chair of the 15th JBF Symposium
  　　Makoto NIWA［Nippon Shinyaku Co., Ltd.］

********************************************************************************* 
 [Note]
All information is subject to change.