12th JBF Symposium

Program Summary

THE 12TH JBF SYMPOSIUM PROGRAM (as of 14th Jan. 2021)
Date : Tue, 9th Mar. – Thu, 11th Mar. 2021
Venue : TOWER HALL FUNABORI, Tokyo, Japan and Virtual meeting
Day 1: Tuesday, 9th Mar.
Opening Remarks: 12:30-12:45
Hitoshi UCHIYAMA (The 12th JBF Symposium Chair / Towa Pharmaceutical)
Yoshiro SAITO (JBF Representative / National Institute of Health Sciences)

Expectations and Challenges for Bioanalysts in Pharmacokinetic Research: 12:45-14:45
  Chair: Nozomu KOSEKI[Kyorin Pharmaceutical]
             Junji KOMABA[Ono Pharmaceutical]
  • What is the most important role for bioanalysts?[Toshio TERAMURA・Aomori University]
  • Expectations for Bioanalysts on ADME-Pharmacokinetic Research[Nobuaki WATANABE・Daiichi Sankyo]
  • Case Study of Supporting Drug Development Based on Bioanalytical Platform[Ryosuke IDE・Mitsubishi Tanabe Pharma]
  • Applications of LC-MS/MS based absolute protein quantification to the drug development[Yutato HOSHI・Ono Pharmaceutical]

Poster Presentation Part 1: 15:00-16:00

Sponsored Seminar: SCIEX (Web venue): 15:00-16:00

Hot topics on biomarker analysis for drug development: 16:15-17:55
Chair: Harue IGARASHI[GlaxoSmithKline]
            Hisao SHIMIZU[Takeda Pharmaceutical]
  • Points to consider document on biomarker assay validation and study sample analysis in Japan[Yoshiro SAITO・National Institute of Health Sciences]
  • Validation of Biomarker Quantification in Japan - Context of use for a biomarker assay validation- (DG2020-45)[Yoshitaka HASHIMOTO・Ono Pharmaceutical]
  • Antibody Free Approaches to Measuring Protein Biomarkers[Timothy W Sikorski・GlaxoSmithKline]
  • Blood-based biomarkers for dementia[Takahiko TOKUDA・National Institutes for Quantum and Radiological Science and Technology]

Day 2: Wednesday, 10th Mar.
Patient centric sampling and bioanalysis: 9:00-10:20
  Chair: Yosuke KAWAI[Otsuka Pharmaceutical]
            Tomoko ARAKAWA[Pfizer R&D]
  • Patient Centric Sampling and Analysis for the Determination of Circulating Concentrations of Drug, Metabolites and Biomarkers[Neil Spooner・Spooner Bioanalytical Solutions]
  • Validating and Implementing Bioanalytical Methods for Patient-Centric Sampling[Enaksha Wickremsinhe・Eli Lilly]
  • Collaborations in Patient Centric Sampling and Microsampling: Working Together to Reduce Patient Burden and Obtain More Informative Datasets[Melanie Anderson・MSD]

Poster Presentation JBF Discussion Groups: 10:30-12:30
  • Guide to ADA Analysis: Considerations in Developing Analytical Methods and Conducting Nonclinical/Clinical Studies (DG2019-43)
  • Validation of Biomarker Quantification in Japan- Context of use for a biomarker assay validation - (DG2020-45)
  • Bioanalysis of Unstable Analytes (DG2020-46)
  • Quantitative analysis of oligonucleotide therapeutics by Hybridization assay (DG2020-48)
  • Neutralizing Antibody Assay: Discussion to Select Assay Format and Improve Assay Performance (DG2020-49)

Sponsored Seminar: Thermo Fisher Scientific K.K. (Web venue): 10:30-11:00

Sponsored Seminar: Toray Research Center (Web venue): 11:00-11:30

Sponsored Seminar: Scrum Inc. (Web venue): 12:30-13:00

Sponsored Seminar: Gyros (Web venue): 13:00-13:30

Hot Topics in Clinical Development (Virtual Clinical Trial): 13:30-15:00

  Chair: Tomoko ARAKAWA[Pfizer R&D]
            Yoshiaki OHTSU[Kyowa Kirin]
  • Towards Realization of Decentralized Clinical Trials in Japan –Recent Status and Perspective learnt from JPMA research–[Soichiro MATSUSHIMA・JPMA]
  • Patient-centric Virtual Clinical trial ~ The latest situation in the US ~[Norikazu EIKI・Eiki Consulting]
  • Bioanalysis in Virtual Clinical Trials[Yoshiaki OHTSU・Kyowa Kirin]

Hot Topics in Clinical Development (Gene Therapy): 15:15-16:15
  Chair: Tomoko ARAKAWA[Pfizer R&D]
             Yoshiaki OHTSU[Kyowa Kirin]
  • Bioanalytical Considerations and Strategies in Gene Therapies[Fraser McBlane・Novartis]
  • Biodistribution and Immunogenicity Assessments to Support Gene Therapies[Wataru HONMA・Novartis Pharma]

Keynote lecture: 16:30-17:30
  Chair: Noriko KATORI[National Institute of Health Sciences]
Development of new cancer antibody drugs
Yasuhiro MATSUMURA (National Cancer Center Research Institute / Innovation Center of NanoMedicine / RIN Institute)

Day 3: Thursday, 11th Mar.
Poster Presentation Part 2: 9:00-10:00

Sponsored Seminar: Hypha Discovery, Ltd. (BioBridge K.K.) (Web venue): 9:00-9:30
Latest Trends in Cancer Genome Medicine: 10:15-11:45
   Chair: Naoaki MURAO[Chugai Pharmaceutical]
              Keiko NAKAI[LSIM Safety Institute]
  • Development of companion diagnostic device using gene profiling test and the environment trend of genomic medicine[Yuki KAMIHARA・Chugai Pharmaceutical]
  • New horizons of DNA adductome analysis for evaluation of carcinogenesis[Yukari TOTSUKA・National Cancer Center Research Institute]
  • Current Status of gene panel testing[Hayato NIIRO・Sysmex]

Sponsored Seminar: ELGA LabWater (Web venue): 12:00-12:30

Sponsored Seminar: Agilent Technologies Japan, Ltd. (Web venue): 12:30-13:00

Let’s Talk to each other about bioanalysis (LBA): 13:00-14:15
Additional registration is required to attend this session

Sponsored Seminar: Nihon Waters Co., Ltd. (Web venue): 13:00-14:00

Current trends in bioanalytics of therapeutic middle molecules: 14:30-16:30
 Chair: Naoaki MURAO[Chugai Pharmaceutical]
            Takahiro NAKAMURA[Shin Nippon Biomedical Laboratories]
  • Current status and future perspective of peptide bioanalysis by LC/MS[Ryoya GODA・Daiichi Sankyo]
  • Points to consider on pharmacokinetics of peptide drugs with non-natural structures[Yoshiro SAITO・National Institute of Health Sciences]
  • High-sensitivity analysis of therapeutic oligonucleotides using an LC-MS/MS approach[Naoto SENDA・Shin Nippon Biomedical Laboratories]
  • Bioanalysis of oligonucleotide therapeutics: Based on approved cases in Japan[Daisuke IWATA・Pharmaceuticals and Medical Devices Agency]

Closing Remarks: 16:30-16:45
Yumi NISHIGUCHI (The 13th JBF Symposium Chair / CMIC Pharma Science)
Takeru YAMAGUCHI (The 13th JBF Symposium Chair / Sumika Chemical Analysis Service)

All information is subject to change.