THE 15TH JBF SYMPOSIUM PROGRAM
Date:Venue:Mon, 5th Feb. – Wed, 7th Feb. 2024
Miyako Messe (Kyoto) and Virtual meetingDay 1: Monday, 5th Feb.
12:00-12:20

Opening Remarks (Main venue and Web / Japanese) Executive Committee Chair of the 15th JBF Symposium
Makoto NIWA［Nippon Shinyaku Co., Ltd.］
12:20-13:20

JBF Representative
Yoshiro SAITO［National Institute of Health Sciences］

Recent Trend and Concerns on the Document-based Inspection in the Japanese New Drug Approval(Main venue and Web / Japanese)
Chair: Noriyuki KOYAMA［Otsuka Pharmaceutical Co., Ltd.］
Yoshiaki OHTSU［Kyowa Kirin Co., Ltd.］About the Checklist for Reliability Standard Studies［Mutsumi SUZUKI・Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee,
Japan Pharmaceuticals Manufactures Association］

Assurance of Study Reliability from the Perspective of Bioanalysis［Noriyuki KOYAMA・Japan Bioanalysis Forum, Otsuka Pharmaceutical Co.,Ltd.］
Poster / Booth Viewing (Poster & Booth Exhibition venue)
To facilitate efficient discussions and interactions, viewing time will be provided on the first day.
13:20-14:20
14:20-16:20

Method Development and Standardization for qPCR (Main venue and Web / Japanese and English)
Chair: Masaaki KAKEHI［Takeda Pharmaceutical Co., Ltd.］Yuu MORIYA［Takeda Pharmaceutical Co., Ltd.］

16:30-17:30

Points to Consider Document on Analytical Method Development and Validation of qPCR Methods
for Nucleic Acid Biomarkers［Yoshiro SAITO・The National Institute of Health Sciences］

Understanding qPCR Bioanalysis Issues before Validation Planning (DG2017-33) -Update［Takeshi HANADA・Daiichi Sankyo Co., Ltd.］

Validation of PCR Assays for Preclinical Studies with Real-World Data
［Haruka INOUE・Shin Nippon Biomedical Laboratories, Ltd.］PCR Methods for Bioanalysis in Cell and Gene Therapies［Mikael KUBISTA・Czech Academy of Sciences and MultiD Analyses］

Basic Lecture (Main venue and Web / Japanese)
Basic lecture targeting early carrier scientists will be provided.
Chair: Koji ARAI［Mediford Corporation］
Ken-ichi YAMAMOTO［Shin Nippon Biomedical Laboratories, Ltd.］

Basic Course on the Development of Analytical Methods Using LC/MS/MS［Takeshi Okuzono・Sekisui Medical Co., Ltd.］
Basic Lecture on Analytical Method Development for ADA in LBA［Tamiki Mori・Mediford Corporation］

Day 2: Tuesday, 6th Feb.
9:00-11:00

Challenges in Setting Cut Points for Anti-Drug Antibody (ADA) Assays(Main venue and Web / English)
Chair: Hiroyuki SHIMIZU［Mitsubishi Tanabe Pharma Corporation］
Ken-ichi YAMAMOTO［Shin Nippon Biomedical Laboratories, Ltd.］Practical Advice on Immunogenicity Cut-Point Evaluations and Demo of an Excel-based Tool
［Viswanath DEVANARAYAN・Eisai, Inc., and University of Illinois Chicago］

Establishing Appropriate Immunogenicity Assay Cut Points in Oncology Disease Indications［Michael A PARTRIDGE・Regeneron Pharmaceuticals Inc.］

11:10-12:10

Poster Presentation (Poster & Booth Exhibition venue)

12:20-13:20

Luncheon (Main venue, Sub venue, Luncheon C, Luncheon D / Basically Japanese, English speaker
can present in English) [LS2-A] Introduction to Analysis Data with 7500 System and Function of SCIEX OS
Including Data Integrity (in Japanese)［Toshifumi TOHDA・SCIEX］

13:40-15:10

[LS2-B] M10 Implementation and Its Impact on Method Validation［Luke BI・Labcorp］

[LS2-C] “Glycoanalysis of Biopharmaceuticals” presented by CIL/Otsuka (in Japanese)［Izumi SAKAMOTO・GlyTech, Inc.］[LS2-D] A Complete Solution for Accelerating Oligonucleotide Analysis- From Preprocessing to Detection - (in Japanese)［Hiroko IWASAKI・Nihon Waters K.K.］

Program A: Next-generation AI Utilization in Day-to-day Operations(Main venue and Web / Japanese)
Chair: Yoshiaki OHTSU［Kyowa Kirin Co., Ltd.］
Makoto NIWA［Nippon Shinyaku Co., Ltd.］
Use of Generative AI in Creating Staff Training Materials［Makoto NIWA・Nippon Shinyaku Co., Ltd.］The Use of Artificial Intelligence in Medical Publication: an Agency’s Perspective［Mami HIRANO・Cactus Communications］

Providing New-age Behavior Analysis Solutions with Human Sensing Technology and LLM［Atom SONODA・Lightblue K.K.］

Program B: Career Visions of Bioanalysts (Sub venue / Japanese)
Chair: Koji ARAI［Mediford Corporation］
Hitoshi UCHIYAMA［Towa pharmaceutical Co., Ltd.］

Report of 2022-DG58 "Effective Instruction for the Bioanalyst Career Path"［Shinsuke UCHIHASHI・Maruho Co., Ltd.］Survey Results on the Career of Bioanalysts［Eiichi SHIMADA・Japan Bioanalysis Forum, Ono Pharmaceutical Co.,Ltd.］

Panel Discussion
Presenters / Panelists:
 Shinsuke UCHIHASHI (Maruho Co., Ltd.) Eiichi SHIMADA (Ono Pharmaceutical Co., Ltd.) Yoshihisa SANO (Eisai Co., Ltd.) Hideo MATSUMOTO (JAC Recruitment)

15:20-16:20

Program A: Data Integrity / JSQA Collaboration Session (Main venue and Web / Japanese)
Chair: Noriyuki KOYAMA［Otsuka Pharmaceutical Co., Ltd.］Ensuring the Integrity of Electronic Data in Non-Clinical studies - A Case Study of Electronic
Notebook Data ［Tadahiro YOSHIYAMA・Japan Society of Quality Assurance GLP Division,
Chugai Pharmaceutical Co., Ltd.］

Program B: t-DG (temporal Discussion Group) (Sub venue etc. / Japanese)
Participants will be divided into small groups to engage in discussions on topics they have selected.
Additional registration is required to attend this session.
16:30-17:30

ICH M10 Implementation Insights: Experiences and Lessons Learned from BioanalyticalCommunities (1) (Main venue and Web / English and Japanese)
Chair: Masayo HASHIMOTO［Sumitomo Pharma Co., Ltd.］
Katsutomo HATA［Shionogi & Co., Ltd.］

18:00-19:30

Toward Implementation of ICH M10 Guideline［Akiko ISHII-WATABE・National Institute of Health Sciences］

One Year into ICH M10: Feedback and Learnings from the Recent EBF Workshop‘Keeping the Finger on the Pulse'［Philip TIMMERMAN・European Bioanalysis Forum］

Banquet (Poster & Booth Exhibition venue)

Day 3: Wednesday, 7th Feb.
9:00-10:00

ICH M10 Implementation Insights: Experiences and Lessons Learned from BioanalyticalCommunities (2) (Main venue and Web / English and Japanese)
Chair: Masayo HASHIMOTO［Sumitomo Pharma Co., Ltd.］
Katsutomo HATA［Shionogi & Co., Ltd.］
Feedback from the JBF Workshop for ICH-M10 Guideline in 2023
［Yuki TAKAMATSU・Japan Bioanalysis Forum, Takeda Pharmaceutical Co., Ltd.］Experiences and Lessons Learned from the AAPS Bioanalytical Community One Year after theImplementation of ICH-M10［Faye VAZVAEI・MSD］

10:10-11:10

Poster Presentation (Poster & Booth Exhibition venue)

11:30-12:30

Luncheon (Main venue, Sub venue, Luncheon C, Luncheon D / Basically Japanese, English speaker
can present in English) [LS3-A] Watson LIMS for Bioanalysis Workflow and Recent DI Trends
and Implementation Examples (in Japanese)［Takayuki MATSUNUMA・Thermo Fisher Scientific K.K.］

12:50-14:50

[LS3-B] Precautions and Know-how in Using Ultrapure Water for LCMS (in Japanese)［Yoshifumi KUROKI・ELGA LabWater］

[LS3-C] Reducing Timelines in Biomarker Development［Leonard COX・Meso Scale Diagnostics, LLC.］[LS3-D] Bioanalytical Strategies and Considerations for Antibody Drug Conjugate Development［Lynn KAMEN・BioAgilytix］

Issues and Solutions for LC/MS Analysis of Peptides (Main venue and Web / Japanese)
Chair: Yuki TAKAMATSU［Takeda Pharmaceutical Co., Ltd.］
Takeru YAMAGUCHI［Sumika Chemical Analysis Service, Ltd.］

14:50-15:10

Research in Development and Standardization of LC-MS/MS Based Peptide Bioanalysis［Kosuke SAITO・National Institute of Health Sciences］

Introduction of Analytical Tips and Examples of Analysis When Quantitatively
Measuring Peptides Using LC/MS［Chie INAGAKI・SCIEX］



Various Approaches to Some Challenges in Peptides Bioanalysis［Ryoma YAMAMOTO・Thermo Fisher Scientific K.K.］

Basics of LC/MS and Tips in Peptide Analysis［Junna NAKAZONO・Shimadzu Corporation］

Poster Award and Closing Remarks
 Poster Award Closing Remarks
Executive Committee Chair of the 16th JBF Symposium
Naohito YAMADA［Japan Tobacco Inc.］