15th JBF Symposium

Program Summary

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THE 15TH JBF SYMPOSIUM PROGRAM
Date : Mon, 5th Feb. – Wed, 7th Feb. 2024
Venue：Miyako Messe Kyoto International Exhibition Hall (Kyoto) and Virtual meeting
Language translation script (Japanese / English) will be projected at the main venue.
 
Day 1: Monday, 5th Feb.
12:00-12:20 Opening Remarks (Main venue / Japanese) 12:20-13:20 Recent Trend and Concerns on the Document-based Inspection in the Japanese New Drug Approval
 (Main venue / Japanese)
A reform regarding the methods for confirming compliance with the reliability criteria of NDA application materials. Potential impact on the practical aspects related to bioanalysis will be discussed.
Presentations/Presenters: 13:20-14:20 Poster / Booth Viewing (Poster venue, Booth)
To facilitate efficient discussions and interactions, viewing time will be provided on the first day.
14:20-16:20 Method Development and Standardization for qPCR (Main venue / Japanese / English)
Latest efforts in technical considerations, implementation examples, and standardization of qPCR will be provided.
Presentations / Presenters: 16:30-17:30 Basic Lecture (Main venue / Japanese)
Basic lecture targeting early carrier scientists will be provided.
Day 2: Tuesday, 6th Feb.

9:00-11:00 Challenges in Setting Cut Points for Anti-Drug Antibody (ADA) Assays (Main venue / English)
There are complex challenges in setting cut-off values for anti-drug antibody assays. Presenters are invited from overseas to facilitate detailed discussions on this topic in Japan.
Presentations / Presenters:

11:10-12:10 Poster Presentation (Poster)
12:20-13:20 Luncheon (Main venue, Sub venue, Luncheon room 1, Luncheon room 2 / Basically Japanese, English speaker can present in English)
Presentations / Presenters:
  • Introduction to Analysis Data with 7500 System and Function of SCIEX OS Including Data Integrity (in Japanese) / Toshifumi Tohda (SCIEX) (Sponsored by SCIEX)
  • M10 Implementation and Its Impact on Method Validation / Luke Bi (LabCorp) (Sponsored by LabCorp)
  • Glycoanalysis of Biopharmaceuticals (in Japanese) / Izumi Sakamoto (GlyTech, Inc.) (Sponsored by Otsuka Pharma)
  • A Complete Solution for Accelerating Oligonucleotide Analysis - From Preprocessing to Detection - (in Japanese) / Hiroko Iwasaki (Nihon Waters K.K.) (Sponsored by Waters)

13:40-15:10
Program A: Next-generation AI Utilization in Day-to-day Operations (Main venue / Japanese)
Due to advancements in AI, work is on the brink of a transformation. Future potential applications will be provided to create an opportunity to initiate diverse discussions.
Presentations / Presenters:
  • 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 (Large Language Models) / Atom Sonoda (Lightblue K.K.)
Program B: Career visions of bioanalysts (Sub venue / Japanese)
Career development has become a significant challenge for each individual. Current expectation on skillset will be provided to gain insights into how to proceed in the future.
Presentations / Programs: Presenters / Panelists
  • Shinsuke Uchihashi (Maruho Co., Ltd.)
  • Eiichi Shimada (Ono Pharmaceutical Co., Ltd.)
  • Yoshihisa Sano (Eisai Co., Ltd.)
  • Hideo Matsumoto (JAC Exective)
15:20-16:20
Program A: Data Integrity (Main venue / Japanese)
Updates in considerations in implementing electronic laoartory notebooks are provided from experts from Japan Society of Quality Assurance.
Presentation / Presenter: Program B: t-DG (temporal Discussion Group) (In all venue in small groups / 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 Bioanalytical Communities (1) (Main venue / English or Japanese)
In a situation where the ICH M10 guideline is in the implementation phase in Japan and already implemented in other regions, review of discussions undertaken is provided by speakers from Japan, the US, and Europe.
In the evening session, one Japanese and one Europe-based presenter is assigned.
Presentations / Presenters:

18:00-19:30         Banquet

Day 3: Wednesday, 7th Feb.

ICH M10 Implementation Insights: Experiences and Lessons Learned from Bioanalytical Communities (2) (Main venue / English or Japanese)

In the morning session, one Japanese and one US-based presenter is assigned.
Presentations / Presenters: 10:10-11:10 Poster Presentation (Poster)
11:30-12:30 Luncheon (Main venue, Sub venue, Luncheon room 1, Luncheon room 2 / Basically Japanese, English speaker can present in English)
Presentations / Presenters:
  • Watson LIMS for Bioanalysis Workflow and Recent DI Trends and Implementation Examples (in Japanese) / Takayuki Matsunuma (Thermo Fisher Scientific K.K.) (Sponsored by Thermo)
  • Precautions and Know-how in Using Ultrapure Water for LCMS (in Japanese) / Yoshifumi Kuroki (ELGA LabWater) (Sponsored by ELGA)
  • Reducing Timelines in Biomarker Development / Leonard Cox (Meso Scale Diagnostics, LLC.) (Sponsored by Meso Scale)
  • Bioanalytical Strategies and Considerations for Antibody Drug Conjugate Development / Lynn Kamen (BioAgilytix) (Sponsored by BioAgilytix)
12:50-14:50 Issues and solutions for LC/MS analysis of peptides (Main venue / Japanese)
Medium-sized peptides have recently gained attention as a promising drug modality. Technical considerations during the LC-MS/MS method development, strategies for overcoming challenges, and introduce the latest technologies will be presented.
Presentations / Presenters: 14:50-15:10 Closing Remarks
  • Naohito Yamada (Japan Tabacco Inc., Executive Committee Chair of the 16th JBF Symposium)