Program Summary (Tentative)
Date : Mon, 5th Feb. – Wed, 7th Feb. 2024
Venue：Miyako Messe Kyoto International Exhibition Hall (Kyoto) and Virtual meeting
12:00-12:20 Opening Remarks (Main venue / Japanese)
- Executive Committee Chair of the 15th JBF Symposium
- JBF Representative
(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.
- Revision of Reliability Criteria Checklist
- Impact on Bioanalytical Practices
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.
- Outcome from qPCR Standardization Research Group
- Best practices discussed in the JBF discussion group
- Examples of qPCR and ddPCR Implementation
- Implementation under GLP and Reporting Standards
Basic lecture targeting early carrier scientists will be provided.
- Basic Lecture of LC/MS
- Basic Lecture on Analytical Method Development for ADA in LBA
9:00-10:50 Challenges in Setting Cut-Off Values for Anti-Drug Antibody 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.
- Practical Advice & Insights on Immunogenicity Cut Points
- Clinical Relevance of Determining Appropriate Cut Points
12:15-13:15 Luncheon (Main venue, Sub venue, Luncheon room 1, Luncheon room 2 / Basically Japanese, English speaker can present in English)
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.
- Significance of Generative AI and Its Potential in Educational Training
- Literature Search and Document Creation with AI
- Potential of Motion Analysis AI for Technical Knowledge Transfer
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.
- Career Development for Bioanalysts
- Essentials for a Career in Bioanalysis
- What has been Beneficial in the Course of Evolving Professional Experiences
- Panel Discussion
Program A: Data Integrity (Main venue / Japanese)
Updates in considerations in implementing computerized systems are provided from experts from Japan Society of Quality Assurance.
- Considerations in implementing computerized systems
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 Bioanalytics 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.
- Presentations: TBD (In the evening session, one Japanese and one Europe-based presenter will be assigned.)
Day 3: Wednesday, 7th Feb.
ICH M10 Implementation Insights: Experiences and Lessons Learned from Bioanalytics Communities (2) (Main venue / English or Japanese)
- Presentations: TBD (In the morning session, one Japanese and one US-based presenter will be assigned.)
11:25-12:25 Luncheon (Main venue, Sub venue, Luncheon room 1, Luncheon room 2 / Basically Japanese, English speaker can present in English)
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.
Planned Presentations: Details are to be determined;
- Standardization of Advanced Peptide Drug Bioanalysis
- TBD (Presentations of basic research to overcome technical challenges from three hardware vendors)
- Executive Committee Chair of the 16th JBF Symposium
This program is provisional and subject to change in the future.