16th JBF Symposium

Program Summary


THE 16TH JBF SYMPOSIUM PROGRAM (tentative)
Date : Mon, 3rd Mar. – Wed, 5th Mar. 2025
Venue：Himeji Culture and Convention Center (Arcrea HIMEJI) (Hyogo)

Language translation script (Japanese / English) will be projected at the main venue (Medium Hall).

Day 1: Monday, 3rd Mar.

10:00-11:15 Basic Lecture (Conference rooms / Japanese)
A foundational course will be offered for individuals with limited practical experience. Additionally, a course will be planned to provide a basic understanding of statistics to facilitate comprehension of DG poster presentations.

  • Basic course on the development analytical methods using LC/MS
  • Basic lecture on analytical method development for ADA in LBA
  • Basic lecture of statistics for the bioanalysis

 

12:30-12:50 Opening Remarks (Medium Hall / Japanese)

  • Welcome Greetings
  • Opening Remarks for 16th JBF Symposium

 

12:50-14:30 Quantitative Proteomics Technologies and Case Studies in Biomarker Research (tentative) (Medium Hall / Japanese)
This discussion will focus on the clinical applications of quantitative proteomics and the approaches adopted at various stages of development.

Presenters:

  • Yoshiya Oda (Department of Lipidomics, Graduate School of Medicine, The University of Tokyo)
  • Makoto Yamazaki (Mitsubishi Tanabe Pharma Corp.)
  • Kuniyasu Kato (Chugai Pharmaceutical Co., Ltd.)

 

14:45-15:45 Poster / Booth Viewing (Exhibition Hall)
Viewing hours will be established to facilitate discussions and networking. Additionally, a stamp rally will be conducted.

16:00-17:00 After the Implementation of ICH-M10 Guideline: Questions and Concerns in the Real Bioanalytical Field (tentative)(Medium Hall / Japanese)
This session aims to address questions and concerns related to the implementation of ICH-M10 through discussions with expert panelists.

  • Panel discussion

 

17:00-17:30 EBF Session (tentative)(Medium Hall / English)
A speaker from European Bioanalysis Forum (EBF) will be invited to give talks on topics currently being discussed at the EBF.

Presenters / Presentations:

  • Philip Timmerman (European Bioanalysis Forum) EBF strategic discussions (tentative)

 

17:35-19:05 Advancing Drug Development: Comprehensive and Optimum Approaches to the Immunogenicity Assessment (1) (tentative)(Medium Hall / English and Japanese)
As a comprehensive evaluation of immunogenicity in the drug development, lectures will be given on the immunogenicity risk assessment, the integrated immunogenicity assessment and its summary document for the BLA, the simpler immunogenicity assessment, and the draft Japanese immunogenicity guidelines. In addition to the discussions at the venue, we also plan to have round table discussions in small groups (Day 2).

Presenters / Presentations:

  • Joleen T White (Bill & Melinda Gates Medical Research Institute) Immunogenicity Risk assessment (tentative)
  • TBA (EBF) Lean approach (Assessment by S/N instead of 3 tired approach) (tentative)
  • Akiko Ishii  (National Institute of Health Sciences) (Draft) Japanese ADA guideline (tentative)

Day 2: Tuesday, 4th Mar.

9:10-10:10 Advancing Drug Development: Comprehensive and Optimum Approaches to the Immunogenicity Assessment (2) (tentative)(Medium Hall / English)

Presentations / Presenters:

  • Lauren F. Stevenson (Immunologix) integrated ADA assessment with PK, efficacy, Tox etc (tentative)
  • João A Pedras-Vasconcelos (FDA) ISI (Integrated Summary of Immunogenicity), expectation from regulatory perspective (tentative)

 

10:10-11:55 Poster Presentation (Exhibition Hall)
The DG leaders will provide introductions to the posters.

  • Introductions to DG posters: 10:20-10:50
  • Core time for posters (1): 10:50-11:55 (Odd number)

 

12:10-13:10 Luncheon (Conference rooms / Basically Japanese, English speaker can present in English)

13:25-15:10 iDG (Exhibition Hall / Japanese or English)
In a casual atmosphere, we will discuss topics related to bioanalysis that interest everyone. Engaging in dynamic discussions will provide opportunities to connect with many people.

  • Information session for iDG : 13:25-13:35
  • Discussion time : 13:35-15:10

 

15:25-16:55： JSQA Collaboration Session (tentative title)(Medium Hall / Japanese)
Topics related to data integrity (DI) will be presented by the Japan Society for Quality Assurance (JSQA), and a panel discussion will be held to address challenges in promoting DI.

Presentations / Programs:

  • TBA (JSQA)
  • Panel discussion

 

17:00-18:00
New Technology of Mass Spectrometry (1)(Medium Hall / Japanese)
This session will discuss new methods for the quantification of macromolecules and the visualization of bioactive substances using MS. The session will be structured in two parts.

Presenters / Presentations:

  • Yoshiharu Hayashi (CMIC Pharma Science Co., Ltd.)
  • Yuki Sugiura (Center for Cancer Immunotherapy and Immunobiology (CCII))

 

15:25-18:00
(Parallel activity) Advancing Drug Development: Comprehensive and Optimum Approaches to the Immunogenicity Assessment (tentative title) (Round table discussion) (Conference Room / English)
A round table discussion will be held with international speakers to engage in advanced and detailed discussions.

  • Discussion time

 

18:10-20:30  Banquet

Day 3: Wednesday, 5th Mar.

9:10-10:10  New technology of Mass Spectrometry (2) (Medium Hall / Japanese)

Presenters / Presentations:

  • Toshiko Yahata (Astellas Pharma Inc.)
  • TBA

 

10:25-11:55 Poster Presentation (Exhibition Hall)

  • Core time for posters (2): 10:55-11:55

12:10-13:10 Luncheon (Conference rooms / Basically Japanese, English speaker can present in English)

 

13:25-14:55 Application of Bioanalysis in CGT: Recent Advancements (tentative)(Medium Hall / Japanese)
An introduction to ICH-S12 and implementation of drug development in cell and gene therapy (CGT) will be provided.

Presenters / Presentations

  • Daisuke Temmizu (Japan Pharmaceutical Manufacturers Association)
  • Shunsuke Yamamoto (Takeda Pharmaceutical Company Limited)
  • Satoshi Kitamura (Astellas Pharma Inc.)

 

15;00-16:30 Hot Topics Related to ADC: New Approaches and Innovations(Medium Hall / Japanese)
Analytical methods for biotransformation and determining the drug-to-antibody ratio (DAR) of antibody-drug conjugates (ADCs) will be provided and discussed.

Presenters / Presentations

  • Noritaka Hashii (National Institute of Health Sciences) Development of analysis method for DAR of ADC in human plasma using LC/MS
  • Yuki Kishino (Daiichi Sankyo Co., Ltd.) Bioanalysis and Biotransformation of Antibody Drug Conjugate
  • Yuji Fujita (Astellas Pharma Inc.) Case study of troubleshooting in ADC bioanalysis

 

16:30-17:00 Closing Remarks(Medium Hall / Japanese)

  • Best poster award ceremony
  • Closing