Language translation script (Japanese / English) will be projected at the main venue (Medium Hall and conference room 409).

---

Day 1: Wednesday, 4^th Mar.

Medium Hall

13:00-13:20: Opening Remarks

• Greetings/ Katsutomo Hata (The 17th JBF Symposium Executive Committee Chair/ Shionogi & Co., Ltd.)
• Opening Remarks for 17th JBF Symposium/ Akiko Ishii (National Institute of Health Sciences) 

 

13:25-14:40: Advances and Challenges in Bioanalysis of Oligonucleotide Therapeutics

(Chairperson: Makoto Takahashi/ Daiichi Sankyo Co., Ltd., Miyuki Ugajin/ Takeda Pharmaceutical Co., Ltd.)

• Development and Validation of LC–MS-Based Bioanalytical Methods for Oligonucleotide Therapeutics: Points to Consider/ Yuchen Sun (National Institute of Health Sciences)
• PAC-LC-MS/MS Tissue Bioanalysis of Oligonucleotide Therapeutics: ICH M10–Based Validation and Multi-center Standardization/ Shin-ichiro Nitta (Mediford Corporation)
• Challenges and Analytical Considerations in Protein Binding Studies for Nucleic Acid Therapeutics/ Kenichi Maeda (SEKISUI MEDICAL CO., LTD)

 

Exhibition Hall

14:50-16:00: Booth introduction by sponsors

It will be set aside for participants to visit the booths of sponsors. Thirty-four sponsors are scheduled to exhibit booths. Please have the opportunity to get the latest information. We will also be holding a stamp rally. We will prepare prizes for those who visit booths and collect stamps, but the number of prizes is limited. Please note that the stamp rally will end once all prizes have been distributed.

 

Medium Hall

16:10-14:50: Challenge for Junior Bioanalysts

(Chairperson: Hitoshi Uchiyama/ Towa Pharmaceutical Co., Ltd., Tamiki Mori/ Mediford Corporation)

• Development of a Riboflavin Analysis Method by LC/MS/MS and Determination of Riboflavin in Human Plasma to Evaluate Its Utility as a BCRP-Specific Endogenous Biomarker/ Asako Usui (Shionogi & Co., Ltd.)
• A Novel Method of Quantifying Multiple Monoclonal Antibodies utilizing LC-MS/MS and Antibody Engineering Technology: Application to Cassette-Dosing Pharmacokinetics/ Takuya Ichikawa (Chugai Pharmaceutical Co., Ltd.)
• Method development and application of a generic monkey ADA assay in the early development stage of antibody drugs/ Shio Maruyama (Tanabe Pharma Corporation)
• Evaluation of Ultra High Sensitivity PK/BM Assay Systems and Comparison of Measurement Platforms: Challenges and Approaches for Sensitivity Enhancement in PK/BM Assays/ Shunki Yasui (Kyowa Kirin Co., Ltd.)
• Challenges in Flow Cytometry Biomarker Assessment from Non-Clinical to Clinical/ Satomi Sugiyama (Astellas Pharma Inc.)

 

17:50-18:40: Strategic activities of EBF towards the Future of Bioanalysis

(Chairperson: Makoto Takahashi/ Daiichi Sankyo Co., Ltd., Takashi Miyayama/ Chugai Pharmaceutical Co., Ltd.)

• From Compliance to Consequence: Context-of-Use as the Foundation for the Next Phase of Bioanalytical Science/ Philip Timmerman (European Bioanalysis Forum (EBF))
• Rethinking Replicates: Singlicate Analysis as a Data-Driven Step Toward the Future of Bioanalysis/ Matthew Barfield (On behalf of the European Bioanalysis Forum (EBF))

 

---

Day 2: Thirsday, 5^th Mar.

Medium Hall

9:00-10:15: AI and Automation in Bioanalysis: Current Challenges and Future Directions

(Chairperson: Naoto Yamada/ Shionogi & Co., Ltd., Masayo Hashimoto/ Otsuka Pharmaceutical Co., Ltd.)

• Current Status and Challenges of Automating Sample Preparation in Bioanalysis during the Drug Discovery Stage/ Yuuma Inamori (SEKISUI MEDICAL CO., LTD.)
• Automation of Bioanalytical Method Validation and Study Sample Analysis Using LC-MS/MS/ Yuya Hidoh (Otsuka Pharmaceutical Co., Ltd.)
• Regulatory Landscape for AI in Bioanalysis: What Scientists Need to Know/ Stephanie Pasas-Farmer (BioData Solutions, LLC)

 

Conference room 408 & 409

 9:00-11:00: Advancing Immunogenicity Assessment: The Latest Topics in ADA/NAb Assays and the Reporting Standardization

(Chairperson: Hisanori Hara/ B2S Life Sciences, Hiroyuki Shimizu/ Tanabe Pharma Corp.)

• Considerations of ADA assay optimization for incretin peptide-based therapeutics in preclinical studies/ Ruoxuan Sun (Takeda Development Center Americas, Inc.)
• Neutralizing Antibody Assay for an Antibody-Drug Conjugate: Killing or not Killing?/ Weifeng Xu (Merck & Co., Inc.)
• ADA and NAb validation testing and reporting harmonization/ Heather Myler (Takeda Development Center Americas, Inc.)
• Systematic Assessment of S/N Ratios as Alternative for ADA Titers -Consideration from a different perspective/ Hisanori Hara/ B2S Life Sciences

 

Medium Hall

10:25-11:55: Shaping the Future of Biomarker Evaluation: Insights from Practice

(Chairperson: Tomohiro Nishimoto/ Nippon Shinyaku Co., Ltd., Tomoko Arakawa/ Pfizer R&D Japan G.K.)

• Biomarker Calibrator Challenges for Assays supporting Clinical Drug Development/ Lindsay King (Pfizer Inc.)
• Parallelism best practices for biomarker assay validation and application to LC-MS approaches/ Barry Jones (Crinetics Pharmaceuticals, Inc.)
• Biomarker Evaluation in Human Tissue Samples: Practices and Perspectives/ Akiko Nagatsuma (Chugai Pharmaceutical Co., Ltd.)
• Demonstrating Mechanism of Action in Patients using IHC; Case study of KRAS G12D selective degrader Setidegrasib (ASP3082)/ Toshiko Yahata (Astellas Pharma Inc.)

 

12:15-13:15: Luncheon Seminar

• Conference room 407: AB Sciex Pte. Ltd.

LC-MS Approaches for Bioanalysis in ADC Development

• Conference room 409: iBody Inc.

1)Marriage of single-cell and cell-free technologies for accelerating the development stage of antibody drugs

2) Influence of anti-drug antibody against therapeutic antibody in clinical practice

• Conference room 401: Nihon Waters K.K.

Analytical Solutions and Method Development Considerations for Quantitative Bioanalytical Oligonucleotide Studies

• Conference room 402: Mediford Corporation

Application of PAC-LC/MS to Quantitative Analysis of New-Modality Drugs and Endogenous Peptides and Proteins

• Conference room 403: SCRUM Inc.

NULISA: Ultrasensitive & Multiplex Immunoassay Platform

 

Exhibition Hall

13:30-14:30: Poster presentation (1)

• DG Poster Presentation (Poster Number: DGP2-01~DGP2-06)
• General Poster Presentation (Poster Number: P2-01~P2-20)

 

Medium Hall

14:45-16:10: Issues and Solutions for Data Integrity in GLP: Exploring Best Practices through Discussions with PMDA, JSQA, and Bioanalysis Facilities

(Chairperson: Nozomu Koseki/ Sunplanet Co.,Ltd., Takeshi Okuzono/ Sekisui Medical Co., Ltd.)

• The points which PMDA expects to the test facility/ Kenji Nakano (Pharmaceuticals and Medical Devices Agency)
• Addressing OECD GLP Data Integrity Guidance -Case Studies Using DI Risk Management-/ Tomoharu Shimokawa (Toray Research Center, Inc./Japan Society of Quality Assurance GLP Division)
• Roundtable Discussion

 

Conference room 408 & 409

14:45-16:10: Patent in Bioanalysis

(Chairperson: Makoto Takahashi/ Daiichi Sankyo Co., Ltd., Hisanori Hara/ B2S Life Sciences, LLC)

• Basics of Patents in BioAnalysis/ Kento Minamino, Yoshihide Tsunobuchi (IP Law Firm Lexceed Tech)
• Licensing of Analytical Method Patents/ Kenichiro Aoki (F. Hoffmann-La Roche AG)
• PandA: How to Turn a New Scientific Methodology into a Business Opportunity/ Daniel Krammer, Aude Glaslonde (Sanofi)

 

Medium Hall

16:25-17:40: Basic Lecture

(Chairperson: Tsubasa Ibushi/ ShimadzuTechno-Research, Inc., Ken-ichi Yamamoto/ Shin Nippon Biomedical Laboratories, Ltd.)

• Basic course on bioanalytical method using LC/MS/MS/ Kazuyuki Murata (Sumika Chemical Analysis Service, Ltd.)
• Basic Course on LBA/ Kaito Kozue (Mediford Corporation)
• Immunogenicity assessment and cut point calculation -Recommendation for data visualization accompanying statistical calculations-/ Hisanori Hara (B2S Life Sciences)

 

Conference room 408 & 409

16:25-17:40: Casual Follow-Up Session (1)

We will provide an opportunity for attendees to pose questions to the panelists of the session, “Issues and Solutions for Data Integrity in GLP: Exploring Best Practices through Discussions with PMDA, JSQA, and Bioanalysis Facilities”.

Advance registration is not required.

 

Exhibition Hall

18:00-20:00: Banquet

 

---

Day 3: Friday, 6^th Mar.

Medium Hall

9:00-10:50: Moving Forward with ICH M10 Implementation: Challenges and Solutions

(Chairperson: Tomohiro Nishimoto/ Nippon Shinyaku Co., Ltd., Masayo Hashimoto/ Otsuka Pharmaceutical Co., Ltd.)

• Overview of M10 implementation progress to date and survey summary/ TMasayo Hashimoto (Otsuka Pharmaceutical Co., Ltd.)
• Panel Discussion: Key Issues, Insights and Experiences in ICH M10 Implementation

 

Exhibition Hall

11:05-12:05: Poster presentation (2)

• DG Poster Presentation (Poster Number: DGP3-01~DGP3-06)
• General Poster Presentation (Poster Number: P3-01~P3-18)

 

12:20-13:20: Luncheon Seminar (2)

• Conference room 407: Thermo Fisher Scientific K.K.

Next-generation mass spectrometers and Lab Information Management System (LIMS): The fusion of innovative data analysis and quality management supporting bioanalysis

• Conference room 409: Olink Proteomics, FUJIFILM WAKO PURE CHEMICAL CORPORATION

High-Reliability PEA-Based Proteomics and Domestic Analytical Framework

• Conference room 401: LabCorp Japan, G.K.

Accelerating ADC Development: Advanced Bioanalysis and Biomarker Strategies

• Conference room 402: B2S Life Sciences

Diligent Design and Tailored Characterization of Critical Reagents: A Key to Successful Large-Molecule Bioanalytical Programs

• Conference room 403: ChromaNik Technologies Inc.

SunBridge C18 and PFP-R: Twin Highly Stable HPLC Columns for Advanced Separations

 

Medium Hall

13:35-14:50: Latest Approaches to Quantification and Biodistribution Evaluation of Gene Therapy Products

(Chairperson: Ken-ichi Yamamoto/ Shin Nippon Biomedical Laboratories, Ltd., Tamiki Mori/ Mediford Corporation)

• Quantification of Viral Vectors Using the QuantStudio Absolute Q Digital PCR System/ Hiroshi Katsumoto (Thermo Fisher Scientific Life Technologies Japan Ltd.)
• Analytical Validation of AAV Dosing Formulation: Digital PCR vs Real-Time PCR/ Yurie Okawa (Shin Nippon Biomedical Laboratories, Ltd.)
• Biodistribution Assessment of Adeno-Associated Virus Vector-Based Gene Therapy Products Across Multiple Species and the Impact of Unit Notation on Quantitative Biodistribution Analysis/ Miyu Nakayama (Takeda Pharmaceutical Company, Ltd)

 

Conference room 408 & 409

13:50-14:50: Casual Follow-Up Session (2)

We will provide an open forum where participants can freely discuss the content of the session, “Moving Forward with ICH M10 Implementation: Challenges and Solutions”, as well as their day‑to‑day questions regarding ICH M10.

No advance registration is required.

 

Medium Hall

15:05-15:55: Bioanalytical Strategy in Biopharmaceutical Development

(Chairperson: Masanori Nagata/ Astellas Pharma Inc., Takashi Miyayama/ Chugai Pharmaceutical Co., Ltd.)

• Bioanalysis in Dual Payload ADC: Case Study of Analytical Strategy and Quantitation of TAb/ADCs by IA-LC/MS/MS/ Yuji Fujita (Astellas Pharma Inc.)
• Strategies for Selecting Critical Reagents and Developing Analytical Methods Based on Antibody and Target Characteristics in Antibody Therapeutics Development/Ken Ohmine (Chugai Pharmaceutical Co., Ltd.)

 

Medium Hall

16:00-16:25: Poster Award and Closing Remarks

• Poster Award
• Closing Remarks / Announcement of the 18th JBF Symposium