[D1-A1-01]Greeting
*Katsutomo Hata1(1. Shionogi & Co., Ltd.)
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2023 - 2026
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| Year : | 2023 - 2026 |
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Search Results(321)
[D1-A1-02]Opening Remarks for 17th JBF Symposium
*Akiko Ishii-Watabe1(1. Division of Biological Chemistry and Biologicals, National Institute of Health Sciences)
[D1-A2-01]Development and Validation of LC–MS-Based Bioanalytical Methods for Oligonucleotide Therapeutics: Points to Consider
*Yuchen Sun1, Shin-ichiro Nitta2, Ryoya Goda3, Yuki Kishino4, Hisashi Fujita5, Masaaki Kakehi5, Yoshiharu Hayashi6, Satoshi Ito7, Tomomi Ishida8, Kiyomi Kikuchi8, Kazuko Inoue8, Kazutaka Shimbo9, Takeru Yamaguchi10, Fumihiro Jinno11, Kaori Murakoshi12, Kentaro Takahara13, Chie Murata14, Mitsuhiko Kawabata15, Kosuke Saito1, Ruri Hanajiri1, Yoshiro Saito1(1. National Institute of Health Sciences, 2. Mediford Corporation, 3. Future Peak Co., Ltd., 4. Daiichi Sankyo Co., Ltd., 5. Takeda Pharmaceutical Co., Ltd., 6. CMIC Pharma Science Co., Ltd., 7. Sekisui Medical Co., Ltd., 8. Eisai Co., Ltd., 9. Ajinomoto Co., Inc., 10. Sumika Chemical Analysis Service, Ltd., 11. Axcelead Drug Discovery Partners, Inc., 12. Tanabe Pharma Corporation, 13. Thermo Fisher Scientific K.K., 14. Ono Pharmaceutical Co., Ltd., 15. Shin Nippon Biomedical Laboratories, Ltd.)
[D1-A2-02]PAC-LC-MS/MS Tissue Bioanalysis of Oligonucleotide Therapeutics: ICH M10–Based Validation and Multi-center Standardization
*Shin-ichiro Nitta1, Yuchen Sun2, Ryoya Goda3, Yuki Kishino4, Xiaoxi Liu5, Hisashi Fujita5, Masaaki Kakehi5, Yoshiharu Hayashi6, Satoshi Ito7, Tomomi Ishida8, Kiyomi Kikuchi8, Kazuko Inoue8, Kazutaka Shimbo9, Takeru Yamaguchi10, Fumihiro Jinno11, Kaori Murakoshi12, Kentaro Takahara13, Chie Murata14, Mitsuhiko Kawabata15, Kosuke Saito2, Ruri Hanajiri2, Yoshiro Saito2(1. Mediford Corporation, 2. National Institute of Health Sciences, 3. Future Peak Co., Ltd., 4. Daiichi Sankyo Co., Ltd., 5. Takeda Pharmaceutical Co., Ltd., 6. CMIC Pharma Science Co., Ltd., 7. Sekisui Medical Co., Ltd., 8. Eisai Co., Ltd., 9. Ajinomoto Co., Inc., 10. Sumika Chemical Analysis Service, Ltd., 11. Axcelead Drug Discovery Partners, Inc., 12. Tanabe Pharma Corporation, 13. Thermo Fisher Scientific K.K., 14. Ono Pharmaceutical Co., Ltd., 15. Shin Nippon Biomedical Laboratories, Ltd.)
[D1-A2-03]Challenges and Analytical Considerations in Protein Binding Studies for Nucleic Acid Therapeutics
*Kenichi Maeda1, Rieko Sakai1, Shun Kumagaya2, Kosuke Chiba2, Takao Suzuki2, Kenta Hashizume1(1. SEKISUI MEDICAL CO., LTD., 2. Luxna Biotech Co., Ltd.)
[D1-A3-01]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 Usui1(1. Shionogi & Co., Ltd.)
[D1-A3-02]A Novel Method of Quantifying Multiple Monoclonal Antibodies utilizing LC-MS/MS and Antibody Engineering Technology: Application to Cassette-Dosing Pharmacokinetics
*Takuya Ichikawa1,3, Naoka Hironiwa2, Naoaki Murao1, Yuki Noguchi1, Keisuke Gotanda1, Nishiki Nagaya2, Taichi Kuramochi1, Toshiyuki Kudo3, Kiyomi Ito3(1. Chugai Pharmaceutical Co., Ltd., 2. Chugai Pharmabody Research Pte. Ltd., 3. Musashino University)
[D1-A3-03]Method development and application of a generic monkey ADA assay in the early development stage of antibody drugs
*Shio Maruyama1, Arisa Inoue1, Hiroko Shimada1, Hiroyuki Shimizu1(1. Tanabe Pharma Corporation)
[D1-A3-04]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 Yasui1, Maiko Adachi1, Shiho Suruki1, Naomi Ootake1, Rena Watanabe1, Tamae Kimura1, Mayumi Hasegawa1, Kousuke Iijima1(1. Kyowa Kirin Co., Ltd.)
[D1-A3-05]Challenges in Flow Cytometry Biomarker Assessment from Non-Clinical to Clinical
*Satomi Sugiyama1(1. Astellas Pharma Inc.)
[D1-A4-01]From Compliance to Consequence: Context-of-Use as the Foundation for the Next Phase of Bioanalytical Science
*Philip Timmerman1(1. European Bioanalysis Forum (EBF))
[D1-A4-02]Rethinking Replicates: Singlicate Analysis as a Data-Driven Step Toward the Future of Bioanalysis
*Matthew Barfield1(1. On behalf of the European Bioanalysis Forum (EBF))
[D2-A1-01]Current Status and Challenges of Automating Sample Preparation in Bioanalysis during the Drug Discovery Stage
*Yuma Inamori1, Hiromichi Ozaki1, Naofumi Terada1(1. SEKISUI MEDICAL CO., LTD.)
[D2-A1-02]Automation of Bioanalytical Method Validation and Study Sample Analysis Using LC-MS/MS
*Yuya Hidoh1, Kazunori Sasaki1, Kazushi Goto1(1. Preclinical Research, Otsuka Pharmaceutical Co., Ltd.)
[D2-A1-03]Regulatory Landscape for AI in Bioanalysis: What Scientists Need to Know
*Stephanie Pasas-Farmer1(1. BioData Solutions, LLC)
[D2-A2-01]Biomarker Calibrator Challenges for Assays supporting Clinical Drug Development
*Lindsay Ewan King1(1. Pfizer Inc.)
[D2-A2-02]Parallelism Best Practices for Biomarker Assay Validation and Application to LC-MS Approaches
*Barry R Jones1(1. Crinetics Pharmaceuticals, Inc.)
[D2-A2-03]Biomarker Evaluation in Human Tissue Samples: Practices and Perspectives
*Akiko Nagatsuma1, Ryoko Takubo1(1. Chugai Pharmaceutical Co., Ltd.)
[D2-A2-04]KRAS G12D IHC Assay Reveals Target Degradation by Setidegrasib in Cancer Patient Tumor Samples
*Toshiko Yahata1, Fumio Osaki1, Masayasu Yoshino1(1. Astellas Pharma Inc.)
[D2-A3-01]The points which PMDA expects to the test facility
*Kenji Nakano1(1. Pharmaceuticals and Medical Devices Agency)
[D2-A3-02]Addressing OECD GLP Data Integrity Guidance
- Case Studies Using DI Risk Management -
*Tomoharu Shimokawa1,2(1. Japan Society of Quality Assurance GLP Division, 2. Toray Research Center, Inc.)
[D2-A3-03]Issues and Solutions for Data Integrity in GLP: Exploring Best Practices through Discussions with PMDA, JSQA, and Bioanalysis Facilities
*Nozomu Koseki1, *Takeshi Okuzono2(1. Sunplanet Co., Ltd., 2. Sekisui Medical Co., Ltd.)
[D2-B1-01]Considerations of ADA assay optimization for incretin peptide-based therapeutics in preclinical studies
*Ruoxuan Sun1, Janey Ronxhi1, Yipei Zhang1, Xiaobin Zhang1, Mark G Qian1(1. Takeda Development Center Americas, Inc.)
[D2-B1-02]Neutralizing Antibody Assay for an Antibody-Drug Conjugate: Killing or not Killing?
*Weifeng Xu1(1. Merck & Co., Inc.)
[D2-B1-03]ADA and NAb validation testing and reporting harmonization
*Heather Myler1, Kelli Phillips1(1. Takeda Development Center Americas, Inc)
[D2-B1-04]Systematic Assessment of S/N Ratios as Alternative for ADA Titers -Consideration from a different perspective-
*Hisanori Hara1, Ronald R Bowsher1(1. B2S Life Sciences, LLC)
[D2-B2-01]Basics of Patents in BioAnalysis
*Yoshihide Tsunobuchi1, *Kento Minamino1(1. IP Law Firm Lexceed Tech)
[D2-B2-02]Licensing of Analytical Method Patents
*Kenichiro Aoki1(1. F. Hoffmann-La Roche AG)
[D2-B2-03]PandA: How to Turn a New Scientific Methodology into a Business Opportunity
*Daniel Kramer1, *Aude Gaslonde2(1. Sanofi R&D, 2. Sanofi Global Intellectual Property Department)
[D3-A1-01]Moving Forward with ICH M10 Implementation: Challenges and Solutions
*Masayo Hashimoto1, *Tomohiro Nishimoto2(1. Otsuka Pharmaceutical Co., Ltd, 2. Nippon Shinyaku Co., Ltd.)
[D3-A2-01]Quantification of Viral Vectors Using the QuantStudio Absolute Q Digital PCR System
*Hiroshi Katsumoto1(1. Thermo Fisher Scientific Life Technologies Japan Ltd.)
[D3-A2-02]Analytical Measurement Methods for AAV Vector Dosing Formulation: Digital PCR vs Real-Time PCR
*Yurie Okawa1, Seulgi Lee1, Naoki Kaname1, Sho Nakazono1, Sekiko Uehara1, Haruka Inoue1, Akiko Suzuki1, Yukiko Arimura1, Asako Uchiyama1, Yohei Hayata1(1. Drug Safety Research Laboratories, Shin Nippon Biomedical Laboratories, Ltd.)
[D3-A2-03]Key considerations in biodistribution evaluation of gene therapy products using adeno-associated virus vectors
*Miyu Nakayama1(1. Takeda Pharmaceutical Company Limited)
[D3-A3-01]Bioanalysis in Dual-Payload ADC: Case Study of Analytical Strategy and Quantitation of total antibody and ADCs by IA-LC/MS/MS
*Yuji Fujita1, Toshihiro Matsuda1, Guifen Xu2, Werner Rubas2(1. Astellas Pharma Inc., 2. Sutro Biopharma Inc.)
[D3-A3-02]Strategies for Selecting Critical Reagents and Developing Analytical Methods Based on Antibody and Target Characteristics in Antibody Therapeutics Development
*Ken Ohmine1(1. Pharmaceutical Science Dept., Chugai Pharmaceutical Co., Ltd.)
[P2-01]Validation of a commercially available ELISA for quantification of human protein in human tissue
*Hiroyuki Shimizu1(1. Tanabe Pharma Corporation)
[P2-02]Improvement of Anti-Idiotype DNA Aptamers for Bioanalysis of Rituximab
*Naruma Uchidate1, Minori Kurihara1, Chiho Hirayama1, Nao Kobayashi1, Aogu Furusyo1, Kenji Kojima1, Kenichiro Todoroki1(1. School of Pharmaceutical Sciences, University of Shizuoka)
[P2-03]Establishment and Validation of a ddPCR-Based Duplex Assay With Diploid Genome Normalization for Accurate Biodistribution: Comparison With DNA Quantity Normalization
*Haruka Inoue1, Sho Nakazono1, Sekiko Uehara1, Yurie Okawa1, Seulgi Lee1, Yukiko Arimura1, Akiko Suzuki1, Asako Uchiyama1, Hiroyuki Yamashita1(1. Shin Nippon Biomedical Laboratories, Ltd.)
[P2-04]Patient-Centric Measurement of M-Protein Using High-Resolution Intact Mass Spectrometry
*Luca Genovesi1, Laurence Mayrand-Provencher1, Pierre Gontard1, Mirzo Kanoatov1, Gwenael Pottiez1(1. CellCarta)
[P2-05]Ultra Fast Analysis of Anticoagulants in Plasma Using Triple Quadrupole Mass Spectrometer
*Miho Kawashima1, Taku Tsukamoto1(1. Solutions COE, Analytical & Measuring Instruments Div., Shimadzu Corp.)
[P2-06]Biomarker Immunogenicity: Exploring method qualification of the anti-FcεR1α autoantibody.
*Matthew Lawless1, Nikki Chan1, Kruti Patel1(1. Syneos Health)
[P2-07]Study on Immunogenicity Assessment Methods for Anti-AAV Antibodies
*Yoichi Tanaka1, Kanna Sato1, Namiko Ogawa1, Akiko Ishii1, Ruri Hanajiri-Kikura1(1. National Institute of Health Sciences)
[P2-08]Determination of sgRNA and mRNA Sequence Identity by Low-Micro Flow Ion-Pair Reversed-Phase Chromatography and High-Resolution Tandem Mass Spectrometry
*Sergio Adrian Guazzotti1, Roxana Eggleston-Rangel1, Yuichi Sugiyama2, Shigeo Tojo2(1. Phenomenex, Inc., 2. Phenomenex Div. of K.K. AB SCIEX)
[P2-09]Evaluation of anti-drug antibodies against therapeutic monoclonal antibodies andrelated product in Japanese patients with rheumatoid arthritis and their clinical impact
*Hiroko Shibata1, Kazuko Nishimura1, Eri Tsukagoshi2, Akiko Ishii-Watabe1, Yoshiro Saito3(1. Devision of Biological Chemistry and Biologicals, National Institute of Health Sciences, 2. Devision of Medical Safety Science, National Institute of Health Sciences, 3. National Institute of Health Sciences)
[P2-10]Development of anti-PEG antibody assays and cut point setting using healthy human sera
*Kazuko Nishimura1, Hiroko Shibata1, Yoshiro Saito2, Akiko Ishii-Watabe1(1. Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 2. National Institute of Health Sciences)
[P2-11]Case study of deviations from incurred sample reanalysis (ISR) and its improvements for bioanalysis of biopharmaceuticals
*Yuichi Yokoyama1, Yoshimi Inoue1, Masahito Ito1, Tetsuya Ohta1(1. Safety Research Laboratories, Research Division, Tanabe Pharma Corporation)
[P2-12]Adsorption Evaluation in LC/MS analysis of peptide
*Daiki Fujimura1, Yusuke Osaka1(1. Shimadzu Corporation)
[P2-13]Validation of an ultra-sensitive PCR assay for biomarker testing in NSCLC patients as Clinical Trial Assay (CTA)
*Nathalie Bernard1, Sara Diels3, Bart Tegenbos3, Dirk Goossens3, Lien Heyrman4, Jurgen Del Favero4, Magdalena Stolarek2, Sam Abujudeh, Barnaby Balmforth2(1. Scientific Business Development, CellCarta NV, 2. Biofidelity Ltd, 3. Assay Development Team, CellCarta NV, 4. Global Operations, CellCarta NV)
[P2-14]Questionnaire on Quantitative Evaluation of Localization and Distribution via Fluorescence Imaging
*Kosuke Saito1, Yuchen Sun1, Akinobu Hamada2(1. National Institute of Health Sciences, 2. National Cancer Center Research Institute)
[P2-15]Evaluation of Critical Reagents Impact for Sensitive Quantification of Antibody-Drug Conjugate in Human Plasma Using ECL
*Akiko Shindou1, Masashi Yoshimura1, Hiromi Okamoto1, Daisuke Nakai1(1. Daiichi Sankyo Co., Ltd.)
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