The 6th JBF Symposium Program“Challenge of Regulated Bioanalysis”
Date: 25th -26th February 2015
Venue: Tower Hall Funabori, Tokyo, Japan
Overall host: Harue Igarashi (GlaxoSmithKline)
th25 February (Wed.)
1. JBF activity update

Masanari Mabuchi (Mitsubishi Tanabe Pharma)
Chair: Noriko Inoue (JCL Bioassay)

2. Global BMV guideline/recommendation
2.1 FDA guidance update

Brian Booth (U.S. Food and Drug Administration)

2.2 GBC update

Shinobu Kudoh (Shimadzu Techno-Research, GBC-SC)

3. JBF’s first session on biomarkers

Chair: Noriko Katori (National Institute of Health Sciences),
Takehisa Matsumaru (Otsuka Pharmaceutical)

3.1 An overview of the draft concept paper on quantitative measurements of endogenous biomarkers for drug
developments; regulatory importance and future directions
Takayoshi Suzuki (National Institute of Health Sciences)
3.2 Fit-for-purpose biomarker assay validation: from concept to practices Jean W. Lee (BioQualQuan, LLC)
3.3 Biomarker assay development based on drug R&D strategy

Nobuhiro Kobayashi (DaiichiSankyo)

3.4 Comparison of biomarker assay between bioanalysis and laboratory test

Keiko Nakai (LSI medience)

3.5 Panel discussion
4. Best practices in Asia-pacific CRO

Chair: Shinobu Kudoh (Shimadzu Techno-Research),Kenji Yahata (Sanofi)

4.1 Cross validation and matrix effect – two critical factors in ensuring successful regulated bioanalysis
Bi Luke (Covance)
Andrew Dinan (CPR Pharma)

4.2 Bioanalytical best practice in Australia
4.3 Bioanalytical Current Circumstances in Korea

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Masahiro Taniguchi (SBB)

26th February (Thu.)
5. Poster presentation and open discussion
5.1 Outcomes and recommendations from JBF Discussion Group
5.1.1 DG2014-06: "The Study of Failure" in analytical studies
5.1.2 DG2014-07: Development of analysis method
5.1.3 DG2014-08: Quantitative analysis of endogenous substance
5.1.4 DG2014-09: Tiered approach for the quantitative assay method
5.1.5 DG2014-10: Partial validation (3)5.1.6 DG2014-11: Anti-Drug Antibody (ADA) Assay
5.1.7 DG2014-12: Quantitative analysis by LBA (PK/Biomarker)
5.1.8 DG2013-01: Recommendation to prepare calibration standards and QC samples
5.2 Achievement of the JBF task force for large molecule MSLMMS task force [Masaki Hoshino (LSI medience) and all]Biomarker task force

5.3 Achievement of the JBF task force for biomarker

6. Bioanalysis of large molecule pharmaceuticals using LC-MS
Chair: Masahiro Utoh (Shin Nippon Biomedical Laboratories),
Hisao Shimizu (Takeda)
6.1 Meaning of large molecule bioanalysis using mass spectrometory
6.2 Outcomes from large molecule MS Task force team

Rieko Goto (JCL Bioassay)
Ryoya Goda (Daiichi-Sankyo)

6.3 LC-MS-based bioanalysis in support of protein biotherapeutics development: current challenges andemerging opportunities

Rand Jenkins (PPD)

6.4 Panel discussion
Short presentation: Recommendations for validation of LC-MS/MS bioanalytical methods for protein
biotherapeutics

Jean W. Lee

Panel discussion:
7. MHLW BMV guidelines

Chair: Masanari Mabuchi (Mitsubishi Tanabe Pharma),
Kazutaka Togashi (Sumika Chemical Analysis Service)

7.1 LC guideline, Implementation for a year
7.1.1 Evaluation of bioanalysis in regulatory review in Japan

Daisuke Iwata (PMDA)

7.1.2 Implementation of the BMV guideline for generic drug development in Japan
Hidehisa Tachiki (Towa, JGA)
7.2 LBA guideline
7.2.1 Guideline/guidance comparison on large molecule bioanalysis (ligand binding assay)
Jun Hosogi (Kyowa Hakko Kirin)
7.2.2 Issues on method validation/ sample assay after application of LBA guideline
Yoshiyuki Minamide (Shimadzu Techno-Research)
8. Panel discussion

Chair: Masanari Mabuchi, ,Kazutaka Togashi
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