間渕雅成（田辺三菱製薬） - Japan Bioanalysis Forum

5th JBF Symposium
http://bioanalysisforum.jp/
Update in JBF Activity
6th March 2014 in Tokyo
Masanari Mabuchi
Mitsubishi Tanabe Pharma Corporation
5th JBF Symposium, 6th March 2014
Contents
1. Japan Bioanalysis Forum
2. JBF Activity
3. Future Direction
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5th JBF Symposium, 6th March 2014
JBF Scope and Mission
 Scope: Regulated Bioanalysis
– Small molecule (e.g. LC/MS/MS)
– Large molecule (e.g. LBA)
– (Possibly biomarker measurement)
 Mission
– Facilitate a discussion on regulated bioanalysis in
Japan
– Interact with Japanese regulators in the field of
bioanalysis
– Represent Japan in worldwide bioanalysis
community
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5th JBF Symposium, 6th March 2014
JBF Organization
Representative
Deputy representative
GBC-SC
Advisors
Committees(10)
・Financial
・Financial auditors
・Website
・Membership
・Event execution
Steering Committee
Task Forces
・GBC-HT
・Chromato-GL
・LBA-GL
・DG
・LM-MS
・Handbook
・Public relations
・Documentation
・International affairs
・EBF window
・CBF window
・Jpn GBC-HT member
・GBC-HT supporter
・JBF partner
・DG-member/supporter
as of February 2014
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5th JBF Symposium, 6th March 2014
Contents
1. Japan Bioanalysis Forum
2. JBF Activity
3. Future Direction
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5th JBF Symposium, 6th March 2014
Previous JBF Symposiums
 1st : 10 August 2011 Tower Hall Funabori
 2nd : 8 March 2012 Tower Hall Funabori
 3rd : 8 August 2012 Keio Univ. (BMAS joint)
 4th : 2 August 2013 Showa Univ. (BMAS joint)
Conference Report, Akira Nakayama, Bioanalysis, accepted (Feb. 2014)
Attendees: more than 200 per symposium, from
academy, industry, and regulatory agencies
■ 5th : 6-7 March 2014
Here in Tower Hall Funabori
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5th JBF Symposium, 6th March 2014
BMV Guideline for LBA method
 BMV study group
 Draft of preliminary text, Glossary, Q&A
 Draft Guideline on Bioanalytical Method (Ligand
Binding Assay) Validation in Pharmaceutical
Development (10 January, 2014, MHLW, Japan)
 To be published in Spring 2014
 New Activity:
Working Group for Large Molecule-MS
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5th JBF Symposium, 6th March 2014
Corporate Membership
 Supporting: CRO/Vendor (15)
- Link from the JBF website
- Preferential treatment for the booth setting and the luncheon holding in JBF symp.
- Preferential treatment for the advertisement in JBF symp.
 Company: Pharma (16)
- Free two participation in JBF symposium
 2014-Registration have started on 1st Feb. 2014
http://bioanalysisforum.jp/join
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5th JBF Symposium, 6th March 2014
Supporting Members
 株式会社エービー・サイエックス
 日本ウォーターズ株式会社
 株式会社新日本科学
 三菱化学メディエンス株式会社
 株式会社住化分析センター
 バイオタージ・ジャパン株式会社
 （株）応用医学研究所
 株式会社ネモト・サイエンス
 株式会社日本医学臨床検査研究所
 サーモフィッシャーサイエンティフィック（株）
 ヴェオリア・ウォーター・ソリューション&テクノロジーエルガ・ラボウォーター
 株式会社島津テクノリサーチ
 株式会社JCLバイオアッセイ
 株式会社東レリサーチセンター
 PPC株式会社
口数および申し込み順 2014/02/28 現在
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5th JBF Symposium, 6th March 2014
Corporate Members
 グラクソ・スミスクライン株式会社
 日本ジェネリック株式会社
 武田薬品工業株式会社
 あすか製薬株式会社
 エーザイ(株)
 興和株式会社
 旭化成ファーマ株式会社
 沢井製薬株式会社
 小野薬品工業株式会社
 田辺三菱製薬株式会社
 大日本住友製薬株式会社
 味の素製薬株式会社
 千寿製薬株式会社
 第一三共株式会社
 JCRファーマ株式会社
 日本たばこ産業株式会社*
申し込み順 2014/02/28 現在
*次年度新規
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5th JBF Symposium, 6th March 2014
JBF Global Action
 International affairs Committee with 4 members
 Guideline/Guidance Comparison on small molecule
bioanalysis among MHLW, EMA and FDA
 Submission of Japanese comments to FDA draft
guidance
 English support for Japanese draft guideline
 Homepage in English http://bioanalysisforum.jp/en
 Annual meeting with EBF/CBF
 GBC-HT JPN member and supporter corporate with
the recommendation papers
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5th JBF Symposium, 6th March 2014
Relationship between JBF and other organizations
JSSX
SCS
Global
Domestic
7th Workshop on Recent Issues in Bioanalysis
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5th JBF Symposium, 6th March 2014
Discussion Group(DG)
 JBF offers “Ba” (room) to discuss casual questions
raised from daily bioanalysis work.
 Group members are selected as individuals (not as
representatives of their companies) and each group
is composed of 6 to 10 members.
 Topics to be discussed are not limited to regulatory
issues (e.g. ambiguous methodology/process).
 Five groups with their own topics have commenced
just after the 4th JBF symposium, and their
discussion for 6 months is underway.
 See you at Poster session tomorrow morning!
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5th JBF Symposium, 6th March 2014
Contents
1. Japan Bioanalysis Forum
2. JBF Activity
3. Future Direction
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5th JBF Symposium, 6th March 2014
Schedule
Draft of FDA BMV
Guidance (revised)
8th WRIB
(LA, USA)
CC-V
(Baltimore)
EBF Open
Symposium
(Barcelona)
APA India
Sep
Aug
2012
2013
Mar
The 3th JBF
Symposium
(Tokyo)
Jul
Aug/2
The 4th JBF
Symposium
(Tokyo)
Preliminary LBA Guideline was listed-up
(by JBF)
BMV Guideline for
LC, small molecule
(by MHLW)
Now!
Dec
Jan
2014
Nov
Mar
The 5th JBF
Symposium
(Tokyo)
Draft of LBA-BMV
Guideline
(by MHLW)
2015
The 6th JBF
Symposium
BMV Guideline for
LBA, large
molecule
(by MHLW)
Japan
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5th JBF Symposium, 6th March 2014
Future direction






Discussion Group
LBA guideline
Comparison among MHLW, EMA and FDA
Large Molecule-MS
Handbook for BMV guideline
JBF session in BMAS2014
 6th JBF Symposium, 2015
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5th JBF Symposium, 6th March 2014
Thank you for your attention
Japan Bioanalysis Forum
URL： http://bioanalysisforum.jp
Email: [email protected]
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