bioanalytical method validation in japan and activities of...
TRANSCRIPT
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Bioanalytical Method Validation in Japan and activities of the Japan Bioanalysis Forum
BMV JBF
2nd JBF Symposium, 8 March 2012
Noriko Katori, Ph.D. National Institute of Health Sciences
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Today’s Topics
1. Recent History of BMV in Japan
2. Activities of JBF
3. BMV Study Group
2nd JBF Symposium, 8 March 2012
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1. RECENT HISTORY OF BMV IN JAPAN
2nd JBF Symposium, 8 March 2012
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Bioanalysis – Global Movement1992 FDA AAPS
. 2001 FDA Guidance for Industry (Bioanalytical method
validation) . 2006 EBF was founded in 2006 at the initiative of 12 pharmaceutical
companies. 2007 FDA AAPS White Paper
. ISR .2009 EMA Draft Guideline on Validation of Bioanalytical
Methods . 2010 CRO Global Bioanalysis
Consortium (GBC) . 2011 EMA Guideline on Validation of Bioanalytical Methods
.
2nd JBF Symposium, 8 March 2012
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Regulatory Organization & Discussion groups in Japan
Authorities ! Ministry of Health, Labour and Welfare(MHLW ) ! Pharmaceuticals and Medical Devices Agency (PMDA ) ! National Institute of Health Sciences (NIHS ) Companies ! Japan Pharmaceutical Manufacturers Association (JPMA ) ! Japan Generic Medicines Association (JGA ) ! Japan Association of Contract Laboratories for Safety Evaluation
(JACL )
Scientific Group ! Pharmaceutical Society of Japan (PSJ ) ! Japan Bioanalysis Forum (JBF )
2nd JBF Symposium, 8 March 2012
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The recent history around BMV in Japan
! May, 2008, First workshop for ISR in Japan ( 56AAPS/FDA White Paper
Dr.Vishwanasan
! 2009 – 2010, Discussion about BMV was held by pharmaceuticals and CROs,
! Late of 2010, GBC (Global Bioanalysis Consortium) approached Japanese organizations and companies for recruiting their members.
! Jan. 12, 2011, The First Asia Pacific Conference on Recent Issues in Regulated Bioanalysis ( BMV , , China),
! Mar. 30, 2011, Kick-off meeting of the JBF foundation members.
2nd JBF Symposium, 8 March 2012
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Foundation Members of JBF
Representative ! Kurokawa, Tatsuo (Prof., Keio Univ.)
Academia ! Haginaka, Jun (Prof., Mukogawa Women's Univ.) ! Masujima, Tsutomu, (Prof., Hiroshima Univ.)
Companies Pharmaceutical ! Hara, Hisanori (Novartis Pharma AG, Switzerland) ! Jinno, Fumihiro (Takeda Pharmaceutical Co.,
Ltd.) ! Kobayashi, Nobuhiro, (DaiichiSankyo Co., Ltd.) ! Kondo, Takahiro (Takeda Pharmaceutical Co.,
Ltd.) ! Mabuchi, Masanari (Mitsubishi Tanabe Pharma
Co.) ! Matsumaru, Takehisa (Nippon Boehringer
Ingelheim Co., Ltd)
! Nakayaka, Akira (Ajinomoto Pharmaceuticals Co., Ltd.)
! Ohtsu, Yoshiaki, (Astellas Pharma Inc.) ! Osumi, Takahiko (Otsuka Pharmaceutical Co., Ltd.) ! Tachiki, Hidehisa (Towa Pharmaceutical Co., Ltd.) ! Yahata, Kenji (Sanofi-Aventis) ! Yoneyama, Tomoki, (Takeda Pharmaceutical Co., Ltd.) CRO ! Inoue, Noriko (JCL Bioassay Co., Ltd.) ! Taniguchi, Masahiro (Sumika Analysis Service, Ltd.)
Regulation ! Katori, Noriko (National Institute of Health Sciences)
2nd JBF Symposium, 8 March 2012
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The recent history around BMV in Japan
! Mar. 30, 2011, Kick-off meeting of the JBF foundation members, ! 2nd quarter, 2011, A lot of JBF members applied for GBC-HT. ! Aug. 10, 2011, The First JBF Symposium (Tokyo),
! Oct. 6, 2011, Kick-off meeting of the BMV Study Group for Japanese BMV guideline ,
! Nov. 2011, EBF 2011 4th Open Symposium (Barcelona), JBF was introduced by Mr. Shinobu Kudoh.
! 2011 2012, ◦ Asian and Brazilian bioanalysis community are enthusiastic to have a regular
communication with JBF. ◦ One of the options would be to establish "Asia-pacific Bioanalysis
Communication Consortium”.
! Dec. 7, 2011, J-BMV Guideline items were listed-up by JBF,
! Mar. 8, 2012, The Second JBF Symposium (Tokyo).
2nd JBF Symposium, 8 March 2012
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2. ACTIVITIES OF
2nd JBF Symposium, 8 March 2012
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JBF Related Symposia and Seminars after Establishment
! Apr. 2011, 5th Workshop on Recent Issues in Bioanalysis (Montreal), JBF establishment was officially preannounced by Dr. Noriko Katori.
! Aug. 10, 2011, The First JBF Symposium (Tokyo),
! Aug. 31- Sep. 2, 2011, JBF was introduced at regulated bioanalysis session in BMAS2011 (Tottori),
! Nov. 1, 2011, JBF was introduced by Mr. Yoshiaki Ohtsu at the Waters Seminar (Tokyo),
! Nov. 2011, JBF was introduced by Mr. Shinobu Kudoh at the EBF 2011 4th Open Symposium (Barcelona),
! Mar. 8, 2012, The Second JBF Symposium (Tokyo).
2nd JBF Symposium, 8 March 2012
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The first JBF Symposium (Tokyo, Aug.2011)
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1. BMV GBC2. 3. 4. CRO
2nd JBF Symposium, 8 March 2012
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BMAS2011 (Daisen, Tottori, Aug. 31- Sep. 2, 2011)! 24 BMAS2011
2nd JBF Symposium, 8 March 2012
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Waters Seminar Waters JBF
2011 11 1
2nd JBF Symposium, 8 March 2012
11 110 00 16 4510 00 16 45
18 00
4040
Christopher A. Evans Ph.D.Christopher A. Evans Ph.D.
2011 10
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EBF 2011 4th Open SymposiumUpdates From The Globe ! Shinobu Kudoh (Shimadzu for Japan Bioanalysis Forum) - Introducing the Japan
Bioanalysis Forum (JBF)
2nd JBF Symposium, 8 March 2012
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Slides
PDF renditions of the powerpoint presentations given at EBF's 2011 open symposium can be viewed and downloaded from this page. NOTE: Authors/presenters who feel that a mistake has been made by the EBF, should contact the OSOC [email protected] Opening
Philip Timmerman (for EBF) - Welcome to the conference
Biomarker Validation Recommendation
Philip Timmerman (on behalf of EBF) - Introduction to biomarker validation recommendation sessionChristian Herling (on behalf of EBF) - EBF reflections on biomarker validationAlexandre Avrameas (Novartis) - Validation of immunoassay for protein biomarkers: bioanalytical study plan implementationBarry Jones (Advion) - LC/MS biomarker assay validation strategies using surrogate matrix and surrogate analyte approachesRichard Houghton (Quotient Bioresearch) - Challenges of validating small molecule LC-MS/MS biomarker methodsJohn Chappell (ICON Development Solutions) - Biomarker Measurement- maximum information from limited volume
How To Implement The EMA Guideline On Bioanalytical Method Validation
Peter van Amsterdam (on behalf of EBF) - IntroductionOlivier Le Blaye (afssaps) - The EMA Guideline on bioanalytical method validationTimothy Sangster (Charles River Laboratories) - EMA – have our prayers been answered!Daniela Stoellner (Novartis) - New EMA guideline on method validation and how it translates into best practice for Ligand Binding AssaysGraeme Smith (Huntingdon Life Sciences) - Partial Validation when is enough, enough?Morten Rohde (Lundbeck) - Matrix Effects in Bioanalysis, when established procedures become obsolete.
Updates From The Globe
Rafael Barrientos (Magabi for ACBio) - ANVISA guideline on bioanalytical method validation updatesShinobu Kudoh (Shimadzu for Japan Bioanalysis Forum) - Introducing the Japan Bioanalysis Forum (JBF)
Global Harmonization – Updates And Feedback From GBC Harmonization Teams
Philip Timmerman (on behalf of GBC) - Global Bioanalysis Consortium status updateJohn Smeraglia (on behalf of GBC Harmonisation Team A1) - Harmonization team A1 (scope and regulations) updateNico van de Merbel (on behalf of GBC Harmonisation Team A6) - Harmonization team A6 (stability) updateMichaela Golob (on behalf of GBC Harmonisation Team L6) - Harmonization team L6 (immunogenicity effect on PK) updateBen Gordon (on behalf of GBC Harmonisation Team S1) - Harmonization team S1 (run acceptance) update
Technology Session I
Patrick Bennett (Thermo Scientific) - Applying proven proteomics workflows and tools for quantitative bioanalysis of large moleculesBarry van der Strate (PRA International) - Flow cytometry for determination of efficacy in phase IAndrew Roberts (Quotient Bioresearch) - Challenges in developing anti-drug antibody ligand binding assays
Technology Session II
Mauro Aiello (AB Sciex) - Differential ion mobility spectrometry, creating a new dimension of selectivity for LC/MS/MS analysisDiego Rodriguez Calabeiro (Waters Corporation) - Beyond sensitivity: improving the performance, productivity and compliance of thebioanalytical assay processLester Taylor (Agilent Technologies) - Automation and optimization of an on-line extraction system for dried blood spot analysis
Bioanalysis Young Investigator Award
Peter van Amsterdam (representing EBF Steering Committee) - IntroductionMichelle Yoo (University of Nebraska) - Development of affinity microcolumns for high-throughput biointeraction analysis
Relationship Between Incurred Sample Reproducibility (ISR) And Incurred Sample Stability (ISS)
Morten Anders Kall (on behalf of EBF) - Feedback on EBF survey on Incurred Sample Stability (ISS)Theo de Boer (QPS) - Incurred sample accuracy assessment: design of experiments based on standard additionRonald de Vries (Janssen Research & Development) - Assessment of ISS using an efficient standardized stepwise “black box’’ process.
Plenary Microdosing /Microtracer
Malcolm Rowland (School of Pharmacy and Pharmaceutical Sciences, University of Manchester) - Microdosing: a simple idea with bigresults
Microdosing /Microtracer Plenary Session With Focus On AMS (Plenary)
Graeme Young (GSK) - “LC+AMS” in support of microdose/microtracer clinical studies at GSK – an evolving scienceDavid Higton (on behalf of EBF) - Towards a recommendation of bioanalytical qualification or validation of microdosing and microtracerstudies – part 1 – LC+AMSStuart Best (Xceleron) - What are the critical factors determining the performance of an LC+AMS assay?
Breakout I: Microdosing /Microtracer Plenary Session With Focus On High Sensitivity LC-MS/MS
David Higton (on behalf of EBF) - Towards a recommendation of bioanalytical qualification or validation of microdosing and microtracerstudies – part 2 – LC-MS/MSRichard Abbott (Shire) - Microdosing and cold LC-MS/MS: bioanalysis and its evolving role in strategic drug developmentAlberto Guenzi (Hoffmann-La Roche) - Microdosing with LC-MS analysis: variations on the themeMagnus Knutsson (Ferring) - Drug development of highly potent therapeutic peptides - A bioanalytical challenge with micro-dosing plasmalevels at therapeutic doses 翻訳
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Communication with Countries other than US and Europe
! Asian and Brazilian bioanalysis community are enthusiastic to have a regular communication with JBF.
! One of the options would be to establish "Asia-pacific Bioanalysis Communication Consortium”.
2nd JBF Symposium, 8 March 2012
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Publications about JBF
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PHARM TECH JAPAN, 27(10), 36 (2011)
! JBF ,
1, 52 (2012)
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PHARM TECH JAPAN, 28(3), 7-27 (2012) !
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! JBF 2nd JBF Symposium, 8 March 2012
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Steering Committee
Task Force
Organization of JBF
2nd JBF Symposium, 8 March 2012
Representative
Deputy Representatives
Committees
GBC-HT Support TF
Guideline TF Other TF
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Committees and Task Forces in JBF
Committee Financial Committee 1
Accounting Auditor Committee 1 Webpage Committee 2
Nominal Register Committee 2 Event Executive Committee 4 Public Relations Committee 2
Task Force GBC-HT GBC-HT TF 5Guideline TF 5
Membership Requirement TF 4
2nd JBF Symposium, 8 March 2012
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Steering Committee Members of JBF
Representative ! Kurokawa, Tatsuo, Ph.D. (Prof., Keio Univ.)
Advisors ! Haginaka, Jun, Ph.D. (Prof., Mukogawa Women's
Univ.) ! Masujima, Tsutomu, , Ph.D. (Prof., Hiroshima Univ.)
GBC-SC ! Shinobu Kudoh (Shimadzu Techno-Research, Inc.)
Deputy Representative ! Noriko Katori (National Institute of Health Sciences) ! Masanari Mabuchi (Mitsubishi Tanabe Pharma
Corporation) ! Yoshiaki Ohtsu (Astellas Pharma Inc.)
Members ! Hisanori Hara (Novartis Pharma AG, Basel) ! Harue Igarashi (GlaxoSmithKline K.K.) ! Mami Imazato (Novartis Pharma K.K.) ! Noriko Inoue, Ph.D. (JCL Bioassay Corporation) ! Nobuhiro Kobayashi, Ph.D. (Daiichi Sankyo Co., Ltd.) ! Takehisa Matsumaru, Ph.D. (Nippon Boehringer
Ingelheim Co., Ltd.) ! Yoshiyuki Minamide, Ph.D. (Shimadzu Techno-Research,
Inc.) ! Keiko Nakai (Mitsubishi Chemical Medience
Corporation) ! Akira Nakayama (Ajinomoto Pharmaceuticals Co., Ltd.) ! Takahiko Osumi (Otsuka Pharmaceutical Co., Ltd.) ! Hidehisa Tachiki, Ph.D. (Towa Pharmaceutical Co., Ltd. ) ! Kazutaka Togashi (Sumika Chemical Analysis Service,
Ltd.) ! Kenji Yahata (sanofi-aventis K.K.) ! Katsuhiko Yamamoto (Kyowa Hakko Kirin Co., Ltd.) ! Tomoki Yoneyama (Takeda Pharmaceutical Company
Limited)
2nd JBF Symposium, 8 March 2012
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Steering Committee Members of JBF
Representative ! Kurokawa, Tatsuo, Ph.D. (Prof., Keio Univ.)
Advisors ! Haginaka, Jun, Ph.D. (Prof., Mukogawa Women's
Univ.) ! Masujima, Tsutomu, , Ph.D. (Prof., Hiroshima Univ.)
GBC-SC ! Shinobu Kudoh (Shimadzu Techno-Research, Inc.)
Deputy Representatives ! Noriko Katori (National Institute of Health Sciences) ! Masanari Mabuchi (Mitsubishi Tanabe Pharma
Corporation) ! Yoshiaki Ohtsu (Astellas Pharma Inc.)
GBC-HT members
Members ! Hisanori Hara (Novartis Pharma AG, Basel) ! Harue Igarashi (GlaxoSmithKline K.K.) ! Mami Imazato (Novartis Pharma K.K.) ! Noriko Inoue, Ph.D. (JCL Bioassay Corporation) ! Nobuhiro Kobayashi, Ph.D. (Daiichi Sankyo Co., Ltd.) ! Takehisa Matsumaru, Ph.D. (Nippon Boehringer
Ingelheim Co., Ltd.) ! Yoshiyuki Minamide, Ph.D. (Shimadzu Techno-Research,
Inc.) ! Keiko Nakai (Mitsubishi Chemical Medience
Corporation) ! Akira Nakayama (Ajinomoto Pharmaceuticals Co., Ltd.) ! Takahiko Osumi (Otsuka Pharmaceutical Co., Ltd.) ! Hidehisa Tachiki, Ph.D. (Towa Pharmaceutical Co., Ltd. ) ! Kazutaka Togashi (Sumika Chemical Analysis Service,
Ltd.) ! Kenji Yahata (sanofi-aventis K.K.) ! Katsuhiko Yamamoto (Kyowa Hakko Kirin Co., Ltd.) ! Tomoki Yoneyama (Takeda Pharmaceutical Company
Limited)
2nd JBF Symposium, 8 March 2012
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JF
Academy
EBF Regulation NIHS
GBC
Companies CVG
JACL
JGA
JPMA
PSJAPAC?
Relationship between JBF and other organizations
DomesticGlobal
2nd JBF Symposium, 8 March 2012
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Logotype of JBF
! Shape & Color: One team of Japan
! Tricolored: Industrial-Academic-Government Cooperation
! Red: Strong will
! White: Uprightness in science
! Brown: Fertile ground in Bioanalysis
! Word arrange: Free from ill-precedents
2nd JBF Symposium, 8 March 2012
Designed by Y. Ohtsu
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3. BMV STUDY GROUP )
2nd JBF Symposium, 8 March 2012
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The recent history around BMV in Japan
! Mar. 30, 2011, Kick-off meeting of the JBF foundation members, ! 2nd quarter, 2011, A lot of JBF members applied for GBC-HT. ! Aug. 10, 2011, The First JBF Symposium (Tokyo),
! Oct. 6, 2011, Kick-off meeting of the BMV Study Group for Japanese BMV guideline ,
! Nov. 2011, EBF 2011 4th Open Symposium (Barcelona), JBF was introduced by Mr. Shinobu Kudoh.
! 2011 2012, ◦ Asian and Brazilian bioanalysis community are enthusiastic to have a regular
communication with JBF. ◦ One of the options would be to establish "Asia-pacific Bioanalysis
Communication Consortium”.
! Dec. 7, 2011, J-BMV Guideline items were listed-up by JBF,
! Mar. 8, 2012, The Second JBF Symposium (Tokyo).
2nd JBF Symposium, 8 March 2012
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BMV Study Group
!
!
!
2nd JBF Symposium, 8 March 2012
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The members of the BMV Study Group
JPMA ! Akira Nakayaka (Ajinomoto Pharmaceuticals
Co., Ltd.) ! Masataka Katashima, Ph.D. (Astellas
Pharma Inc.)
JGA ! Hidehisa Tachiki, Ph.D. (Towa
Pharmaceutical Co., Ltd.)
JACL ! Noriko Inoue, Ph.D. (JCL Bioassay Co., Ltd.) ! Kazutaka Togashi (Sumika Analysis Service,
Ltd.)
NIHS ! Yasuo Ohno, Ph.D. (Chief) ! Haruhiro Okuda, Ph.D. ! Nana Kawasaki, Ph.D. ! Noriko Katori, Ph.D.
MHLW ! Toshinari Mitsuoka
PMDA ! Reiko Sato, Ph.D. ! Daisuke Iwata
2nd JBF Symposium, 8 March 2012
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Differences in Mission! BMV Study Group ◦ Helping to make Japanese Guidelines for BMV ◦ Spreading the concept of BMV to regulation
sides in Japan ◦ Making basic consensus between organizations
around BMV ! JBF ◦ Facilitating science driven discussions on
bioanalysis ◦ Helping setting in Japan BMV by providing
scientific rationale and consensus amongst Japanese bioanalysts ◦ To be a partner representing Japanese
bioanalytical community for global harmonization
2nd JBF Symposium, 8 March 2012
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JBF
Academy
EBF
GBC
CVG
BMV Study Group
Regulation
MHLW
PMDA
NIHS
CompaniesJPMA
JGA
JACL
PSJ
Relationship between JBF and BMV Study Group
DomesticGlobal2nd JBF Symposium, 8 March 2012
Draft of BMV Guideline
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Schedule
! Draft BMV guideline (TF version, for small molecule) 29 February 2012
! 6th Workshop on Recent Issues in Bioanalysis (San Antonio) Japanese Guideline will be introduced by Mr. Mitsuoka (MHLW)
26-29 March 2012 ! Draft BMV guideline (JBF version, for small molecule)
31 March 2012 ! Comment from JPMA, JGA,JACL, and others
2nd quarter, 2012 (scheduled) ! Q&A (BMV guideline for small molecule)
May 2012 (scheduled) ! 3rd JBF Symposium (Tokyo)
8 August 2012 ! Draft guideline (large molecule)
end of 2012 (scheduled)
2nd JBF Symposium, 8 March 2012
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3rd JBF Symposium (Tokyo)
! Date: Aug. 8, 2012 ! Place: Tokyo (Keio University)
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2nd JBF Symposium, 8 March 2012
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Thank you!
2nd JBF Symposium, 8 March 2012
http://bioanalysisforum.jp/