Bioanalytical Method Validation in Japan and activities of...

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

Today’s Topics

1.  Recent History of BMV in Japan

2.  Activities of JBF

3.  BMV Study Group


1. RECENT HISTORY OF BMV IN JAPAN


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

.


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 )


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.


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)



!  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).


2. ACTIVITIES OF


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),



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The first JBF Symposium (Tokyo, Aug.2011)

" " "  JCL

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1. BMV GBC2. 3. 4. CRO


BMAS2011 (Daisen, Tottori, Aug. 31- Sep. 2, 2011)!  24 BMAS2011


Waters Seminar Waters JBF

2011 11 1


11 110 00 16 4510 00 16 45

18 00

4040

Christopher A. Evans Ph.D.Christopher A. Evans Ph.D.

2011 10

EBF 2011 4th Open SymposiumUpdates From The Globe !  Shinobu Kudoh (Shimadzu for Japan Bioanalysis Forum) - Introducing the Japan

Bioanalysis Forum (JBF)


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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

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”.


Publications about JBF

!  −

PHARM TECH JAPAN, 27(10), 36 (2011)

!  JBF ,

1, 52 (2012)

−

PHARM TECH JAPAN, 28(3), 7-27 (2012) ! 

!  ( )

! 

!  JBF 2nd JBF Symposium, 8 March 2012

Steering Committee

Task Force

Organization of JBF


Representative

Deputy Representatives

Committees

GBC-HT Support TF

Guideline TF Other TF

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


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)


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)


JF

Academy

EBF Regulation NIHS

GBC

Companies CVG

JACL

JGA

JPMA

PSJAPAC?

Relationship between JBF and other organizations

DomesticGlobal


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


Designed by Y. Ohtsu

3. BMV STUDY GROUP )



!  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,



BMV Study Group

! 

! 

! 


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


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


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

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)


3rd JBF Symposium (Tokyo)

! Date: Aug. 8, 2012 ! Place: Tokyo (Keio University)

! 


Thank you!


http://bioanalysisforum.jp/

Bioanalytical Method Validation in Japan and activities of...

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