GLOBAL BIOANALYSIS CONSORTIUM

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1 GLOBAL BIOANALYSIS CONSORTIUM Regulated Bioanalysis - A Proposed Global HarmonizaDon Process presented by Peter Van Amsterdam on behalf of GBC at 3 rd EBF Focus Mee=ng June 13 th Brussels - BELGIUM

Mission Statement Create an all inclusive Global Bioanalysis Consortium (GBC) consisting of represented scientific associations with world wide influence to merge

2 Mission Statement Create an all inclusive Global Bioanalysis Consortium (GBC) consisting of represented scientific associations with world wide influence to merge existing or emerging bioanalytical guidance to create one, unified consensus document that can be presented to the regulatory bodies/health authorities in various countries.

3 Organization Chart Steering Committee (GBC-SC) Scientific Leadership Team (GBC-SLT) Harmonization Team # 1 Harmonization Team # 2 Harmonization Team # n

4 Which Harmonization Teams? Overview GBC SC GBC-SLT A: S: L: Harmonization teams focusing on topics which apply for both chromatography based assays and Ligand Binding Assays (All molecules) Harmonization teams focusing on topics which apply for Chromatography based assays (Small molecules) Harmonization teams focusing on topics which apply for Ligand Binding Assays (Large molecules)

Active Harmonization Teams All Topics Common to all molecules A Large Molecule L Small Molecule (Chromatographic Assays) S A1 Scope and regulations A2 Tiered approaches for method validation L1 Large

5 Active Harmonization Teams All Topics Common to all molecules A Large Molecule L Small Molecule (Chromatographic Assays) S A1 Scope and regulations A2 Tiered approaches for method validation L1 Large molecule specific run acceptance S1 Small molecule specific run acceptance A3 Method Transfer, partial/cross validations A4 Reference standards and reagents L2 Large molecule specific assay operation S2 Small molecule specific assay operation A5 Sample Management A6 Stability L3 Assay formats S3 Chromatographic Run Quality Assessment A7 Repeat analysis and ISR A8 Documentation L4 Reagents and their Stability A9 Analytical Instrument Qualification A10 New Frontiers L5 Automation practices in LM bioanalysis A11 Biomarkers L6 Immunogenicity effect on Pk 5

6 SC Sponsorship of Harmonization Teams A1: A2: A4: A6: A11: Team Leaders SC Sponsor Team Leaders SC Sponsor Surendra Bansal Steve Lowes Joseph Bower Nico van den Merbel Russ Weiner Philip Timmerman EBF, Europe Daniel Tang BBDS & SBDS, Asia Pacific Shinobu Kudoh JBF, Asia Pacific L1: L2: L3: L4: L5: L6: Marian Kelley Lauren Stevenson Sherri Dudal Lindsay King Scott Davis Jeff Sailstad Michaela Golob EBF, Europe Fabio Garofolo CVG, N America Binodh DeSilva AAPS, N America A3: A5: A7: A8: Ray Briggs Mike Redrup Eric Fluhler Tom Verhaeghe Peter van Amsterdam EBF, Europe Shrinivas Savale APA- India, Asia Pacific A9: Chad Briscoe A10: Bob Bethem/ Chad Ray S1: Douglas Fast S2: Eric Woolf S3: Stuart McDougall Rafael Barrientos ACBio, L America Mark Arnold AAPS, N America

7 Europe, 55 A1 1 A11 3 A2 3 L1 3 A3 3 L2 2 A4 2 L3 4 A5 3 L4 2 A6 3 L5 2 A7 3 L6 1 A8 3 S1 3 A9 2 S2 2 A10 7 S3 3 APAC China, 7 A1 1 A11 - A2 - L1 1 A3 1 L2 - A4 - L3 - A5 - L4 - A6 1 L5 - A7 1 L6 - A8 - S1 - A9 1 S2 - A10 - S3 1 APAC Japan, 20 A1 1 A11 1 A2 1 L1 1 A3 1 L2 1 A4 1 L3 1 A5 1 L4 1 A6 1 L5 1 A7 1 L6 1 A8 1 S1 1 A9 1 S2 1 A10 1 S3 1 N. America, 87 A1 4 A11 4 A2 5 L1 4 A3 3 L2 4 A4 2 L3 5 A5 3 L4 6 A6 3 L5 5 A7 4 L6 11 A8 3 S1 5 A9 4 S2 3 APAC India, 21 A10 5 S3 4 A1 1 A11 - A2 1 L1 2 A3 1 L2 1 A4 - L3 1 A5 1 L4 - A6 1 L5 - A7 2 L6 1 A8 1 S1 1 A9 1 S2 3 Latin America, 17 A1 1 A11 - A2 1 L1 - A3 1 L2 1 A4 2 L3 - A5 1 L4 - A6 1 L5 - A10 1 S3 2 A7 2 L6 - A8 1 S1 2 A9 1 S2 2 A10 - S3 1

Timmerman (EBF) Live P. van Amsterdam, S.

8 Steering CommiSee Members North America (US + Canada) Asia Pacific (Asia + Pacific area) Mark Arnold (AAPS) Binodh DeSilva (AAPS) Fabio Garofolo (CVG) LaDn America (South America + Mexico) Rafael Barrientos (AcBio) Live P.Timmerman D. Tang, S. Kudoh, Shinobu Kudoh (JBF) Shrinivas Savale (APA-India) Daniel Tang (SBDG&BBDG) Europe (Europe + Africa/Middle East) Peter van Amsterdam (EBF) Michaela Golob (EBF) Philip Timmerman (EBF) Live P. van Amsterdam, S. Savale, M. Golob. EBF: European Bioanalysis Forum AAPS: American Association of Pharmaceutical Scientists 8 Canadian LC-MS Group CVG: ACBio: Assosiacao BRASILEIRA DOS CENTROS DE BIODISPONIBILIDADE E BIOEQUIVALENCIA BBDS/SBDS:Beijing Bioanalytical Discussion Group/Shanghai Bioanalytical Discussion Group F. Garofolo, B. DeSilva, R. Barrientos, M. Arnold,

9 Global Bioanalysis Consortium Important update: Change of venue and timing for Global GBC Meeting HT-L/SC F-2-F in San Antonio (TX) 30/31-MAR-2012

Summary Original planning HT-L/SC face to face in San Antonio Continue FB at regional meetings across all regions Load HT draft recommendation slides on GBC website in June GBC meeting in Noordwijk,

10 Summary Original planning HT-L/SC face to face in San Antonio Continue FB at regional meetings across all regions Load HT draft recommendation slides on GBC website in June GBC meeting in Noordwijk, the Netherlands September Publish final recommendation slides on the website in October Updated planning HT-L/SC face to face in San Antonio (done) Load progress slides on GBC website from April onwards (new) Continue feedback and dialogue with broader scientific community at regional meetings across all regions (intensify) Load HT draft recommendation slides on GBC website in June GBC meeting in Noordwijk, the Netherlands Sept. (relocated see next bullet) GBC meeting moved to Washington DC area, 2 days prior to CC-V (new) Publish final recommendation slides on the website in October (postpone until clarity on dates of GBC meeting)

11 What triggered this change? FDA plan/communication to release draft of updated Guidance in summer. As follow up, AAPS/FDA will organize a 5 th Crystal City meeting (CC-V) in Washington DC area within 90 days of draft Guidance release. Impact on GBC global meeting: CC-V and GBC global meeting involve the same audience separated potentially by only few weeks or months. Travel restrictions in industry will limit delegates to travel to two similar meetings in 2 different regions Attendance to CC-V may be prioritized by industry over GBC global meeting By connecting the GBC global meeting in time and place, GBC and delegates can participate in both meetings: Provide consolidated feedback to and get input from the global community on draft GBC recommendations (= original intent of GBC global meeting) At the CC-V meeting, share this consolidated GBC as input into the FDA draft Guidance (= impact as per GBC Mission &Vision)

12 Additional reflections GBC needs to ensure their global mission is not redirected to only providing input on draft FDA Guidance but maintains it global perspective. Scope and agenda of GBC remains unchanged. Upon release of the draft FDA Guidance, Harmonization Teams(-L) needs to ensure that the scope and content of the team discussions doesn t change relative to the FDA guidance. Nevertheless, major discussion points can be identified in preparation for CC-V By intensifying the feedback from other regional meetings and earlier publication of our draft recommendation slides on the GBC website from April onwards, scientist in all regions should feel invited to also intensify their input.

13 Original Proposed way forward : Done : Planned Start up phase HT- L iden=fica=on HT iden=fica=on HT working on content working close with SLT SLT f- 2- f Consolida=on and joint discussion of all topics in prepara=on of Global Mee=ng Global Mee=ng 3- day Conference in Noordwijk- Amsterdam (NL) in week of Sept. 24, Other regional mee=ngs Iden=fied regional mee=ngs Invite 4-5 topics to present the progress of their teams and to share. Present high level progress on other topics and Get input

Change : Done : Planned Start up phase HT- L iden=fica=on HT iden=fica=on HT working on content working close with SLT SLT f- 2- f Consolida=on and joint discussion of all topics in prepara=on of

14 Change : Done : Planned Start up phase HT- L iden=fica=on HT iden=fica=on HT working on content working close with SLT SLT f- 2- f Consolida=on and joint discussion of all topics in prepara=on of Global Mee=ng Global Mee=ng 3- day Conference in Noordwijk- Amsterdam (NL) in week of Sept. 24, Other regional mee=ngs Iden=fied regional mee=ngs Invite 4-5 topics to present the progress of their teams and to share. Present high level progress on other topics and Get input

15 Updated Proposed way forward : Done : Planned Start up phase HT- L iden=fica=on HT iden=fica=on HT working on content working close with SLT SLT f- 2- f Consolida=on and joint discussion of all topics in prepara=on of Global Mee=ng Global Mee=ng 2- day Conference in Washington DC (USA), 2 days before Crystal City V Other regional mee=ngs Iden=fied regional mee=ngs Invite 4-5 topics to present the progress of their teams and to share. Present high level progress on other topics and Get input

16 Updated Proposed way forward : Done : Planned Zoom in SLT f- 2- f Consolida=on and joint discussion of all topics in prepara=on of Global Mee=ng Global Mee=ng 2- day Conference in Washington DC (USA), 2 days before Crystal City V 2012 Other regional mee=ngs

17 Proposed way forward - details : Done : Planned Con=nued slide itera=ons, based on HT team mee=ngs and input form the regions HT- L/SC F2F San Antonio (Tx) Consolida=on and joint discussion of all topics in prepara=on of Global Mee=ng dra_ slides Consolida=o n of slides from all HTs from SA (Tx) on GBC website RecommendaDon Slides on GBC website for all to read, in prepara=on of Global Mee=ng GBC Global MeeDng 2 days prior to CC- V Crystal City V max. 90 days aber release of drab FDA Guidance. March April e.o. June exact date unknown today 2012 Intensify consolida=on and consulta=on from teams and from regional mee=ngs, building on slides presented at HT- L in San Antonio APAC CPSA e.o. April LA ACBio mid May NA NBC mid May EU EBF mid June US LoL e.o. July APAC JBF mid Aug.

Updates on the Progress of the. Harmonization Teams (GBC-HT) for Small & Large Molecules

Updates on the Progress of the Global BioanalyticalConsortium Harmonization Teams (GBC-HT) for Small & Large Molecules Dr. Fabio Garofolo for GBC AAPS Annual Meeting October 2011 - Washington DC -USA Agenda