global&bioanalysis&consortium...agreed best practices for bioanalytical method validation...
TRANSCRIPT
GLOBAL BIOANALYSIS CONSORTIUM
General Updates
Binodh DeSilva, Michaela Golob and Fabio Garofolo for GBC
at 2012 NBC May 2012, San Diego -‐ USA
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.
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GBC: Goals and Objec@ves
• To bring together stakeholders from the pharmaceutical industry, contract research organizations and academia to share current understanding of bioanalysis guidelines, identify differences in these guidelines or differences in the interpretation or application thereof to routine regulated bioanalysis.
• To come forward with recommendations to Health Authorities and regulatory bodies worldwide on globally agreed best practices for Bioanalytical Method Validation (BMV) and application of such methods/technologies to the analysis of drugs of all molecular sizes in support of clinical and nonclinical studies.
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• To invite relevant stakeholders, from industry, academia, Health Authorities and regulatory bodies, to jointly discuss the GBC recommendations at a global conference(s) in order to achieve globally agreed guidelines on bioanalysis.
• Going forward, to serve as a pivot point on the continued harmonized interpretation and/or updates of globally agreed guidelines.
GBC: Goals and Objec@ves
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Organization Chart
Harmonization Team # 1
Harmonization Team # 2
Harmonization Team # ‘n’
Steering Committee (GBC-SC)
Scientific Leadership Team (GBC-SLT)
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Active Harmonization Teams All
Topics Commonto all molecules
A
A1Scope and regulations A2
Tiered approachesfor method validation
A3Method Transfer,
partial/cross validations
A4Reference standards
and reagents
A5Sample Management
A6Stability
A7Repeat analysis
and ISR
A8Documentation
A9Analytical Instrument
Qualification
A10New Frontiers
A11Biomarkers
Large MoleculeL
L1Large molecule
specific run acceptance
L2Large molecule
specific assay operation
L3Assay formats
L4Reagents andtheir Stability
L5Automation practices
in LM bioanalysis
L6Immunogenicity
effect on Pk
Small Molecule(Chromatographic
Assays)S
S1Small molecule
specific run acceptance
S2Small molecule
specific assay operation
S3Chromatographic
Run Quality Assessment
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Team Leaders SC Sponsor Team Leaders SC Sponsor
A1: Surendra Bansal A2: Steve Lowes A4: Joseph Bower A6: Nico van den
Merbel A11: Russ Weiner
Philip Timmerman Daniel Tang Shinobu Kudoh
L1: Marian Kelley L2: Lauren Stevenson L3: Sherri Dudal L4: Lindsay King L5: Scott Davis L6: Jeff Sailstad
Binodh DeSilva Michaela Golob Fabio Garofolo
A3: Ray Briggs A5: Mike Redrup A7: Eric Fluhler A8: Tom Verhaeghe
Peter van Amsterdam Shrinivas Savale
A9: Chad Briscoe A10: Bob Bethem/
Chad Ray S1: Douglas Fast S2: Eric Woolf S3: Stuart McDougall
Rafael Barrientos Mark Arnold
SC Sponsorship of Harmonization Teams
Original planning • SLT face to face in San Antonio (March 2012) (done) • Continue feedback at regional meetings across all regions (on-going) • Load HT draft recommendation slides on GBC website in June • GBC Global Meeting in Amsterdam, the Netherlands in Sep. 2012 • Publish final recommendation slides on the website in October
New planning • 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 Global Meeting moved to Washington DC area, 2 days prior to
Crystal City V (new) • Publish final recommendation slides on the website: postpone until
clarity on dates of GBC Global Meeting
Planning
• FDA communication to release draft of updated Guidance in summer. • As follow up, AAPS/FDA will organize a Crystal City-V meeting in
Washington DC area within 90 days of draft Guidance release. Consequence for GBC Global Meeting: • Crystal City-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 Crystal City-V may be prioritized by industry over GBC Global
Meeting • By connecting the GBC Global Meeting in time and place with Crystal City-V,
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)
• Provide the necessary input into the FDA draft Guidance (= impact as per GBC Mission &Vision)
What triggered this change?
GBC needs to ensure its 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 does NOT change relative to the FDA guidance. • Nevertheless, major discussion points can be identified in preparation for
discussion at Crystal City 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.
Additional reflections
Change
HT-‐ L idenHficaHon
2011
Start up phase
2012
HT idenHficaHon
HT working on content working close with SLT
IdenHfied regional meeHngs • Invite 4-‐5 topics to present the progress of their teams and to share. • Present high level progress on other topics and Get input
SLT f-‐2-‐f ConsolidaHon and joint
discussion of all topics in
preparaHon of Global MeeHng
Global MeeHng
3-‐day Conference in Noordwijk-‐
Amsterdam (NL) in week of Sept.
24, 2012
New way forward
Global Mee@ng ‘Recommenda@on
Slides’ on GBC website for all to read, in preparaHon of
Global MeeHng
March e.o. June
max. 90 days post release of FDA draZ Guidance. Current
exact date unknown
2012
SLT F2F San Antonio (Tx) ConsolidaHon and joint discussion of
all topics in preparaHon of Global MeeHng
Crystal City V
April
draJ slides ConsolidaHon of slides from all HTs from SA (Tx) on
GBC website
Intensify consolidaHon and consultaHon from teams and from regional meeHngs, building on slides presented at HT-‐L
in San Antonio
APAC CPSA e.o. April
LA ACBio mid May
EU EBF mid June
APAC JBF mid Aug.
2 days prior to
Crystal City V
NA NBC mid May
NA LoL e.o. July
ConHnued slide iteraHons, based on HT team meeHngs and input form the regions