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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History

Bioanalysis (2010)2(4), 683

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  

•  The GBC Founding Members •  The GBC Steering Committee •  The Harmonization Team leaders and

members

Acknowledgements

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