EBF Focus

ICH M10 - Public consultation & Industry Feedback
Towards a Science based Global Bioanalytical Guideline

Hesperia Tower
Barcelona, Spain
20-22 May 2019

Each of the sessions includes discussions, presentations and, if required, panel discussion or Q&A sessions on the highlighted themes. Presentations will include community feedback from the EBF and/or AAPS/JBF/CBF communities.

Agenda is coming together: we already have confirmed contribution from many senior experts in each of the sessions. Moving forward, we are inviting additional experts from the AAPS, CBF, EBF, JBF and the Health Authorities community to present in the sessions and/or contribute to panel discussions. In this way, we hope to discuss and consolidate a broad community feedback. The agenda will be updated regularly to reflect their contributions. 

Also, all registered delegates will get the opportunity to voice their Feedback in a pre-meeting survey (will be sent a few weeks prior to the meeting to allow us to prepare).

Day 1      
Monday   Plenary session 1  
(morning)   Introduction, objective, background and scope of the Guideline  
    Comparison of draft ICH M10 with existing Guidance/Guidelines  
    Session includes contributions from Eric Woolf (MSD), Stephen White GlaxoSmithKline), Boris Gorovits (Pfizer) and Joanne Goodman (MedImmune)  
    coffee break  
    Plenary session 2  
    General principles of method development/Validation  
    Session includes contributions from Michaela Golob (Nuvisan) and Faye Vazvaei (Roche)  
    lunch break  
Monday   Plenary session 3  
(afternoon)   General principles of method development/Validation, Partial and cross validation, Incurred Sample Reanalysis (ISR)  
    Session includes contributions from Magnus Knutsson (Ferring) and Morten Kall (Lundbeck)  
    Introduction to Tuesday workshops  
    coffee break  
    Breakout session 1: Chromatography  
    Key validation parameters for chromatography assays: Selectivity, specificity, Matrix Effect.  
    Session includes contributions from Tim Sangster (Charles River) and Faye Vazvaei (Roche)  
    Breakout session 2: LBA  
    Parallelism, Minimum Required Dilution  
    Session includes contributions from Robert Nelson (Novimmune) and Susanne Pihl (Ascendis)  
Day 2      
Tuesday   Focussed parallel sessions (duration: 90 minutes approx.)  
(morning)   Dried Matrix Methods (coordinated by Enaksha Wickremsinhe, Lilly)  
    New or Alternative Technologies (coordinated by Scott Summerfield, GlaxoSmithKline)  
    Commercial and Diagnostic Kits (coordinated by Arno Kromminga, Bioagilytix)  
    Analytes that are also Endogenous Compounds (coordinated by Birgitte Buur Rasmussen, Ferring)  
    coffee break  
    Breakout session 3: Chromatography  
    Key Validation parameters for chromatography assays – cntd: Cal curve, A&P, QCs, Carry-over, stability assessment, dilution integrity, reinjections and extraction recovery  
    Session includes contributions from Peter van Amsterdam (Abbott Healthcare Products) and Stuart McDougall (Arcinova)  
    Breakout session 4: LBA  
    Key Validation parameters for ligand binding assays: Selectivity, specificity, Cal curve, A&P, QCs, Carry over, stability assessment, dilution linearity and Hook Effect  
    Session includes contributions from Renuka Pillutla (BMS), Wibke Lembke (Janssen Biologics)  
    lunch break  
Tuesday   Breakout session 5: Chromatography  
(afternoon)   Study Sample Analysis using chromatography assays:  
    includes Acceptance Criteria for an Analytical Run, calibration range reanalysis & reinjection of study samples, (re)integration of chromatograms  
    Session includes contributions from Johannes Stanta (Covance),  Eric Woolf (MSD) and Stephen White (GlaxoSmithKline)  
    Breakout session 6: LBA  
    Study Sample Analysis using Ligand binding Assays:  
    includes Acceptance Criteria for an Analytical Run, calibration range, reanalysis of study samples  
    Session includes contributions from Michaele Golob (Nuvisan), Anna Laurén (SVAR) and Stephen Williams (Charles River)  
Day 3      
Wednesday   Plenary session 4  
(morning)   Documentation for Validation and Bioanalytical Reports  
    Session includes contribution from Tom Verhaeghe (Janssen R&D)  
    Plenary session 5  
    FB from interactive discussions during workshops on day 2  
    coffee break   
    Summarising the 2 days – our FB to EWG & Wrap up