EBF
EBF Focus

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


Hesperia Tower
Barcelona, Spain
20-22 May 2019

The program will be updated regularly.

Program version 29 April 2019

All underlined presenters will be presenting ‘on behalf of the EBF‘. Their presentations will highlight on (i) changes to current guidelines, (ii) potential impact on industry of draft guideline, (iii) comments and recommendations by the EBF and (iv) comment and recommendations by meeting delegates.

    Sunday 19 May
     
18:00 19:00 Complementary welcome reception
     
    Monday 20 May
     
08:25 08:30 Welcome, aim of the meeting
     
08:30 10:00 Plenary session 1
    Introduction, objective, background and scope of the Guideline
    Comparison of draft ICH M10 with exisiting Guidance/Guidelines
     
08:30 09:30 Comparison of draft ICH M10 with exisiting Guidance/Guidelines
      EMA/MHLW – presenter: Joanne Goodman (AstraZeneca)
      NMPA(China) – presenter: Fan Jin (Covance, on behalf of the CBF)
      FDA 2018 – presenter: Boris Gorovits (Pfizer, on behalf of the AAPS)
09:30 10:00 Scope of ICH M10 – learnings from EBF Strategy Meeting, ICH M3 (R2) and metabolite quantification
      presenter: Philip Timmerman (EBF)
     
10:00 10:30 Coffee break
     
10:30 12:20 Plenary session 2
    Did we consider the world around us?
     
10:30 10:35 Introduction in the session
      presenter: Michaela Golob (Nuvisan) 
10:35 10:50 3Rs and surrogate matrix
      presenter: James Lawrence (Envigo)
10:50 11:10 Clinical vs. Preclinical
      presenter:  Eric Woolf (MSD)
11:10 11:25 Informed consent and GCP
      presenter: Cecilia Arfvidsson (AstraZeneca)
11:25 11:40 The Value of Decision-based acceptance criteria!
      presenter: Magnus Knutsson (Ferring)
11:40 12:20 Panel Discussion – including stakeholders from PK/TK and representatives of the UK-MHRA
     
     
12:20 12:40 Introduction to Tuesday workshops
     
    General introduction: aim of the workshops Philip Timmerman, EBF
    A. Dried Matrix Methods (introduction by Enaksha Wickremsinhe, Lilly)
    B. New or Alternative Technologies (introduction by Scott Summerfield, GlaxoSmithKline) 
    C. Commercial and Diagnostic Kits (introduction by Arno Kromminga, Bioagilytix)
     
12:40 13:40 Lunch break
     
13:40 14:10 ICH M10: a global harmonised BMV Guideline
      presenter: Brian Booth (CDER) (Video/TC-link)
     
14:10 15:40 Plenary session 3
    General principles of method development/Validation, Partial and cross validation
     
14:10 14:20 Introduction in the session
      presenter: Magnus Knutsson (Ferring)
14:20 14:40 Method Development
      presenter: Marco Michi (Aptuit)
14:40 15:00 Full & Partial Validation – LBA and CHROM
      presenter: Mark Arnold (Covance)
15:00 15:20 Cross validation
      presenter:  Tom Verhaeghe (Janssen R&D)
15:20 15:40 Panel discussion
     
15:40 16:10 Coffee break
     
16:10 18:00 Plenary session 4: common themes in stability assessment
     
16:10 16:20 Introduction in the session
      presenter: Faye Vazvaei (MSD)
16:20 16:40 General Principles of Stability Testing
      presenter: Stuart McDougall (Arcinova)
16:40 16:55 Benchtop and F/T
      presenter: Tim Sangster (Charles River) 
16:55 17:10 Blood stability testing
      presenter:  Johannes Stanta (Covance)
17:10 17:25 F/T and LT stability testing: intra- or extrapolation?
      presenter: Susanne Pihl (Ascendis)
17:25 18:00 Day 1 closing panel discussion
     
    Tuesday 21 May
     
08:30 10:00 Focussed parallel sessions (duration: 90 minutes approx.)
    A. Dried Matrix Methods (moderated by Enaksha Wickremsinhe, Lilly) 
    B. New or Alternative Technologies (moderated by Scott Summerfield, GlaxoSmithKline) 
    C. Commercial and Diagnostic Kits (moderated by Arno Kromminga, Bioagilytix)
     
10:00 10:30 Coffee break
     
10:30 17:30 Tuesday Breakout sessions: Chromatography
     
    Key Validation parameters for chromatography assays will be discussed. The sessions will include short or full presentations on selectivity, specificity, Matrix Effect, Cal curve, A&P, QCs, Carry-over, stability assessment, dilution integrity, reinjections and extraction recovery, Acceptance Criteria for an Analytical Run, calibration range reanalysis & reinjection of study samples, (re)integration of chromatograms – some panel discussions may include input from PK/TK stakeholders.
     
10:30 12:20 Breakout session 1: Chromatography
     
10:30 10:40 Introduction to the morning session
      presenter: Magnus Knutsson (Ferring)
10:40 11:00 Guideline paragraphs anticipated of not needing a discussion
      presenter: Johannes Stanta (Covance)
11:00 11:10 Considerations from the JBF for general requirements (with focus on Chromatographic assays)
      presenter: Masanari Mabuchi (Mitsubishi Tanabe Pharma, on behalf of the JBF)
11:10 11:30 Considerations on reference standards for chromatographic assays
      presenter: Amanda Wilson (AstraZeneca)
11:30 11:50 Haemolysed/hyperlipidaemic – matrix effects
      presenter: Steve White (GlaxoSmithKline)
11:50 12:20 Panel discussion
     
12:20 13:30 Lunch break
     
13:30 15:20 Breakout session 2: Chromatography
     
13:30 13:40 Introduction to the afternoon session
      presenter: Johannes Stanta (Covance)
13:40 14:00 Stability assessment: considerations on FDC
      presenter: Eric Woolf (MSD)
14:00 14:20 Considerations on specificity and selectivity for MS/MS assays
      presenter: Tim Sangster (Charles River)
14:20 14:30 Value of Dilution QC in batch analysis
      presenter: Stuart McDougall (Arcinova)
14:30 14:50 QC samples – considerations on geometric vs. arithmetic placement of the midQC
      presenter: Peter van Amsterdam (Abbott Healthcare Products)
14:50 15:20 Panel discussion
     
15:20 16:00 Coffee break
     
16:00 17:30 Breakout session 3: Chromatography
     
16:00 16:20 Considerations on re-injection
      presenter: Amanda Wilson (AstraZeneca)
16:20 16:40 Considerations from the JBF for requirements specific to chromatographic assays
      presenter: Masanari Mabuchi (Mitsubishi Tanabe Pharma, on behalf of the JBF)
16:40 17:00 Documentation & Glossary – Specific to Chromatographic assays
      presenter: Tom Verhaeghe (Janssen R&D)
17:00 17:30 Closing Panel discussion CHROM
     
     
10:30 17:30 Tuesday Breakout session: Ligand Binding Assays
     
    Key Validation parameters for LBA  will be discussed. The sessions will include short or full presentations on selectivity, specificity, Cal curve, A&P, QCs, Carry over, stability assessment, dilution linearity, Parallelism, Minimum Required Dilution, Free/total and Hook Effect, Acceptance Criteria for an Analytical Run, calibration range, reanalysis of study samples  – some panel discussions may include input from PK/TK stakeholders.
     
10:30 12:20 Breakout session 1: LBA
     
10:30 10:40 Introduction to the session
      presenter: Robert Nelson (Novimmune)
10:40 11:00 Guideline paragraphs anticipated of not needing a discussion
      presenter: Robert Nelson (Novimmune)
11:00 11:20 Considerations for reference standards and key reagents
      presenter: Johanna Mora (BMS)
11:20 11:40 Scientific aspects for the use of surrogate matrix in calibration, dilution and QC
      presenter: Roland Staack (Roche)
11:40 11:50 Analytes that are also Endogenous Compounds – Focus on LBA
      presenter: Birgitte Buur Rasmussen (Ferring)
11:50 12:20 Panel discussion
     
12:20 13:30 Lunch break
     
13:30 15:20 Breakout session 2: LBA
     
13:30 13:40 Introduction to the afternoon session
      presenter: Joanne Goodman (AstraZeneca)
13:40 14:00 Stability assessments
      presenter: Michaele Golob (Nuvisan)
14:00 14:20 Considerations on calibration range during validation & sample analysis
      presenter: Anna Laurén (SVAR)
14:20 14:40 Specificity and Selectivity
      presenter: Wibke Lembke (Janssen Biologics)
14:40 15:20 Panel discussion
     
15:20 16:00 Coffee break
     
16:00 17:30 Breakout session 3: LBA
     
16:00 16:20 Partial validation and/or Dilution linearity & Parallelism
      presenter: Robert Nelson (Novimmune)
16:20 16:40 Documentation & glossary – Specific to LBA
      presenter: Stephen Williams (Charles River)
16:40 17:30 Closing panel discussion LBA
     
    Wednesday 22 May
     
08:30 09:50 Plenary session 4
    ISR, general aspects of Documentation for Validation and Bioanalytical Reports and Glossary
     
08:30 08:50 ISR
      presenter: Morten A. Kall (Lundbeck)
08:50 09:10 General aspects of Documentation & Glossary for Validation and Bioanalytical Report
      presenter: Steve White (GlaxoSmithKline)
09:10 09:30 Repeat Analysis
      presenter: Mark Arnold (Covance) and Boris Gorovits (Pfizer)
09:30 09:50 Panel dicsussion
     
09:50 10:20 Plenary session 5
    FB from interactive discussions during workshops on day 2 (10 min each)
    A. Dried Matrix Methods (feedback by Enaksha Wickremsinhe, Lilly) 
    B. New or Alternative Technologies (feedback by Scott Summerfield, GlaxoSmithKline) 
    C. Commercial and Diagnostic Kits (feedback by Arno Kromminga, Bioagilytix)
     
10:20 11:00 Coffee break
     
11:00 13:00 Summarising the 2 days – our FB to EWG & Wrap up
    Panel, including Brian Booth (CDER) (Video/TC-link)
     
13:00   Adjourn