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Focus Workshop Slides 2019 May

Program of EBF Focus Workshop  “ICH M10 – Public consultation & Industry Feedback Towards a Science based Global Bioanalytical Guideline”
May 20-22, 2019

PDF renditions of the powerpoint presentations given at the Focus Workshop can be viewed and downloaded from this page. The program itself can be viewed and downloaded by clicking here 

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