European Bioanalysis Forum


Focus Workshop Slides 2019 September

Program of EBF Focus Workshop  “Biomarker Assay Validation – Bringing Context of Use into practice” September 18-19, 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


Wednesday 18-Sep-2019
08:45 09:00 Welcome and aim of the meeting
09:00 10:20 Session 1: Setting the Scene
09:00 09:20 Philip Timmerman (EBF)
  A recap on the EBF Biomarker Recommendation
09:20 09:50 Lars Karlsson (Ferring Pharmaceuticals)
  Biomarker work should begin at the end – first why? then how?
09:50 10:20 Lauren Stevenson (Immunologix Laboratories)
  No context, no assay – demanding Context of Use in a demanding world
10:20 11:00 Coffee break
11:00 12:20 Session 2: Limitations of the current analytical paradigm for Biomarker assays
11:00 11:20 Kyra Cowan (Merck KGaA)
  Optimizing our Biomarker Interface
11:20 11:40 Dave Fairman (GlaxoSmithKline)
  The importance of communication between PKPD modellers and bioanalytical scientists
11:40 12:00 Sari Häkkinen (Orion Pharma)
  How to boost workflows on biomarker analytics between stakeholders in early research projects?
12:00 12:20 Philip Timmerman (EBF)
  Feedback from the survey and introduction into the Workshops
12:20 13:30 Lunch – connect around posters
13:30 15:20 Afternoon Parallel Breakout Sessions
13:30 15:00 Session 3a: Context of use – Case studies – Focus on communication (Breakout)
13:30 13:50 Anders Sjödin (SVAR)
  A Custom Approach to an Anti-cN-1A Assay as a Semi-quantitative Disease Activity Marker in Inclusion Body Myositis
13:50 14:10 Liz Hickford (UCB Biopharma)
  Translating Context of Use into High Quality Fit-for-Purpose Biomarker Assays
14:10 14:30 Sophie Cotton (Charles River Laboratories)
  Biomarkers assay development: Do you know your context of use?
14:30 14:50 Stephanie Traub (Cancer Research UK)
  Context of Use – Case studies: What went wrong in context with Biology?
14:50 15:00 Short break to move from breakout into plenary
13:30 15:00 Session 3b: Context of Use – Case studies – Focus on the assay (Breakout)
13:30 13:50 Devangi Mehta (Immunologix labs)
  Do you know what you are measuring? Developing biomarkers that have clinical impact
13:50 14:10 Tim Townend (GlaxoSmithKline)
  Effective life cycle management of an assay: A case study
14:10 14:30 Johannes Stanta (Covance)
  LC-MS-MS assay for cholestane-3,5,6-triol and 7-ketocholesterol to support a pivotal clinical trial
14:30 14:50 Michael Wright (LGC)
  Demonstrating control over multiplexed biomarker methods – can the context of use save the day?
14:50 15:00 Short break to move from breakout into plenary
15:00 15:50 Plenary panel discussion on sessions 3a/b: Context of Use – Learnings from case studies
15:00 15:00 Linda Terry (GlaxoSmithKline)
  It’s good to talk: How communication gets us closer to the truth, a case study
15:00 15:00 Panel discussion
15:50 16:30 Coffee break – connect around posters
16:30 18:20 Session 4: Starting from a white page…preparation for Day-2 round tables
16:30 16:50 Hans Ulrichts (UCB Biopharma)
  The changing COU of a biomarker within drug development: a case study
16:50 17:10 Martin Gerl (Boehringer Ingelheim)
  Case Study: Aldosterone measurement outside the qualified diagnostic context of use in a phase-I trial – challenges to make the grade
17:10 17:30 Radboud van Trigt (PRA-HS)
  Best practices for quality control and inter-laboratory standardization of biomarker results in the clinical chemistry laboratory
17:30 17:50 John Allinson (Immunologix labs)
  What can we learn from clinical labs?
17:50 18:20 Panel discussion
Thursday 19-Sep-2019
08:30 09:00 Summary of day 1 
09:00 10:20 Morning Parallel Breakout Sessions
09:00 10:20 Session 5a: Bioanalytical lab challenges (Breakout)
09:00 09:20 Robert Nelson, on behalf of EBF
  EBF TT61 – Considerations on parallelism
09:20 09:40 Hervé Farine (Idorsia)
  Scientific lab challenges: when reagents and technology matter to measure low abundant protein biomarkers.
09:40 10:00 Agostinho Gomes Rocha (Syneos Health)
  The challenges in validating a biomarker assay for IKAP quantification in whole blood
10:00 10:20 Michael Naughton (GlaxoSmithKline)
  Assessment of Parallelism in Biomarker Support: Strategies for application and real-life data interpretation.
09:00 10:20 Session 5b: Bioanalytical lab challenges (Breakout)
09:00 09:20 Ulrich Kunz (Boehringer Ingelheim)
  How to assess long term stability of endogenous proteins in highly variable assays
09:20 09:40 Rachel Hewitt (LGC)
  Case study of Coproporphyrins as a DDI marker: The importance of fresh endogenous plasma stability controls whilst keeping eyes on the prize
09:40 10:00 Pia Davidsson (AstraZeneca)
  Validation of LC-MS/MS assays for Leukotriene B4 in human plasma and Leukotriene E4 in human urine
10:00 10:20 Florian Neff (F. Hoffmann-La Roche)
  Assay Strategies And Technologies To Analyse – Soluble Targets Of New Antibody Therapeutics
10:20 11:00 Coffee break – connect around posters
11:00 13:00 Session 6: Focus Workshop Round tables
Workshop delegates will be assigned to discuss in a round tables format. Each (group of) tables will be tasked to develop (a part of) a sustainable Context of Use process considering the presentations and the discussions at the meeting.
Round table moderators: Lauren Stevenson, Kyra Cowan, Robert Nelson, Lars Karlsson and Jo Goodman
13:00 14:15 Lunch
14:15 15:30 Summary from round tables – Closing Panel discussion – agree on next steps
15:30 16:30 Connect at Close out Coffee break – Adjourn



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