EBF Focus
15-16 SEPTEMBER 2022 - NH Malaga, Spain
Managing GCP in Regulated Bioanalysis

29-30 SEPTEMBER 2022 – NH Malaga, Spain
Biomarkers/CoU - Sharing Experience through Examples


Agenda workshop


    Agenda Outline v.20JUL2019
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 Maria Key Prato (UCB Biopharma)
      Discovering, developing and validating biomarkers… The role of the clinical and non-clinical statisticians.
12:20 13:30 Lunch – connect around posters
13:30 15:20 Afternoon Parallel Breakout Sessions
13:30 15:20 Session 3a: Context of use – Case studies – Focus on communication (Breakout)
13:30 13:50 Linda Terry (GlaxoSmithKline)
      It’s good to talk: How communication gets us closer to the truth, a case study
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 15:10 Anders Sjödin (SVAR)
      A Custom Approach to an Anti-cN-1A Assay as a Semi-quantitative Disease Activity Marker in Inclusion Body Myositis
15:10 15:20 Short break to move from breakout into plenary
13:30 15:20 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 Maija Pfenniger (Celerion)
      TFPI – a key Biomarker for modern haemophilia therapy
14:30 14:50 Johannes Stanta (Covance)
      LC-MS-MS assay for cholestane-3,5,6-triol and 7-ketocholesterol to support a pivotal clinical trial
14:50 15:10 Michael Wright (LGC)
      Demonstrating control over multiplexed biomarker methods – can the context of use save the day?
15:10 15:20 Short break to move from breakout into plenary
15:20 15:50 Plenary panel discussion on sessions 3a/b: Context of Use – Learnings from case studies
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 John Allinson (Immunologix labs)
      What can we learn from clinical labs?
16:50 17:10 Hans Ulrichts (UCB Biopharma)
      The changing COU of a biomarker within drug development: a case study
17:10 17:30 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
17:30 17:50 Radboud van Trigt (PRA-HS)
      Best practices for quality control and inter-laboratory standardization of biomarker results in the clinical chemistry laboratory
17:50 18:20 Panel discussion
Thursday 19-Sep-2019
08:30 09:00 Summary of day 1 &  Introduction of round tables
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 Maria Bhat (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 12:30 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