EBF Focus
Biomarker Assay Validation – Bringing Context of Use into practice
NH Málaga Centro
Málaga, Spain
18-19 September 2019


Agenda Workshop

    Preliminary Agenda Outline v.06 JUNE, 2019
Wednesday 18-Sep-2019
08:45 09:00 Welcome and aim of the meeting
09:00 10:30 Session 1: Setting the Scene:
    Presentations will include the EBF Biomarker Recommendation from 2012 revisited, connecting with Context of Use, Integrating Biomarker data into projects: an end user or stakeholders’ perspective, The value of open communication between the stakeholders and the bioanalytical lab
    Presenters: Kyra Cowan (Merck KGaA), Philip Timmerman (EBF), Lars Karlsson (Ferring), Steven Piccoli (GlaxoSmithKline)
10:30 11:00 Coffee break
11:00 12:15 Session 2: Limitations of the current analytical paradigm for Biomarker assays:
    Presentations will include : Creating awareness of our current limitations as BA experts; Breaking down the silos: The value of a new paradigm of analysis, i.e. the Bioanalyst / Stakeholder interface; Concomitant development of biomarkers and respective assays during the lifetime of a project; The biostatistician and bioclinician’s perspective
    Presenters: Lauren Stevenson (Immunologixlabs), Kyra Cowan (Merck KGaA), Dave Fairman (GlaxoSmithKline), Maria Key Prato (UCB Biopharma)
12:15 13:30 Lunch
13:30 15:30 Session 3: Context of Use – Case studies:
    Presentations will include: case studies of examples of setting up BM assays and/or supporting a project and where it went wrong and/or where it worked out fine
    Presenters include: Linda Terry (GlaxoSmithKline), Ulrich Kunz (Boehringer Ingelheim).
    You can still submit abstracts with fit into the session
15:30 16:15 Coffee break
16:15 18:00 Session 4: Starting from a white page…preparation for Day-2 round tables:
    Presentations will include: What can we learn from clinical labs?; What does a sustainable Bioanalyst / Stakeholder relationship look like; Introducing the concept of “The Certified Biomarker Analytical Scientist”? 
    Presenters include: Hans Ulrichts (UCB Biopharma), Lauren Stevenson (Immunologixlabs)  
    You can still submit abstracts with fit into the session
Thursday 19-Sep-2019
08:30 09:00 Summary of day 1 &  Introduction of round tables
09:00 10:30 Session 5: Bioanalytical lab challenges (Plenary or Breakout)
    Presentations will include: Scientific presentations on challenges for Biomarker assays – (scientific/regulatory) strategic of project related.
    Presenters include: Ragu Ramanathan (Pfizer), Robert Nelson (Novimmune)
    You can still submit abstracts with fit into the session
10:30 11:00 Coffee break
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 the discussions during the meeting.
    Round table moderators: Lauren Stevenson (Immunologixlabs), Kyra Cowan (Merck KGaA), Robert Nelson (Novimmune)
13:00 14:15 Lunch
14:15 15:30 Summary from round tables – Closing Panel discussion – agree on next steps
  15:30 Adjourn
15:30 16:30 Closing Coffee break