EBF
EBF Focus

Biomarkers in Pharma R&D

A roadmap from Context of Use to Using the data
NH Málaga Centro
Málaga, Spain
12 May 2020 (Training Day)
13-14 May 2020 (Workshop)

Program Workshop

TRAINING DAY (TD) – 12 May 2020

The theme for the training day is “Bioanalytical tools and challenges for Cell & Gene Therapies”.  There will be no call for speakers for the TD

FOCUS WORKSHOP (FW) – 13-14 May 2020

INTRODUCTION AND AIM

Considering the learnings from our most recent Autumn FW we want to continue the discussions at our 2020 Spring FW

At the FW, we plan to focus on at least 4 areas:

  1. Creating a framework for Biomarkers, i.e. further discussions real or perceived differences applying principles of Context of Use (CoU) by different stakeholders
  2. (A) session(s) focus on the importance of the assay development phase – examples (successes and failures) and strategies
  3. Using the data: (a) session(s) around modeling and simulations, consequences of (correct or incorrect) decisions made from the data in different stages of drug development.  
  4. We are working to include a session with the regulators on mutual understanding how CoU impacts the assay requirements during filings.
  5. Based on the abstracts received during the Call for Speakers period we are committed to include a session on your most important additional area of interest not covered in above 4 areas