Biomarkers in Pharma R&DA roadmap from Context of Use to Using the data
12 May 2020 (Training Day)
13-14 May 2020 (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:
- Creating a framework for Biomarkers, i.e. further discussions real or perceived differences applying principles of Context of Use (CoU) by different stakeholders
- (A) session(s) focus on the importance of the assay development phase – examples (successes and failures) and strategies
- 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.
- We are working to include a session with the regulators on mutual understanding how CoU impacts the assay requirements during filings.
- 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