Date & Time 13 April 2023
Location Utrecht, The Netherlands

Biomarkers and Companion Diagnostics – The future of precision medicine

The MEB Science day 2023 is all about sharing knowledge and connecting with colleagues in regulatory science. This year the MEB Science Day focuses on Biomarkers and Companion Diagnostics. The event will dive into how their use shapes drug development and evaluation, allowing more personalised medicine to reach the clinic. You will be brought up to speed on how regulators review and endorse biomarkers through expert presentations, learn about the use of biomarkers and companion diagnostics in clinical practice, and be challenged to contribute to the interactive audience-panel discussion.

The first part of the afternoon focuses on biomarkers, which play a crucial role in drug development. ‘Prognostic’ biomarkers can be used to select patients most in need of treatment. ‘Predictive’ biomarkers are indicative of a druggable target. Biomarkers may therefore greatly expedite drug development and may identify patients most in need for, and responsive to certain drug interventions. Successful implementation of new biomarkers depends on their discovery as well as a thorough validation process. Endorsement of validated biomarkers by regulators in the form of qualification may be an important step in adoption of precision medicine in clinical practice. But how does a biomarker qualification procedure work at the EMA? For which type of biomarkers was qualification sought? And what does the process to clinical implementation look like for novel fluid biomarkers for neurological diseases?

Companion Diagnostics
In the second part of the afternoon we will get into the topic of Companion Diagnostics (CDx). Until May 2022, CDx in the EU were not assessed by a regulatory authority, but instead were self-certified by manufacturers. From May 2022, this changed with the EU In Vitro Diagnostics Regulation (IVDR) coming into effect, as CDx in the EU are now assessed by Notified Bodies (NBs) prior to certification. As part of the new IVDR, NBs consult the European Medicines Agency and national medicine agencies on the performance and safety of CDx. What are the experiences of the regulators in this 1st year with these consultation procedures? What is the impact of this new regulation on the practice of hospital diagnostics laboratories? And how to deal with the rapid developments in precision medicine in clinical practice?

Poster sessions, panel discussion and networking opportunities
Besides these main topics, the MEB Science Day will also focus on the research in PhD trajectories the MEB is involved in. Sixteen PhD students will present their poster, varying from work on 3R’s, use of real-world data to risk communication.

Learn more and register for the event here.