IBD Biomarker Regulatory Science Webinar on 10 March 2021: 3TR Partners Host Joint Workshop with Critical Path Institute
The 3TR teams for Inflammatory Bowel Disease (IBD) and Engagement with Regulators have joined forces with the Critical Path Institute to host an IBD Biomarker Regulatory Science Webinar on Wednesday 10 March 2021 from 10 AM to 1 PM (ET) / 4 to 7 PM (CET).
Bringing together key stakeholders from the IBD medical community, representatives of public research institutes, industry members and patient advocates, the three-hour LIVE session aims to understand how “real world” biomarker evidence generated by academic centers and Public-Private Partnerships can contribute to biomarker validation in IBD along with industry sponsored trials.
Part of the discussion will be the question of how to progress biomarkers through the regulatory acceptance processes of the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). To this end, the workshop also seeks to help establish partnerships to facilitate the progression of IBD biomarkers through regulatory acceptance. Despite the event’s focus on IBD, some outcomes are expected to be applicable to other disease areas, too.
Major points of discussion will be:
- IBD Biomarker Pre-Consortia Experience
- 3TR Overview and Goals
- Case Study Review
- FDA & EMA – Unmet Regulatory Needs for Biomarkers IBD
LIVE Session & Pre-recorded Presentations
Prior to the LIVE panel discussions with representatives of FDA and EMA on 10 March 2021, participants are encouraged to watch a series of pre-recorded presentations by renowned expert speakers. The set of presentations includes an introduction of 3TR by project member Prof. Sven-Erik Dahlén from Karolinska Institutet, Sweden.
Also, participants are invited to pre-submit questions for the panelists. Due to the anticipated high number of questions, queries should be sent in good time before 10 March to firstname.lastname@example.org.
For registration, agenda and the full overview of pre-recorded presentations, please visit the dedicated event website.
Participation in the event is free of charge. Join us!