On behalf of the 3TR IMI project consortium and Critical Path Institute we would like to formally invite you to participate in the IBD Biomarker Regulatory Science Webinar being hosted by the groups on Wednesday, March 10, 10 a.m. ET. Together, with a collection of public research institutes, industry members and patient advocates, we will align on how to progress biomarkers through the FDA & EMA’s regulatory acceptance process. This free webinar will include key stakeholders from the IBD medical community focused on establishing a partnership to facilitate the progression of IBD biomarkers through regulatory acceptance.
We will be discussing:
- Crohn’s Disease and Ulcerative Colitis Biomarker Pre-Consortia Experience
- 3TR Overview and Goals
- Case Study Review
- FDA & EMA – Unmet Regulatory Needs for Biomarkers IBD
Meeting Objective: Establish a partnership to facilitate the progression of IBD biomarkers through regulatory acceptance.
- Meeting Link: https://criticalpath.webex.com/criticalpath/onstage/g.php?MTID=ef2efd5d4255a072bb2498a04eac11347
- Meeting Password: IBD2021
- Date: March 10, 2021
- Time: 10 a.m. – 1 p.m. ET (4-7 p.m. CEST)
- Length: 3 hours
Presentations: You can find links to pre-recorded presentations in the table below. Please take some time to view the presentations prior to the live panel discussions on March 10.
Q&A: Due to the anticipated high volume of questions during the live panel sessions, it is encouraged that you review the presentations below and submit questions ahead of time to cbirch@c-path.org.
Recorded Presentations
| Topic | Title | Organization | Speaker / Panelist |
| Patient Perspective | Patient Accu Espana |
Dr. Robert Hinton Beatriz Mateos |
|
| Crohn’s Disease and Ulcerative Colitis Biomarker Landscape | Outcomes of the Crohn’s Disease Biomarker Pre-Consortia | C-Path | John-Michael Sauer |
| 3TR Presentation | 3TR Overview | 3TR | Sven-Erik Dahlen |
| IMI Presentation | The Innovative Medicine’s Initiative – Europe’s Partnership for Health | IMI | Natalie Seigneuret |
| Case study examples | UCSD J&J Alimentiv MGH |
Parambir Dulai Diana Koletzki Bryan Linggi Ashwin Ananthakrishnan |
|
| Health authority perspective | Regulatory needs for IBD drug development – | FDA | Chris Leptak Tara Altepeter |
LIVE panel sessions Wednesday, March 10, 10 a.m. ET with representatives from EMA and FDA
- Meeting Link: https://criticalpath.webex.com/criticalpath/j.php?MTID=md7f742a6bb3cb53c3fff9dcca12c5189
- Meeting Password: IBD2021
Live Panel Discussions
| Topic | Title | Organizations | Panelists |
| Live round table discussion and questions | Takeda Janssen C-Path MGH UCSD FDA EMA |
Moderators John-Michael Sauer Vijay Yajnik Panel 1 Panel 2 |