Muelle 1, Malaga
EBF Spring Focus Workshop
IVDR: our next Challenge?
- NH Malaga, Spain
- 06 - 07 June 2024
Note:
For all the slide decks on this website, the presenter/affiliation continues holds the copyright. The EBF was provided approval to upload the slides as PDF on their conference website. For slides presented on behalf of the EBF, the EBF vzw holds the copyright.
The program itself can be viewed and downloaded by clicking here.
Program details of the EBF SPring Focus WS 2024
| Day 1: Thursday 06 June 2024 | ||
| 09:30 | 10:00 | Welcome coffee |
| 10:00 | 10:15 | Welcome & Why this meeting? |
| 10:00 | 10:15 | Philip Timmerman, EBF (not released for publication) |
| 10:15 | 12:30 | Setting the Scene |
| 10:15 | 10:30 | Matthew Barfield, on behalf of the EBF |
| Is IVDR impacting drug development beyond the intention of the regulations? | ||
| 10:30 | 10:50 | Diana Steinbuesch, F. Hoffmann – La Roche |
| Impact of IVDR on Patients, Clinical Development and Healthcare costs | ||
| 10:50 | 11:15 | Lee Monk, UCB-Pharma |
| When Pharma incorporates IVDs: a dynamic unification | ||
| 11:15 | 11:40 | Fabian Iltzsche, Boehringer Ingelheim |
| Impact of IVDR on patient enrichment in ongoing trials | ||
| 11:40 | 12:00 | Robert Nelson, on behalf of the EBF |
| IDE & LDT vs. IVDR – a next hurdle? | ||
| 12:00 | 12:30 | Q&A – discussion |
| 12:30 | 13:30 | Lunch break |
| 13:30 | 14:30 | Preparing the two round tables for day 2 and Gauging the audience on experience with IVDR |
| incl. feedback from pre-meeting survey to delegates Opportunity for the delegates to share experience | ||
| 14:30 | 15:30 | A bit of technology… |
| 14:30 | 14:50 | Ivonne Bernal, BioAgilytix |
| Challenges and Learnings from Validation of AAV Neutralising Antibody (NAb) Assays under IVDR | ||
| 14:50 | 15:10 | Toralf Roch, CheckImmune |
| Proximity Extension Assay (PEA) as novel technology for pharmacodynamic assessments and CDx? | ||
| 15:10 | 15:30 | Anne-Laure Bauchet, Sanofi |
| IVDR challenges in Pathology/immunohistochemistry | ||
| 15:30 | 16:10 | Coffee break |
| 16:10 | 17:10 | IVDR impacting the choice of lab you work with |
| 16:10 | 16:30 | Jennifer Russell, A4P Bio |
| Health Institution Exemption – the easy way out? | ||
| 16:30 | 16:50 | Cecilie Freja Dalby Kjelgaard, Novo Nordisk |
| In Vitro Diagnostic assay for genotyping of clinical study participants | ||
| 16:50 | 17:10 | Claire Seal, invoX Pharma (not released for publication, not presented) |
| Impact of the IVDR on Vendor Selection: a Case Studies | ||
| 17:10 | 17:15 | Day 1 close out |
| Day 2: Friday 7 June 2024 | ||
| 09:00 | 10:30 | Case studies impacting the lab activities |
| 09:00 | 09:20 | Tracy Iles, Labcorp Drug Development |
| 09:20 | 09:40 | Marco Klinge, BioAgilytix |
| Roads to IVDR Compliance – Requirements and Strategies Following the In-House Test Approach | ||
| 09:40 | 10:00 | Kyra A. Gelderman, Sanquin Diagnostic Services |
| Complement functional assays to support clinical studies: under IVDR or not? | ||
| 10:00 | 10:20 | Pratiksha Gulati, F. Hoffmann – La Roche |
| Impact of IVDR on biomarker assessments in clinical studies – examples from Case studies | ||
| 10:20 | 10:30 | Getting ready for round table 1 |
| 10:30 | 11:00 | Coffee break |
| 11:00 | 12:30 | Round table discussion 1 |
| 11:00 | 12:30 | Impact of IVDR on lab activities |
| Delegates will be grouped into tables of maximum 10 (incl. moderator and note taker). The discussions will be moderated around questions related to the impact of IVDR on lab activities prepared on day 1 | ||
| 12:30 | 13:30 | Lunch |
| 13:30 | 14:40 | Case studies impacting clinical programs |
| 13:30 | 13:50 | Claire Seal, invoX Pharma (not released for publication, not presented) |
| Impact of the IVDR on Project Strategy: a Case Studies | ||
| 13:50 | 14:10 | Jason Simon, Regeneron Pharmaceutical |
| Contradicting advice from national competent authorities when seeking clarity on use of lab tests in clinical trials; A case study | ||
| 14:10 | 14:30 | Lien Dejager, Argenx |
| Sailing through uncharted IVD waters | ||
| 14:30 | 14:40 | Getting ready for round table 2 |
| 14:40 | 15:10 | Coffee break |
| 15:10 | 16:40 | Round table discussion 2 |
| 15:10 | 16:40 | IVDR impacting clinical programs |
| Delegates will be grouped into tables of maximum 10 (incl. moderator and note taker). The discussions will be moderated around questions related to IVDR impacting clinical programs prepared on day 1 | ||
| 16:40 | 17:00 | Summarising the workshop, next steps and adjourn |
| Organising Committee: Robert Nelson (BioAgilytix), Lee Monk (UCB Biopharma), Matthew Barfield (F. Hoffmann – La Roche) and Philip Timmerman (EBF) |
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EBF Focus workshops are organised by the EBF vzw as non-sponsored non-profit events and are independent from EBF member companies.
