Online seminar. Date: 17 Feburary 2023 | 9:00 – 13:45 CET (Amsterdam, Berlin, Paris)
Apply for this unique online seminar to learn about the importance of pre-analytics in biomarker discovery and the benefits of biomarker validation. The online seminar is offered by Integrated Biobank Luxembourg and targets SMEs from North-West Europe and other European regions that develop biomarkers for diagnostics. The interactive online seminar is divided into two parts.
In part I, experts from BBMRI.be, Strategiqual and IBBL will present strategies for biomarker validation in three lectures. You will also learn first-hand from SMEs about successful biomarker commercialisations.
In part II, you will have the opportunity to arrange individual 30 minute 1:1 meetings with our experts from BBMRI.be and Strategiqual. Please contact the respective experts after successful registration. If you want to receive tailored coaching for strategic biomarker development from IBBL experts, please apply for a Consultancy Service on specific biomarker topics.
|9:00 – 9:15||Welcome and introduction of Codex4SMEs projectSpeaker: Monica Marchese, PhD, Translational Biomarker Group Leader IBBL (Integrated BioBank of Luxembourg)|
|9:15 – 9:45||The importance of biobank networks for SME’sSpeaker: Annelies Debucquoy, National Node Director BBMRI.be, Belgian Cancer Registry, Belgium An introduction to biobank networks, services and opportunities for collaboration with the largest European biobank infrastructure BBMRI-ERIC from the perspective of the National biobank network in Belgium (BBMRI.be), access to samples and data, support and guidance on topics related to ethical/legal aspects of biobanking and how to assure the highest quality of samples.|
|9:45 – 10:45||Collaboration with SME’s from a hospital integrated biobank point of viewSpeaker: Elke Smits, Chief Science & Innovation Officer, University Hospital Antwerp & President BBMRI.be, Belgium This session, will bring some hands-on examples of collaborations between SME’s and biobanks from a hospital integrated biobank point of view. Experiences in merging translational and clinical research within clinical practice both in an academic as industrial setting as well as how to get the best out of collaborations between SME’s and biobanks will be shared.|
|10:45 – 11:15||Biomarker Validation: a critical step for successful Personalised MedicineSpeaker: Monica Marchese, PhD, Translational Biomarker Group Leader IBBL (Integrated BioBank of Luxembourg) Pre-clinical biomarker validation is an essential tool to increase the successful exploitation of newly discovered and potentially repurposable biomarkers, to transform them into powerful diagnostic tools, predictors for proper treatments, or successful Cdx.The talk will focus on the biomarker validation paradigm and its systematic approach to assess biomarker robustness, while evaluating analytical method fitness-for- purpose. Some real-life scenarios from the interaction between SMEs and the IBBL, in the context of the Codex4SMEs project, will be shared with the audience.|
|11:15 – 11:30||Coffee Break|
|11:30 – 12:30||IVDR transition – How to survive it, from a regulatory point of view ?Speaker: Delphine Audureau, StrategiqualRegulatory context – transition periodMajor impacts of IVDR on QMS and productsTechnical File : focus on clinical evidenceNotified body : timelines and cost|
|12:30 – 12:45||Coffee Break|
|12:45 – 13:15||Digital Biomarker Development|
|13:15 – 13:45||Q&A session|
Note: The online training is limited to ten SMEs. The selection is made on a first-come, first-served basis. The training will only be carried out after three SMEs have registered for it.
Note: Our services are in general open to SMEs from all over North-West Europe with preference given to SMEs from one of the participating partner regions (see table of partners) for the services offered.
More information: The online coaching is part of the Interreg NWE-funded Codex4SMEs project. Since 2017, Codex4SMEs has built a large European network in the field of diagnostics and personalized medicine. More than 300 small and medium-sized enterprises have so far benefited from the opportunities offered. These include various events and tailored services that support SMEs in the development of innovative diagnostics.
BioRegio STERN Management GmbH is the lead partner in the Interreg NWE project Codex4SMEs. Based in southwest Germany, BioRegio STERN Management GmbH acts as a business development agency for the regional biotech and life science sector. The primary goal is to anchor the BioRegion STERN and their business throughout Germany and internationally on a high level. An important strategy for the development of the regional cluster is to build on existing strengths. The regions Stuttgart and Tübingen are characterised by a prominent network of biotechnology and medical technology SMEs as well as universities & research institutes and including service provider companies.