INTEGRATED BIOBANK OF LUXEMBOURG YOUR EUROPEAN BIOSERVICE PROVIDER codex4smes@ibbl.lu
About IB IBBL A not-for-profit public institute, dedicated to supporting biomedical research for the benefit of patients, integrated within the Luxembourg Institute of Health (LIH). IBBL’s strategy is to ▪ Support Luxembourg research ▪ Promote biobanking and infrastructure services to medical science research internationally Founded in 2008 Move in 2017 55 EMPLOYEES codex4smes@ibbl.lu
IBBL’s role in Codex4SMEs • The road from the discovery of a potential biomarker to its use in the clinic can be long, expensive and risky • You need to have a detailed evidence-based dossier to demonstrate its robustness and effectiveness • The role of IBBL in this project is to: ✓ improve the value of your biomarker discovery ✓ assess objectively and accurately biomarker robustness and its analytical characteristics for a quicker and smoother clinical translation ✓ increase the chances to secure an investment through an overall de- risking process for investors codex4smes@ibbl.lu
✓ Codex4SMEs offers 4 biomarker validation services at no costs to the SMEs ✓ Call for proposals opens on October 15 th 2018 . Please consult the Codex4SMEs website or contact your regional partner for guidelines, application form and deadlines for application submission ✓ Second call will be available in 2019 codex4smes@ibbl.lu
Where IB IBBL can help you in in the bio iomarker development valu lue chain? Analytical Pre-Analytical Biomarker Biomarker Early Translate Validation Validation Clinical Clinical Discovery Discovery Assay Performance, Analyte-, Reagents-, Verification Validation Biology Verified Clinical Measure Fit-for-purpose Technology- Patient Samples Established Robust IBBL service ✓ With a successful validation, IBBL helps you bring the biomarker to market ✓ If the validation is not successful, it helps you refocus your resources codex4smes@ibbl.lu
IB IBBL Bio iomarker Vali lidation Service • Pre-Analytical Validation Assessment and reporting of the robustness of your biomarker to common pre-analytical variables such as sample processing delays, storage and processing temperatures and freeze- thaw cycles • Analytical Validation Assessment and reporting of the analytical characteristics of your biomarker assay including, precision, matrix effect, analytical range, specificity, sensitivity and stability • Clinical Verification Pilot study of a limited sample size to verify the performance of your biomarker in clinical sample sets codex4smes@ibbl.lu
Selection process SMEs Regions Lead partner organisation 1. Get in touch with your 2. Complete the application form by December 14 th 2018 regional partner Innovative Companion 3. If complete, application transmitted to the biobanks and diagnostics candidate experts Codex4SMEs Jury Expert Group Lead Support BioBank BioBank input 4. Selection of a short list according to the criteria indicated in the guidelines 5. Teleconference with short- listed participants codex4smes@ibbl.lu
Selection process Steering Committee (representatives of Recommendation all partners) 6. Final decision announced by January 21 st 2019 codex4smes@ibbl.lu
IP IP rules for the BMV services • IBBL and the awardees will sign a mutual NDA to cover the discussions leading to a contract between IBBL and the awardee • IBBL and the awardee will sign a contract which: • Clarifies responsibilities of the parties • States IBBL has, in principle, no rights to awardee IP • States Codex4smes partners will be acknowledged for their contribution codex4smes@ibbl.lu
Conclusions Great opportunity for SMEs of the NWE region to improve the value of their products • At no cost for SMEs • Without any risks (all information will be treated as confidential, including the final report) • No loss of IP for awardee Don’t be shy, just apply! codex4smes@ibbl.lu
Thank you for your attention www.ibbl.lu codex4smes@ibbl.lu
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