INTEGRATED BIOBANK OF LUXEMBOURG YOUR EUROPEAN BIOSERVICE PROVIDER - - PowerPoint PPT Presentation

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

55

EMPLOYEES

Founded in 2008 Move in 2017

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 15th 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?

✓ 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

IBBL service

Early Discovery

Biology Verified Patient Samples

Translate Discovery

Clinical Measure Established

Pre-Analytical Validation

Analyte-, Reagents-, Technology- Robust

Analytical Validation

Assay Performance, Fit-for-purpose

Biomarker Clinical Verification Biomarker Clinical Validation

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

codex4smes@ibbl.lu

Innovative Companion diagnostics candidate SMEs Regions

• 1. Get in touch with your

regional partner

• 2. Complete the application

form by December 14th 2018

Lead partner organisation

Expert Group Lead BioBank Support BioBank

Codex4SMEs Jury

input

• 3. If complete, application

transmitted to the biobanks and experts

• 4. Selection of a short list according to the

criteria indicated in the guidelines

• 5. Teleconference with short-

listed participants

Selection process

codex4smes@ibbl.lu

Recommendation

Steering Committee (representatives of all partners)

• 6. Final decision announced by January 21st 2019

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

codex4smes@ibbl.lu

Don’t be shy, just apply!

Thank you for your attention

www.ibbl.lu codex4smes@ibbl.lu