1. EDRN Biomarker Review Process Heather Kincaid, Andrew Hart, Kristen Anton, Mark Thornquist, Dan Crichton and Christos Patriotis

2. Introduction Organ Collaborative Groups will be performing EDRN biomarker data reviews Hanash Protein Markers for Lung Cancer using CARET Sera will be first markers to be reviewed This presentation walks through how do perform the review Goal: Complete 1 st review of Hanash markers and obtain feedback from Lung Collaborative Group prior to August EDRN Meeting

3. Review Process Markers are selected for review by Organ Collaborative Group and approved by NCI When necessary, marker review is scheduled on next available Organ Collaborative Group call. Biomarker Review Report and worksheet are sent to Collaborative Group members one week prior to call for review prior to call Collaborative Group review markers Chair sends comments to Kristen If marker is approved it is “published” to portal

4. Performing the Review Use Biomarker Review Report to navigate through all maker annotations and documentation – The Biomarker Review Report is a pdf contains clickable links (screen shot on next slide) You will be given a user name and login to access the data Review report and make comments on worksheet prior to Collaborative Group call

5. Biomarker Review Report Click on the name of the marker to review the biomarker details (aliases, organ data, studies, publications, related resources) Click on Studies to review the biomarker study detail Click on the science data to review all the related science data

6. Review of Biomarker Annotations Click on the biomarker name (e.g. 14-3-3 theta) and you will see the following items to review: – Aliases – Biomarker Description – Organ Data – Studies (see next slide) – Sensitivity/Specificity – Publications related to the specific study – Related resources to the specific study – Studies related to the Biomarker/Organ – Publications related to the Biomarker/Organ – Resources related to the Biomarker/Organ

7. Biomarker Screen Shot - 1

8. Biomarker Screen Shot - 2

9. Biomarker Screen Shot - 3

10. Review of the Study Information Click on Study Name (e.g. Validation of Protein Markers for Lung Cancer using CARET Sera and Proteomics Techniques) and you will see the following items to review: – Objectives – Specific Aims – Outcomes – Sites – Related Resources – Scientific Datasets (will be covered in next slides) – Biomarkers (covered in previous slides) – Publications

11. Study Data Screen Shot - 1

12. Study Data Screen Shot -2

13. Review of the Related Data Click on Science Data (e.g. Hanash 3-marker panel for Lung Cancer) to review the following: – Abstract – Results and Conclusion Summary – Study Design – Analytic Methods – Analytic Details – Eligibility Criteria

14. Science Data - Dataset Screen Shot - 1 Click on associated product to see product information and download the file

15. Science Data - Dataset Screen Shot - 2

16. Review of the Related Data Files and Information Click on the Related Products to review the following: – Instrument Details – Data Stage – Product Description – Product Title – Recommended Software – Product Function – Specimen Type – Analytic Methods

17. Science Data - Product Screen Shot Click on Save to review the data file

18. Review the files associated with the study

19. Next Steps Send Lung Collaborative Group Biomarker Review Report and Check List for each of the biomarkers to be reviewed in next few weeks. Hanash Lung Cancer using CARET Sera reviewed on next Lung Collaborative Group call in July Feedback received on Biomarker Database, Science Data Warehouse (eCAS) and review process received and prioritized for future versions.

20. Steps to Perform the Review Review 5 markers and a panel from Hanash Study (Annexin1, LAMR1, 14- 3-3 theta, DJ-1, PGP9.5 and Hanash 3-marker panel for Lung Cancer) One week prior to review call - receive a Biomarker Review Report and Checklist for each marker 1 st marker review the following: – Marker Annotations – Study Annotations (only once for entire study) – Science Data (only once for entire study) Subsequent markers review only the marker annotations Complete the checklist with any comments prior to the review call Send checklists to Karl Kruger Review comments for all markers on the call Karl will send comments to Kristen Anton If approved, markers will be made public on the EDRN Public Portal

21. Biomarker Checklist