1.8.7.1PROJECT CONCEPT SUBMISSION APPLICATION

Researchers interested in submitting a Project Concept to The Biomarkers Consortium should complete this Project Concept Submission Form and send it via e-mail to the Foundation for the National Institutes of Health at .

The purpose of the submission is to succinctly and clearly define the background and rationale for the proposed project, and to describe findings that demonstrate the feasibility of the proposed study and the likelihood of the expected outcome. As described in Appendix A of The Biomarkers Consortium Membership Manual, approval of project concepts are based on (1) suitability to the goals of The Biomarkers Consortium, (2) scientific importance, (3) clinical importance, (4) regulatory importance, (5) feasibility, (6) degree of providing commercial implications, and (7) whether partners have been identified to conduct and fund the project.

The Biomarkers Consortium

Project Concept Submission Form

1. Title of Project Concept
2. Submitter and co-investigator name(s), and title, email address, and phone number of each
3. Name of Submitting Organization
4. Name(s) of Other Partner Organization(s), If Applicable / Name of Organization / Organizational Contact
5. Submission Date
6. Disease area addressed (Cancer, Cardiovascular, etc.)
7. Technologies proposed and suppliers (imaging, molecular, genetic, etc.)
8. List of who has reviewed the project concept
9. Estimated budget for the project.
10. Estimated duration of the project.

NOTE – ALL TABLES WILL EXPAND TO ACCOMMODATE TEXT AS ADDED.

11. State the objective of the project and its relevance to patients. (50 word limit).

12. Describe the experimental bases of the proposed project, including anticipated experimental groups, sample sizes, and the key dependent and independent variables. Demonstrate that both the experimental precision and sample sizes are sufficient to provide statistical power for evaluating the hypothesis. For example, which positive and negative controls from prior studies are incorporated? 300 words

13. Provide prior findings that directly substantiate the feasibility of the proposed study, particularly preliminary results that demonstrate the expected outcome. Provide up to 5 publications from you or co-investigators that document these results. 300 words not including references.

Note: If your concept is approved by The Biomarkers Consortium, a brief summary of your concept based on your answers to the preceding Questions 11 and12 may be posted on the consortium’s website.

14. How would the project benefit from a partnership under The Biomarkers Consortium? 150 words.

15. How will biomarker discovery, development or qualification increase our understanding of the (patho)biology of disease or health? 150 words.

16. How will biomarker development or qualification promote clinical diagnosis, assessment of disease activity, stage, severity or outcome, or affect the course of clinical trials? 150 words.

17. What advantages does the project have with respect to other approaches? How does the proposed project fill scientific gaps? 150 words.

18. Would biomarker development or qualification facilitate drug development or regulatory approval? 150 words.

19. Is the technology available to carry out this project? Please describe the methods, publications, and suppliers for the technology. 150 words.

20. What are the prospects for development and commercialization of biomarkers developed in this project? 150 words.

21. Is the project already linked to a particular commercial product? 150 words.

22. Please identify known and potential funding partners.

23. If a specific investigator or group is proposed to do the work, please provide curriculum vitae that are no more than 3 pages each in length.

For more information about Project Concept Submissions to The Biomarkers Consortium, please contact us at