The Biomarker Factory
Bringing Biomarkers to Clinical Practice
Project Concept
Submission Form
Introduction
Thank you for your interest in the Biomarker Factory. The Biomarker Factory provides research fundingand domain expertise for translational medicine projects in the field of bringing biomarkers to clinical practice. Principal Investigators who are interested in applying for Biomarker Factory funding are encouraged to first contact Jeffrey Shuster, General Manager, by emailat , or by phone at (919) 474-4330, to discuss the project idea and assess suitability for a Biomarker Factory project concept submission.
Instructions
The purpose of this form is intended to help us better understandthe medical needs in your research area and how a biomarker approach can address these needs. There are 10 sections below. Please fill in the fieldsfor all questions. If a question is not relevant for your particular idea, or if you do not have information for a specific question, please indicate "not relevant", or "do not know". Please note that the answers you provide are for preliminary evaluation purposes only. Do not include any confidential information.
Getting Started
Please download a copy of this form, fill in the information, save the file with a new name, and email the completed form to:.
Contact Information
If you have any questions, please feel free to contact:
Jeffrey Shuster
General Manager
The Biomarker Factory
phone: (919) 474-4330
email:
Submitter Information
Submitter Name:
Affiliation (Department, and Organization/Institution/Company name):
Address (Street/City/State/postal code):
Contact email address:
Contact phone number:
Date
Project ConceptInformation
1. Disease Area
2. Proposed Project Title
(1200 char)
3. Medical Need and Market Opportunity for a New Biomarker-based Test
3a. Clinical need: What is the medical need for the test?
(2400 char)
3b. Patient population to be tested: What patient criteria will a physician use to order the test?
(1200 char)
3c. Actionablein clinical practice: Based on the test result, what will the physician do differently than he/she does today?
(2400 char)
3d. Number of patients: How many patients are estimated to be tested? How often?
(200 char)
4. Technology
4a. Are there preliminary results?with human clinical specimens?
(Y or N)(Y or N)
4b. Have results been published or presented? If so, please provide the reference(s).
(1200 char)
4c. Is the proposed study design retrospective banked materials, or prospective collection?
(1200 char)
4d. Has a biostatistician been consulted for experimental design and/or data interpretation?
(1200 char)
5. Product
5a. What is the basic detection technology for the test?
(1200 char)
6. Regulatory
6a. Is this a companion diagnostic or stand alone test?
(200 char)
6b. Will the test require FDA approval/clearance or CLIA?
(200 char)
7. Intellectual Property
7a. Has intellectual property been filed as any of the following: invention disclosure form, provisional patent application, full patent application?
(1200 char)
7b. Have any patent applications been published or patentsissued? If so, please list.
(1200 char)
8. Competition
8a. Are there competitors?
(1200 char)
8b.What, if any, other technologies could be considered for the test?
(1200 char)
9. Management
9a.Who will lead the project?
(1200 char)
10. Any other comments or things you would like us to know?
(1200 char)