Contact:

Tracy G. Lugo, PhD
Cancer Diagnosis Program
Telephone 301-496-1591
e-mail: @TL82Snih.gov

Objective of Project:

This initiative will invite Small Business applications for research projects enabling investigators to apply new analytic strategies to clinical problems in cancer prognosis and prediction of response to treatment.

Description of Project:

The NCI has sought to encourage the rapid appraisal of new candidate prognostic and predictive markers. It is essential to encourage these studies to move beyond the exploratory stage. Frequently the transition from an exploratory marker study to initial confirmatory testing in a clinical setting requires additional developmental work, such as the modification of an assay format. The fast-track review option for Small Business applications will permit the investigator to perform initial developmental work in Phase I, demonstrate feasibility by meeting peer-reviewed milestones and then move directly into the clinical study in Phase II. This program will utilize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) mechanisms, but will be run in parallel with a program of identical scientific scope that will utilize the Phased Innovation Award (R21/R33) mechanism.