Diagnostic Research

Accelerating Progress

Lack of funding and focus on important biomarker research initiatives, including those within FDA’s Critical Path initiative have kept the pace of innovation slower than desirable.  Accelerate Progress will focus on several of these areas and will expect to fund independent research in strategic areas, collaborating when appropriate and providing solo funding when necessary.  Prioritization of areas to be funded will be set by the Scientific Advisory Board in consultation with the Director.  We believe that some work published by Dr. Bruce Chabner, a pioneer in his own right, elegantly lays out a pathway and background for further research into biomarkers, subgroup research, and a ‘selective approval’ mechanism.  It’s well worth reading and discussing. 

Dr. Chabner’s article is available here. We also discuss it briefly on our “Regulatory Research” page. 

Creating a network of national or international systems to assess and communicate clinical responses tied to molecular diagnostics will be one important focal point for our “Coalition to Accelerate Progress”.  Creating better diagnostic assays using newly identified biomarkers and continuing to research and validate newly discovered biomarkers will be another area of focus.