Rethinking and Redisigning (and/or Realigning) Biomarker Discovery
July 14-15, 2014
The Phoenician, Scottsdale, AZ
“The mission of the NBDA is to enable the creation of a standards based end-to-end pipeline for biomarker development”. The NBDA was founded to address the dismal success rate of advanced biomarker-driven clinical trials –and the equally poor rate of FDA approval for molecular diagnostics and biomarkers overall, especially protein biomarkers (less than 1 per year approved since the early 1990’s). The field does not currently have (or agree on) the “standards” (guidelines, processes, standard operating procedures, etc.) required to remove what are a formidable number of barriers.
Working with groups of experts, over the past several months, it has become obvious that many (perhaps most) of the problems that ultimately "derail" biomarkers begin in early and/or translational (late) discovery. Unfortunately, these issues have received significant attention of late in both the scientific and in the lay press. The irreproducibility of biomarker research and development represents a recurrent theme in these publications.
NBDA Workshop V, “RETHINKING AND REDESIGNING BIOMARKER DISCOVERY”, analyzed the following major issues in biomarker discovery: formulating the right clinical question; appropriate quality and numbers of biospecimens; correct/robust study design; setting and using technology standards; ensuring data quality and provenance; and ensuring responsive analytics and analysis. Outcomes from the workshops consisted of very clear recommendation to the NBDA for actions to achieve solutions to the problems which plaque biomarker discovery.
This information will be available in Spring 2016 to those individuals and organizations that join the NBDA as Partners, Collaborators or Members.