Although robust and clinically meaningful biomarkers are key to achieving the current vision for precision (molecularly based), cancer medicine (patient stratification, early diagnosis, drug development), few ever successfully advance beyond discovery to the clinic. For example, protein biomarkers have received FDA approval at a rate of less than 1 per year since the mid 1990's. Numerous publications report the discovery of hundreds of thousands of cancer biomarkers, yet fewer than 100 are routinely used in the clinic. The staggering costs and dismal success rate of cancer clinical trials and the lack of development of the molecular diagnostics industry are tied to this history of biomarker failures.
Achieving robust, reproducible and clinically important cancer biomarkers is one of the great "value propositions" in biomedicine. Realizing this value will require systemic changes which recognize that achieving success will require standards-based end-to-end systems approaches. Biomarker discovery and development occurs in overlapping but discrete phases; but there are currently no broadly accepted or applied standards (guidelines, best practices, standard operating procedures, etc.) to support evidence-based transition of a biomarker through these phases - much less robust systems-based models. Although complex, these problems can be solved.
The National Biomarker Development Alliance (NBDA) is a non-profit, trans-sector network-based organization whose mission is to create/assemble the "standards" needed to support systems based approaches to biomarker development. The NBDA will partner with all affected stakeholders and the regulators to ensure that high value, robust standards are broadly employed to create the systems based approaches to biomarker development so desperately needed to transition precision medicine from a vision to reality for all cancer patients.