A set of critical decision points in cancer biomarker and drug development has been summarized in a commentary published online October 23 in the Journal of the National Cancer Institute.
The points, which emerged from a workshop, include developing a clear understanding of the biology of the target and its interaction with the drug and the factors affecting the performance of the biomarker assay.
As described in the commentary by Sheila E. Taube, Ph.D., of ST-Consulting in Glen Echo, Md., and colleagues, workshop participants agreed that the more that is known about the biology and the stronger the association between the analytical signal of the biomarker assay and a clinical result, the less risky the development process will be. The workshop was co-sponsored by the National Cancer Institute and the U.S. Food and Drug Administration and held in October 2007.
"This article...presents a set of issues for consideration and proposed development paths," the authors write. "We hope that this will serve as the beginning of a productive dialogue in the community."