A commentary published online October 23 in the Journal of the National Cancer Institute summarizes a set of critical decision points in cancer biomarker and drug development. 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.
According to the authors, a rigorous approach involving careful sample collection and standardized quality controlled data collection are critical for the rapid entry of predictive biomarkers and drug combinations into clinical practice. The attendees concluded that interaction with regulatory agencies early in the development process will ensure proper study design and performance characterization of biomarker assays.
"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."