Biomarkers In Oncology Studies: The Science, The Medicine, And The Impact On Development

By Matthew Confeld, PharmD, PhD; Gabriela Rosu, MD; Craig Dorer-Abadia; Michael F. Murphy, MD, PhD.

Advances in discovery research, precision therapeutics, and a growing need for patient stratification to inform pharmacotherapy in oncology require integrating scientific, medical, and operational factors for biomarker development. Pharmacodynamic and disease-related analyte discoveries are increasing, and trial operations implications are evolving alongside these advances. They span domains from treatment decision algorithms to acquiring and processing biomarkers and assessing clinical and commercial implications. This paper provides an overview of oncology biomarker development and strategic considerations.