About Drug & Biomarker Development
A highlight of the Consortium’s research strategy is our co-development of therapies and biomarkers. It is underappreciated in the field that biomarker development is analogous to drug development. Drugs are approved for indications, while biomarkers are validated or qualified for a specific context of use, which requires a dedicated sequence of trials, each informing the other, focused on the context. This unique approach, represented by our parallel development of drugs directed at key oncogenic alterations in the AR and the AR signaling axis identified by our group and correlative imaging and CTC biomarker programs, has led to the FDA approval of abiraterone acetate and enzalutamide; collaborative development of bone scan endpoints; and the analytical validation of the CTC survival surrogate endpoint. Designing trials that address clinically relevant questions with informative endpoints that can be evaluated prospectively as potential surrogates of clinical benefit in phase III trials serves to accelerate the overall pace of research in prostate cancer.