Biomarkers in Clinical Trials: From Cancer Researcher and Cancer Patient Perspective

Dr. Magdalena B. Wozniak

Abstract

Biomarkers have been used for diagnosis, assessment of disease risk, prognosis, prediction, as well as treatment response and safety at virtually every stage of drug discovery and development. In an era of targeted therapies, and precision medicine, clinical trials have adapted their designs to bring new medicines to the right patient population and improve treatment outcomes. In my presentation, I will provide an overview of the landscape of biomarkers discovery at various stages of drug development with specific examples to illustrate diagnostics and therapeutic monitoring. Biomarkers also play an important role in the detection and management of patients with breast cancer. Biomarkers that aid in the diagnosis, prognosis, and prediction of breast cancer are crucial for early detection and appropriate disease control throughout treatment. As a breast cancer survivor, I will share my experience of how biomarkers affected my treatment decision making during my cancer journey and discuss challenges in biomarker and clinical development from cancer researcher and cancer patient perspectives.

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