Biomarkers in Drug Development: Classification and Applications

Despite significant advances in medicine and clinical research, many serious conditions remain undetected until late stages or respond poorly to existing therapies. Physicians and researchers are often left seeking better methods of identifying patients who are at risk, gauging disease activity, or determining the best therapeutic approach. The emergence of biomarkers—measurable indicators of biological processes—offers new ways to address these challenges and move toward truly personalized care.  

In this HMX short course, you will learn from industry experts and Harvard Medical School faculty about topics ranging from basic biomarker categories to more advanced concepts, such as regulatory approval pathways and companion diagnostics. You will also see real-world applications of this field in a case study on biomarkers for Alzheimer's disease. Understanding the critical role that biomarkers play in diagnosis, therapy selection, and regulatory approval is essential for learners whose work intersects with clinical research, drug development, or patient care.