Biomarkers in Drug Development: Classification and Applications
- HMX
Dive into the different FDA categories of biomarkers and discover how they are applied in drug development and patient care.
- Online; Self-Paced
Enroll and gain access to course materials to complete at your own pace.
Certificate
Earn a short course certificate of completion when you finish all coursework within 8 weeks.
3-4 Hours
Most people can expect to complete short courses in 3-4 hours.
On This Page
Overview
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 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.
Learning Objectives
- Learn to identify the major categories of biomarkers, including their characteristics, uses, and limitations.
- Apply their understanding of the context of use of biomarkers to real clinical and research scenarios, including specific clinical applications.
- Calculate and interpret key performance metrics of diagnostic or predictive tests.
About the Course
HMX short courses feature targeted lessons on the latest medical science topics and advancements. Stay up to date on essential knowledge in a format designed to fit your busy schedule.
Who Should Enroll
This course will be of interest to pharma and biotech professionals who want to learn about the landscape and use of biomarkers, and what metrics can be used to understand and interpret them. Health care professionals in related fields will also benefit from this course.
Course Format
Most people can expect to spend 3-4 hours total on an HMX short course. To be considered for a short course certificate of completion, you must complete your coursework within eight weeks.
Group Enrollments
HMX courses are ideal for organizations looking to train teams or larger groups. Group pricing is available, making it a cost-effective investment in team development.
Faculty
HMX courses are led by Harvard Medical School faculty, working in collaboration with a multi-disciplinary team of experts in biomedical visualization, assessment, and the science of learning to create a unique learning experience that will stay with you.

Liza Wick
PhD
- Pharmacology Curriculum Lead, HMX

Alessandra Cesano
MD, PhD
- Chief Medical Officer, Executive Vice President, ESSA Pharma Inc.
From Our Learners
"I found the real-world examples of clinical trials, presented by top investigators who had been part of them, to be the most exciting course content."
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