Biomarkers in Drug Development: Classification and Applications

  • HMX

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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.

$495

Explore options to bundle courses and save.

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.

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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.

Participant Types

Pharma and biotech professionals; health care professionals in related fields.

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.

Additional Course Information

For information around payments and policies, please review our frequently asked questions.

  • Introduction to Biomarkers
  • Diagnostic Biomarkers
  • Interactive: Clinical Validation of Diagnostic Tests  
  • Prognostic and Predictive Biomarkers, Part 1
  • Prognostic and Predictive Biomarkers, Part 2  
  • In Focus: Clinical Validation of Companion Diagnostics - Assessing Diagnostic Performance
  • Monitoring Biomarkers, Part 1
  • Monitoring Biomarkers, Part 2
  • Biomarker Discovery and Development  
  • Clinical Linkage: Biomarkers of Alzheimer's Disease

Earn a short course certificate of completion when you finish all coursework within 8 weeks.

Are you ready to elevate your educational journey and maximize the investment in your future?

You can bundle up to five HMX short courses. Bundle discounts apply to all courses selected. All courses in a bundle must be completed during the following two enrollment periods.

Two-course bundle: 25% discount  
Three-course bundle: 30% discount  
Four-course bundle: 35% discount 
Five-course bundle: 40% discount

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. 

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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