Biomarkers: Discovery, Validation, and Clinical Implementation
- HMX
Learn how biomarkers are transformed from concept to clinical setting.
- Online; Self-Paced
Enroll and gain access to course materials to complete at your own pace.
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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
Biomarkers are used daily by medical professionals to diagnose patients, monitor conditions, make treatment decisions, and evaluate disease risk. They are used at every step of drug discovery and development: from assay development to patient stratification in the clinic. Biomarkers are an integral part of research and medicine, but many health conditions lack specific biomarkers that would be helpful for patient care. Unlike clinical drug development, the process for biomarkers is generally not well understood and articulated by the scientific community, and lacks clearly defined phases.
In this HMX short course, you will learn from Harvard Medical School faculty about the biomarker discovery and development pipeline. You will gain a practical framework for how to approach this process and see the real-world impact of having the validated biomarkers with clinical utility.
Learning Objectives
- Map the entire biomarker discovery and development pipeline, from initial signal identification to clinical deployment.
- Apply understanding of analytical and clinical validation and clinical utility concepts to assess the requirements that a biomarker needs to meet to receive a regulatory approval.
- Explore the factors that determine whether a well-validated test achieves clinical adoption.
Who Should Participate
Clinicians; biomedical and translational researchers; professionals in biomedical sciences, pharmaceutical, biotechnology, diagnostics, and digital health sectors.
About the Course
HMX short courses feature targeted lessons on the latest medical science topics and advancements. Stay up-to-date on essential knowledge by exploring specialized topics in a shorter format designed for busy professionals.
Who Should Enroll
This course is designed for professionals in biomedical sciences who are looking for an end-to-end understanding of the process of biomarker discovery, as well as the principles and metrics that are used to understand and evaluate biomarkers. This course will also benefit clinicians, biomedical and translational researchers who are interested in learning about and participating in the process of biomarker discovery. It will also be suitable for professionals in pharmaceutical, biotechnology, diagnostics, and digital health sectors who need a practical view of the evolving standards, regulatory expectations, and challenges that impact biomarker development.
Recommended Prerequesites
We recommend knowledge of basic biology and an understanding of the FDA-defined biomarker categories. For those who require more background in biomarkers, we offer Biomarkers in Drug Development: Classification and Applications course.
Course Format
Most people can expect to spend 3-4 hours total on an HMX short course. In order 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.
Rushdy Ahmad
PhD
- Director of the Wyss Diagnostics Accelerator and Director of Strategic Partnerships, Wyss Institute at Harvard University
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