The use of biomarkers is expanding across all stages in the drug development process, helping bring about new and innovative practices in the treatment of many diseases, including Alzheimer's and cancer. With their ability to revolutionize development of advanced therapeutics, biomarkers have become essential tools.
Dr. Tanja Schubert, my colleague at Bioclinica Lab where molecular markers is the focus of our work, and I recently co-authored an article for EBR in the April 2017 issue. We begin the article taking a look at biomarkers'growing role in clinical trials across the drug development spectrum from target identification and preclinical tests through Phase 1 studies into post-marketing.
During fact-finding, we came across a report showing about 12 percent of all trials registered in 2013 included biomarkers with outcome measures and/or inclusion criteria. These biomarkers are primarily used in Phase 2 studies, helping to prove that the investigated product has the expected biological effect. As far as Phase 1 trials where safety and tolerability of a new investigational drug is assessed, biomarkers serve as a starting point to identify the most valuable biomarkers for a subsequent Phase 2 study. And over in Phase 3 studies where well-developed and characterized biomarkers are used - they very often prove to be those selected during Phase 2.
Biomarkers Categories
Next we take a look at the different categories of biomarkers as defined by the FDA-NIH Biomarker Working Group. We currently have eight biomarkers categories. Can you name them all?
- Diagnostic
- Monitoring
- Pharmacodynamic (PD)/response
- Predictive
- Prognostic
- Safety
- Susceptibility/risk
Biomarkers in Precision Medicine
Precision medicine is a particularly exciting area in which progress is being made in a number of areas like companion diagnostics. Biomarkers have contributed to advancement of precision medicine and continue to bring discoveries on what seems to be a daily basis. Companion biomarkers, with their ability to predict response to a specific therapy help to classify patients into responders and non-responders. Usually co-developed with drugs, companion biomarkers provide essential information on the safe use of therapies.
Biomarker Validation and Qualification
Also in the article we take a look at biomarker validation and qualification, how assessed and how performance characteristics of the assay are measured.
You can find out more on this and the exciting work going on in biomarkers in the EBR article which can be accessed here. Happy reading!
Preview Bioclinica Lab
If you'd like to preview our capabilities here, visit Bioclinica Lab where you can explore what we do, how we do it and our growing biomarkers menu. If you have a specific question please take a moment to submit an online contact request form here, and Dr. Schubert or myself will get back with you.
This is an area we're passionate about, and we'd love to hear from you as to what you're seeking to achieve by using biomarkers and how we may support your efforts.