By Christi Bird, Principal Consultant, Transformational Health, Frost & Sullivan
Frost & Sullivan recently invited academic and industry leaders in neuroscience research to participate in a unique thought leadership forum, our Virtual Think Tank series, titled Biomarkers for the Brain. This forum brought together leading minds involved in the study of biomarkers of central nervous system (CNS) diseases and disorders. The Virtual Think Tank stirred discussion about technological advancements in the field, current progress, future implications of the research and development occurring today, plus unmet needs in tools, key challenges that still remain, and expectations for future usage of biomarkers in CNS diseases.
A biomarker, or biological marker, is a term used to describe any measurable biological indicator or characteristic that can reflect a physiological state, such as a protein, cell, gene, hormone, or other type of molecule. The study and use of biomarkers in medicine is nothing new. Some biomarkers are straightforward and can give a definitive yes or no answer in a wide time range. Other biomarkers are difficult to detect given the minute amount of the markers present, their fleeting presence, or their occurrence in a location that is challenging to access. This means that even when a clinically relevant biomarker has been discovered, it does not necessarily translate to a viable diagnostic test or therapy.
When thinking about biomarkers, most would associate them with diagnostic tests to predict, diagnose, or provide a prognosis for a particular disease. However, biomarkers are now being utilized in drug development and regulatory decision making as they have the potential to improve the efficiency of the drug discovery and development process. In particular, if specific biomarkers that monitor or reflect the status of a disease can be identified, then researchers can use the expressed changes in these biomarkers to better understand how effective a new therapy is against a particular disease. Known as surrogate markers, they are tested to measure the effects of a specific treatment on disease status or progression. Including that data in a clinical trial would allow researchers to focus their efforts and resources on therapies that prove to be the most effective. In addition, pharmaceutical companies are using biomarkers to stratify patients, allowing them to move forward with the patients most likely to benefit from the drug being tested. These methods provide a greater chance of clinical trial success and regulatory approval. Ultimately, the use of biomarkers in the drug development process can reduce the time and cost of bringing new drugs to market, an ongoing goal of the pharmaceutical industry. Most importantly, biomarkers can provide clinicians with critical information to make better diagnoses and treatment plans, leading to better patient outcomes.