Challenges of introducing new biomarker products for neuropsychiatric disorders into the market

Abstract

There are many challenges associated with the discovery and development of serum-based biomarkers for psychiatric disorders such as schizophrenia. Here, we review these challenges from the point of view of psychiatrists, general practitioners, the regulatory agencies, and biomarker scientists. There is a general opinion in psychiatric medicine that improvements over the current subjective tests are essential. Despite this, there is a reluctance to accept that peripheral molecules can do the job any better. In addition, psychiatrists find it difficult to accept that peripheral molecules, such as those found in blood, can reflect what is happening in the brain. However, the regulatory health authorities now consider biomarkers as important for the future of drug development and have called for efforts to modernize methods, tools, and techniques for the purpose of developing more efficient and safer drugs. We also describe here the development of the first ever molecular blood test for schizophrenia, and its reception in the market place, as a case in point.