Bioanalysis of biomarkers for drug development

“We hope the readers will benefit from the current thinking in the biomarker field while appreciating the diversity of challenges still facing the industry. This field is still evolving and we are excited to be part of these challenging times of drug development.” The complexity and the cost of drug-development programs in the pharmaceutical and biotechnology industry have increased tremendously over the past two decades. The US FDA’s Critical Path Initiative in 2004 gave the industry a boost in the midst of the growing concern of the attrition rate of the portfolio of products entering clinical development. While it was...