Abstract

Biomarkers are measurable characteristics of a living organism, from blood pressure to the abundance of proteins or small molecule metabolites. They play an increasingly important role in drug development, where they can facilitate every step within the drug development process from basic research and preclinical development to clinical trials and post-marketing safety assessment.

Once drug development proceeds from research to clinical stages, regulated bioanalysis has to be applied for biomarker determination. Development and validation of such bioanalytical methods can pose a multitude of problems, depending on the abundance and number of biomarkers to be monitored, the availability of an appropriate blank matrix, and the complexity of sample preparation.

Focusing on small molecule biomarker analysis, we showcase challenges in implementing complex workflows and ways to overcome these to ultimately obtain scientifically valid assays. In addition, we show how small molecule biomarker analytics and its inherently high precision can be utilized to monitor large molecule characteristics like enzyme activity.

Interested in learning how to respond to some of the most complex analytical challenges encountered during all the phases of drug development?

In this 45-minute presentation, Dr. Achim Freisleben, Managing director & COO, and Dr. Heike Wiese, Senior Scientist, will cover:

• Enzymatic Assays
• Pathway mapping
• Monitoring small molecule metabolites in blood
• Use of microsampling
• Live Q&A session