Biomarker Discovery
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Biomarker discovery: the first link in the biopharmaceutical chain

Biomarker discovery encompasses the journey from target and lead discovery through to preclinical and clinical research and process development. Biomarkers provide information critical to the safety and efficacy of drug discovery and development.

Biomarkers can be diverse, ranging from certain molecules such as a protein, gene sequence or expressed RNA, to physiological factors such as blood pressure or body temperature. They may be expressed in a specific location or tissue or found in serum, plasma, and other bodily fluids. Because of this diversity, most successful biomarker programs have a broad reach and investigate cellular, proteomic, and genetic sources in order to discover the most valuable biomarkers.

Biomarkers are used to design and develop more effective therapies, by evaluating drug candidates to establish which to take forward into development. There are a wide range of types of biomarkers that can be monitored, such as safety and efficacy markers. Safety markers, for example, are being developed to help determine which drug candidates are most likely to be safely tolerated in humans.

Biomarker validation requires a change in levels in response to a disease and identification and characterisation of biomarkers can reduce the number of drug candidates that fail clinical trials, supporting the introduction of more effective therapeutics.

Biomarker identification can be undertaken using a combination of MALDI Imaging and LC-MS techniques, in order to establish the distribution of biomarker candidates in tissue. For example, MALDI Imaging preserves the spatial distribution and the histology of the samples, making it perfectly suited for the analysis of human cancer samples. MALDI Imaging has been successfully applied to the detection of previously unknown proteins in cancer.

Biomarkers often need to be directly detected from tissues of complex biological matrices, for which MS/MS spectra must be acquired. Molecular drug imaging solutions must be fast and accurate, to measure proteins, peptides, lipids, drugs and metabolites from tissue for quick drug discovery turnaround times.