Research & Development - Biomarkers

illustrationBiomarkers can be at the DNA level (such as deletions, polymorphisms, SNPs) or RNA level (transcriptional alterations / splicing / editing). However, by far the most robust and reliable biomarkers are physiological chemicals such as phospholipids, peptides and proteins, since these are closest to the endpoint of the pathological pathway and thus the functional abnormality.

 

Biomarkers can be influential in every phase of drug development, from drug discovery and pre-clinical evaluations through each phase of clinical trials and into post-marketing studies.  Biomarkers can predict a patient’s response to a compound, act as surrogate endpoints, and aid in making efficacious and cost-saving decisions earlier in the drug discovery process.

 

Patient enrichment strategies use biomarkers to identify patients who are more likely to respond to drug therapy or who are less likely to be susceptible to adverse events. This shift towards “personalised medicine”, in which the patient receives a treatment based on their genetic as well as medical profile, is helping the drug industry to achieve the goal of cost-effective and faster health outcomes