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Precision Medicine


Figure 1


Omics technologies in precision medicine can help identify new disease biomarkers, for diagnosis, 


DNA


RNA


Genomics


Transcriptomics


Protein


Metabolites


Proteomics


Metabolomics


 Trial participation selection Diagnosis Prognosis


Precision medicine Network


Single Biomarker 


showing promising trial results or have been licensed for clinical use by the FDA, often demon- strating potent and durable effects in patients. However, due to the targeted nature of these drugs and complex signalling networks at play in the tumour microenvironment, less than half of US patients with cancer were estimated to be eligible for precision medicine drugs in the form of cancer immune checkpoint inhibitors, with a projected response rate of only 12.46%8. Despite considerable investment in terms of


time, money, human resource and logistics in pre- cision medicine, this has failed to be accompanied by parallel increases in the number of diagnostic or therapeutic entities gaining regulatory approval. Questions regarding the value of this approach are being raised across the industry9,10. Reducing attrition rates and reversing the current productiv- ity trend requires consideration of the approach to disease biomarkers, including the methods for stringent and reliable target selection and valida- tion, along with the definition of reliable surrogate endpoints to facilitate effective clinical trials. If errors exist in the validity or measurement of


34


biomarkers the whole framework surrounding pre- cision medicine begins to crumble, thus precision medicine is effectively impossible without precision in the measurement and validation of biomarkers.


Precision medicine biomarkers in an omics landscape Biomarkers are used in the precision medicine field within companion diagnostics to identify and strat- ify patients for treatment and to monitor therapeu- tic efficacy both during clinical trials and in post- launch follow-up studies. Beyond companion diag- nostics, many are investigating the application of biomarkers in early diagnostic and screening pro- grammes. Identification of diseases, notably vari- ous forms of cancer, at early and initial stages is associated with improved patient outcomes and significantly-reduced healthcare costs11, hence identifying biomarkers that can diagnose disease early offers the potential to transform healthcare. While many of the drug targets that have proven


profitable in precision medicine were identified through molecular biological analysis of the specif- ic disease physiology, this approach is slow,


Drug Discovery World Winter 2019/20


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