| Matched biomarkers |
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Supporting pharma-driven biomarker discovery, translational medicine and clinical trials with new chemical entities (NCEs)
Translational medicine is increasingly becoming an important part of the drug development process, with many pharmaceutical companies establishing specialist departments. Through the use of biomarkers, these departments oversee the three key phases of a compound’s life: exploration, confirmation and marketing. The exploratory phase focuses on accelerating drug development using pharmacodynamic, efficacy and safety biomarkers for rational decision making, based on who is most likely to respond. In the confirmatory phase, biomarker use aims to shorten trials which would otherwise require long-term study, by developing surrogate markers. In this phase, reducing the safety risk by identifying susceptible patient populations through biomarker use is also important. In the final marketed product phase, biomarkers enable therapeutic drug monitoring, efficacy and toxicology, as well as culminating in the delivery of a companion diagnostic. The importance of biomarkers in providing valuable data that propels an NCE through end development is highlighted in the cases of trastuzumab and imatinib. These now important therapeutic options for people with cancer may not have otherwise completed drug development based on traditional assessment without biomarkers. Biomarker assessment such as gene or mutation detection (DNA), gene expression (RNA) or level of protein presence, provides diagnostic and prognostic information. PamGene’s matched biomarkers application directly assesses protein (kinase) activity and the effect of a drug (kinase inhibitor) on this activity. This measures the effect of the drug at this vital protein activity level and aims to increase the chances of successfully predicting the outcome of the chosen therapy, throughout all stages of drug development. In the course of translational research from discovery to clinical development, no platform transfer is needed in PamGene’s Matching Medicines approach. This means that our technology and CE marked equipment can be used in research and development laboratories in pre-clinical work through to use in hospitals in testing of patients. |