How Can Biomarkers Be Integrated Into Clinical Development To Enhance Value?

In general, a biomarker can be merged into a clinical development program in two ways. In the first, genome-wide association studies can be used to detect a biomarker signature that corresponds to a healthy drug response. Because this method is indirect it may be affected by multiple factors, including population and geographic modifications in biomarker spreading. Therefore, this approach is less likely to deliver value to either the payer or the pharma company.

In another, more ideal, method, the biomarker is directly associated with the method of the drug’s action. This is characteristic for directed oncology drugs, in which the biomarker may be the drug target itself. Such is the case with epidermal growth factor receptor (EGFR) inhibitors (e.g., erlotinib) and human epidermal growth factor receptor 2 (HER2) inhibitors (e.g., pertuzumab). In other cases, the biomarker may classify additional protein in the drug’s act pathway whose alteration allows the tumor to escape the drug’s effect (e.g., RAS mutation as a contraindication for the HER2-targeting drug panitumumab).

In each case, the connection of the biomarker measurement with drug activity is first determined in nonclinical (in vitro) studies and then undergoes an initial calculation in early clinical studies.

Provided with these initial data, the drug developer can project and execute the essential trials using a clinical trial assay to include or exclude patients based on a biomarker measurement that indicates likely drug response. This, in turn, establishes the basis for an expectation of enhanced value for the drug developer (higher likelihood of trial success; support for a higher drug price) as well as the payer (biomarker-enabled ability to grant drug access only to likely responders).

International Conference on Biomarkers and Clinical Research scheduled to be held during January 30-31, 2019 at Abu Dhabi, UAE would cover a broad session focusing on Biomarkers and Clinical research. We invite all the academic leaders, educationalists and, clinicians as well as for professionals and scholars of higher education from all over the world to con-vane and share novel ideas for a healthy life.

For more details visit our website: https://biomarkerscongress.conferenceseries.com/