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25th World Congress on Cancer Science and Therapy

Baltimore, USA

Nina Mezu-Nwaba

Food and Drug Administration, USA

Title: Current regulatory trends and applicability of biomarkers in drugs, biologics and devices: A US FDA Outlook


Biography: Nina Mezu-Nwaba


The US Food and Drug Administration (FDA) defines a biomarker as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.” The increasing worldwide trend in the utilization of biomarkers has shown to be a significant element in the field of healthcare. Biomarkers have been integrated as measuring outcomes in the regulation of drugs, devices and biologics. Biomarkers in drug and medical device development provide information concerning detection of disease states in early stages as well as efficacious treatment options. For example, non-specific biomarkers such as WBC, D-dimers, C-reactive protein and criteria to diagnose sepsis have also played a part in therapy. In a recent study, biomarkers were utilized for a mice model of retinopathy of prematurity to ultimately benefit premature neonates in the early detection of this disorder. Based on the current trend, biomarkers offer an optimistic, yet challenging perspective on the future of its incorporation into personalized medicine. Clinicians can potentially measure and identify positive and negative responses to therapies benefitting both providers and patients. However, there have been several challenges in application of biomarkers due to lack of regulations in developing these biomarkers. In order to address these challenges, the FDA developed the Biomarker Qualification Program to establish the regulatory framework in biomarker evaluation and acceptance. As part of this program the FDA is working together with external stakeholders to develop a list of qualified biomarkers that can be applied in development of any drug, biologic or medical device. With more regulations put in place to assess and verify a biomarker’s value, the integration of biomarkers will continue to expand our understanding of human health.