The Immunotherapy stream will address the two biggest challenges in pharmaceutical IO programs: designing rational combination immunotherapies and strategies to address intrinsic and acquired resistance.Finally, a new track on Digital Biomarkers will cover the clinical utility of biosensors, wearables and mobile health, and their emerging applications in drug development.A biomarker that can be obtained in a minimally invasive manner, typically from blood, plasma, serum, saliva or urine. The correlated combinations of these features constitute the trait or disease.Therefore, these types of antecedent biomarkers may or may not be directly involved in the etiology.Russell Katz, Biomarkers and Surrogate Markers: An FDA Perspective, Neuro Rx 1(2): 189-195, April 2004 artid=534924 A characteristic that is measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacological responses. Danhof, Meeting Report, Markers of pharmacological and toxocological action, Bio Med Central, 2001 Biomarkers Definitions Working Group defined a biomarker as "a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention."Narrower terms: genetic biomarkers, genomic biomarkers, high-impact biomarkers, protein biomarkers, proteomic biomarkers Related/synonymous?Our recommendations for sponsors focus on the identification and prioritization of biomarkers and assays, the coordination of activities for the development and use of assays, and for operational activities.We also provide recommendations for investigators developing clinical trials with biomarker studies for scientific rationale, assay criteria, trial design, and analysis.
In essentially all cases, these markers quantitatively correlate (either directly or inversely) with disease progression.
They can be used to predict response to therapy or risk of side effects for personalized medicine applications.
Additional types include predisposition, screening, diagnostic, prognostic, toxicity, pharmacodynamic, and other biomarkers.
terms: biological markers, genetic markers, surrogate markers.
Broader term: markers Biomarkers can be valuable tools in clinical diagnostics as well as in therapeutic discovery and development.