70 research outputs found
Interleukin-10-dependent down-regulation of interferon-gamma response to Leishmania by Mycobacterium leprae antigens during the clinical course of a coinfection
Protection against live rotavirus challenge in mice induced by parenteral and mucosal delivery of VP6 subunit rotavirus vaccine
Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials
Ronald L Van Heertum, Robert Scarimbolo, Robert Ford, Eli Berdougo, Michael O’Neal BioClinica Inc, Princeton, PA, USA Abstract: In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes. Keywords: companion diagnostics, molecular imaging, oncology trials, personalized medicine, diagnostic assay
Immune responses elicited against rotavirus middle layer protein VP6 inhibit viral replication in vitro and in vivo
Comparative immunogenicity in mice of rotavirus VP6 tubular structures and virus-like particles
Improving the frosting and defrosting performance of air source heat pump units: review and outlook
Acute kidney injury after cardiac surgery is associated with mid-term but not long-term mortality: A cohort-based study
Numerical Analysis of the Stress Distribution in Symmetrical Backfilled Trenches with Inclined Walls
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