News & Events
Dr. Rachel Skelton, Insight Genetics’ Regulatory Scientist I, presented at the 4th Annual Clinical Operations in Oncology Trials East Coast 2015 conference on July 15, 2015 in Boston, Massachusetts. The conference focused on practical examples for improved clinical operations, marketing challenges in oncology, and new areas of innovation.
Dr. Skelton co-presented a talk entitled, “A Cost-Effective Way to De-Risk Biomarker Clinical Trials; Early Development Considerations,” with Susan Albert, Senior Director of Clinical Operations at Ce3, Inc. The presentation included an overview of the current FDA regulations and guidelines for In Vitro Diagnostics and Lab Developed Tests; case studies of risk mitigation using Companion Diagnostic assays; and the importance of site support, sample integrity, and site management during targeted therapy clinical trials.
This co-presentation is an extension of Insight Genetics’ partnerships with Clinical Research Organizations (CROs) to provide oncology therapeutic developers with seamless coordination of biomarker-driven clinical trials.