JUN 20, 2018 6:00 AM PDT

Standardized Precision Medicine? - A Quality Management Perspective on NGS-based Individualized Therapies

Speaker

Abstract

Precision medicine and next-generation sequencing – Two terms characterized by a highly dynamic nature, strong innovations and a bright future. Both merged together will exert a decisive influence on academia, industry and the clinical environment. However, both are still facing several challenges and to do’s, which will need to be addressed in order to receive a standard status in the healthcare sector. Beginning with general problems like physicians awareness, novel clinical study designs as well as refunding policies and regulatory issues, the NGS upstream pipeline exhibits additional pitfalls such as quality of FFPE samples, missing standards and restrictive guidelines as well as biomarker validation and certification concerns. The data landscape represents an adjunct construction site, covering questions about the implementation of quality assured data, possible benchmarks, SOP’s, minimum requirements for quality metrics and final data storage considerations. The presentation will shine a light on those obstacles and will provide suggestions on how to possibly overcome them in order to pave the way for reliable, traceable and reproducible results within a standardized environment.


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JUN 20, 2018 6:00 AM PDT

Standardized Precision Medicine? - A Quality Management Perspective on NGS-based Individualized Therapies



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