JUN 20, 2018 06:00 AM PDT

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

C.E. CREDITS: CME | P.A.C.E. CE | Florida CE
  • Independent Freelancer
      Christoph Endrullat is an independent freelancer in the life science and healthcare sector. Beforehand he held positions as a key account manager for oncology at Merck/EMD Group and as a scientific staff member in the Molecular Biotechnology and Functional Genomics division of the Technical University of Applied Sciences Wildau. His research interest and current expertise relies on next-generation sequencing (NGS) in association with precision medicine with a special focus on standardization and quality management. Especially, his efforts in the development and establishment of standards for NGS with the promising application in clinical oncology/precision medicine led to several delegations in authorities and projects. The ISO/TC 276 'Biotechnology', an expert group of the European Commission (JRC) as well as the COST Action CHARME represent his recent affiliations. His academic career comprised a Master of Science in Biotechnology from the University of Glasgow (UK) and a Bachelor of Science in Biosystems Technology/Bioinformatics from the Technical University of Applied Sciences Wildau (Germany). Further, he has published different scientific papers and gave presentations on diverse conferences and workshops.


    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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