Real Time Oncology solution for large pharmaSITUATION

  • Global development organization of large pharma was initiating “Real time Oncology” trials where the goal was to detect early signs of cancer recurrence post SoC therapy to enable switch to an investigational 2nd line therapy
  • Datasets to be generated : standard NGS on tumor (DNA, RNASeq), Liquid Biopsy (circulating tumor DNA with NGS) every 2 weeks post therapy, PET-CT scans, various immune markers
  • Study was to be initiated at a leading academic institution in the US

Questions

  • Can we predict which patients are likely to show early recurrence after first line therapy by combing multiple data-sets and with advanced analytics
  • Which data-platform will enable us to seamlessly integrated NGS data, circulating tumor DNA data and PET-CT data?
  • What advanced algorithms need to be developed?

Approach

  • Conducted detailed interviews with translational and biomarker leads, biostats leads as well as medical leads to understand the data requirements
  • Create product / solution requirements
  • Evaluated vendors and selected one of them for this project
  • Led the process of development of a pilot with our technology partner to test solution’
  • Led two workshops with participation from client and their biopharma customers to refine value proposition and opportunity

Results

  • After a successful pilot that was limited to one study, the biomarker statistical solution being rolled out across a broader set of trials

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