Learn more about Elevation Strategic Development UK's President and Co-Founder, Sabina Patel. We are excited to have Sabina on our team! #companiondiagnostics #regulatory #IVDR #diagnostics #queenofIVDR
Meet Elevation Strategic Development UK's President, Sabina Patel. Recently deemed the "Queen of all things IVDR" Sabina has more than 15 years of experience working across the diagnostic, pharmaceutical and regulatory sectors. She specializes in the design and implementation of regulatory and product development strategies for companion diagnostics. Sabina has led the diagnostic development of the first EGFR and KRAS companion diagnostics devices and was instrumental in developing the first ctDNA-based companion diagnostic for Tagrisso, as well as leading the implementation of using ctDNA for prospective selection. After a brief spell at a Notified Body as a technical file reviewer and the CDx expert under the IVDR, she moved back to pharma to lead the implementation of IVDR requirements in clinical studies including pharma-sponsored clinical performance studies. In this role, Sabina played a critical role in generating IVDR compliant templates and processes for clinical performance studies, and acting as an internal advisor on EU-IVDR, CFR820 and CLIA requirements. This is in addition to her role as a clinician in primary care allowing her to provide valuable insights into key aspects of disease management within the NHS. Help us in welcoming Sabina Patel to the Elevation Strategic Development UK team. #diagnostics #IVDR #cdx #regulatory #queenofIVDR