Analytical Validation of CTC Enumeration using the RareCyte Platform and Implementation in a Global Clinical Trial


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July 15, 2020
11 am to 12 pm EDT

Sponsored by

Webinar Description:
This webinar describes how the RareCyte platform for CTC analysis was validated in the Clinical Diagnostics Lab (CAP accredited CLIA Lab) at Eli Lilly. Validation studies including analysis of accuracy and precision of CTC enumeration will be presented. As these results met the requirements of the Clinical Drug Study Team, the team at Lilly added the RareCyte platform to a global clinical trial for further evaluation in collaboration with a CRO.

A short presentation on RareCyte CTC assays for enumeration, multi-biomarker analysis, and custom assay development capabilities will follow.

Learning Objectives:

  • Learn why Eli Lilly is interested in CTCs and how they implement CTC analysis in clinical trials
  • Learn what attributes of a CTC platform are important
  • Learn how Eli Lilly analytically validated the RareCyte platform for CTC analysis in a CAP/CLIA laboratory
  • Learn about validated CTC assays from RareCyte and options to create custom assays

Speakers:

Jeff Fill, MBA, MT(ASCP)
Senior Director, Diagnostic and Experimental Pathology, Lilly Research Laboratories
Eli Lilly and Company Studies

Jeff Fill is the Senior Director in Diagnostic and Experimental Pathology at Eli Lilly. With over 25 years of experience in clinical biomarker laboratories, Jeff has extensive experience developing and implementing biomarker solutions for clinical trial support. Spanning from research grade to IVD level development efforts, he utilizes a unique risk-based quality system to validate, verify or qualify assays and instruments to support Therapeutic Drug Team requirements. Jeff is a military veteran who received his BS in Medical Technology from Indiana University in 1993, MBA from Kelly School of Business (Indiana University) in 2011 and Lean Six Sigma Black Belt in 2012.

Arturo Ramirez, PhD
Director of Oncology, Biology R&D
RareCyte, Inc.

Arturo Ramirez has worked at RareCyte since 2010. His current role as Director of Oncology R&D is to oversee the development of new applications for their technology, the optimization of new assays for customers, and facilitate collaborations with outside institutions. Arturo was the first Research Scientist at RareCyte and has been integral to the development of RareCyte’s comprehensive CTC platform. Before joining RareCyte, Arturo completed his PhD at the University of Washington while working at the Fred Hutchinson Cancer Research Center developing an antibody microarray platform for the discovery of serum biomarkers for early detection of breast and ovarian cancer. Arturo also holds a Bachelors in Science degree in Chemistry from the University of Guanajuato in Mexico.


Cost: No cost!

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