Webcast Recording: Tissue-Based CDx Development and Image Analysis in a Regulated Space


Recently Flagship hosted a webcast on Tissue-Based CDx Development and Image Analysis in a Regulated space. Our discussion stems from the fact that the United States Food and Drug Administration (FDA) requires comprehensive analytical validation and clinical evaluation of new in vitro diagnostic (IVD) tests as companion diagnostics (CDx) to demonstrate that an IVD is safe and effective. We covered that a CDx can be an IVD or imaging tool.

As precision-based medicine expands across therapeutic areas like oncology, accompanying diagnostics are greatly optimized by digital image analysis (IA) tools that support pathologist decisions. To maximize budget, time, and other resources, it is important that CDx development is understood early in the context of existing regulations and the specifics of a drug development program.

Moderated by Meredith James, Chief Operating Officer, Flagship Biosciences, our multidisciplinary panel of experts provided insights into tissue-based (biomarker) IVDs/CDx development and how the integration of IA tools can advance and accelerate CDx development from drug discovery to clinical trials and drug approval.

Our expert panelists included:

  • David Sidransky, M.D., Professor of Oncology, Otolaryngology, Urology, Pathology, and Genetics, The Johns Hopkins University
  • Mike Kagey, Ph.D., Senior Director of Translational Medicine, Leap Therapeutics 
  • Suzana Corritori, M.D., M.S., President, Corritori Consulting
  • Roberto Gianani, M.D., Chief Medical Officer, Flagship Biosciences

You’ll even get to hear a bit of a case study from Mike at Leap Therapeutics. 

Or if you’re ready to schedule a consultation with Flagship to discuss your drug development or regulatory challenges, contact us!