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. 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, this multidisciplinary panel of experts will provide 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.
- 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