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Session 3: Challenges in Implementing Companion Diagnostics in the Clinical Laboratory - Part One
Session Chair(s)
Rosanne Welcher, PhD, MBA, RAC
Senior Director, Quality Assurance, Regulatory and Clinical Affairs
Dako North America, an Agilent Technologies Company, United States
Clinical and reference laboratories are essential contributors to the success of companion diagnostics in precision medicine. This session will address some of the challenges these labs face and the impact on precision medicine. Topics will include how LDTs play a role in clinical trials and beyond, and how issues like pre-screening may bias the clinical trial results and statistical analysis. FDA and industry experts will provide their perspective on these topics.
Speaker(s)
Implementing Quality System Regulations at Myriad Genetics
Russell Henderson
Myriad Genetic Laboratories, United States
Project Manager
FDA Quality System Implementation for CoDx Laboratory Developed Tests
Joshua Levin, PhD
ASELL, United States
Director, Quality Assurance and Regulatory Affairs
Statistical Issues with Local Testing and Next Generation Sequencing in Clinical Trials
Douglas Robinson, PhD
Novartis Institutes for BioMedical Research (NIBR) , United States
Global Head, Biomarkers and Diagnostics Biometrics
Issues of Prescreening Bias for Companion Diagnostics
Yuying Jin
FDA, United States
Mathematical Statistician, CDRH
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