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Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers
Session Chair(s)
Hillary Andrews, PhD
Director, Regulatory and Research Partnerships
Friends of Cancer Research, United States
This session examines innovative regulatory strategies and validation approaches for developing diagnostics for rare biomarkers, focusing on oncology and how to optimize the use of alternative data sources and regulatory flexibilities to enhance test
Learning Objective : Identify regulatory flexibilities and strategies to support the development of diagnostics for rare biomarkers in oncology; Recognize approaches for leveraging alternative data sources to validate diagnostics, including real-world data, alternative samples, and in silico methods.
Speaker(s)
Establishing a National Clinical Laboratory Network of Validated Assays
Chris Karlovich, PhD
Frederick National Laboratory for Cancer Research, United States
Director, Molecular Characterization Laboratory
Regulatory Considerations and Strategies for Rare Biomarker Validation
Dun Liang, PhD
Eli Lilly & Co., United States
Director, Global Regulatory Affairs, Diagnostics
Discuss challenges and best practices for CDx validation
Elaine Katrivanos
Tempus AI, United States
Vice President Regulatory Affairs
Provide global regulatory expectations, challenges, and approaches
Chris Bray
Merck Serono Ltd., United Kingdom
Head of Global Regulatory Affairs Precision Medicine & Companion Diagnostics
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