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Session 6B: The Journey to Identifying Useful Biomarkers: Are We There Yet?
Session Chair(s)
Chava Zibman, PhD
Mathematical Statistician, CDRH
FDA, United States
This session will explore the process of developing biomarkers into clinically useful diagnostic and therapeutic products. From a data science perspective, we will consider all the forms that biomarkers may take and how they are developed and validated. We will do this with a focus on the expertise represented on the team that is developing a biomarker. We will also focus on ways to identify patients that would benefit from a biomarker and the data needed throughout the process.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe what biomarkers are and how they are clinically used
- Identify traditional and non-traditional sources of data and methods to identify potential biomarkers
- List the professionals involved in biomarker development and differentiate their roles
- Discuss the validation process that would result in regulatory approval
Speaker(s)
Speaker
Adam Pavlicek, PhD
Monoceros Biosystems, LLC, United States
Founder and CEO
Speaker
Lee Albacker, PhD
Foundation Medicine, United States
Senior Director, Biomarker Development and Analytics
Speaker
Abena Agyeman, PhD
FDA, United States
Senior Biologist