SESSION KEYNOTE

Title: Precision Imaging for Precision Medicine- Biomarkers and Beyond
Speaker: Sue-Jane Wang, FDA
Moderator: Alfred H. Balch


Abstract:

In recent years, the landscape of medical imaging or radiopharmaceuticals is increasingly widening. The large amount of imaging data and the imaging analytical systems allow further quantitative imaging analysis as well as applications of artificial intelligence, machine learning and deep learning. Precision imaging is receiving broad attention. Many imaging measures have been proposed as biomarker tools for therapeutic drug developments. There is also a growing interest in integrating imaging and therapeutic drug developments. We are witnessing the growing clinical utilities of medical imaging and imaging radiopharmaceuticals. In this presentation, the advances in these areas from scientific underpinning and regulatory consideration on tangible benefits with newer developments and design considerations will be highlighted.

*The views expressed are those of the author and should not be construed to represent the views or policies of the U.S. Food and Drug Administration.

Instructor’s Bio:

Dr. Sue-Jane Wang is Associate Director for Adaptive Design and Pharmacogenomics and the Biostatistics Leader for the Biomarker Qualification Program from Office of Biostatistics, Office of Translational Sciences in Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Other than her current role representing the Office providing services to all 18 medical divisions in CDER/FDA on adaptive designed clinical trials, biomarker associated pharmacogenomics clinical trials and biomarker qualification, Dr. Wang has published over 80 peer-reviewed collaborative research papers in clinical trials, medical genetics, bioinformatics and pharmacogenomics journals and has given more than 200 invited presentations domestic and internationally. Recently, she received Thomas Teal Award for Excellence in Publishing awarded by Drug Information Association and was recognized by the statistical profession and elected a fellow in the American Statistical Association. In the past year, she received the FDA level individual scientific achievement award on Excellence in Analytical Science. She has served as an Editor-in-Chief for Pharmaceutical Statistics. Currently, she is an elected member of International Statistics Institute, an associate editor for Statistics in Medicine and for Statistical Biosciences Journal.

 

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