Event Summary:
A one-day workshop organized by the Center for Interdisciplinary Research and
Consulting at the University of Maryland, Baltimore County (UMBC), and the
Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.
Registration is now closed
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Organizing Committee:
Faculty from UMBC and Stanford University and leaders from FDA and industry.
For more information:
Please contact Dr. Yi Huang, Department of Mathematics and
Statistics, University of Maryland Baltimore County (UMBC),
1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.
For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.
Participant Information
Mike Hale from Shire.
Paper: Precision Medicine: The Biomarker Meets Big Data
Drug development has historically been mostly about evaluating efficacy and safety "on average", similar to the way that many consumer products have been mass marketed. Modern businesses (non-pharma) are increasingly adopting technologies for targeting the needs of individual consumers, yet many drug development programs have continued with a population perspective. This talk considers an eco-system which pulls together various elements, including big data, product label, and individual characteristics to enable precision medicine. A historical perspective of big data and predictive analytics is included, suggesting that the basic objectives have a long history, with recent advances being technology-fueled.