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Session 5: Alternative Data Sources and Historical Controls
Session Chair(s)
Pritibha Singh, MBA, MSc
Senior Manager, Corporate Affairs Analytics & Insights
Novartis AG, Switzerland
Maria Apostolaros, JD, PharmD, MS, RPh
Deputy Vice President, SRA
PhRMA, United States
Representative Invited
FDA, United States
Karen Lynn Price, PhD
Senior Research Fellow, Statistical Innovation Center/Design Hub
Eli Lilly and Company, United States
The CID program enables the exploration of the innovative use of alternative data sources. This exploration continues to be increasingly important as we encounter the emerging challenges with alternative data sources in methodological approaches to data collection, analysis, and benefit to the patients, regulators, and biopharmaceutical companies. This session will inspire and open you to the possibilities of utilizing alternative data sources, e.g. digital approaches to identify, screen, enroll, collect data on, and provide an intervention to patients.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand how to use digital applications to identify, screen, enroll, collect data on, and provide an intervention to patients
Speaker(s)
Speaker
Pritibha Singh, MBA, MSc
Novartis AG, Switzerland
Senior Manager, Corporate Affairs Analytics & Insights
Apple Heart Study
Manisha Desai, PhD
Stanford University School of Medicine, United States
Professor of Medicine and of Biomedical Data Science
Borrowing Information from Historical Data: A Double-edged Sword
Ying Yuan, PhD
University of Texas MD Anderson Cancer Center, United States
Bettyann Asche Murray Distinguished Professor
DIA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients
Jackson Kempber Burton, PhD
Critical Path Institute, United States
Scientific Director, Quantitative Medicine
Speaker
Laura Lee Johnson, PhD
FDA, United States
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
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