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Thursday, June 18 • 5:00pm - 6:00pm
#561 OD: ON DEMAND - Hype or Hope: Quantifying the Risk of Patients with Complex Diseases

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Component Type: Session
Level: Advanced

Risk scores offer hopes and challenges in their quantification for patients with complex diseases. This session will give an overview with case studies from clinical and drug development perspectives.

Learning Objectives

Discuss the value of risk scores, their clinical utility and application in clinical development; Explain how to apply risk scores and describe the outcomes; Identify some of the current challenges associated with their use and propose risk mitigation strategies.


Matt Baldwin, MS


Risk Scores and Clinical Utility
Sivakumar Gowrisankar, PhD

Statistical Evaluation of Risk Scores
Gene A. Pennello, PhD, MS

Genetic Risk Scores in Cancer
Meijuan Li, PhD

avatar for Sivakumar Gowrisankar

Sivakumar Gowrisankar

Director, Genomic Medicine, Parexel International, United States
Sivakumar Gowrisankar, PhD is a director in the translational medicine group at Parexel International. His work focusses on integrating genetics into drug discovery and development, including preclinical and all phases of clinical trials. He has a broad range of expertise in genetics... Read More →

Meijuan Li

Vice President, Head of Biometrics and Biomarkers, Foundation Medicine
Dr. Meijuan Li is currently VP, Head of Biomarkers and Biometrics, Foundation Medicine, manage the Biometrics and Biomarkers team, including functional units of Biostatistics, Data Management, and Biomarker analysis and Development. Dr. Meijuan Li was the chief of Diagnostic Statistics... Read More →
avatar for Matt Baldwin

Matt Baldwin

Senior Biostatistician, Advance Research Associates, Inc (ARA), United States
Matt Baldwin is a Senior Biostatistician who works with Advance Research Associates to advance clinical solutions through analysis. Matt’s various positions have provided experience in randomization, generic and new drugs, statistical clinical development, DMC support, and analysis... Read More →
avatar for Gene Pennello

Gene Pennello

Senior Mathematical Statistician, OSEL, DIDSR, CDRH, FDA
Gene Pennello is an FDA Senior Statistician in the Division of Imaging, Diagnostics, and Software Reliability, Center for Devices and Radiological Health. Previously, he gained many years of experience leading an FDA team that provided statistical review of diagnostic devices (in... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044