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More Nuanced Clinical Outcomes from Person-Generated Health Data: The New Frontier
Session Chair(s)
Nancy A Dreyer, PhD, MPH, FISPE
Founder
Dreyer Strategies LLC, United States
Person-generated data offers nuanced effectiveness measures for clinical and regulatory decision-making for new medical products, like the wearable-derived digital clinical outcome assessment for Duchenne muscular dystrophy. What's next?
Learning Objective : Describe practical applications of person-generated health data, and key business and regulatory perspectives on opportunities and challenges; Explain the value of this type of information to patients, clinicians, and colleagues to help inform decision-making.
Speaker(s)
Panelist
Christina Mack, PhD, MPH
IQVIA, United States
Chief Scientific Officer, Real-World Solutions
Panelist
Jeffrey Nahum Siegel, DrMed, MD
FDA, United States
Director, Office of Drug Evaluation Sciences, OND, CDER
Panelist
Martha Azer, PharmD, RPh
Johnson & Johnson, United States
Associate Director, Global Regulatory Policy & Intelligence
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