Supporting digital therapeutic development with real world evidence


About this Roundtable

In digital therapeutics, real-world evidence (RWE) is increasingly important for regulatory and payer decision-making. RWE provides patient-generated data and insights that add value at different stages of an asset’s life cycle. Digital therapeutics and SaMDs have utilized RWE evidence generation for pre-approval development, peri-launch, and at post-approval for different reasons. Pre-approval, RWE can be used to lay the foundation for a digital therapeutic through the development and validation of digital biomarkers and instruments. Post-market, RWE is used to monitor safety and adverse events as part of the regulatory process and to provide evidence as to clinical effectiveness and cost of care.

This Pharma USA 2021 roundtable was an interactive discussion exploring the opportunities and challenges for collecting and using real-world data in support of the development, approval, and commercial success of digital therapeutics.

About the Hosts

Todd Greenwood –  Director of Outcomes

Todd is a healthcare digital strategist who has more than a decade of experience driving and designing digital strategy for patient-centric programs designed to educate patients and caregivers, engage patients with their providers and improve adherence to therapy. Todd’s experience spans the digital space from Opportunity Development to Program Design to Outcomes and Insights.

Sean Glynn – Principal Researcher for Healthcare Outcomes

Sean has conducted health outcomes and product research for program improvement and brand positioning. He developed economic models to demonstrate program impact to the pharmaceutical and health insurance industries. He has worked with physicians and clinical trials teams to integrate medication tracking tools into research studies, facilitated, designed, implemented and adapted client programs to positively impact patient health outcomes and organizational efficiency. 

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