Agenda at a Glance

• RWE applications in early phase of drug development
• RWE applications in late phase of drug development
• RWE applications in label expansion/ label update
• Building Efficiency to optimize use of RWE in drug development 

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• Business case for Real World Data (RWD) in Therapeutic Discovery and Development
• Common sources of RWD and landscape of data providers
• Use cases of RWD in Translational Science
• Need for data standardization, validation and fit-for-purpose analytics to enable confidence in and acceptance of RWD

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• Defining RWD and RWE and its use
• Technology choices to perform RWE
• Examples of using AI to help in RWE
• Caveats to ensure patient privacy is preserved while leveraging AI

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• Overview of current RWE regulatory framework in the USA and Europe
• Review of present roadblocks in the regulatory use of RWE and gaps in the RWE regulatory framework
• Discussion on how RWE regulatory frameworks could evolve in the future 

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• Enhance optimal treatment to patients by clearly demonstrating value to practitioners, payers, and providers
• Accelerate coordination and integration of different health
  outcomes data and achieve external recognition for providing credible scientific information
• Assess and provide real-world insights on patient journey and clarify opportunities for improving patient outcomes

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• Understand the growing role of real world data/evidence in regulatory and payer decision making in US
• Case studies where real world data/evidence have formed an integral part of regulatory and payer decision making
• Understand the growing role that real world data plays in ICER 2020 value framework

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• Factors leading to the increased need and utilization of RWD
• The 21st Cure Act of Congress and FDA’s mandate to develop RWE program for drug development
• Types and roles of RWD in the drug development life cycle: past and present
• How we are currently able to leverage RWE to inform clinical trials by phase
• Example for leveraging RWE to inform and support clinical trials
• Current limitations of RWD and RWE 

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• Understanding the importance of patient diversity in clinical trials for RWE
• Leveraging target profiles to expand the demographic mapping
• The key factors required in the future for regulatory submissions leveraging experiential and RWE data sources and testing

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• Using comparative EMR data to drive quality improvement at health systems
• Incorporating patient perspective in a registry using longitudinal surveys and medical device data
• Forging relationships with nonprofit and for-profit organizations to improve population health

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• Discuss the appropriate application of real-world evidence when communicating with healthcare providers
  
• Provide examples of how real-world evidence guides practice
  

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• Discuss the evolving nature of US environment leading to an increase in use of Real-World Evidence (RWE)
• Evaluate the role of RWE in Oncology Product Registration in the US

• Identify opportunities in leveraging RWE to support access, reimbursement, and commercialization in the US

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