7:30 am Conference Registration & Networking
8:15 am Chair’s Opening Remarks
Benchmarking Progress & Regulatory Guidance for Applying RWE to Clinical Development
8:30 am Integrated Evidence Generation Planning: The Key is Starting Early
Synopsis
• Collaborating across different data types and functions at a very early stage in the drug lifecycle
• Establishing a common vision for the evidence needed for a product across the organization
• Creating a culture for efficient utilization of resources, including data and analytics capabilities
9:00 am Navigating Heterogeneity in the Global Landscape for Leveraging RWE in Regulatory Approvals
Synopsis
• What does the global regulatory landscape look like for RWE?
• What challenges does the heterogeneity across jurisdictions pose for industry?
• How can we overcome these challenges and what do we need to see from industry, data service providers, and regulators to drive adoption?
9:30 am Panel Discussion: Benchmarking the Progress of RWE & Its Applications to Clinical Development in The Pharmaceutical Industry
Synopsis
• How are we challenging the mindset in our organizations to incorporate RWE into clinical development for future benefit?
• How are we aligning across evidence generating functions to work intentionally and reduce the duplication of effort?
• What does the gold standard for look like for utilizing RWE as components of regulatory submissions?
10:00 am Speed Networking:
Synopsis
Introduce yourself to RWE experts across the ecosystem, including the brightest minds capturing the main challenges and changes in the RWE space to establish meaningful business relationships.
Harnessing Innovative Data Threads & Technologies to Maintain RWD Best Practises
11:00 am Using AI to Unlock Unstructured Healthcare Data to Transform Disease Treatment
Synopsis
• Learn how AI models are developed and applied to clinical notes and images
• Understand how these models can be applied to unstructured data at scale for research
• Hear 3 real-world use cases across neurology, urology and ophthalmology
11:30 am NICE’s Perspective: Best Practises on the Use of Real World Data & Assessment of Data Suitability
Synopsis
• An overview of NICE’s RWE framework to understand best practises on planning, conducting and reporting RWD for NICE submissions
• Highlighting the data suitability assessment section of the framework
• Exploring how NICE assesses data quality, including accuracy, missingness and suitability
12:00 pm Panel Discussion: Unlocking the Value of EHR Data to Generate RWE & Inform Clinical Development Decision Making
Synopsis
• What are the advantages of using EHR datasets compared to more traditional claims-based data sets?
• What type of information can be unlocked from EHR data and how can this inform clinical development?
• What lessons can be learned from case studies utilizing EHR to advance clinical development for vulnerable populations?
12:30 pm Lunch & Networking
Generating & Applying RWE to Achieve Regulatory Approval
1:30 pm The Token is Broken: Synchronizing Patient Journeys from Clinical Trials to Registries and Beyond
Synopsis
• Avoid high error rates with legacy technologies
• Understand the current shortfalls of tokenization and discover how synchronization offers a more comprehensive and compliant approach for managing patient journeys across the product lifecycle
• Discover how HealthVerity FLOW, a new pharma-grade solution, serves as a single source of truth for engaged patients across the enterprise, tracking and managing their participation and permissions over time, with the option to synchronize novel deidentified or identifiable data, all in a HIPAA-compliant, 21 CFR 11 manner
2:00 pm Panel Discussion: Working Together to Harmonize the Global Regulatory Landscape for Utilizing RWE in Regulatory Submissions
Synopsis
- What do we need to see from industry collaboration bodies to achieve international harmonization around RWE?
- What challenges are currently being faced by the pharmaceutical industry across the product lifecycle (regulatory and HTA) due to heterogeneity in guidance's.
- What will it take to harmonize these processes and align globally?
2:30 pm Utilizing RWE as a Component of Regulatory Submissions to Achieve Regulatory Approval
Synopsis
• Learnings from included RWE in licensing and/or marketing authorization applications
• Key considerations in preparing and establishing RWE strategy to demonstrate value to regulators
• Review of successful and less successful uses cases
3:00 pm Afternoon Break & Networking
Navigating the RWE Regulatory Landscape to Gain Market Access on a Global Scale
3:30 pm Accelerating & Innovating Real-World Evidence with Study Automation, Outcomes Data & Artificial Intelligence
Synopsis
- Using study automation to dramatically scale, accelerate enrollment, and drastically reduce per patient costs
- Combining passive data collection with protocol-driven clinician and patient-reported outcomes to fill data and evidence gaps
- Applying AI to find patients and understand and predict outcomes with validated models
4:00 pm Benchmarking the Progress of the EMA’s Data Analysis & Real World Interrogation Network (DARWIN) to Gain Insights into the Evolving European Health Data Space
Synopsis
• After its first year of establishment, what are some of DARWIN’s early learnings?
• How is the EMA utilizing RWE to support regulatory decision making?
• How can regulatory bodies learn from eachother to harmonize guidances related to RWE?