Conference Day Two
Wednesday, October 29
We Are Now Live!
8:45 Check-In & Coffee
9:25 Chair’s Opening Remarks
Transformability from Clinical Trials to Real-World Evidence to Provide Holistic Perspectives on Treatment Effectiveness & Safety
9:30 Bridging the Gap Between Surrogate Endpoints & Real-World Outcomes to Strengthen Accelerated Approvals
Synopsis
- Leverage RWE to validate surrogate endpoints by comparing them with long-term real-world outcomes, enhancing the reliability of accelerated approval processes
- Use advanced statistical models to demonstrate how surrogate endpoints can be predictive of actual patient outcomes in real-world settings
- Collaborate with regulatory agencies to align on the use of surrogate endpoints in RWE, ensuring faster access to treatments while maintaining clinical integrity
10:00 Real-World Evidence Secret to Success: Contextualizing Patient Pathways
Synopsis
- Understand the industry best practice for evidence generation – starting with a backbone of claims, coupled with lab results, structured EHR – including notes, to ensure conviction of data accuracy and depth
- Discover insights from the most studied therapeutic areas – designed to empower your teams with the most illustrative patient journey data available
- Validate your strategy to ensure both treatment effectiveness and safety, putting you on a path to accelerate clinical development
10:30 Harnessing Real-World Evidence to Support Early Development Pipelines & Key Inflection Points
Synopsis
- Use RWE to identify key patient populations and treatment patterns early in development, guiding clinical trial design and optimizing recruitment strategies
- Leverage RWD to inform key inflection points in the development pipeline, such as dose selection, endpoint validation, and market entry timing
- Integrate RWE into decision-making processes to minimize risks, refine clinical strategies, and accelerate development timelines from early-stage to post-market phases
11:00 Morning Break & Networking
Elevating Patient Voice to Enhance Real-World Evidence & Develop More Patient-Centric Healthcare Solutions
12:00 Incorporating the Patient Voice into Real-World Evidence to Drive Better Decision-Making & Policy Development
Synopsis
- Integrate patient-reported outcomes (PROs) and preferences into RWE to ensure that RWD reflects the experiences and needs of patients
- Use RWE to capture a comprehensive view of treatment impact, including quality of life and patient satisfaction, to influence healthcare decision-making and policy development
- Collaborate with patient advocacy groups to ensure the patient voice is consistently included in evidence generation, enhancing the relevance and credibility of RWE in shaping healthcare policies
12:30 Using a Prevalence App to Analyze Patient Medical Journeys & Determine Disease Prevalence
Synopsis
- Leverage longitudinal patient data to uncover patterns in diagnosis, treatment, and disease progression
- Identify and quantify true disease prevalence using RWD analytics
- Support healthcare planning and resource allocation through accurate population insights
1:00 Lunch & Networking Break
2:00 Harnessing Real-World Evidence to Design Smarter Trials & Identifying Patient Populations & Boosting Recruitment Efficiency
Synopsis
- Use RWD to identify targeted patient populations, refine eligibility criteria, and optimize trial design for greater efficiency
- Leverage RWE insights to streamline site selection and enhance recruitment strategies, reducing timelines and improving enrollment outcomes
- Integrate real-world treatment patterns and patient behaviors into early trial planning to increase protocol relevance and patient engagement
Aligning with Regulatory Guidelines to Accelerate Real-World Evidence Submissions
2:30 Demystifying the Roles of Real-World Evidence & Health Economics & Outcomes Research to Strengthen Evidence Generation & Enhance Cross-Functional Collaboration
Synopsis
- Clarify the distinct yet complementary roles of RWE and HEOR in evidence generation to ensure alignment and maximize their impact on clinical, regulatory, and market access strategies
- Foster collaboration between RWE and HEOR teams by defining shared objectives, improving communication, and integrating methodologies for more comprehensive evidence development
- Use cross-functional workshops and training sessions to enhance understanding of both RWE and HEOR, driving more effective teamwork and more robust evidence for decision-making
3:00 Roundtable: Strategies to Overcome Fragmentation in Healthcare Data Systems to Improve Real-World Evidence Utility
Synopsis
- Develop interoperable data frameworks that facilitate seamless integration of fragmented healthcare data from diverse sources, enhancing the comprehensiveness of RWE
- Standardize data formats and coding systems across systems to ensure consistent data quality and facilitate cross-platform analysis
- Leverage AI and ML to harmonize and analyze fragmented data, uncovering insights and improving the reliability and utility of RWE for decision-making