Conference Day Two
Wednesday, October 29
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 Presentation Reserved for HealthVerity
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 & Poster Awards
Synopsis
The winning poster will be selected by our advisory board during the meeting. They will receive an engraved trophy and have their poster showcased on our website as a downloadable file.
12:00 Linking Clinical Trials & Real-World Clinical Practice with Real-World Evidence Use Cases & Success Stories
Synopsis
- Showcase successful RWE use cases that demonstrate how clinical trial findings translate to real-world clinical settings, ensuring broader patient access and better outcomes
- Leverage RWD to address gaps in clinical trial design, such as patient diversity and long-term treatment effects, making clinical findings more applicable to routine practice
- Highlight case studies where RWE has been pivotal in bridging the gap between controlled trial environments and everyday clinical decision-making, strengthening evidence for policy and reimbursement
Elevating Patient Voice to Enhance Real-World Evidence & Develop More Patient-Centric Healthcare Solutions
12:30 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
1:00 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
1:30 Lunch & Networking Break
2:30 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
3:00 Unlocking the Global Potential of Tokenization While Complying with Varying Data Privacy Laws Across Different Regions
Synopsis
- Implement flexible tokenization frameworks that adapt to regional privacy laws while maintaining data security and interoperability across global markets
- Leverage privacy-preserving technologies, such as federated learning and homomorphic encryption, to enable cross-border data sharing without exposing sensitive patient information
- Establish collaborative industry standards to harmonize tokenization approaches, ensuring compliance with regulatory requirements while maximizing RWE usability worldwide
3:30 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
4:00 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