Day Two
Wednesday 11, June 2025
08:00 Coffee + Light Breakfast
8:50 am Chair’s Opening Remarks
Optimizing HEOR & Market Access Approaches to Maximize RWE Utility
9:00 am Understanding FMV Assessments in Global Medical Affairs for Research & Market Access
Synopsis
- Providing clarity around the purpose of FMVs in research and market access.
- What is required in a FMV for a clinical study?
- Case study-based examples of FMV application
9:30 am Optimizing Understanding Around How RWE Can Support Pricing & Reimbursement Strategies
Synopsis
- Explore how real-world evidence (RWE) can substantiate the clinical and economic value of therapies to strengthen pricing and reimbursement proposals
- Understand how to tailor RWE to meet the specific needs of payers, including costeffectiveness analysis and patient outcomes
- Learn how to use RWE to navigate pricing negotiations and reimbursement processes, ensuring that evidence supports broader access to treatments
10:00 am Roundtable: Transition of HEOR Teams from Market Access to Medical Affairs to Understand the Evolving Role & Responsibility of HEOR Teams
Synopsis
- Explore the evolving responsibilities of Health Economics and Outcomes Research (HEOR) teams as they transition from market access to medical affairs, and how this impacts strategic priorities
- Learn how HEOR teams can foster collaboration between market access and medical affairs to ensure alignment in evidence generation and communication with stakeholders
- Understand how HEOR teams can adapt their methodologies and expertise to support both clinical development and post-market evidence, driving value across the product lifecycle
10:30 Morning Break & Networking
Optimizing Study Designs & Empowering Patients to Elevate RWE Utility
11:00 am Methodologies for Designing Robust ECAs to Enhance the Quality & Reliability of ECA Studies
Synopsis
- Explore best practices for selecting appropriate external control populations, ensuring that data sources are comparable, and the methodology is robust for reliable outcomes
- Addressing potential biases and confounding factors in ECA design through statistical techniques, matching methods, and sensitivity analyses to improve study validity
- Key strategies for ensuring the reproducibility and generalizability of ECA results, including careful consideration of data quality, external validity, and regulatory acceptance
11:30 am Roundtable: Analysis of Regulatory Differences Across EU Member States to Navigate Complex Regulatory Landscapes Effectively
Synopsis
- Identifying key differences in RWE requirements and compliance standards across EU member states to streamline submission strategies
- Explore tactics to align evidence generation and reporting to accommodate diverse regulatory expectations
- Strategize proactively address challenges posed by evolving regulations and cross-border discrepancies to ensure successful market access
12:00 pm Improving Patient Experience Data Collection in Real-World Settings to Advance the Utility of Treatments
Synopsis
- Optimizing patient-reported outcomes (PROs), surveys, and mobile health apps to gather real-time feedback on patient experiences and treatment effectiveness in realworld settings
- Strategies to improve the consistency and reliability of patient experience data through standardized questionnaires, targeted follow-ups, and integration with electronic health records (EHRs)
- Analyzing patient experience data to identify unmet needs, refine treatment protocols, and shape personalized care strategies to improve overall treatment outcomes
12:30 Lunch
1:30 pm Overlooking Effects of Cardiologists & Their Patients When Adhering to Guidelines & Implementing Them as Affectively As Possible
Synopsis
- Current issues that cardiologists are faced with and how real-world evidence can be used to tackle this issue
- Ways to improve patient outcomes
- Case-study led insights
2:00 pm Aligning with the European Health Data Space Current Initiatives to Empower Patients With Their Own Data
Synopsis
- The European Health Data Space (EHDS) in promoting patient empowerment and enabling secure access and control over personal health data.
- Aligning data collection and sharing practices with EHDS initiatives to ensure patients can seamlessly access, share, and benefit from their health data.
- Strategies to leverage EHDS frameworks for advancing research and personalized care while maintaining compliance with data privacy and security standards.
2:30 pm Bridging the Gap: From Clinical Trials to Real-World Evidence in Product Life Cycle Management
Synopsis
- Translating clinical trial data to real-world settings
- Enhancing patient outcomes with RWE
- How to capture the RWE data to strengthen the value of the data through Product Life Cycle Management