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 & HEOR
Synopsis
- Providing clarity around the purpose of FMVs in research and HEOR
- What is required in an FMV assessment 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 & 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.
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 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
2:30 pm Strategies for Ensuring Data Privacy & Security While Protecting Patient Data & Enabling Valuable Research
Synopsis
- Explore techniques like data anonymization, pseudonymization, and federated learning to safeguard patient data without compromising research quality
- Understand how to align RWE studies with data protection laws such as GDPR, HIPAA, and other regional regulations
- Learn best practices for securing healthcare data, including encryption, access controls, and real-time monitoring, to foster trust and compliance