13th RWE, MARKET ACCESS, PRICING & REIMBURSEMENT World Congress 2026 Europe
Powering Market Access Through Real-World Evidence, Digital Innovation & Value-Based Strategies
Day 1 - Thursday 3rd September 2026 - Hilton London Kensington, London, UK
RWE Integration in European HTA & Evidence Strategy
- EU HTA Regulation and Joint Clinical Assessments (JCA)
- Acceptance of RWE across member states
- Methodological challenges and credibility
- Future outlook for hybrid evidence models
Moderator:
Panelist:
- Key requirements under Joint Clinical Assessments (JCA)
- Aligning clinical development with HTA expectations
- Evidence submission timelines and coordination challenges
- Strategic implications for pan-European launches
- Current limitations of RWD: Real-world data is often fragmented across systems, inconsistent in quality, and difficult to access or harmonize across countries and institutions.
- Promise of EHDS: The European Health Data Space could improve access, interoperability, and secondary use of health data, creating a stronger foundation for research, innovation, and evidence generation.
- EHDS shortcomings: However, success will depend on practical implementation, governance clarity and data standardization.
- Why partnerships matter: No single stakeholder can solve the RWD challenge alone; collaboration between industry, regulators, academia, healthcare providers, and technology partners is essential.
- What are the ingredients of success: Can Industry create sustainable partnerships that can lead to better RWD for faster evidence generation, better patient outcomes, and shorter development times in Europe? What are the appropriate models?
Meni Styliadou, VP Health Data Partnerships, Data Science Institute, Takeda
- Introduction to Cancer Patients Europe
- When RCTs are not possible, what kind of evidence can be acceptable at regulatory and HTA level?
- Where we stand today with patients’ involvement in the EU HTA (JCA & JSC)
- What worked well and what needs to be improved
- How we are preparing for the 2028 report on the EU HTA implementation
Antonella Cardone, CEO, Cancer Patients Europe
- Identifying and mitigating selection bias
- Ensuring data completeness and consistency
- Transparency in methodologies and reporting
- Building trust with regulators and payers
Senior Representative, AstrazenecaÂ
- Opportunities from EU data-sharing initiatives
- Accessing cross-border datasets
- Data interoperability challenges
- Governance and compliance considerations
- Why RWE matters in rare disease decision-making?
- What makes RWE credible, usable, and relevant for regulators, HTA bodies, and the NHS?
- How can NICE dynamic advice improve your RWE submission?
- Key lessons from working across policy, evidence generation, and stakeholder engagement.
Sheela Upadhyaya, Board Trustee, Medics for Rare Disease, Founder, Rarely Ordinary
Pricing & Market Access Strategies in a Constrained European Landscape
- Rare disease is not a niche, but one of the largest structurally underserved populations in medicine.
- Many rare disease programs do not fail because the science is wrong; they fail because the funding architecture collapses before the science can mature.
- Traditional grant funding and venture capital are often poorly matched to rare disease timelines, small populations, regulatory uncertainty, and access complexity.
- New funding architectures are needed, including venture philanthropy, public-private partnerships, blended finance, advanced market commitments, patient-driven funding networks, and outcome- linked financing.
- Real-world-evidsence, regulatory alignment, transparent impact metrics, and AI-enabled portfolio management can help de-risk programs earlier and attract more durable capital.
- The ultimate goal is a triple win: faster therapies for patients, more investable assets for partners, and a more sustainable rare disease innovation ecosystem.
James Levine, President, Ipsen Foundation
- Review use of RWD to guide pipeline and portfolio strategy
- Considerations when using RWD to inform internal decisions
- The growing use of data tokenization and advanced analytical techniques based on artificial intelligence in RWE
- The importance of data quality and methodological transparency in RWE.
- How to use patient-level external controls in a comparative efficacy analysis
- Explore the evaluation and selection of index dates for RW subjects
- Discuss the impacts and potential biases of common index date selection methods
- Tips for considering which indexing method to use in studies that use external controls
- Macro-economic pressures on healthcare budgets
- Policy reforms affecting pricing decisions
- Increasing scrutiny on high-cost therapies
- Strategic pricing adaptations
John Purdy, Global Access- Population Health Strategy Lead. Roche
- Structuring value narratives effectively
- Integrating clinical, economic, and patient outcomes
- Tailoring dossiers for different markets
- Common mistakes in value communication
- External reference pricing and cross-border impact
- National vs EU-level pricing tensions
- Balancing access, affordability, and innovation
- Increasing payer influence
Moderator:
Funmi Oluwa, Head, Market Access & External Engagement, UK/Ireland, UCB
Panellist:
Pedro Borga, Director, Regional Market Access and Pricing, Amicus Therapeutics
Robert Fairless, Vice President, Law and Compliance International, Incyte