Day Two

Thursday- February 29, 2024

Leveraging Real World Evidence for Trial Design & Overcoming Privacy Concerns

9:20 am Chair’s Opening Remarks

9:30 am Fireside Chat: Lessons Learned in Engaging the Right Stakeholders & Selecting the Most Relevant Partner for Your Needs

  • Laura Fabbri Head of Real World Evidence Department, Chiesi Farmaceutici
  • Sebastian Kloss Global Real World Evidence & Epidemiology Lead, Menarini
  • Maartje Smulders Senior Director - Global Real World Evidence, Astellas Innovation Management LLC


• Examining the criteria and considerations for selecting the most suitable partners to meet specific research and clinical trial needs

• Uncovering the next steps needed to be taken to build a life cycle strategy for a product

• Discussing ideas on how industry can help educate medical practitioners and patients on real world evidence

Moderated by: Lill-Brith von Arx, RWE Northern Europe Hub Lead, Eli Lilly

9:45 am Uncovering the Use of Real World Evidence to Elevate Drug Development


  • Exploring techniques to support robust evidence generation
  • Discussing considerations to undergo data analysis and assessments to ensure data readiness
  • Deep dive into specific RWE support of clinical development

Leveraging Real World Evidence for Trial Design & Overcoming Privacy Concerns

10:45 am Morning Break

11:45 am Tokenising Clinical Trial Subjects to Overcome Data Privacy Concerns & Support Data Linkage

  • Alexander Liede Senior Director, Head, Evidence & Partnerships, Global Epidemiology, Abbvie


  • Explore the transformative approach of tokenizing clinical trial subjects to establish secure links with de-identified real world data
  • Understanding the privacy-enhancing techniques that enable seamless data integration
  • Uncovering the potential feasibility of extending data linking methodologies from the United States to Europe

12:15 pm Lunch Break

Breakout Roundtable Sessions


This session is your opportunity to share your most pressing challenges, and work as a group to come up with solutions that you can implement right away! Each topic area will have several small groups, and each group will have 20 minutes to discuss ways to use these innovative tools in their workflows. Groups will then share their findings with all attendees in the last 10 minutes, giving you maximum exposure to new ideas.

1:15 pm Implementing computational approaches to supercharge current RWE processes


  • Discussing the challenges and opportunities of linking diverse data sources to gain a more comprehensive understanding of patient journeys, and the feasibility of achieving this integration within the European context
  • Revealing processes to link these existing databases to support product life cycle management
  • Highlighting the value of the integration of data use into a unified program that complements clinical trials and strengthens decision-making

1:15 pm Large language model (LLMs) applications in data integration


• Addressing the growing potential of this computational approach in harmonizing and unifying heterogeneous healthcare data sources

• Demonstrating how LLMs can comprehend and semantically enrich diverse datasets, enabling deeper contextual analysis and accelerating real world evidence generation 

Understanding Post-Marketing Processes Across Different Disease & Indications

1:45 pm Panel Session: Navigating the Real World Evidence Landscape & Uncovering Insights from Working Across the Post-Marketing Process

  • Helene Chevrou-Severac Senior Director - Global Health Economics Outcomes Research, Real World Evidence,Head of Outcomes Centre of Excellence, Alexion
  • Lill-Brith von Arx RWE Northern Europe Hub Lead, Eli Lilly & Co.


  • Understanding working relationships with HTA agencies and how they accept RWE in drug submissions, covering similarities and difference across different countries
  • Delving into the role of RWE in value-based agreements, and understanding its role in decision-making processes, potentially impacting reimbursement and market access strategies
  • Discussing opportunities to enhance the collaboration between biopharma companies and agencies to maximize the value of RWE in healthcare decision-making

2:30 pm Afternoon Networking & Refreshments Break

3:00 pm Spotlighting Methods to Ensure Strategic Registry Development for PostLaunch Success for Rare Disease

  • Helene Chevrou-Severac Senior Director - Global Health Economics Outcomes Research, Real World Evidence,Head of Outcomes Centre of Excellence, Alexion


  • Uncovering the role of real world evidence to support post-marketing activities including HTA submissions and expanding the regulatory label in rare diseases
  • Highlighting approaches to develop registries that cover the patient population and meet standards for HTA agencies
  • Exploring best practices for real world evidence generation to facilitate label expansion and support data-driven decision-making throughout the product’s lifecycle, ensuring its continued success in the market 

3:30 pm Applications of Implementing Real World Evidence Secondary Data Approaches for Post-Authorisation Safety Activities

  • Stefania Pirondi Head of Clinical Project Management Unit, Global Clinical Development, Chiesi Farmaceutici


• Navigating the current systems and frameworks for real world evidence along the product lifecycle

• Understanding the strategies and methodologies that make real world data a valuable asset in enhancing safety assessments

• Uncovering the benefits of cross-project collaboration with secondary data sources, ultimately improving safety-related decision-making processes

4:00 pm Chair’s Closing Remarks & End of Summit