All agenda timings below are displayed in EDT. For PDT, please download the full program here.

Day One


9:00 am Online Registration & Virtual Coffee Networking

9:55 am Chair’s Opening Remarks

Pre-Clinical Value Generation & Research

10:00 am Panel: Determining Where Value Lies in RWE

  • Maarten Beekman Respiratory Medical Director, International Region, AstraZeneca
  • Angela Dobes Vice President, IBD Plexus, Crohn’s & Colitis Foundation
  • Dan Hennessy Vice President, Medical Affairs, EMD Serono
  • Frida Schain CEO & Founder, Schain Research
  • Omar Ali Pharmacist Consultant, QIPP Adviser Payer Network


  • A thought experiment to determine where value is found in RWE from functional perspectives

Strategy & Implementation

10:45 am Interweaving RWE into the Strategic Fiber of Therapeutic Areas


• Sharing previous experience in the unique randomized trial of Merkel Cell Carcinoma using an EMR data set
• Dissecting methodologies and mistakes when integrating RWE into a trial
• Highlighting the importance that each department has towards the shared RWE trial objective

11:15 am Virtual Speed Networking

12:15 pm How to Use RWE to Better Define Trial Protocol: Syneos’s Case Studies


  • Walking you through the methods to increase evidence from a wealth of experience
  • Outlining how RWE can accelerate the time to market
  • Reflecting on the benefits of synthetic and external control arms in the seeking of conditional approval

12:45 pm RWE and Patient Advocacy – Patient Centricity


  • Development of innovative medicines where there is no current standard of care poses unique challenges
  • Outline considerations in fully understanding patient burden and translating value into patient-relevant outcomes
  • Share experiences of how patient advocacy partnerships and RWE can support access strategie

1:15 pm Lunch & Networking

2:15 pm Identifying Gaps in Current Patient Care Partnering to Accelerate Patient-Centric Real-World Evidence

  • Angela Dobes Vice President, IBD Plexus, Crohn’s & Colitis Foundation


  • Describing IBD Plexus: the largest US collaborative real-world database and biobank in the IBD field with 8 pharma members, over 80 academic and community medical centers, and over 25,000 patients
  • Detailing the identification and co-development process for high priority real world outcomes and endpoints including rare real-world patient experience data and a new PRO endpoint
  • Improving patient access to effective treatments and diagnostics by generating real-world evidence to enhance product labels and scientific communications

2:45 pm Understanding the Global RWE Regulatory Landscape

  • David Anstatt Executive Director, Center for Observational Research & Data Sciences, Bristol-Myers Squibb


  • Analyzing the differences in EU/US evidence demand from health authorities
  • Considering the different regulatory propensities
  • Strategizing how to best use reasonable data for each approach

3:15 pm Contextualising Real World Data to Ensure Real World Evidence

  • Miriam Fenton Former Director, Real World Investigator at Takeda, Syneos Health


• Where and how to get started to strategically address this project
• What are the common grounds of understanding required?
• Providing guidance on how to approach and address challenges that will be faced

3:45 pm Afternoon Break & Networking

4:15 pm RWE Pre & Post Launch Elements


  • Scrutinizing how this data is being used for discussion with payers, regulators, physicians etc. pre and post launch
  • Analyzing HTA/RWE pre and post launch
  • Using RWE to guide ICER assessments
  • Fostering cross functional collaboration (internal colleagues and partners) in RWE pre and post launch

4:45 pm Case Study: RWE Global Opportunities & Emerging Markets

  • Maarten Beekman Respiratory Medical Director, International Region, AstraZeneca


  • Developing a global RWE framework based on evidence gaps
  • Exploring ways to create and collate data in emerging markets
  • Explaining ways to present RWE data to prove value in changing clinical practice

5:15 pm Setting Standards for RWE in Comparative Effectiveness Research: Methods, Transparency & Governance

  • Dan Ollendorf Director, Value Measurement & Global Health Initiatives, Center for the Evaluation of Value and Risk in Health (CEVR)


  • Articulating robust approaches to ensure that RWE data is fit for purpose and methods are applied in a clear and interoperable manner across settings
  • Providing standards for multi-stakeholder transparency regarding study intent, design, and outcome
  • Hypothesizing possible venues for a repository of RWE studies and guidance for content, governance and maintenance

5:45 pm End of Summit & Virtual Happy Hour Begins

6:15 pm End of Virtual Happy Hour