8:00 am Registration & Welcome Coffee

8:35 am Chairperson’s Opening Remarks

  • Kelly H. Zou PhD, PStat®, FASA Head Global Medical Analytics and Real World Evidence, Viatris

Where Are We Now? Exploring the Use of RWE to Support Regulatory Decision Making

8:45 am Panel Discussion: Your Industry Leaders Outline Their Innovative Uses of RWE in the Past Year

  • Alexander Cole Executive Director, Global Head Epidemiology, Alexion
  • Shrividya Iyer Executive Director, Oncology Worldwide Real World Evidence (RWE) & US HEOR, Eisai
  • Anand Chokkalingam Head of RWE Virology, Executive Director, Gilead

Synopsis

  • Industry leaders share their RWE progressions from the past 12 months and give insights on what the next 12 months has to offer for RWE

9:30 am Exploring the Use of Real World Evidence for Regulatory Purposes in a Global Perspective

  • Kelly H. Zou PhD, PStat®, FASA Head Global Medical Analytics and Real World Evidence, Viatris

Synopsis

  • Use RWE to support regulatory decisions in key jurisdictions
  • Examine various roles of RWD and RWE for medicines regulation
  • Identify patient-centric ways, such as digital endpoints, in studies

10:00 am Overview of FDA’s Real World Evidence Guidances

  • Kenneth Quinto Senior Medical Advisor for Real World Evidence Analytics, FDA

Synopsis

  • An overview of four FDA RWE draft guidances released from Sept-Dec 2021
  • Exploring topic areas for two planned FDA RWE draft guidances currently in development

10:30 am Speed Networking & Morning Coffee Break

Synopsis

Your chance to continue the discussions from the morning sessions and network to gain perspectives from across the world. This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the field and establish meaningful business relationships to pursue for the rest of the conference.

Benchmarking Global Regulatory & HDA Framework for the Use of Real World Evidence for Regulatory Submissions

11:30 am Regulatory Considerations for the Use of Real World Evidence (RWE) to Support Post-marketing & Pre-approval for Drug & Biological Products

  • Yun Lu Mathematical Statistician, Office of Biostatistics and Pharmacovigilance, FDA, CBER

Synopsis

  • Real world evidence (RWE) has been increasingly utilized to help support approval of new indication of a medical product that has been approved or to help support post-approval study requirements
  • This talk will address regulatory considerations and applications of FDA Guidelines to RWE related submissions

12:00 pm Exploring the EMA’s Data Analysis & Real World Interrogation Network (DARWIN) to Determine How it Will Support Regulatory Decision Making

  • Jesper Kjær Director of Data Analytics Centre, Danish Medicines Agency

Synopsis

  • How DARWIN EU will deliver RWE from across Europe on diseases, populations and the uses and performances of medicines.
  • Discussing how EMA and national competent authorities in the European regulatory network will use these data during the life cycle of a medicinal product
  • Exploring the plans for establishing the network, use cases and how the Big Data Steering Group is interacting with industry on real world data/evidence area

12:30 pm Panel Discussion: The Future of Medicine Powdered by Real-World Evidence

Synopsis

This session will outline the benefits of leveraging real-world evidence to accelerate discoveries and advancements with vulnerable populations is represented accurately in future innovation

1:00 pm Lunch Break & Networking

2:00 pm NICE’s RWE Framework: A Step Towards Improving Quality of RWE in Clinical Guidelines & Health Technology Appraisals

  • Páll Jónsson Programme Director, Data and RWE, National Institute for Health and Care Excellence (NICE)

Synopsis

  • Discussing the key elements required for generating trust in real world evidence
  • How fit-for-purpose real world evidence be achieved for healthcare decision making.
  • Outlining key elements of NICE’s RWE framework and the next steps for implementing this in practice

Navigating the use of Real World Evidence in the Current Regulatory Landscape to Create a Robust Framework

2:30 pm A framework for Leveraging RWE for Label and Indication Expansion: a Pharmaceutical Industry Perspective

  • Khaled Sarsour Vice President, Data Science Real World Evidence and Insights, Janssen

Synopsis

  • Evaluation framework to assess and compare between relevant sets of opportunities
  • Establishing a coherent strategy to make the case for label expansion
  • Best practices for creating a successful evidence package

3:00 pm Fireside Discussion: Exploring Parameters Needed to Maintain Patient Privacy in a Global Landscape

  • Jesper Kjær Director of Data Analytics Centre, Danish Medicines Agency
  • Shrividya Iyer Executive Director, Oncology Worldwide Real World Evidence (RWE) & US HEOR, Eisai

Synopsis

  • Discussing what steps need to be taken to ensure patient privacy and fair data collection of RWE

3:30 pm Afternoon Break & Networking

Exploring Analytical Techniques & Technologies to Drive Best RWE Insights

4:00 pm Innovative Applications of RWE to Drive Your Value Story to Regulators, Prescribers and Payers

Synopsis

  • Discover best practices in developing methodologically rigorous approaches to conducting RWE studies.
  • Learn the insights you can glean from your RWE studies
  • Discuss how best to deploy RWE to help your organization succeed across a wide range of applications

4:30 pm Designing Pre-Approval and Post-Marketing Studies in the Current Regulatory Landscape

  • Lina Titievsky RWE Industry Expert and Pharmaco- epidemiologist, Vertex Pharmaceuticals

Synopsis

  • Exploring how current regulatory guidance documents can be used effectively in the study design of non-interventional studies
  • How study design can support therapy in pre and post approval phases
  • Exploring case studies and lessons learned

5:00 pm Exploring Common Pitfalls for the Use of RWE for Regulatory Submissions and How They Have Been Tackled

  • Khaled Sarsour Vice President, Data Science Real World Evidence and Insights, Janssen

Synopsis

  • Dealing With Small Patient Cohorts Through Linkages of Data While Avoiding Data Heterogeneity
  • Appreciating How a Well-Defined Diagnostic Criteria Can Change the Course of a RWE Study

5:30 pm Chairperson’s Closing Remarks

  • Kelly H. Zou PhD, PStat®, FASA Head Global Medical Analytics and Real World Evidence, Viatris