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Real World Evidence Conference

How Real World Evidence can be used for regulatory purposes

Session 7: What’s Next: Real World Evidence in the Development and Access of Novel Therapeutics

Session Chair(s)

Mark  Stewart, PhD

Mark Stewart, PhD

  • Vice President, Science Policy
  • Friends of Cancer Research, United States
James  Harnett, PharmD, MS

James Harnett, PharmD, MS

  • Executive Director, Health Economics and Outcomes Research
  • Regeneron Pharmaceuticals, Inc. , United States
This session will discuss the increasing convergence of industry, payer, and regulator interests in the use of RWD for the generation of evidence on the effectiveness of therapeutic interventions. Opportunities for use of emerging RWD sources and artificial intelligence earlier in the pipeline to identify novel targets, biomarkers, and shape/improve efficiency of clinical trials will be shared. Considerations for application of RWE for supporting confirmation of efficacy in the post-marketing setting and labelling will be discussed leveraging extensive learnings from pharmacovigilance, outcomes research, and early regulatory case studies. The growing importance of RWE for payers in informing reimbursement decisions and realizing future value-based contracting models will be reviewed. Panel members will discuss expected trends for RWD/E for the next three years across industry, payer, and regulators.
Learning Objective :
  • Identify at least 2 opportunities for use of RWD analyses in biopharmaceutical R&D organizations
  • Discuss study design and real world endpoint considerations and how to apply “cutting-edge” approaches and technologies
  • Review case studies for use of RWE in label expansion, innovative access programs and developing confirmatory evidence for products
  • Identify opportunities and challenges for leveraging RWD/E across healthcare stakeholders over the next 3 years


Jeremy A Rassen, DrSc, MS

Beyond the RCT vs RWE Dichotomy: Using RWE to Augment and Extend RCT Evidence

Jeremy A Rassen, DrSc, MS

  • Co-Founder and President
  • Aetion, United States
Mark  Stewart, PhD

rwEndpoints Use Case: Assessing Frontline Treatment Regimens in Real-World Patients with Advanced Non-Small Cell Lung Cancer

Mark Stewart, PhD

  • Vice President, Science Policy
  • Friends of Cancer Research, United States
Srihari  Gopal, MD

RWE in a US Product Label: Paliperidone Palmitate (Invega Sustenna)

Srihari Gopal, MD

  • Senior Director
  • Jansen Research & Development LLC, United States
Mark J Cziraky, PharmD

Accelerating the Development of Relevant Evidence in Healthcare

Mark J Cziraky, PharmD

  • Vice President of Research
  • Anthem HealthCore, United States

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