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Thursday, June 18 • 5:00pm - 6:00pm
#567 OD: ON DEMAND - Real World Use of Real World Evidence

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Component Type: Session
Level: Intermediate

Real world evidence (RWE) is playing a significant role in healthcare. RWE is utilized to help make coverage decisions, develop guidelines, and better inform treatment decisions. Regulatory bodies rely on RWE for post-marketing surveillance, assessment of effectiveness as well as to aid the regulatory decision process. The design of clinical trials is being informed by real world evidence. Further, value propositions for pharmaceutical products are being driven by evidence generated from claims and electronic medical records. This session will help the audience gain an appreciation for how RWE is being practically utilized in healthcare today, as well as the outlook for RWE use in the future.

Learning Objectives

Describe d practical applications of real world evidence (RWE) in today’s healthcare and regulatory environments; Discuss how RWE can be generated to maximize its utility


Christopher Marrone, PharmD, RPh


Framework for Evaluating Real World Data and Real World Evidence for Use in Regulatory Decisions
Nirosha Mahendraratnam Lederer, PhD, MS

Current and Future Trends in Utilization of Real World Evidence
Edmund Joseph Pezalla, MD, MPH

Innovations in Real World Evidence Generation
Imad Al-Dakkak, DMD, MPA, MPH

avatar for Christopher Marrone

Christopher Marrone

Outcomes Liaison Advisor – National Accounts, Value, Evidence and Outcomes (VEO), Eli Lilly and Company, United States
Chris received his BS in Pharmacy from Rutgers University, and his PharmD from the University of Texas at Austin. He completed a Pharmacy Practice Residency at The University of Vermont Medical Center, and a Drug Information Specialty Residency with Lilly and Purdue University. Chris... Read More →

Imad Al-Dakkak

Director, Huron Consulting Group
Imad is a clinical epidemiologist with over 14 years of experience from government, industry, and academia across multiple disease areas. His areas of expertise include research methodology, epidemiology, study designs, database analytics, and evidence-based medicine. Imad is based... Read More →
avatar for Edmund Pezalla

Edmund Pezalla

Chief Executive Officer, Enlightment Bioconsult, LLC
Dr. Pezalla is Founder and CEO of Enlightenment Bioconsult, LLC, a strategic payer consultancy advising biopharmaceutical firms on access, technology assessment, and drug evaluation in the US market. His clients include established pharmaceutical firms and emerging companies with... Read More →

Nirosha Lederer

Managing Associate, Real World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy
Dr. Lederer oversees the real world evidence portfolio at the Duke-Margolis Center for Health Policy. Immediately prior, she was a Subject Matter Expert in the Oncology Center of Excellence at FDA. Dr. Lederer has over a decade of pharmaceutical policy and health economics and outcomes... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Session |   03: Data-Data Standards, Session