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Tuesday, June 21 • 4:15pm - 5:15pm
#278: FDA Real-World Evidence Guidance for Regulatory Approval: Implications for Evidence Needs for Payers and Population-Based Decision Makers and Healthcare Providers

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-591-L04-P ; CME 1.00; RN 1.00

This panel will discuss and debate what is needed to ensure that real-world data (RWD) used in the generation of real-world evidence (RWE) meets the draft FDA guidance. Also, we will discuss what pharmaceutical companies are doing to incorporate these new draft guidances into RWE generation and evidence dissemination. Finally, we will wrap up the panel discussion with what future initiatives will be needed (by sponsors and broader industry groups) to meet the FDA draft guidance recommendations and what panelists anticipate will be the consequences of these new draft guidance documents on external communication of RWE to payers and HCPs.

Learning Objectives

Discuss how the recent FDA real-world evidence/real-world data guidance relates to US payers; Describe what pharmaceutical companies and real-world data providers should do to implement these new real-world evidence/real-world data requirements; Identify how to design real-world evidence studies to serve the evidence needs of regulators and payers.


Bart Barefoot, JD


Jennifer Graff, PharmD

Matthew Reynolds, PhD, FISPE

Dan Gratie, PharmD, MS

avatar for Bart Barefoot

Bart Barefoot

Senior Director, European Regulatory Policy, GlaxoSmithKline, United Kingdom
Bart Barefoot, JD, is Senior Director of European Regulatory Policy at GlaxoSmithKline. He formerly served as GSK's global head of RWE policy development and engagement, where he led the company's efforts to advance the appropriate use of RWE in health care decision-making. He served... Read More →
avatar for Jennifer Graff

Jennifer Graff

Senior Director, Professional Affairs, AMCP, United States
Jennifer Graff, PharmD, is the Senior Director, Professional Affairs at the Academy of Managed Care Pharmacy (AMCP), where she oversees and leads strategic efforts for AMCP and collaborates with members and other stakeholders to advance medication management strategies, including... Read More →

Dan Gratie

Director, Strategic Partnerships, AESARA, United States
As a consultant, Dan has partnered with industry clients to design real-world studies, improve payer-facing communication tools, and evaluate and creatively address potential evidence gaps in a variety of therapeutic areas, including oncology and other specialty products. Additionally... Read More →
avatar for Matthew Reynolds

Matthew Reynolds

Vice President, Real World Evidence, IQVIA, United States
Dr. Reynolds is a member of the Center for Advanced Evidence Generation, Real World Solutions at IQVIA. He designs innovative solutions for real world evidence on effectiveness and safety. Dr. Reynolds brings more than 20 years of diverse experience in non-interventional research... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  12: Value-Access, Forum
  • Level Intermediate
  • Featured Topics RWD-RWE
  • Level Intermediate
  • Feature Topics RWD-RWE
  • Credit Type ACPE, CME, RN
  • Tags Forum