Real World Evidence Conference

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Overview

Short Courses: November 8
Conference: November 9-10

Real World Evidence (RWE) is increasingly becoming important for regulatory decision-making and beginning to touch all areas of the healthcare value chain. Historically used for post-market safety monitoring, sponsors are now beginning to use RWE to support clinical trial design and observational studies in order to generate better treatment approaches, while healthcare systems are collecting and using RWE to substantiate coverage decisions.

DIA’s Real World Evidence Conference will explore new and innovative applications of RWE, and deliver cutting-edge insights in how stakeholders are leveraging RWE to advance healthcare knowledge and decision-making.

While we work on the agenda for 2020, please view our 2019 Final Program to see the topics presented.

Who should attend?

Professionals from industry, academia, and government involved in all phases of the medical product lifecycle including:

Real World Evidence
Epidemiology
Policy
Regulatory Science
Technology development
Data analytics
Clinical Research

Learning objectives

At the completion of this forum, the participant should be able to:

Explain how RWE is being used today to inform biopharmaceutic development across product lifecycle
Describe the recent FDA strategic framework for RWD in regulatory decisions
Evaluate the future applications of RWE in drug development
Appraise how mobile technologies, AI, machine learning, and other technologies are being used to generate RWE
Evaluate how patient reported outcomes, EHR, and other patient data is expanding the resources for RWE
Discuss “lessons learned” from current uses of RWE, and how these can be applied for other future applications of RWE
Describe the most common designs using Master Protocols and their utility in solving clinical development challengess

Program Committee

Nancy A. Dreyer, PhD, MPH, FISPE • Chief Scientific Officer and Senior Vice President
IQVIA, United States
Steven A. Anderson, PhD • Director, Office of Biostatistics and Epidemiology, CBER
FDA, United States
Brian D. Bradbury, PhD, MA • Vice President, Center for Observational Research
Amgen, Inc., United States
Paul M. Coplan, MBA, FISPE • Vice President, Medical Device Epidemiology & Real-World Data Analytics
Johnson & Johnson, United States
Marni Hall, PhD, MPH • Vice President, Clinical Evidence
IQVIA, United States
James Harnett, PharmD, MS • Senior Director, Lead, Real World Data and Analytics, Patient and Health Impact
Pfizer Inc., United States
Jingyu (Julia) Luan, PhD • Regulatory Affairs Director, BioPharmaceuticals R&D, Late-stage Development, CRM
AstraZeneca, United States
David Martin, MD, MPH • Associate Director for Real World Evidence Analytics, OMP, CDER
FDA, United States
David Miller • Global Head of Real World Evidence Methods, Analytics and Safety
UCB Pharma, Inc., United States
Robert Reynolds, FISPE • Vice President, Epidemiology
GlaxoSmithKline, United States
Debra Schaumberg, MPH • Vice President, Scientific Affairs Real World Evidence
Evidera, United States
Mark Stewart, PhD • Vice President, Science Policy
Friends of Cancer Research, United States