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DoubleTree Bethesdan

Sep 23, 2019 7:00 AM - Sep 24, 2019 5:00 PM

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Biosimilars Conference

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Session 2: The Pitfalls and Promises of Real World Evidence in Evolving the Biosimilar Industry

Session Chair(s)

Mark Stewart, PhD

Mark Stewart, PhD

Vice President, Science Policy

Friends of Cancer Research, United States

Anna Welch, MA

Anna Welch, MA

Chief Editor, Biosimilar Development

Life Science Connect, United States

Real world evidence has been a critical tool for reassuring stakeholders of the long-term safety and efficacy of biosimilars. But how else can RWE shape the evolving use of biologics and biosimilars? This panel will discuss the challenges of collecting and using RWE today to improve biosimilar understanding. It will also identify other areas of inquiry that can be addressed with RWE and the existing potential of RWE to evolve regulatory requirements and clinical treatment pathways.

Learning Objective : At the conclusion of this session, participants should be able to:
Evaluate current best-practices and challenges in RWE collection, analysis, and promotion
Assess evolving strategies for employing RWE in education
Discuss the impact RWE can have on pre-approval clinical data and the treatment pathway

Speaker(s)

Jaclyn Bosco, PhD, MPH, FISPE

Speaker

Jaclyn Bosco, PhD, MPH, FISPE

IQVIA, United States

Vice President, Global Head of Epidemiology & Database Studies

Nancy Lin, DrSc, MS

Speaker

Nancy Lin, DrSc, MS

Optum, United States

Senior Scientist, Epidemiology

Speakers

Edward Li, PharmD, MPH

Sandoz, United States

Associate Director, HEOR & RWE

Gianluca Trifiro, MD, PhD

Speaker

Gianluca Trifiro, MD, PhD

University of Verona, Italy

Scientific Lead, INSPIRE; Professor, Pharmacology, Diagnostics and Public Health

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