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Tuesday, June 29 • 2:00pm - 3:00pm
#238 SL: Are External Control Arms Ready for Primetime?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-574-L04-P; CME 1.00; IACET 1.00; RN 1.00

There are increasing examples of companies submitting real-world data as part of an external control arm. This panel will discuss whether external control arms are really ready for regulatory use and what it will take to achieve broader acceptance.

Learning Objectives

Describe how and when to use control arms; Discuss the risks and benefits; Identify the FDA's willingness to accept external comparators in regulatory submissions.

Chair

Zoe Li, MBA

Speaker

Panelist
Ravinder Dhawan, PhD

Panelist
Leah Burns, MPH

Panelist
Aaron Kamauu, MD, MPH, MS


Speakers
LB

Leah Burns

Group Director, Real World Evidence Strategy, Bristol-Myers Squibb Company, United States
Leah is a Global Real World Evidence Strategic Advisor at Bristol-Myers Squibb Company. Based in Princeton, she provides strategic consult to Therapeutic Areas and in close collaboration with regional and local teams. She leads RWE initiatives focused on regulatory sciences and digital... Read More →
avatar for Ravinder Dhawan

Ravinder Dhawan

Vice President, Outcomes Research, Oncology CORE, Merck & Co., Inc., United States
- Vice President & Head of Oncology, Center of Observational & Real-World Evidence, MSD (2015-present) - Oncology TA Strategy Leader, Sanofi (2013-2015) - Senior Director and Director in various roles, Janssen/Johnson & Johnson (2003-2013) - Director, Global Health Outcomes, Pharmacia... Read More →
avatar for Aaron Kamauu

Aaron Kamauu

Managing Director, Ikaika Health LLC, United States
Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to support a variety of clinical research, informatics, clinical... Read More →
avatar for Zoe Li

Zoe Li

Director, Life Sciences, COTA, United States
As a leader in the Life Sciences group at COTA, Zoe builds partnerships with pharma and biotech companies to support and accelerate clinical development with the use of real world data. She brings expertise from the pharma, tech, and consulting industries to thoughtfully design and... Read More →

Tuesday June 29, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Forum |   09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum