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Tuesday, June 29 • 10:00am - 11:00am
#213 SL: Perspectives on Real-World Data/Evidence Collection Through Expanded Access During the Covid-19 Pandemic

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-562-L04-P; CME 1.00; IACET 1.00; RN 1.00

A panel of international experts in drug development, patient advocacy, clinical trial design, and bioethics will discuss the role of data from expanded access and its complementary relationship to clinical trial-derived evidence.

Learning Objectives

Identify policy challenges that mediate real-world data and clinical trial data collection; Assess evidence-based on real world data collected through expanded access programs; Describe successes and failures of policies based on real- world data in the Covid-19 pandemic.

Chair

Alison Bateman-House, PhD, MA, MPH

Speaker

Panelist
Claudia Hirawat

Panelist
Tom Watson

Panelist
Hayley Belli, PhD


Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, Dept of Population Health, NYU Grossman School of Medicine, United States
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Grossman School of Medicine and a Professor of Practice in Law at University of Arizona James E. Rogers College of Law. She is co-chair of the Working Group on Compassionate Use... Read More →
avatar for Claudia Hirawat

Claudia Hirawat

Executive Chair, VOZ Advisors, United States
Cláudia is the owner and Executive Chair of VOZ Advisors, which she acquired in May of 2018 after serving as a member of the board of advisors for three years and being a client for twelve years. She is also a venture partner at Nest Bio and, in very select instances, an advisor... Read More →
avatar for Tom Watson

Tom Watson

Executive Vice President, Early Access Programs, Bionical Emas, United Kingdom
For the last decade, Tom has partnered with Pharma and Biotech companies to design their strategy for Early/Expanded Access. Within this time, Tom has been involved in setting up and running over 250 EAPs in roles based in the U.S. and E.U. Tom heads up the Early/Expanded Access Programs... Read More →
avatar for Hayley Belli

Hayley Belli

Assistant Professor, New York University School of Medicine, United States

Tuesday June 29, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum |   03: Data-Data Standards, Forum