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Monday, June 28 • 4:00pm - 5:00pm
#144 SL: Launching Megatrials During a Pandemic: Lessons Learned from COVID-19 Vaccine Clinical Trials

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Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

As drug development moves toward precision and targeted medicines, megatrials which include tens of thousands of participants are uncommon. But the developers of COVID-19 vaccines launched complex trials of this size in 2020, encountering not just the challenges of massive clinical trials but also those of running clinical trials during the pandemic. In this forum, senior-level executives from biopharma companies which conducted COVID-19 vaccine trials will discuss the experience of clinical operations in this context, sharing what they expected and did not expect, lessons learned, and what they will take forward to the conduct of future research.

Learning Objectives

Describe some of the unique challenges of launching extremely large clinical trials; Discuss unique and innovative practices and solutions that clinical teams developed to manage these challenges; Assess ideas for best practices that can be applied to future clinical trial conduct.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

Panelist
Melanie Ivarsson, PhD, MBA

Panelist
Dawn M Furey

Panelist
Sarah Tweedy



Speakers
avatar for Lindsay McNair

Lindsay McNair

Chief Medical Officer, WCG, United States
Lindsay McNair, MD, MPH, MS in Bioethics is the Chief Medical Officer for the WIRB-Copernicus Group (WCG). She oversees the physician team within the WCG IRB, and provides consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol design... Read More →
DF

Dawn Furey

Vice President, Portfolio Delivery Operations, Janssen, United States
Dawn Furey is a 20+ year clinical operations leader and currently VP and Head of Portfolio Delivery Operations (PDO) at Janssen, Research & Development where she leads central planning and delivery for Janssen’s active therapeutic areas (Oncology, Immunology, Neuroscience, Vaccines... Read More →
MI

Melanie Ivarsson

Chief Development Officer, Moderna, United States
avatar for Sarah Tweedy

Sarah Tweedy

Vice President, Clinical Operations Head – Vaccines, Pfizer Inc, United States


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  07: ProjMgt-StrategicPlanning, Forum |   02: ClinTrials -ClinOps, Forum