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Session 9: Clinical Research in a Global Pandemic: Lessons Learned for Drug Development
Session Chair(s)
Cristiana Mayer, DRSC, PHD
Head of Biostatistics, Johnson & Johnson Vision, United States
AnnCatherine M. Downing, PHARMD
Chief Operating Officer - Lilly Research Laboratories, Eli Lilly and Company, United States
Rui (Sammi) Tang
Vice President, Global Head of Biometrics, Servier Pharmaceuticals, United States
Traditional ethical principles that guide clinical research remain the guiding compass for physicians, patients, public health officials, investigators, drug developers, and the public. Accelerating the process of delivering safe and effective treatments and vaccines for areas of unmet medical need is a moral imperative. The COVID-19 pandemic has resulted in innovative new approaches in clinical research and brought vaccine and drug development into mainstream consciousness. Some of the innovations offer new insights into trial design, conduct, data sharing, and regulatory interactions that are broadly applicable. This session will highlight COVID-19 clinical research examples with an emphasis on practices that should be carried forward to speed new therapies to patients.
Learning Objective : - Outline multiple research efforts for the prevention and treatment of COVID-19
- Describe innovative approaches utilized and found most efficient driven by the COVID-19 pandemic
- Identify transferable learnings from COVID-19 research into other research programs
Speaker(s)
An Vandebosch, PHD
Senior Scientific Director, Statistical Modeling and Methodology, Janssen R&D, Belgium
The Race Towards the COVID-19 Vaccine: the Janssen Example
Kristi Huntington, MS
Sr. Advisor, Pharmaceutical Project Management, Eli Lilly and Company, United States
Developing a Neutralizing Antibody Treatment for COVID-19: Lessons Learned on the Journey from Discovery to Emergency Use Authorization
Lisa LaVange, PHD
Professor Emerita, University of North Carolina at Chapel Hill, United States
Master Protocols in a Pandemic
Steve Webb, MD, PHD
Professor of Critical Care Research, Monash University, Australia
REAMP-CAP: An Adaptive Platform Trial Simultaneously Evaluating Multiple Interventions for Severe COVID
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